Good Manufacturing Practices
(2010 – Hazelnut Industry Office)
Introduction: Why We Need Good Manufacturing Practices
Food safety and product quality have always been top priorities for the northwest hazelnut industry. All food products are coming under increased scrutiny by government agencies and consumer groups.
This GMP guide is designed to help you examine and improve your own manufacturing practices and ensure that they meet the generally accepted standards of Good Manufacturing Practices (GMPs). GMPs are the minimum sanitary and processing requirements necessary to ensure the production of wholesome food. They have been written and organized with reference to the U.S. FDA GMP Regulations, Code of Federal Regulations (21 CFR 110). In no case do the recommendations in this guide supersede applicable federal, state or local laws or regulations for U.S. operators.
By executing and documenting Good Manufacturing Practices (GMPs), Oregon and Washington hazelnut processors can assure government regulators and customers worldwide that our industry is diligent in its commitment to processing safe, high-quality nuts.
GMPs are broadly written and are not intended to be plant specific, but instead, they explain requirements for the food industry. Finally, GMPs, along with Good Agricultural Practices (GAPs) and Sanitation Standard Operating Procedures (SSOPs), are prerequisite activities to the development and writing of a Hazard Analysis and Critical Control Point (HACCP) plan unique and specific for each facility.
The GMP portion of the Hazelnut Food Safety Program (HFSP) represents generally accepted, broad based guidance, developed from current knowledge of food safety practices. The guide focuses on risk reduction, not risk elimination. Current technologies cannot eliminate all potential food safety hazards with product eaten in a raw form.
These GMP’s provide broad, scientifically based principles. You may use the guide to help assess microbiological hazards within the context of the specific conditions (climatic, geographical, cultural, economic) that apply to your own operation, and implement appropriate and cost-effective risk reduction strategies.
A Proactive Approach
Growers and handlers are urged to take a proactive role in minimizing food safety hazards potentially associated with hazelnuts. Being aware of and addressing common risk factors will result in a more effective, cohesive response to emerging concerns about the microbial safety of hazelnuts. The adoption of safe practices should be encouraged throughout the “farm-to-table” food chain– including growers, dryer operators, processors, shippers, exporters, retailers, food service operators and consumers – to ensure that your individual efforts will be enhanced.
Minimizing Microbiological Hazards
Microbiological contamination from Salmonella or E. coli, for example, is a significant concern. Why?
• Testing is not always able to identify contamination.
• New strains of contamination can evolve.
• Contaminants/pathogens on the ground may be transferred to hazelnuts during harvest operations, and then to the processing facility.
Basic Principles of Minimizing Microbiological Hazards
Principle 1. Prevention of microbial contamination is favored over reliance on corrective actions once contamination has occurred.
Principle 2. To minimize microbial food safety hazards, growers, handlers, processors and shippers should use good agricultural and management practices.
Principle 3. Hazelnuts can become microbiologically contaminated at any point along the farm-to-table food chain. The most common source of microbial contamination is associated with human or animal feces.
Principle 4. Water, which comes in contact with food products, may be a potential source of microbiological contamination.
Principle 5. Practices using animal and avian manure should be managed closely to minimize the potential for microbial contamination. Do not use either product unless it has been certified by its supplier to be free from contamination through composting or similar treatment, and chemical and microbiological test results accompany the shipment.
Principle 6. Worker hygiene and sanitation practices during production, harvesting, sorting, processing, packing, and transportation play a critical role in minimizing the potential for microbial contamination. Building structure, equipment design, and pest control are also critical elements.
Principle 7. Follow all applicable local, state, and federal laws and regulations.
Principle 8. Accountability at all levels of agricultural processes is important to facilitate the ability to track hazelnuts back through the distribution channels to the producer by use of a unique lot identification scheme.
Food and Drug Administration – Guide to Minimize Microbial food Safety Hazards for Fresh Fruits and Vegetable, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (CFSAN), Oct. 26, 1998. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm064574.htm
Section I: Personnel
Employee training in good handling practices, covering the key areas of sanitation and worker hygiene, is critical to achieving the goals of the Hazelnut Industry Food Safety Program (HIFSP). Establishing a written training program for employees that addresses general sanitation and good hygiene practices will help reduce the risk of all forms of contamination. All training programs should be evaluated routinely and updated as necessary. Documentation of employee training is also necessary to verify that federal, state and local requirements for worker safety training are met.
It may be necessary to have bilingual training classes, depending on the composition of your workforce. You can use the Employee Training Documentation (Appendix 3) to document the subject material covered during training classes or create your own.
It is important to ensure that all personnel, including those indirectly involved in hazelnut operations such as equipment operators, potential buyers and pest control operators, comply with established hygienic practices. Personnel responsible for ensuring the sanitation of the plant should be experienced with sanitation practices or have educational background to support their work.
Company Organization Chart
An organizational chart helps clarify and document the roles of staff. This chart should identify who is responsible for the various phases of your operation. Identify who is responsible to answer customer, consumer, or state and federal government regulator inquiries. Describe each individual’s specific responsibilities relevant to each aspect of GMP’s, (e.g., pest control is the responsibility of the QA Manager) in a manner that is clear and easy to understand to avoid confusion when describing who is responsible for making decisions and for their consequences. The chart should include office, cell, and home phone numbers, pager numbers, and after hours emergency contact information.
Basic Personnel Safety and Hygiene Requirements
The following steps should be taken to minimize potential contamination associated with employees and visitors to your plant:
- Employees must wear clean outer garments that protect against contamination of hazelnuts, hazelnut-contact surfaces or hazelnut packaging materials. Garments shall have no shedding fibers. No tank tops are allowed. Shoes must be in good repair and of leather construction. No open toed shoes are allowed.
