Wholesale Food Warehouse Risk Control Plan Workbook
Wholesale Food Warehouse Risk Control Plan Workbook
Wholesale Food Warehouse Risk Control Plan Workbook
County of San Diego Department of Environmental Health Food & Housing Division P.O. Box 129261 San Diego, CA 92112-9261 (619) 338-2379 (619) 338-2245 fax www.sdcdeh.org
San Diego County Department of Environmental Health Food and Housing Division
The San Diego County Department of Environmental Health Food and Housing Division seeks to enhance the quality of life by promoting public health and safety for the residents and visitors to San Diego County. Our commitment is embedded in our goals and objectives and includes providing the greatest opportunity for reducing health disparities community wide. One of the Food and Housing Divisions main goals is to reduce the number of foodborne illnesses in San Diego County. We plan on working toward this goal by focusing our efforts on risk factors that can lead to foodborne illness in food facilities and by working to improve food employee behaviors and food preparation practices that directly relate to foodborne illness in food establishments. This guidance document* is designed to provide Wholesale Food Warehouse Operators with information on how to develop and implement a risk control plan. A risk control plan helps to identify and mitigate food safety and security risks. It also helps to prepare wholesale food warehouse operators to quickly and efficiently respond to recalls. In general, a risk control plan includes procedures for addressing the following areas: 1. Temperature Control 2. Approved Food Sources 3. Food Storage 4. Receiving, Transportation, and Delivery 5. Food Security 6. Food Recalls 7. Traceback/Traceforward Procedures 8. Employee Practices 9. Sanitation 10. Pest/Vermin Control 11. Self-Inspection/Verification 12. Recordkeeping Wholesale food warehouse operators are encouraged to use the general recommendations in this guidance to tailor food safety practices appropriate to their particular operations.
*Please note that this document is intended to be a guideline and may not be all-inclusive for every situation.
Verifying Approved Sources Worksheet Food Storage Procedures Worksheet Receiving, Transportation, & Delivery Procedures Worksheet
A. Sample Receiving Log B. Sample Shipping Log
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VIII. IX. X. XI.
Traceback/Traceforward Procedures Worksheet Employee Practices Procedures Worksheet Sanitation Operating Procedures (SOPs) Worksheet Pest/Vermin Control Procedures Worksheet Self-Inspection/Verification Procedures Worksheet
A. Sample Self-Inspection Form
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Temperature Control Procedures are intended to ensure that perishable/potentially hazardous foods (PHF) are held at proper temperatures to maintain quality and safety. Temperature control logs, or equivalent methods, need to be kept for the following: a. Each refrigeration/cooler unit: Record temperatures at the beginning of each day and every four hours while open for business (see sample temperature control log). A continuous read system with alarm capacity is recommended for refrigeration/cooler units and can be used in lieu of temperature control logs. In this case, a manual check should be made at the beginning of each shift to verify the system is working. b. Receiving temperatures of PHF: Record temperature PHF received with each shipment. Have a receiving log, note temperature on the invoice/shipping document (see sample receiving log), or other suitable method. c. Temperature of transportation vehicles used to transport PHF: Record temperature inside pre-cooled truck (prior to loading) on a log or on the invoice/shipping document (see sample temperature control log), or other suitable method. d. Temperature of PHF at the time of delivery at the retail food facility or other distribution center: Record temperature of PHF delivered. Record on a shipping log or on the invoice/shipping document (see sample shipping log).
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Calibration Logs
Procedures for calibrating temperature-recording devices are important to ensure accuracy. The manufacturers instructions should be followed. Temperature measuring devices should be accurate to plus or minus two degrees Fahrenheit. Devices such as metal probe thermometers should be calibrated at least once per week or replaced by a newly calibrated thermometer. A calibration log must be kept on file (see thermometer calibration procedures and sample calibration log). It is important to note that a probe thermometer must be replaced with a newly calibrated thermometer any time it is dropped, shaken, or otherwise had its accuracy compromised.
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Written Procedures
a. Person/position that will record temperatures:_______________________________ b. Person/position that will conduct calibration: ________________________________ c. What foods (or truck refrigerated compartments) will temperatures be recorded:___ ______________________________________________________________________ ______________________________________________________________________ d. When will temperatures be recorded:______________________________________
e. How will temperatures be logged:_______________________________________ ______________________________________________________________________ f. What temperature recording devices will be calibrated or verified in- house and which, if any, will need calibration by the manufacturer or authorized service representative:_______________________________________________________
g. When will each temperature recording device be calibrated:____________________ ______________________________________________________________________ ______________________________________________________________________ h. How will in-house temperature recording devices be calibrated:_________________
i. Where will temperature and calibration logs be kept:__________________________ ______________________________________________________________________ j. What is your procedure for sanitizing thermometers (i.e., alcohol wipes):__________
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Thermometer Calibration
Food temperature measuring devices must be calibrated in accordance with the manufacturers specifications as often as necessary to ensure their accuracy. Additionally, a record log should be kept of your thermometer calibrations. A sample log is attached. If a thermometer does not have specific instructions for calibration, the following methods may be used. I.
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a) b r a t i o
C. Sensing Area (It is recommended that thermometers be calibrated or replaced with a new thermometer weekly) 3
Thermometer ID#
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Calibration Method
Ice Point method
Comments
Initials
J.G.
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Written Procedures
Written procedures should include (at a minimum): a. Who will verify approved sources:________________________________________ b. What records will be kept as evidence of approved sources:___________________
d. When and how often will you ask for verification of approved source from your
suppliers:_______________________________________________________
Notes
k. Cleaning and organizing food storage areas. l. Maintaining proper food storage temperatures.
m. Maintaining an unobstructed, clearly delineated, space that is 12 to 18 inches between both interior and exterior walls and stored items. n. Storing food off the floor and easily movable by pallet jacks, forklifts or other similar devices.