- All employees must wash hands with soap and warm water before work, after using restrooms, upon returning to their work station from a break or lunch, or any other time when their hands may have become soiled. Sanitizers are also recommended after washing to afford additional protection, but they are not a substitute for hand washing.
- All employees are to wear effective hair restraints, including hairnets and beard and mustache covers where applicable.
- No objects–pens, pencils, cell phones, etc.– shall be carried above the waist or placed in pockets above the belt.
- No food, candy, chewing gum, lozenges, or other comestibles are allowed in the plant.
- Personal items must be stored in lockers or other designated locations outside processing areas.
- All jewelry must be removed when entering the plant (plain wedding bands are frequently exempted from this requirement). No hairpins or other objects that could fall into food may be worn in the process areas. Fingernail polish and false fingernails should not be allowed.
- No employee infected with or showing symptoms of any infectious or communicable disease, or that demonstrate open sores, boils, infected wounds or any other affliction that may spread disease, shall be in contact with hazelnuts, hazelnut contact surfaces or hazelnut packaging materials. Supervisor shall monitor for these conditions.
- Monitor employees, conduct internal audits and record corrective action taken when appropriate.
- Visitors and contractors shall follow the same rules as employees. Use the Plant Visitors Agreement sample form in Appendix 6.
- No glass items of any kind are permitted in the plant processing areas.
- If employees wear gloves they shall be of an impermeable material. Gloves shall be cleaned and/or sanitized at the beginning of work, after returning to work station, or at any other time when the gloves become soiled.
- Tobacco is not permitted in the plant. Smoking is permitted only in designated areas outside the plant.
- Personnel working in the shelling or other “dirty” areas of the plant should not enter other areas of the plant as this movement could possibly contaminate equipment and product with extraneous matter or pathogens. Forklifts and other equipment used in the inshell area also should not move into processed product areas due to the risk of contaminating finished product.
Specific steps to take to implement these rules:
Establish a training program
All employees, including supervisors, full-time, part-time and seasonal personnel should have a good working knowledge of basic sanitation and hygiene principles. They should understand the impact of poor personal cleanliness and unsanitary practices on food safety. Good hygiene not only protects the worker from illness, but it reduces the potential for contaminating hazelnuts,, which, if consumed by the public, could cause a large number of illnesses. The level of understanding needed will vary as determined by the type of operation, the task, and the assigned responsibilities.
- Handlers should develop a sanitation training program for their employees. Depending on the situation, formal presentations, one-on-one instruction, or demonstrations may be appropriate. Depending on the worker’s job requirements, periodic updates or follow-up training sessions may be needed.
Educate workers on the importance of proper hand washing techniques
Thorough hand washing before commencing work and after using the restroom is very important. Employees must wash their hands before working with hazelnuts. Any employees having contact with food should also wash their hands before returning to their workstation. Many of the diseases that are transmissible through food may be harbored in the employee’s intestinal tract and shed in the feces. Contaminated hands can also transmit infectious diseases. Do not assume that workers know how to wash their hands properly. Proper hand washing before and after the workday, using the bathroom, and eating, drinking, or smoking is a simple eight–step process:
1. Wet hands with clean water
2. Apply soap
3. Scrub hands and fingernails for 20 seconds
4. Rinse off soap thoroughly with clean water
5. Dry hands with single-use towels
6. Discard used towels in trash
7. Sanitize hands with an appropriate sanitizer
8. Dry hands
Become familiar with typical signs and symptoms of infectious diseases
The pathogens such as Salmonella, Shigella species, E.Coli O157:H7, listeria, Endamoeba histolytica, and hepatitis A virus have a high infectivity (the ability to invade and multiply in the body) and virulence (the ability to produce severe disease). Any worker showing symptoms of an active case of illness that may be caused by any of these pathogens must be excluded from work assignments that involve direct or indirect contact with hazelnuts. Workers with diarrheal disease, colds, flu and/or symptoms of other infectious diseases must not work with hazelnuts or the working and packing equipment in the packing facility and should be trained to report such conditions to their supervisor.
Supervisors should be familiar with the symptoms of infectious diseases so that if symptoms are evident, the supervisor can take appropriate steps.
Provide protection from a lesion
A lesion, such as a boil or infected wound that is open or draining and that is located on exposed parts of the body, presents an increased risk of contamination. If a worker has a lesion he or she must not work with hazelnuts, hazelnut contact surfaces or packaging and should be trained to report such conditions to their supervisor.
Consider alternative good hygienic practices
Single-service disposable gloves can be an effective hygienic practice on sorting tables in combination with hand washing. If gloves are used, be sure they are used properly and do not become another vehicle for spreading pathogens. The use of gloves in no way lessens the need or importance of hand washing and proper hygienic practices. If used, gloves need to be washed and sanitized just like hands.
Ensure that visitors to the facility follow good hygienic practices whenever they come into contact with any hazelnuts.
Require hazelnut inspectors, buyers, and other visitors to comply with established hygienic practices when inspecting facilities or product (Sample Plant Visitor Form Appendix 6).
Occupational Safety Health Administration 29CFR1910.141(g) (Food and beverage consumption on premises)
Section II: Plant and Grounds
Contamination can be significantly reduced through practical maintenance and organization. The same steps used for maintaining cleanliness inside your facility should be used for the exterior and perimeter of your operation.
Most operations have a plant schematic (a blueprint or layout of the facility) on file. This is a vital reference document for customers, government regulators and anyone in your company involved in planning production changes or implementing GMPs. If any parts of the processing are subcontracted to another facility, those subcontracted operations should have GMPs of their own and should be included in any third party audit or certification activity. Schematics should be reviewed and updated each year prior to the beginning of the processing season.
A schematic can be a simple line drawing by hand or an elaborate, mechanically drawn blueprint.
In addition to a simple schematic of your plant, processors are advised to create a drawing that demonstrates the product or “process” flow. The process flow schematic should briefly describe the most relevant features of each processing step: time, temperature, etc.
Maintain plant grounds so as to reduce the potential for contamination. Grounds must be free of trash and debris. Grounds must have adequate grading and/or drainage to avoid standing water. Vegetation should be controlled to prevent pest harborages.
- If there are other activities on site of the facility or nearby, preventive measures shall be taken to prevent the cross contamination of hazelnuts stored or processed on the facility by biological, chemical or physical hazard.
- Building and grounds must be maintained to prevent entry of pests. Provide, where necessary, adequate screening or other protection against pests. Building roof, walls, doors, floor and windows shall be constructed and maintained to prevent pest entry.
- Waste facilities must be well maintained and designed to prevent contamination of product or packaging material. Waste containers must be emptied in a timely manner .
- Roads, yards and parking lots must be maintained so as to not pose a threat of contamination to any stored hazelnuts on site.
- Equipment stored on the grounds shall not provide sources of contamination or pest harborages.
- Conduct internal audits of grounds by inspecting and recording observations concerning items 1-6 above. If deviations are found, record them and take appropriate corrective action.
- Store, convey and dispose of rubbish and processing waste to minimize odor and the potential for attracting flies and other pests and to protect against contamination of hazelnuts, hazelnut contact surfaces, water supplies and ground surfaces.
Plant environment: The following recommendations should be implemented to minimize the potential for contamination associated with the plant:
- Ensure that all glass lights in processing and warehouse areas are shielded or otherwise protected against hazelnut contamination in case of glass breakage.
- Provide adequate lighting in all hazelnut processing and support areas, including hand-washing areas, dressing and locker rooms, restrooms, and all areas where hazelnuts are examined, processed or stored.
- Whenever possible, glass and hard plastics are prohibited in food factories.
- Provide adequate space and layout to facilitate production and prevent accidental contamination of hazelnuts.
- Ensure that floors, walls, and ceilings are constructed of appropriate materials, may be adequately cleaned and kept clean and in good repair; that drip or condensation, and foreign matter from fixtures, ducts and pipes does not contaminate hazelnuts, hazelnut-contact surfaces, or hazelnut-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating hazelnuts, hazelnut-contact surfaces or hazelnut packaging.
- Provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate hazelnuts. Locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating hazelnuts, hazelnut-packaging materials, and hazelnut-contact surfaces.
- Develop procedures for reviewing any potential changes in the facility for their impact on GMP’s and modify accordingly. This would include changes in layout, infrastructure, changes in equipment or addition of new equipment. Changes should be reviewed in light of their effect on executing current GMP’s or the possible introduction of contaminants.
Section III: Sanitary Operations Toxic Chemicals and Pest Control
Implementation of the following recommendations regarding chemical handling and employee training are critical to minimizing issues associated with chemical use:
- Those employees designated to handle hazardous materials must be trained in proper handling. Each employee should sign a certificate after he or she has been properly trained. These records should be maintained in the employee file.
- Chemicals must be stored away from hazelnut processing areas so as not to contaminate hazelnuts, hazelnut contact surfaces or hazelnut packaging materials. Store pesticides and pesticide equipment separately from oils and products used in food processing.
- All chemicals must be properly labeled and packaged.
- Procedures and controls should be established for the securing, checkout and return of chemicals to avoid unauthorized use.
- Workers authorized to apply chemicals shall receive appropriate training in the use, storage, documentation and disposal of these chemicals.
- The plant should maintain an inventory and Material Safety Data Sheets (MSDS) for all chemicals used in the facility.
- Chemical control procedures should be developed that outline procedures for listing all chemicals used in the facility; the handling, storage and labeling of chemicals; procedures for distribution and control of chemicals; procedures for ensuring MSDSs are maintained and are current; procedures for ensuring that cleaners, sanitizers and lubricants have documentation that guarantees approved regulatory status; and procedures for disposition of empty chemical containers or waste chemicals.
- Cleaning and sanitizing agents shall meet appropriate regulations and documentation shall be obtained from suppliers verifying this.
- Chemicals that may contact hazelnuts or hazelnut contact surfaces (such as lubricants) must be food grade.
- Disposal of empty containers or waste must conform to local and state regulations for the particular chemical. No empty containers must ever be stored in areas that would present the possibility of potential contamination to hazelnuts, hazelnut packages or water sources.
Manufacturers’ recommendations for use of chemicals used in or around food contact areas should be adhered to. Records should be kept detailing chemical usage, including date of application, location, dosage rate, purpose, etc.
All animals, including mammals, birds, reptiles, and insects, are potential sources of contamination in processing environments because they harbor, or could be a vector for a variety of pathogenic agents, such as Salmonella or E. coli. A good pest control program is essential to good plant sanitation.
Basic pest control requirements
Each facility should establish a pest control program to reduce the risk of contamination by rodents, insects, birds and any other pests. The program should include regular and frequent monitoring of affected and treated areas to accurately assess the program’s effectiveness. Assign a staff member to train and work with the employee or outside contractor who will be in charge of the pest control program.
- No pests shall be allowed in any area of a hazelnut plant. No domestic animals shall be brought into any hazelnut facility.
- Maintain the grounds in good condition. Grounds in the immediate vicinity of all packing areas should be cleared of all waste, litter, and improperly stored garbage. Keep all grasses cut to discourage the breeding, harboring, and feeding of pests, such as rodents and reptiles. Remove any unnecessary items, including unused and inoperative equipment to eliminate areas that harbor rodents and insects.
- Clean and sanitize daily to remove product or product remnants that attract pests in and around the packing facility and any other location where hazelnuts are handled or stored.
- Maintain adequate surface drainage to reduce breeding places for pests and food contamination by seepage.
- Operate water treatment and disposal systems so that they do not become a source of contamination. If grounds not under your control border the processing plant, protect your facility by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination.