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The items listed above should be included in the facilitys monthly self-inspection procedure (see sample self-inspection procedure worksheet). The written procedures developed for the food warehouse should include (at a minimum):
a. Who is responsible for ensuring compliance with food storage procedures:_______ ______________________________________________________________________ b. What procedures will you implement to ensure compliance with each of the items listed above:
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
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Records
How will you document, and where will you store the following records: a. Monthly self-inspection report:__________________________________________ b. Disposition of salvaged, expired, damaged, or contaminated foods:_____________ _____________________________________________________________________
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___________________________________________________________________ How will corrective actions be documented:________________________________ ___________________________________________________________________ e. Reconciling amount of product received with that ordered. How will you reconcile amount received with amount ordered:__________________ ___________________________________________________________________ f. Notifying law enforcement and public health if evidence of tampering is found. When will staff need to notify law enforcement and public health:________________ ___________________________________________________________________ II.
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Do you distribute Gulf oysters during April October? If so, do your procedures include distributing treated Gulf oysters:___________________________________ ___________________________________________________________________ d. Ensuring transport vehicle compartments are clean, sealed, and secured. What are your procedures for ensuring food compartments are clean, sealed, and secured:____________________________________________________________ ___________________________________________________________________ ___________________________________________________________________ e. Documenting temperature of PHF prior to loading. What are your procedures for documenting temperatures of PHF prior to loading:___ ___________________________________________________________________
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Written procedures must include (at a minimum): a. Never conducting unattended deliveries (ensure delivery is accepted by receiving facility personnel). What are your procedures for ensuring deliveries are not unattended:___________ ___________________________________________________________________ b. Handling items removed from cases. If company policy permits the break down of cases for food delivery or sale, what procedures will you implement to trace items removed from cases and delivered to various facilities:____________________________________________________ __________________________________________________________________ c. Unloading foods with frozen first, refrigerated second, and dry goods last is a good practice. Transporting and delivering produce must also be conducted with care so it is not damaged. What are your loading and delivery procedures:_____________________________
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___________________________________________________________________ d. Documenting temperature of PHF (and if frozen food is frozen) at time of delivery (log or note on invoice/shipping document). Who will check temperature of PHF at time of delivery at the retail food facility, or other food warehouse, and how will that be documented:____________________ ___________________________________________________________________ e. Proper handling of returned foods to ensure food safety. What are your procedures for handling returned food items:____________________ ___________________________________________________________________
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a. b. c. d.
Records:
Temperature of PHF and condition of food received and delivered. Temperature of pre-cooled refrigerated truck compartments used to transport PHF Invoices/shipping documents Corrective actions (i.e. rejecting food because contaminated or not at a safe food temperature)
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Food security, as well as food safety, is of concern. Food facilities must be conscious of taking proper precautions to ensure food is not intentionally tampered with. For the protection of the food facility and its customers, written food security procedures must include (at a minimum): a. Assigning someone in charge of security. Who is responsible for security:__________________________________________ b. Checking in and identifying visitors and employees. How will you check in and identify visitors:_________________________________ ___________________________________________________________________ How will you identify employees:_________________________________________ ___________________________________________________________________ c. Limiting access to food areas How will you restrict access (and ensure proper supervision) to food storage areas:_ ___________________________________________________________________ d. Securing doors and windows How will doors and windows be secured:___________________________________ ___________________________________________________________________ e. Fencing around perimeter if appropriate (and if approved by zoning or other ordinances) Should fencing/walls be installed/maintained around the perimeter of your facility:_____________________________________________________________ ___________________________________________________________________ f. Reporting unusual activity to manager/security (train employees to be aware and report suspicious activity).
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What are your procedures for reporting unusual or suspicious activity:____________ ___________________________________________________________________ g. Securing and testing backflow prevention devices (if you have testable devices). If applicable, how often will backflow prevention devices be tested and where will you keep the testing records:_______________________________________________________ ___________________________________________________________________ If applicable, how are your backflow prevention devices secured:________________ ___________________________________________________________________ h. Securing and storing ice machines inside the food facility Where will you locate your ice machine and how will you secure it:______________ ___________________________________________________________________ i. Conducting background checks for new hires How will you conduct background checks for new hires:_______________________ ___________________________________________________________________ j. Creating and training employees on emergency evacuation procedures (include a map and meeting location to account for all employees). Who is your emergency contact person and the 24-hour number where they can be reached (where will you post that number?):________________________________ ___________________________________________________________________ k. Providing adequate lighting around the outside of building. Is there adequate lighting on the outside of your building:______________________ l. Locking trailers unless loading or unloading (never leave filled containers unsupervised). Who is responsible for loading and unloading trailers(are they kept locked when not loading):____________________________________________________________
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___________________________________________________________________ m. Restricting access to computer systems (if applicable). How will you restrict access to computer systems:___________________________ ___________________________________________________________________
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Guidance for Food Safety and Security for Wholesale Food Warehouses
The following guidance document was extracted from the United States Food and Drug Administration website: January 9, 2002 Guidance for Industry Food Producers, Processors, Transporters, and Retailers: Food Security Preventive Measures Guidance This guidance represents the Agency's current thinking on appropriate measures that can be taken by food establishments to minimize the risk of food being subjected to tampering or criminal or terrorist actions. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance is being issued in accordance with FDA's Good Guidance Practices regulation (21 CFR 10.115; 65 FR 56468; September 19, 2000). This guidance is designed as an aid to operators of food establishments (i.e. firms that produce, process, store, repack, re-label, distribute, or transport food or food ingredients or that prepare or distribute food at retail). It identifies preventive measures that they can take to minimize the risk that food under their control will be subject to tampering or criminal or terrorist actions. It is relevant to all sectors of the food system (i.e., from farm-to-table), including farms, aquaculture facilities, fishing vessels, producers, transportation operations, processing facilities, packing facilities, warehouses, and retail and food-service establishments. Operators of food establishments are encouraged to review their current procedures and controls in light of the potential for tampering or criminal or terrorist actions and make appropriate improvements. This guidance is designed to focus operators sequentially on each segment of the farm-to-table system that is within their control, to minimize the risk of tampering or criminal or terrorist action at each segment. Implementing enhanced preventive measures requires the commitment of management and employees to be successful and, therefore, both should participate in their development and review. This guidance is divided into seven sections that relate to individual components of a food establishment operation: management of food security; physical security; employees; computer systems; raw materials and packaging; operations; and finished products. It also covers security strategies and evaluation of the security system. Not all of the guidance contained in this document is appropriate or practical for every food establishment. Operators should review the guidance in each section that relates to a component of their operation, and assess which preventive measures are suitable for their operation. A process called Operational Risk Management (ORM) may also help operators prioritize the preventive measures that are most likely to have the greatest impact on reducing the risk of tampering or criminal or terrorist actions against food under their control (See: Food Safety and Security: Operational Risk Management
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Systems Approach, November 26, 2001; www.cfsan.fda.gov). Food Establishment Operations. MANAGEMENT OF FOOD SECURITY Food establishment operators should consider: Security procedures assigning responsibility for security to qualified individual(s) encouraging all staff to be alert to any signs of tampering with product or equipment, other unusual situations. or areas that may be vulnerable to tampering, and alerting identified management !!bout any findings (e.g.. providing training, instituting a system of rewards. building into job performance standards)
Investigation of suspicious activity immediately investigating all information about suspicious activity alerting local law enforcement about all suspected criminal activity Supervision providing an appropriate level of supervision to all employees, including cleaning and maintenance staff. contract workers, data entry and computer support staff. And especially new employees conducting daily security checks of the premises for signs of tampering with product or equipment. other unusual situations, or areas that may be vulnerable to tampering Mail/packages implementing procedures to ensure the security of incoming mail and packages (e.g.. securing mailroom. visual or x-ray mail package screening) Physical facility Food establishment operators should consider: Visitors inspecting incoming and outgoing vehicles for suspicious. inappropriate or unusual items or activity restricting entry to the establishment (e.g.. checking in and out at security or reception. requiring proof of identity, issuing visitors badges -collected upon departure) ensuring that there is a valid reason for the visit before providing access to the facility -beware of unsolicited visitors restricting access to food handling and storage areas (e.g., accompanying visitors, unless they are otherwise specifically authorized) restricting access to locker rooms applying the above procedures to everyone, including contractors, supplier representatives, truck drivers, customers, couriers, third-party auditors, regulators, reporters, visitors, etc.
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Physical security protecting perimeter access with fencing or other appropriate deterrent .securing doors (including freight loading doors), windows, roof openings/hatches, vent openings, trailer bodies, tanker trucks, railcars, and bulk storage tanks for liquids, solids, and compressed gases, to the extent possible (e.g., using locks, "jimmy plates," seals, alarms, intrusion detection sensors, guards, monitored video surveillance [remember to consult any relevant federal, state or local fire or occupational safety codes before making any changes]) using metal or metal-clad doors to the extent possible, especially when the facility is not in operation (remember to consult any relevant federal, state or local fire or occupational safety codes before making any changes) minimizing the number of entrances to restricted areas (remember to consult any relevant federal, state or local fire or occupational safety codes before making any changes) accounting for all keys to establishment using security patrols (uniformed and/or plain-clothed) and video surveillance, where appropriate minimizing places that could be used to hide temporarily intentional contaminants (e.g., minimizing nooks and crannies providing adequate interior and exterior lighting, including emergency lighting implementing a system of controlling vehicles authorized to park on the premises (e.g., using placards, decals, key cards, cipher locks) Laboratory safety restricting access to the laboratory (e.g., using key cards or cipher locks [remember to consult any relevant federal, state or local fire or occupational safety codes before making any changes) restricting laboratory materials to the laboratory, except as needed for sampling or other appropriate activities restricting access (e.g., using locks, seals, alarms, key cards, cipher locks) to sensitive materials (e.g., reagents and bacterial, drug, and toxin positive controls) assigning responsibility for integrity of positive controls to a qualified individual keeping track of reagents and positive controls .investigating missing reagents or positive controls or other irregularities outside a pre- determined normal range of variability immediately, and alerting local law enforcement about unresolved problems, when appropriate Storage and use of hazardous chemicals (e.g., cleaning and sanitizing agents, pesticides, processing aids) changing combinations and/or collecting the retired key card when an employee is terminated, either voluntarily or involuntarily, and additionally as needed to maintain security reassessing levels of access for all employees periodically
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Personal items restricting personal items allowed in establishment preventing workers from bringing personal items (e.g., lunch containers, purses) into food handling areas establishing policy and providing for regular inspection of contents of employee lockers (e.g., provide metal mesh lockers, company-issued locks), bags, and vehicles when on company property
Training in food security procedures providing food security training to all new employees, including information on how to prevent, detect, and respond to tampering or criminal or terrorist activity providing periodic reminders of the importance of security procedures ensuring employee buy-in (e.g., involving employees in food security planning, demonstrating the importance of security procedures to the employees themselves) Unusual behavior watching for unusual behavior by new employees or workers (e.g., workers who 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)