- Exclude pests by blocking areas, such as holes in walls, doors, flooring and vents that allow entrance into the facility. Use screens, wind curtains and traps.
- Pest control procedures should describe the location of any outdoor bait stations, glue boards, and insectocutors (bait stations are not permitted inside the plant). Trap or bait station locations should be documented with a schematic map. Traps and stations should be checked frequently to detect activity and a record should be maintained. Traps should be cleaned and maintained. Dead pests should be removed and disposed of to prevent any potential contamination or infestation.
- A list should be maintained of all pesticides used at the facility along with Manufacturer Safety Data Sheets and recommendations. All pesticides shall be used in accord with manufacturer’s recommendations and State and Federal regulations. Individuals using and applying pesticides shall receive appropriate training and shall have certificates or licenses from appropriate authorities. A record should be maintained of all pesticide applications including chemical, concentration, where applied, and date. If the plant was fogged with insecticide, clean, sanitize and inspect all equipment afterwards to insure removal of all dead insects and ensure that no residues of insecticide remain.
Food and Drug Administration 21 CFR 110.35(c) (Pest control)
Sanitation: The following general practices should be implemented when appropriate to maintain an effective cleaning and sanitation program:
- Establish an employee sanitation program including training for cleaning plant equipment, facility and utensils. Records of training should be maintained.
- All hazelnut contact surfaces, including utensils and hazelnut contact surfaces of equipment, shall be cleaned and sanitized as frequently as necessary to protect against contamination.
- General Cleaning and Sanitation Procedures for Equipment
a. Dry Cleaning vs. Wet Cleaning – Research conducted by the University of California, Davis, under the auspices of the Almond Board, has demonstrated that dry cleaning is more effective than improperly dried wet cleaning in eliminating the risk of pathogen contamination. Accordingly wet cleaning during the hazelnut season, unless equipment can be completely dried to reduce the potential for spreading contamination is not recommended.
b. Dry Cleaning Procedures
i. Lockout/Tagged procedure for power.
ii. Check for and remove all products from the work area.
ii. Wear proper protective equipment.
iv. Check for oil leaks on all gear boxes and motors, report problems to maintenance supervisor and document the incident.
v. Vacuum all equipment and motors to remove all debris. Begin at the highest point of equipment and work downward. Remove all hazelnut residues from equipment and surfaces.
c. Wet Cleaning Procedures
i. Lockout / Tagged procedure for power.
ii. Check for and remove all products from the work area.
iii. Wear proper protective equipment.
iv. Follow all label and Manufacturer Safety Data Sheet precautions for chemicals.
v. Check for oil leaks on all gear boxes and motors, report problems to maintenance supervisor and complete action slip.
vi. Vacuum all equipment and motors to remove loose debris. Start at the highest piece of equipment and work down. Remove all hazelnut products from the area.
vii. Cover all motors and gear boxes with plastic coverings.
viii. Rinse with water, apply detergent with hot water or steam clean.
ix. Scrub with brushes and other cleaning tools as needed. Agitate all equipment and food contact surfaces to remove dirt or residue buildup.
x. Rinse with fresh water.
xi. Sanitize with appropriate sanitizer (quaternary ammonia or other sanitizer). Do not apply sanitizers (quaternary ammonia or other sanitizer) to edible product.
xii. Rinse off sanitizer. Allow equipment to thoroughly dry before use.
- Hazelnut contact utensils should be cleaned and sanitized daily using a food grade sanitizer. Utensils should be washed to remove dust and debris then sanitized using a commercial sanitizer of a concentration specified by the supplier that meets government regulations.
- A master sanitation schedule should be developed for the facility which lists the frequency of cleaning for all equipment, surfaces, utensils and infrastructure.
- Develop written procedures that detail all steps in cleaning including chemicals used, contact time, temperatures, and who conducts cleanup.
- Effectiveness of cleaning should be verified by visual inspection or other means: for example, environmental testing with swabs or bioluminessence testing. Verification of cleaning should be done at an interval that ensures cleaning is effective and consistent and a record should be kept. If verification results in an unacceptable condition, items should be re-cleaned or changes made in the cleaning procedures.
Section IV: Sanitary Facilities and Controls: Water, Sewage, Toilets, Handwashing
Water can clean – or contaminate
Water used in food processing is required to be safe and sanitary. This water must meet drinking water standards for microbiological activity. If using an on-site well, a water sampling schedule must be in place with documented sampling results demonstrating that the water is suitable for its intended purpose. Well and municipal water samples should be collected at the point of use to ensure that there has not been contamination within the facility’s water delivery system. Only potable water should be used in production areas. Health officials also require proof in the form of a certificate of potability which can be supplied by your water provider.
Plant water from a ground source should be tested at least once a year for pesticides, heavy metals and microbiology. If well water is used, Oregon has several water laboratories that can assist with the testing and certification process.
If municipal water is used, the microbiological quality should be checked to ensure it has not been re-contaminated by leaking pipes, dead-ends or cross connections with waste lines. City water supplies are tested frequently and certification papers should be obtained from the local Department of Public Works to show regulators.
Water of inadequate quality has the potential to be a direct source of contamination and a vehicle for spreading localized contamination in the field, facility, or transportation environments. If water comes in contact with hazelnuts, its quality dictates the potential for pathogen contamination. If pathogens survive on the hazelnuts, they may cause food borne illness.
Water can be a carrier of many microorganisms including pathogenic strains of Escherichia coli,
Salmonella spp., Vibrio cholerae, Shigella spp., Cryptosporidium parvum, Giardia lamblia, Cyclospora cayetanensis, Toxiplasma gondii, and the Norwalk and hepatitis A viruses. Even small amounts of contamination with some of these organisms can result in food borne illness.
You should consider the following issues and practices when assessing water quality and in applying controls to minimize microbial food safety hazards.
- All water used for hazelnut contact or hazelnut contact surfaces or used in the facility for employee services must be potable and meet state and federal regulations for drinking water.
- If chlorine is added to water as a disinfectant, the concentration of chlorine should be recorded daily.
- There must be no cross-connections between potable and non-potable water supplies. A plumbing diagram should be on file to verify this.
- All hoses, taps, and piping systems must be designed to prevent back-flow or siphonage of standing water and/or have backflow devices installed. Have a map of any backflow devices that are installed in the water lines. Piping shall not have any “dead ends”.
- If water is from a non-municipal source the almond processor must establish that the water meets microbiological and chemical criteria for potable water. This should be done via a testing program with a recognized third party laboratory. Water should be tested at a minimum of once per year.
- There should be a certificate of analysis on file for the water if it is from a municipal source.
- Equipment designed to assist in maintaining water quality, such as chlorine injectors, filtration systems, and backflow devices, should be routinely inspected to ensure efficient operation. Provide map.
- Monitor practices via internal audits, record observations and take corrective action when appropriate.
- Clean and sanitize water contact surfaces as often as necessary to ensure the safety of the hazelnuts.
- Change water as necessary to maintain sanitary conditions. Develop water change schedules for all processes that use water.
- Water supply must be adequate for peak usage and hot water supply must be adequate for clean-up requirements.
- Plumbing must be adequate to convey water to required locations and to convey sewage and liquid waste from the processing facility.
- Sewage disposal must be deposited into an adequate sewage treatment system or another method that eliminates potential for contamination.
- Each hazelnut facility must provide employees with adequate, readily accessible toilet facilities.
- Toilet facilities must not have doors that open into areas where food is exposed to airborne contamination, except where alternate means have been taken to protect against contamination, such as double doors or positive airflow systems.
- Toilet facilities must have self-closing doors.
- Toilet facilities must be kept clean, neat and in good repair. Basins, toilets, urinals, walls, ceilings and floors should be cleaned and sanitized daily or as necessary. There must be adequate waste disposal.
- Signs must be posted instructing employees to wash their hands.
- Toilet facilities must be adequately supplied with toilet paper, warm water, soap, and paper towels or air dryers for drying hands. Multiple use towels should not be used. Toilet facilities must be checked daily and re-stocked as necessary to ensure adequate supplies.
- Each hazelnut facility must provide adequate and convenient hand-washing facilities furnished with running water at a suitable temperature, soap, sanitary towels or hand dryers. Multiple use towels should not be used. Hand wash stations must be checked daily and re-stocked as necessary to ensure adequate supplies.
- Restroom fixtures, such as water control valves, should be of a type designed to protect against recontamination of clean, sanitized hands. Foot control valves or sensing systems should be used.
- Easily understood signs must be posted directing employees to wash and, if appropriate, sanitize their hands before they begin work, before returning to work from a break and any time their hands may have become soiled or contaminated. These signs should be posted in restrooms, in the processing rooms and anywhere employees may handle food or materials and surfaces involved in the production process. Signs should be bi-lingual, if appropriate to the facility.
- Provide and maintain waste receptacles in ways that protect against food contamination.
- Hand sanitizers are not a substitute for hand washing. However, hand sanitizers may be placed at various locations within the plant, to be used as a supplement to hand washing.
ReferencesFood and Drug Administration21, CFR 110.37(d)(1)-(4) (Toilet facilities) 21 CFR 110.37(e)(1)-(6) (Hand washing facilities) Occupational Safety and Health Administration 29 CFR 1910.141(c)-(f ) (Toilet, washing and clothes drying facilities, changing rooms)
Section V: Design, Construction and Maintenance of Equipment and Utensils
Hazelnuts are constantly in contact with the equipment surfaces and utensils in your facility. Specific attention should be given to equipment and utensils used in the processing of hazelnuts to ensure that the design is sanitary in nature and that programs are in place for preventive maintenance, cleaning and sanitation.
Section VI: Processes and Controls
Raw Materials, Manufacturing, Warehousing and Distribution:
- Ensure that vehicles used to transport inshell hazelnuts to the facility are not used to convey any other items but hazelnuts – no chemicals, livestock, waste products or other potential contaminants.
- Hazelnuts must be stored under conditions that protect against contamination and minimize deterioration.
- Reduce the potential for cross contamination of hazelnuts, hazelnut-contact surfaces, or hazelnut-packaging materials with biological, chemical or physical hazards. Inshell hazelnut areas shall be physically separated from processed areas and controls shall be in place to prevent the contamination of inshell hazelnuts by workers, equipment or utensils.
- Warehouses used for finished products shall be maintained in a condition that protects hazelnuts against biological, chemical and physical contaminants. Warehouses shall be neat, orderly and designed to prevent contamination with pests. Warehouses should be audited at least monthly. Audits should focus on pest control, cleanliness, neatness, maintenance of space between rows and walls, and protection against potential contaminants.
- Preventive measures shall be taken to prevent contamination of hazelnuts with metal. Facilities should use inspection or metal detection devices (magnets or metal detectors) to prevent metal contamination. In line magnets should be cleaned and tested daily to ensure they are performing correctly. A record should be kept of inspections. Metal detectors should be calibrated at an appropriate interval and recorded. An investigation should be made of metal rejected by magnets or metal detectors in order to determine the source and corrective action. Sample magnet check and metal documentation forms are included in Appendices 7& 8.
- Carrier vehicles used to transport finished product should be inspected before loading for signs of insect infestation, moisture, chemical residues, foreign material, unusual odors, and evidence of other nut meats or contaminates. A record should be kept of the inspection. Microbial cross-contamination from other foods and non-food sources and contaminated surfaces may occur during loading, unloading, storage, and transportation operations. Wherever produce is transported and handled, the sanitation conditions should be evaluated. Trailers used to transport chemical or waste products should not be used for shipment of food products .