Computer systems Food establishment operators should consider: Access restricting access to computer process control systems and critical data systems to those with appropriate clearance (e.g., using passwords, firewalls) eliminating computer access to past employees immediately upon voluntary or involuntary termination establishing a system of traceability of computer transactions reviewing the adequacy of procedures for backing up critical computer-based data systems validating the computer security system
Raw materials and packaging Food establishment operators should consider: Suppliers using only known, appropriately licensed or permitted (where applicable) sources for all ingredients, compressed gas, packaging, and labels taking steps to ensure that suppliers and transporters practice appropriate food security measures (e.g., auditing for compliance with food security measures that are contained in purchase and shipping contracts or letters of credit)
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authenticating labeling and packaging configuration in advance of receipt of shipment inspecting incoming ingredients, compressed gas, packaging, labels, and product returns for signs of tampering (e.g., abnormal powders, liquids, or odors) or counterfeiting (inappropriate product identity, labeling, product lot coding or specifications), where appropriate evaluating the utility of testing incoming ingredients, compressed gas, packaging, labels, and product returns for detecting tampering or criminal or terrorist activity requesting locked and sealed vehicles/containers/railcars, obtaining the seal number from the supplier, and verifying upon receipt- make arrangements to maintain the chain of custody when a seal is broken for inspection by a governmental agency establishing quarantine and release procedures reconciling the amount received with the amount ordered and the amount listed on the invoice and shipping documents, taking into account any sampling performed prior to receipt supervising off-loading of incoming ingredients, compressed gas, packaging, labels, and product returns alerting local law enforcement about evidence of tampering or counterfeiting keeping track of ingredients, compressed gas, packaging, labels, salvage products, rework products, and product returns investigating missing or extra stock or other irregularities outside a pre-determined normal range of variability and reporting unresolved problems to local law enforcement, when appropriate destroying outdated or discarded product labels
Operations Food establishment operators should consider: Security of water securing water wells, hydrants, storage and handling facilities ensuring that water systems and trucks are equipped with backflow prevention testing for potability regularly, as well as randomly, and being alert to changes in the profile of the results chlorinating water systems and monitoring chlorination equipment maintaining contact with the public water provider to be alerted to problems identifying alternate sources of potable water (e.g., trucking from an approved source, treating on-site or maintaining on-site storage)
Security of plant air securing access to air intake points for the facility, to the extent possible (e.g., using fences, sensors, guards, video surveillance) examining air intake points for physical integrity routinely
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Finished Products Food establishments should consider: Security of finished products keeping track of finished products investigating missing or extra stock or other irregularities outside a predetermined normal range of variation and alerting local law enforcement about unresolved problems, when appropriate ensuring that public storage warehousing and shipping (vehicles and vessels) practice appropriate security measures (e.g., auditing for compliance with food security measures that are contained in contracts or letters of guarantee) performing random inspection of storage facilities, vehicles, and vessels requesting locked and sealed vehicles/containers/railcars and providing the seal number to the consignee (remember to consult any relevant federal, state or local fire or occupational safety codes before making any changes) advising sales staff to be on the lookout for counterfeit products during visits to customers and alerting management if any problems are detected evaluating the utility of finished product testing for detecting tampering or criminal or terrorist activity monitoring closely the serving of foods in open display areas (e.g. salad bars, open bulk containers)
Security Strategies Food establishment operators should consider: Response to tampering or criminal or terrorist event having a strategy for triaging the event planning for emergency evacuation, including preventing security breaches during evacuation identifying critical decision-makers identifying management that employees should alert about potential security problems identifying 24-hour contact information for local, state, and federal police/fire/rescue/government agencies identifying a media spokesperson having generic press statements and background information
Recall strategy identifying the person responsible, and a back-up providing for proper disposition of recalled product identifying customer contacts, addresses and phone numbers
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Additional steps maintaining any floor or flow plan in a secure, off-site location making employees aware of internal, fire, and police emergency phone numbers becoming familiar with the emergency response system and the Emergency Command Center operations in the state in which the facility is located making employees aware of the company officials to alert about potential security problems, and where they can be reached
Evaluation: Food establishment operators should consider: Evaluation program evaluating the lessons learned from past tampering or terrorist events annually reviewing and testing the effectiveness of strategies (e.g., conducting mock criminal, terrorist or tampering event and mock recall, challenging computer security system) and revising accordingly -using third party or in-house security expert performing routine and random food security inspections of facility (including receiving and warehousing areas and intrusion detection system) -using third party or in-house security expert verifying that security contractors are doing an adequate job
Emergency Point of Contact: Local law enforcement San Diego County Department of Environmental Health (619) 338-2356 U.S. Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 If a food establishment operator suspects that any of his/her products that are regulated by the FDA have been subject to tampering or criminal or terrorist action, he/she should 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. The operator should also notify local law enforcement. Field Instructions for "Food Producers, Processors, Transporters and Retailers: Food Security Preventive Measures Guidance" and "Importers and Filers: Food Security Preventive Measures Guidance" June 2002 Food Safety and Terrorism Foods Home FDA Home Search/Subject Index Disclaimers & Privacy Policy I Accessibility/Help Hypertext updated by cjrn/dms 2002-JUL-03
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SCOPE
The following guidelines are intended to assist food warehouse owners and managers in preparing a recall plan. A recall plan is a written collection of documents, or sub plans (placing them in a binder or folder is recommended), that together answer the following questions if you have to recall a food product: 1. 2. 3. 4. 5. What are the products sold to you that are part of the recall? Who did you distribute the recalled product to? How will you give notice of your recall? What procedure will you follow in recalling your food products? What procedure will you use for identifying, collecting, warehousing, and controlling recalled products? 6. How will you determine your recalls effectiveness?