- Obtain certificates of analysis or continuing letters of guarantees for ingredients other than hazelnuts and for food contact packaging.
- Develop a vendor control program to qualify hazelnut vendor supplies, identify approved suppliers and rate the quality of suppliers.
- Protect hazelnuts stored outdoors by an effective means, including the use of protective coverings.
- Control areas over and around hazelnut storage to eliminate harborages for pests.
- Monitor hazelnut storage areas as necessary for evidence of pests and pest infestations.
- Protect unused, cleaned and new packaging containers from contamination when in storage. Packing containers and other materials that are not used immediately should be stored in a way that protects them from contamination by pests (such as rodents), dirt, and water condensation from overhead equipment and structures. If packing containers are stored outside the packing facility, they should be cleaned and sanitized before use.
- Remove as much dirt and mud as practical from hazelnuts outside of packing facilities or packing areas. Take additional care to protect inshell hazelnuts from possible contamination because of possible exposure to manure and animal fecal material in the soil. Operators of open packing facilities should also be aware of potential contamination from airborne contaminants from any nearby livestock or poultry areas or manure storage or treatment facilities.
- Hazelnut totes should be inspected for damage on a regular basis. Totes with damaged surfaces should not be used.
- Hazelnut totes should be cleaned before they are used to transport raw hazelnuts.
- Separate containers must be used for handling raw and processed hazelnuts.
- Containers used for ready to eat hazelnuts should be cleaned and sanitized before each use.
- Except for eyewear, glass should not be allowed in hazelnut processing plants.
- Adapt the Carrier Inspection Form in Appendix 9. While you may encounter initial resistance from your carrier it is better to reject an unsanitized carrier vehicle than to have your product rejected because of contamination.
ReferenceFood and Drug Administration Guide to Minimize Microbial food Safety Hazards for Fresh Fruits and Vegetable, Section VIII, “Transportation.”
Traceback is the ability to track food items, including almonds, back to their source (growers, dryer operators, handlers, shellers, etc.). A system to identify the source of hazelnuts alone cannot prevent the occurrence of a microbiological hazard that may lead to an initial outbreak of food borne disease. However, the ability to identify the source of a product through traceback serves as an important component of good agricultural and management practices intended to prevent the occurrence of food safety problems. Information gained from traceback investigation may also be useful in identifying and eliminating a hazardous pathway.
Overview of the traceback process
Once an outbreak is suspected, public health officials begin scientific studies to determine common food items consumed during the period of infection for the pathogen. If these studies implicate a particular food product and hazard analysis shows that other contributing causes were not to blame (for example, cross-contamination, ill food workers, other sources of infectious agent, etc.), health officials attempt to obtain the following information:
• At the Point-of-Service establishment (where the product was sold or prepared), pertinent product identifying information (including product types, packaging, labeling, and lot numbers if applicable) is obtained. Health officials also determine when the product was purchased or prepared, and determine receiving, stock rotation, inventory, handling and shipping procedures. Records are collected about suppliers and shipments of the implicated product to the Point-of-Service over the shelf life of the implicated product.
• Data relating to distribution of the implicated product is charted and analyzed. This analysis is accomplished either by tracing lot numbers, if they are available, or using a shipment delivery time line to identify suspect shipments based on knowledge about the time period when the implicated product was produced and shipped.
• Distributor interview, data collection, and analysis are repeated for each level of distribution until health officials identify the source of the product. Depending on the contamination involved and the suspected food source, there can be wide variations in the reliability of the data obtained from such studies. Public health investigators must rely on record review and interviews. This method increases the time and resources necessary to trace an implicated product back to its source. Further, review of records that may not be complete and interviews with people whose memories may be imperfect make it more difficult to narrow down the cause(s) of an outbreak.
Advantages of an effective traceback system
Despite the best of efforts by food processors, food may never be completely free of microbial hazards. However, an effective traceback system, even if only some items carry identification, can give investigators clues that may lead to a specific region, packing facility, or even orchard, rather than your entire inventory or an entire commodity group. It also builds confidence among regulators and consumers that the industry is truly in control of all phases of production.
From a public health perspective, improving the speed and accuracy of tracing implicated food items back to their source may help limit the population at risk in an outbreak and the accompanying publicity. Rapid and effective traceback can also minimize the unnecessary expenditure of valuable public health resources and reduce consumer anxiety. Tracing implicated food items may also help public health officials to determine potential causes of contamination, thereby providing data for growers, shippers, and others for identifying and minimizing future microbial hazards.
Instituting effective traceback systems
Because of the diversity of handling practices throughout the hazelnut distribution and marketingchain, a traceback system may be more easily implemented for some companies than others. Forexample, traceback systems may be more easily implemented for operations that have more direct control over a greater number of steps in the growing/packing/distribution chain. However, industry associations, growers, and handlers are encouraged to consider ways to provide this capability where feasible.
Handlers should examine current company procedures and develop additional procedures if necessary to track individual containers from the farm to the handler, and then to and through the distributor to the customer in as much detail as possible. An effective traceback system should document the source of a product and a mechanism for marking or identifying the product that can follow the product from the farm to the consumer. Documentation at minimum should include:
• Orchard identification and date of harvest
• Dryer Operator / Handler
• Who the product was sold to and date of sale and shipment
• Anyone else who handled the hazelnuts, from grower to handler
Food and Drug Administration
Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, Section IX, “Traceback”
Positive Lot Identification
A key element of a traceback program is positive lot identification. In the event of a foodborne illness associated with your product, the ability to quickly trace the product through your plant to the consumer and back to the delivering grower will minimize the impact to your operation in terms of production delays, product recall/retrieval costs, and negative public opinion.
Adequate coding and distribution records are critical. Lack of a coding system and accurate records could lead to a total product recall with notification to all customers.
Lot numbering counts
For this reason, every load of hazelnuts that comes into your plant should be assigned a unique lot number for control purposes. Your number should link back to the lot number assigned by your grower for that lot. Your lot number identifies the product to everyone who will be associated with it, and is a major component should a recall be necessary. It should remain with the lot through all processing steps, grading, chemical and microbiological testing, storage and shipping.
Julian code dating
Lot codes can use Julian dating. For instance, the lot code “5030” indicates the 30th day of the year 2005. The year is the first number (5). The “030” is the number of days since January 1. The Julian date may also be written “0305,” with “030” as the number of days since the beginning of the calendar year and “5” as the year. This method varies from handler to handler.
Be consistent in your lot numbering so there is no confusion. If you begin with a lot code using the year first and then the number of days since January 1, do not switch in mid-year to placing the number of days first and then the year.
Lot codes should at minimum be traceable to grower, production line, and production date and time. This code should be listed on the shipping invoice and plant records. Computer records of lots sent with shipments will make recall simpler and product tracing significantly faster.
Work with growers who implement their own on-farm food quality and safety program and GAP’s
It is much easier and safer to carry out a HFSP when growers implement GAP’s. Growers who utilize safe and effective agricultural practices will minimize the potential for microbiological contamination. You can verify your grower’s quality and GAP program through written documentation and on-site inspection.
- Check with the grower to see if he or she has established GAP’s
- Maintain a copy of the grower’s GAP’s.
- Conduct on-site inspections to verify that growers are utilizing GAP’s. You can have your own GMP manager do the inspection or hire a third party.
- Have each grower sign a Grower Agreement (Appendix 10). This agreement should outline any requirements or exclusions for the hazelnuts the grower will deliver to you.
References Food and Drug Administration 21 CFR 110.80(a)(2)-(4) (Raw materials)
Maintain accurate records
- Abide by all federal, state and local regulations to keep your workplace safe and your product in compliance.
- Document each treatment.
- Ensure workers have been properly trained and certified.
- Record the dates of fumigation on tags attached to the product container.
- Follow all applicable label directions.
- Keep the Material Safety Data Sheet for each pesticide on file.
The USDA requires food processors to document each fumigation treatment in a logbook for
examination by USDA officials. Sample Fumigation Control Form in Appendix 11.
What are lethal processes?
In the context of this document, lethal processes refer to a step or process of steps that sufficiently reduces bacteria that may be present on hazelnuts. Experts recommend that a “5-log” reduction is an appropriate lethal process for hazelnuts. 5-log reduction is a term used to describe how much bacterial contamination can be reduced during a process such as pasteurizing with heat or chemicals. A simple way to think of “a log” is that it refers to the number of zeros behind the number 1. A 5-log reduction decreases bacteria by five zeros or 100,000 fold. Therefore, if you achieve a 5-log reduction in bacteria you eliminate five zeros.
Maintain records of lethal processes with all other records by specific lot number. Include copies of all blank lethal process documents adapted from the Fumigation Control Form located in Appendix 11.
Food and Drug Administration – 21 CFR 110.80(a)(2) and (b)(4)(Control of microorganisms)
Why an allergen program?
Tree nuts are among the eight most allergenic foods responsible for 90% of food allergies. Whileafflicting a small percentage of the overall population, food allergies, particularly to peanuts and tree nuts, can be severe and even fatal.
Even if a person is not allergic to hazelnuts, he or she may be allergic to other types of nuts. Therefore, it is very important for handlers to ensure that no other nuts – even in small amounts – are processed with or come in contact with hazelnuts. It is highly recommended that other nuts NOT be processed in the hazelnut plant, particularly if using hazelnut processing equipment.
This safety measure will protect consumers and your reputation.
Cleaning reduces the possibility of cross-contamination
However, if your business requires processing nuts other than hazelnuts, you need an allergen prevention program. This is especially true if more than one type of nut is processed on the same line, because the potential for cross-contamination increases substantially.
A documented cleaning program is essential for eliminating even the smallest residue of othernut products. Every time a product other than hazelnuts is processed at your plant, be sure ALL line equipment is completely cleaned before the next production run. Products are frequently recalled because of mislabeling, and this may become even more common as researchers develop new methods for detecting cross-contamination.
Food Allergy Issues Alliance -
Food Allergen Labeling Guidelines
• Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens
• Guide to Inspections of Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients
Product hold and release
Product Hold Timing
A product hold and release program should be established to ensure that no product is released until all the necessary chemical, physical, grade and microbiological analyses have been completed and customer specifications have been met.
All “HOLDS” should be coordinated through the Quality Control (QC) Department. Each department should notify QC personnel of any “HOLDS” and secure the tags for the product. HOLDS should be clearly labeled (e.g., with a red “HOLD” tag) on the containers or pallets (Appendix 12).
All incoming product to the plant should be automatically placed on hold until tests have been completed and the central QC authority has determined the products are within specification. Products that do not meet standards should remain on hold until it is proven that they are in compliance with specifications.
Any product in process and any finished product determined to be out of specification should be held for further evaluation. Finished product should be logged in and controlled by the lot number or by a control number stamped on each case or pallet of hazelnuts.
Procedures for “HOLDS” include:
- Hold notices are completed with all necessary information.
- The Hold notice is issued to all departments involved.
- The product on hold will be labeled with a completed Hold tag and the lot number will be recorded.
- Product pallets will be removed to the hold area pending disposition.
- Disposition of the product will be determined by senior management or the QC Manager.
- Hold tags may only be removed by QC personnel.
- All Hold tags must be accounted for by QC.
Grading and Inspection
USDA inspection and grading of hazelnuts is mandatory and must be conducted by USDA licensed inspectors.
In order to receive a USDA certification, final product ready for shipment must comply with established USDA standards. The final product must also comply with the stated standards if there are claims on invoices, product labels or advertising as to the grade of the final product.