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A. Assemble documents or ensure availability of information that you will need to be included in the Recall Plan: 1. Product inventory (product name, item/code/lot number, quantity, expire/use-by dates, location in warehouse) with suppliers' names, addresses, telephone numbers, fax numbers. 2. Customer information including names, addresses, telephone numbers, and fax numbers. 3. Distribution information (what products, quantities, customer, date of delivery) B. Identify individuals in the company that will be responsible for carrying out food recall actions. Include contact information for each individual, including after hours phone numbers. C. Develop a procedure for identifying (see Section IV. Model Recall Worksheet and Procedures), collecting, warehousing, and controlling suspect products.
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IV.
A. RECALL INFORMATION WORKSHEET. The following information should be collected when a supplier or agency notifies you of a recall: 1. Type of recall: _____Class I (removal of products that present a threat to consumer health or safety) _____Class II (removal of products that pose a potential threat to health or safety or legal violation) _____Class III (health hazard remote or non-existent) 2. Other food withdrawal action: _____Market withdrawal _____Stock recovery _____Product hold 3. Product Involved (product name/description, item/code/lot number, size, use-by date, etc.): _____________________________________________________ 4. Estimated amount on the market ______________________________________________________________ 5. Name, address, phone, and contact information of manufacturer, re-packer, or distributor ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ 6. Who is the recalling firm ________________________________________________________________ ________________________________________________________________
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________________________________________________________________ 7. Reason for and scope of recall (or other action) ________________________________________________________________ ________________________________________________________________ 8. Injuries or deaths attributed to recall (if applicable) ________________________________________________________________ ________________________________________________________________ 9. How firm/agency learned about the problem (attach copies of notifications and phone notes) ________________________________________________________________ ________________________________________________________________ 10. Action to be taken by your facility (disposal or return of product) ________________________________________________________________ ________________________________________________________________ 11. Who should consumers contact to find out more about the recall. ________________________________________________________________ ________________________________________________________________ B. MODEL PROCEDURE TO IMPLEMENT RECALL 1. Company employees with recall assignments will meet to discuss recall information listed on above Recall Information Worksheet. Review Recall Plan and implementation. Discuss documentation of implementation of recall. 2. Conduct search of existing inventory for recalled product, and if located, place product in specially designated recall area with sign stating, " HOLD - DO NOT SHIP" 3. Notify customers that they received recalled product with information from Recall Worksheet by telephone, fax, and certified mail. Provide information on return policy and procedure. Confirm recall plan and storage procedure with employees responsible for receipt of returned product (products involved in class I recalls require notification to customers within 24 hours).
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4. Notify recalling firm of details of recalled product being held. Get information on procedures for return or disposal of held product. 5. Monitor progress of recall by contacting supplier and or local, state or federal agency involved. 6. Collect and retain documentation and information on implementation of recall. 7. After the recall is completed, review the implementation of the recall to identify lessons learned. This information will help identify weaknesses in your recall procedures that can be strengthened in order to improve the recall process next time one is issued. Please note that this is intended to be a guideline and may not be all- inclusive for every situation. In the case of reported illness or death, contact the San Diego County Department of Environmental Health at (619) 338-2356. For other recall assistance, please call (619) 338-2379 or e-mail [email protected]
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Field inspectors and compliance officers, in the course of their routine duties, gather information and make observations that may lead to the discovery of unsafe or improperly labeled foods. Agencies may learn of unsafe food from consumer complaints, epidemiological data submitted by state or local public health departments, other agencies.
As soon as an agency learns that a possibly unsafe or mislabeled food is in commerce, it conducts a preliminary investigation to determine whether a recall of the food is necessary. The preliminary investigation may include some or all of the following steps: Collecting and verifying information about the suspected food; Documenting a chronology of events; Contacting the manufacturer of the food for more information; Discussions with field inspection and compliance personnel; Interviewing a consumer who allegedly became ill or injured from eating the food; Collecting and analyzing food samples; and Contacting state and local health departments.
What is the role of the USDA and the FDA? During a food recall, the public health is protected by ensuring that potentially hazardous foods are removed from commerce as quickly as possible. The primary role of regulatory agencies is to closely monitor the effectiveness of the firm's recall procedures and to provide scientific and technical advice. What are the various types of recalls? Class I -A Class I recall involves a health hazard situation where there is a reasonable probability that eating the food will cause health problems or death. Meat that is contaminated with pathogenic bacteria, such as Listeria monocytogenes in a ready-toeat product or Escherichia coli 0157:H7 in raw ground beef, would be subject to a Class I recall. Also, adding Class I allergens, such as peanuts or eggs, as an ingredient in processed meat without listing them on the label would justify a Class I recall. Class II -A Class II recall involves a potential health hazard situation where there is a remote probability of adverse health consequences from eating the food. An example of a Class II recall would be the presence of dry milk, a Class II allergen, as an ingredient in sausage without mention of the dry milk on the label. Class III -A Class III recall involves a situation when eating the food will not cause adverse health consequences. An example would be improperly labeled processed meat in which added water is not listed on the label as required by Federal regulations. In addition to determining the class of the recall, the appropriate agency verifies that the company has identified production and distribution information to facilitate the recall.
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What are other food withdrawal actions? Other food withdrawal actions can include stock recovery, market withdrawal, or product hold. These actions may be initiated by a manufacturer or supplier to address quality control or other issues not likely to impact the publics health. How does the USDA and the FDA ensure that products subject to the recall are returned? Field enforcement personnel conduct "effectiveness checks" to ensure that the firm makes all reasonable efforts to retrieve the recalled meat or poultry .A sufficient number of effectiveness checks are made to verify that the recall is conducted in an effective manner, and that the firm locating, retrieving, controlling, and disposing of the food is acting according to regulatory requirements. After the agency has determined that the recalling firm has made all reasonable efforts to retrieve and appropriately dispose of the recalled food, the firm is officially notified by letter that the recall is completed and no further action is expected. Does USDA keep documentation on recalls? The Recall Management Division maintains comprehensive case files for all recalls coordinated by FSIS (USDA). Where can consumers find information on recalls of food products? For additional information on recalls of meat and poultry products, consumers may contact the following: .Open Federal Cases area of the Web site USDA Meat and Poultry Hotline 1-800-535-4555 Email: [email protected] For information on recalls of all other foods, please contact FDA's Center for Food Safety and Applied Nutrition's Outreach and Information Center at 1-888-SAFE FOOD (1-888-723-3366). Additional information is also available on the Web site: www.foodsafety.gov .