Maintain files of your plant’s grading and inspection forms for review by customers and government agencies.
Food and Drug Administration
21 CFR 110.80(a)(1) (Raw materials inspection)
7 CFR 982 Hazelnuts Grown in Oregon and Washington
US Department of Agriculture
Net weight control
Labels must accurately state the quantity of food in the container exclusive of wrappers or packaging. Reasonable variation in quantity is recognized but cannot be unreasonably large. Customers, as well as government regulators, negatively regard under weights. Over weights can result in a loss of income. An effective GMP program includes a well-managed net-weight control plan. See Sample Control Chart for Weights form in Appendix 13.
Institute a program of random sampling to ensure labeled net weight reflects actual net weight. Document the weights of all random samples. When a discrepancy occurs, document the corrective action taken.
Food and Drug Administration
21 CFR 101.105(g) (accurate quantity), and 21 CFR 101.105 (q) (quantity variation)
Recalls – mock and real
No handler wants to face a product recall. However, an established product recall program is invaluable when a given lot is found to be in violation of regulatory requirements. These programs also demonstrate to regulatory officials that if necessary, any given lot number can be recalled from its destination. In fact, mock recalls are part of sound GMP’s.
To begin, appoint a Recall Coordinator and team. Use a recall team contact list to identify the recall team. See Sample Crisis/Recall Team Contact List in Appendix 14. The recall team should include at minimum a coordinator, a designated spokesperson, and representatives from marketing, distribution, technical, and production departments. Give the coordinator the authority to notify each customer who has received hazelnuts that must be returned to your facility. See Sample Recall Decision Tree in Appendix 15.
Conduct a mock recall to determine if you are able to produce accurate information on a timely basis verifying that all affected product can be rapidly identified and removed from the marketplace. Mock recalls are important for the following reasons:
- Test the overall effectiveness of your recall plan
- Assess supplier/customer recall programs
- Evaluate the reliability and accuracy of traceback systems
- Evaluate response time
- Assess the accuracy of record keeping systems
- Identify opportunities for program improvement
Implementing the recall
- The recall coordinator first determines the lot, day codes and total number of cases involved. All products are tracked by lot number, and that number should be shown on all documents from production to shipping.
- Find out where every case has been shipped. The lot number will reveal every customer who received the hazelnuts in question.
- Notify each of those customers that they must return the product to your plant.
- As the product arrives back at your plant, account for every case and store it safely, clearly marked “HOLD,” in a holding location away from other hazelnuts.
- Talk with the appropriate regulatory agency to decide how or whether to dispose of the hazelnuts in question.
- Hazelnuts can then be reworked, sterilized or destroyed, depending on the agreement reached with the regulatory agency.
- If the product is still usable, it must be retested and re-evaluated before shipping. It is highly recommended that a third party be used to confirm the effectiveness of treatment.A regulatory agency may have to provide approval before the product can be shipped.
- Make all your recall records available to everyone involved who has a legal right to see them.
- Alert the Hazelnut Marketing Board of the recall.
Types of FDA Action
According to the FDA, a recall is the removal of a marketed product considered to be in violation of FDA regulations. Market withdrawal is the removal of a distributed product, which involves a minor violation not subject to legal action by FDA. Stock recovery is the removal of product that has not been marketed or has not left direct control of the company.
Class I: Reasonably likely that the use of, or exposure to, a contaminated product will cause serious health consequences or death.
Class II: Reasonably likely that the use of, or exposure to a contaminated product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Class III: Reasonably likely that the use of, or exposure to, a contaminated product is not likely to cause adverse health consequences.
It is critical that recall communications be handled correctly and as expeditiously as possible. Only designated people should speak to the media. The company President/CEO should approve any changes in the recall procedure. In the event it becomes necessary to issue a press release, the following information should be included:
- Company name, contact names and phone numbers
- Address, including city and state
- Quantity and/or type of product
- Reasons for recall and a statement of possible hazard
- Area of distribution
- Specific information as to how the product can be identified
- Status and number of illnesses or injury
- A brief explanation of what is known about the problem
- Information on what consumers should do with the product and where they can get additional information
Crisis/Recall Team Contact list and Sample Recall Decision Tree located in Appendix 14 and 15.
Recall Team Responsibilities
1. Manage activities related to recall.
2. Convene recall team meetings and coordinate activities.
3. Keep recall master file.
4. Maintain recall plan.
1. Stop all in-transit shipments of questionable material and arrange for return of product to collection points.
2. Prepare inventory and distribution status of product showing where, when, and to whom quantity shipped.
Production and Quality Assurance
1. Prepare lot identification.
2. Halt production of product if a related problem exists.
3. Investigate cause of problem. Check all records.
4. Clear product only as recommended by the Recall Coordinator.
5. Do not destroy any product without observation by FDA if a health hazard is involved.
6. Keep records of any destruction.
1. Prepare responses for consumers.
2. Answer all consumer inquiries.
1. Set up collection system to determine cost of recall.
1. Handle legal implications.
2. Review all press and company correspondence.
1. Prepare press releases.
2. Prepare message points for people authorized to speak to the press.
3. Handle all media inquiries.
4. Coordinate all activities through Recall Coordinator.
1. Obtain lot identification and samples.
2. Obtain product analysis.
3. Coordinate all action through the Recall Coordinator until problem is resolved.
4. Consult with the lab testing the recalled product.
5. Consult with regulatory agencies if there is a recall.
1. Notify sales managers and brokers.
2. Arrange for pick-up at retail location if necessary.
3. Arrange for proper credit to be given.
Regional Sales Managers
1. Aid in contacting customers.
2. Assist in product pick-up and issuance of credit.
1. Aid in contacting customers.
2. Utilize sales force in actual product pick-up.
Appendices are available at the industry office.