Where can the public find other information on the recall process? For additional Information on the recall process, consumers may want to read the following documents available through FSIS: Recall of Meat and Poultry Products, FSIS Directive 8080.1,Rev.3(Jan 19,2000)PDF Product Recall Guidelines for Firms, FSIS Directive 8080.1, Rev. 3, Amendment 2 (Jan 19,2000). I PDF .Improving Recalls at the Food Safety and Inspection Service, Report of the Recall Policy Working Group (Aug 1998). PDF A Review of Recall Policies at the Food Safety and Inspection Service, The Product Recall Research Group, Directed by Dirk C. Gibson, Ph.D. (Jun 1, 2000). Evaluation Report -FSIS Recall Notification and Industry Guidance, Evaluation and Analysis Division, OPPDE (Sep 2000, PDF Only)
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b. What system do you have in place to trace food items distributed to the retailer or other wholesale facility:___________________________________________ ________________________________________________________________ ________________________________________________________________ c. How will you maintain records:_______________________________________ ________________________________________________________________ d. Does this system fit into your recall procedures plan:______________________
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Food worker knowledge is the foundation to instituting good practices for your facilitys operation. All people who work with food in your facility should have a good working knowledge of basic food safety and hygiene principles. Depending on the situation, formal presentations, one-on-one instruction, or demonstrations (proper hand washing demonstration) may be appropriate. Written procedures should include (at a minimum): a. Conducting food worker food safety training within 10 days of hire (training materials can include Level One wholesale training or equivalent). How and when will you conduct food worker food safety training:____________ _______________________________________________________________ _______________________________________________________________ b. Conducting a food safety test (70% is passing grade) at least once every three years. Who will conduct the training and how will you administer the test issued by the County:_________________________________________________________ _______________________________________________________________ c. Renewing training once each year. When will you conduct refresher training (a certain month, at employee evaluation, etc.):__________________________________________________ _______________________________________________________________ d. Keeping an employee training log. Where will you keep employee training records:__________________________ ________________________________________________________________
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II.
Written Employee Health & Hygiene Procedures should include (at a minimum): a. Providing hand-washing signs at hand wash sinks. Where will you post hand-washing signs:________________________________ b. Teaching employees how and when to wash hands. When and how will you teach employees to wash their hands:_______________ ________________________________________________________________ c. Ensuring employees wear clean clothes and have employee lockers or other personal storage areas. Where will employees store their personal belongings:_____________________ ________________________________________________________________ d. Having procedures for managing sick employees What is your policy for managing sick employees (i.e. reassigning sick employees who handle unpackaged food, etc):___________________________ ________________________________________________________________ e. Providing gloves/band aids for employees with cuts or lesions. What is your policy for managing employees with cuts or lesions on their hands:__________________________________________________________ ________________________________________________________________ f. Providing a clean, separate employee break/lunch area. Where is your employee lunch/break area located:________________________ ________________________________________________________________ Who is responsible for cleaning the employee lunch/break area and when will cleaning be conducted:_____________________________________________ ________________________________________________________________ g. Having a policy of no smoking, eating, or drinking in food areas. 43
What is your policy regarding smoking, eating, or drinking in food areas (it is ok to drink from an enclosed drink container in food areas): ________________________ ___________________________________________________________________
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Notes
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The warehouse facilities must be kept clean and in good repair. Effective cleaning must also be conducted in a manner that does not result in contamination of foods or food related equipment or utensils. Your SOPs should include (at a minimum): a. A daily cleaning/maintenance log for toilet rooms (clean, maintained, stocked). b. Water sample results if water is from a well (particularly if ice is made at the facility). Water sampling should take place in accordance with applicable laws, but should be conducted at least twice per year. c. A master cleaning and maintenance schedule and procedures.
II.
Written Procedures
Written procedures should include (at a minimum): a. A daily cleaning/maintenance log for toilet rooms (clean, maintained, and stocked). Who will clean and stock toilet rooms daily?___________________________________ Where will you post the cleaning log?________________________________________ b. Water sample results if water is from a well (particularly if ice is made at the facility). This is generally covered under a state or local permit, but you will need to verify safety of your water supply with the regulatory agency. Who will take your water samples:__________________________________________ What is your water permit number (if on a well):________________________________ ______________________________________________________________________ How often will water samples be taken:_______________________________________ c. A master cleaning and maintenance schedule and procedures. Who is responsible for ensuring cleaning is completed:__________________________ What are your procedures for cleaning and maintaining (at least) the following: Forklifts and pallet jacks:__________________________________________________ ______________________________________________________________________ Overhead pipes (not leaking):______________________________________________ 46
______________________________________________________________________ Pallets, skids, bins, totes:_________________________________________________ ______________________________________________________________________ Litter or ponding water, outside or inside facility:________________________________ ______________________________________________________________________ Food transportation compartments:__________________________________________ ______________________________________________________________________ Refrigerators/coolers (floors, walls, ceilings, coils):______________________________ ______________________________________________________________________ Ice machine/ice scoops or shovels:_________________________________________ ______________________________________________________________________ Drains and equipment:____________________________________________________ ______________________________________________________________________ Refuse pick up frequency:_________________________________________________ ______________________________________________________________________ Refuse bin/compactor area:________________________________________________ ______________________________________________________________________ Other equipment or facilities needing cleaning or maintaining:_____________________ ______________________________________________________________________ ______________________________________________________________________
III.
Records
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Notes
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Written Procedures
Pests/vermin, such as rodents, flying insects, crawling insects, and others must be kept out of a food facility. Having a proactive pest control plan in place will help avoid contamination of food and product loss. The following are suggestions on what an effective pest control program should include: a. Using a Licensed Pest Control Operator (PCO) [include environmental assessment as part of PCO contract (findings, recommendations, corrective actions)]. Who is your PCO:______________________________________________________ What is your PCO license number:_________________________________________ Does your PCO conduct inspections and provide recommendations as part of your service contract:_______________________________________________________ b. Using only approved pesticides (check Material Safety Data Sheets (MSDS)). Have you reviewed the MSDSs for all pesticides used on the premises:_____________ Are pesticides applied according to the use intended on the label:_________________ c. Numbering and mapping all devices/bait stations. How are bait stations/devices numbered and mapped:___________________________ ______________________________________________________________________ d. Weekly log (should be at least daily if a problem is noted. It is also recommended that produce warehouses or farm packing operations conduct daily checks). Who is responsible for checks of bait stations/devices both inside and outside of the facility:_____________________________________________________________ How will checks be logged:____________________________________________ e. Servicing inside and outside no less than once per month (do not use bait stations inside). How often does your PCO service your facility:_________________________________ f. Eliminating rodent breeding or harborage conditions(standing/pooling water, accumulation of trash/litter, clutter, spilled food items, potential nesting areas, etc.)
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Does your monthly self-inspection procedures include monitoring for and eliminating rodent breeding and/or harborage conditions:__________________________________ What will you monitor for to ensure no rodent breeding or harborage conditions are present on your premises (see above for guidance):____________________________ ______________________________________________________________________ ______________________________________________________________________ g. Maintaining an unobstructed 12-18 inch distance from walls to pallets (paint a stripe). How will you maintain an unobstructed space of at least 12-18 inches between walls and pallets (or other food/nonfood storage):___________________________________ ______________________________________________________________________ h. Vermin-proofing doors and screens (no holes in walls, screened windows, no gaps under doors greater than inch) Do you ensure that when doors are closed, they are closed all the way to the floor:____ How will you ensure your facility is vermin-proof:_______________________________
II.
Records
a. Pest control service receipts (include environmental assessment as part of service agreement). b. Map of all devices/bait stations. c. Weekly pest control inspection logs.
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Notes
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Self-Inspection Procedures
Self-inspections help to ensure a wholesale food warehouse is operating in accordance with its risk control plan. The measures put in place by a facility to control risks will go a long way to ensuring food safety and security. Having a risk control system in place will also assist in identifying problem areas that need to be corrected, helping facilities operate more efficiently, and letting your customers know that you have a comprehensive system in place to assure the food they receive is safe and unadulterated. Self-inspection logs should include (at a minimum): a. Weekly pest control inspection log b. Monthly self-inspection checklist (see sample self-inspection form provided). Who will conduct the monthly self-inspection:__________________________________ Is the designated person trained in food safety and your risk control plan:____________ II.
Verification Procedures
Ensuring reasonable compliance with your risk control plan by a neutral outside source is important because it provides unbiased assessment of your facilitys operations. The San Diego County Department of Environmental Health (DEH) or other outside entity can verify your adherence to your plan. DEH will verify your adherence to your plan twice per year. After each assessment, DEH will grade your facility as A, B, or C. This program is similar to the restaurant grading system that has been in place in San Diego County since 1946. An inspection report with a point value grading system will be used. 90100% = A, 80-89% = B, and 70-79% = C. a. Who will verify adherence to your risk control plan:__________________________ b. What credentials does your verifier have to ensure adequate food safety knowledge [DEH staff have advanced science-based degrees and pass a comprehensive state examination to become Registered Environmental Health Specialists (REHS)]: _________________________________________________________________________________ _________________________________________________________________________
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TEMPERATURE CONTROL
Safe Temperature of Potentially Hazardous Foods (such as meats, poultry, eggs, fish, shellfish, dairy products or foods containing dairy products, sliced melons, or cooked produce) 41 F or below (or 140 F or above) 45 F molluscan shellfish, pasteurized milk or milk products in original containers, raw shell eggs. Frozen foods frozen Temperature Control Logs Refrigeration/cooler units Receiving temperatures logged Transportation (Pre-cooling) temperatures logged Shipping temperatures logged Thermometer Calibration Thermometers Calibrated Calibration dates logged
FOOD STORAGE
Adequate Storage Space Unobstructed Aisles Food off floor 6 inches or on pallets (Equipment such as pallet jacks or forklifts available on demand to move the pallets) Chemicals and cleaning items separate from food. Poisonous/toxic chemicals (not held for sale) stored in a secured location. Raw animal foods separate from ready-to-eat foods Food protected from contamination (proper packaging and coverage). Separate, labeled storage area for salvage items. Handling salvaged, expired, damaged, or contaminated foods (include timely disposal of damaged, spoiled, or expired products) according to procedures. Rotating stock to ensure First In First Out (FIFO). Providing adequate lighting and ventilation. Assuring food received is labeled. Cleaning and organizing food storage areas. Maintaining an unobstructed, clearly delineated, space that is 12 to 18 inches between walls and stored items.
Sanitary Practices/No Expectorating (spitting)/No Smoking in Food Areas Clean hands. Clean lunch area.
SANITATION
Safe Ice Ice machine, ice scoops and shovels clean. Daily cleaning/maintenance log maintained. Forklifts and pallet jacks clean. Overhead pipes not leaking. Pallets, skids, bins, totes clean No litter or ponding water, outside or inside facility. Food transportation compartments clean. Refrigerators/coolers clean and good repair. Drains and equipment clean. Refuse pickup frequency adequate. Refuse bin/compactor area clean.
FOOD SECURITY
Visitors log maintained Access to food areas limited. Doors and windows able to be secured. Backflow prevention devices tested. Ice machine secured (restricted access). Background checks for new hires. Employees trained on emergency evacuation procedures. Adequate lighting outside of building. Trailers locked/secured when not loading. Access to computer systems restricted.
PEST/VERMIN CONTROL
No insects, rodents, animals, or birds No breeding or harborage conditions for Insects or rodents (such as clutter, trash, pooling water or leaky plumbing, damaged/open food containers) Vermin-Proof (holes in floors or walls or ceilings, no screens on openable windows, or gaps larger than inch under or around openings to the outside) Pest Control Operator licensed. Approved pesticides used. Pest/vermin control service at least monthly.
RECALL PLAN
Recall plan current. Emergency contact phone numbers current. Recall records maintained.
TRACEBACK/TRACEFORWARD
Trace forward system in place. Trace back system in place.
EMPLOYEE PRACTICES
Food worker training current. Employee lockers/storage area provided. Procedures in place to manage sick employees.
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Floor drains in areas subject to flooding-type cleaning or where operations release water. Warm water of 100 F at hand washing sinks Hot water of 120 F when a utensil washing sink is required
SELF-INSPECTION/VERIFICATION
Monthly self-inspection reports kept on file. Regulatory inspection reports kept on file
TOILET ROOMS
Dispensers supplied with soap, paper towels, and toilet paper Operable toilet facilities Operable hand washing sinks within or adjacent to toilet rooms. Proper lighting Proper ventilation Hand washing signs posted
DOCUMENTATION/RECORD KEEPING
Neat, organized filing system Customer complaint file maintained and periodically reviewed. Risk Control Plan Invoices and shipping documents Current approved source verification records. Current approved source verification records. Temperature control logs or computer print outs Thermometer calibration logs Monthly facility self-inspection logs Receiving logs or equivalent Shipping logs or equivalent Employee training records. Cleaning logs and schedules Disposition of salvaged, expired, damaged, or contaminated foods. Documentation and information on implementation of recalls. Water sample testing results (well water) Map of all pest control devices/bait stations. Weekly pest control inspection logs. Pest control service receipts (include environmental assessment as part of service agreement). Regulatory agency inspection reports/verification documentation
FACILITIES
Plumbing in good repair Proper disposal of refuse Refuse in leak proof containers with tightfitting lids Enclosed building of sound construction Utensil washing sinks where handling unpackaged foods or washing or trimming of produce Janitorial facilities (janitorial sink to dispose of mop water and a storage area for cleaning supplies)
EQUIPMENT
Walk-In refrigerators/freezers functioning Thermometers in refrigeration units Ice makers located inside building Indirect drainage for ice machines (Indirect drainage means to a floor sink, hub drain. Other methods should be approved by the inspector).
OPERATIONS
Permits/licenses current Health permit posted Other________________________________
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XIII. GUIDELINES FOR DETERMINING XIV. MAJOR RISK FACTOR FOOD SAFETY VIOLATIONS
Major risk factor violations pose an imminent public health danger and require immediate correction. According to the Centers for Disease Control and Prevention (CDC), they are the most significant risk factors contributing to food-borne illness outbreaks. As such, they are clearly of an imminent public health nature.
Co-mingling of shellfish/improper wet storage of shellfish No sanitizer for multiuse utensils. Improper ware washer machine temperature. Gross contamination to food contact surfaces.
Vermin Infestation
Major Violations Include: Active heavy infestations by rodents, insects, birds, or fowl that has resulted in contamination of food contact surfaces and adulteration of foods and warrants immediate closure.
No Water/Hot Water
Major Violations Include: Hot or cold water is not available at all hand washing or utensil washing sinks in the food facility. Note that hand wash sinks should have warm water of at least 100F. Hot water at utensil washing and mop sinks should not be less than 110F. Hot water should not be less than what is required to operate the dishwashing machine. Contaminated water supply. Note that this is intended to be a guideline document and may not be all-inclusive as individual facilities and severity of violations can vary from the guidelines established in this document.
Contaminated Food/Equipment
Major Violations Include: Obvious cross contamination between raw and ready to eat food. Physical or chemical contamination of foods.
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Notes
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Documentation and record keeping are important in tracking a facilitys operation. An efficient system needs to be in place to ensure records are being properly maintained as outlined in your plan. Records also need to be organized, stored in a secure location, and maintained for an extended period of time. One important concept to remember is, if you didnt record it, it didnt happen! a. Keep records organized. Where do keep your records:______________________________________________ Who is responsible for maintaining your records:_______________________________ How long will you maintain your records:_____________________________________ b. Keep and periodically review a customer complaint file. Review the file for trends in types of complaints to indicate whether or not there is a problem with a particular food item or practice. Who maintains your customer complaint file:__________________________________ Where are your customer complaint file records maintained:______________________ c. Records that you should maintain (at a minimum): 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Risk Control Plan Invoices and Shipping documents Verification of approved sources Temperature control logs or computer print outs Thermometer calibration logs Monthly facility self-inspection logs Receiving/transportation/delivery logs Training records. Cleaning logs and schedules Disposition of salvaged, expired, damaged, or contaminated foods. Documentation and information on implementation of recalls. Water sample testing results. Pest control service receipts (include environmental assessment as part of service agreement). 14. Map of all pest control devices/bait stations. 15. Weekly pest control inspection logs. 16. Regulatory agency inspection reports/verification documentation
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Notes
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