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U.S. Department of Health and Human Services
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National Shellfish Sanitation Program
Guide for the Control of Molluscan Shellfish
2003

Model Ordinance

XII. Repacking Of Shucked Shellfish

Table of Contents


Additional Guidance - IV. Guidance Documents
.01 Critical Control Points.
  1. Receiving Critical Control Point - Critical Limits. The dealer shall repack only shellfish which:
    (1)
    Originated from a dealer; and [C]
    (2)

    Are identified with a label as outlined in Chapter X.06. [C]
  2. Processing Critical Control Point - Critical Limits. The dealer shall ensure that repacked shucked shellfish do not exceed an internal temperature of 45° Fahrenheit (7.2° Centigrade) for more than 2 hours. [C]

  3. Shucked Meat Storage Critical Control Point - Critical Limit. The dealer shall store repacked shellfish in covered containers at an ambient temperature of 45 ° Fahrenheit (7.2 ° Centigrade) or less or covered in ice. [C]
.02 Sanitation.
  1. Safety of Water for Processing and Ice Production.
    (1)
    Water Supply.
    (a)
    The dealer shall provide a potable water supply in accordance with applicable federal, state and local regulations. [C]
    (b)
    If the water supply is from a private source, the dealer shall make arrangements to have the water supply sampled by persons recognized by the Authority and tested at laboratories sanctioned or certified by the Authority: [K]
    (i)
    Prior to use of the water supply; [C]
    (ii)
    Every six months while the water supply is in use; and [K]
    (iii)
    After any water supply has been repaired and disinfected. [SC/K]
    (c)
    The dealer shall assure that any steam used in food processing or that comes in contact with food contact surfaces if free from any additives or deleterious substances consistent with federal and state laws and regulations. [K]
    (2)
    Ice Production. Any ice used in the processing, storage, or transport of shellstock or shucked shellfish shall:
    (a)
    Be made on-site from potable water in a commercial ice machine; or [C]
    (b)
    Come from a facility sanctioned by the Authority or the appropriate regulatory agency.[C]
    (3)
    Plumbing and Related Facilities.
    (a)
    The dealer shall design, install, modify, repair, and maintain all plumbing and plumbing fixtures to:
    (i)
    Prevent contamination of water supplies; [C]
    (ii)
    Prevent any cross-connection between the pressurized potable water supply and water from an unacceptable source. [C] The dealer shall install and maintain in good working order devices to protect against backflow and back siphonage. [K]

  2. Condition and Cleanliness of Food Contact Surfaces.
    (1)
    Equipment and utensil construction for food contact surfaces.
    (a)
    Except for equipment in continuous use and placed in service prior to January 1, 1989, the dealer shall use only equipment that conforms to Shellfish Industry Equipment Construction Guides (August l993), U.S. Department of Health and Human Services. [K]
    (b)
    The dealer shall use only equipment and utensils, including approved plastic ware which is:
    (i) Constructed in a manner and with materials that can be cleaned, sanitized, maintained or replaced in a manner to prevent contamination of shellfish products; and [K]
    (ii) Free from any exposed screws, bolts, or rivet heads on food contact surfaces; and [K]
    (iii) Fabricated from food grade materials. [K]
    (c)
    The dealer shall assure that all joints on food contact surfaces:
    (i) Have smooth easily cleanable surfaces; and [K]
    (ii) Are welded. [K]
    (d)
    All equipment used to handle ice shall be kept clean and stored in a sanitary manner, and shall meet the construction requirements in Chapter XI.02.B.(1)(a), (b), and (c). [K]
    (e)
    The dealer shall provide a temperature measuring device accurate to +/- 2° Fahrenheit for use in monitoring product temperatures. [K]
    (2)
    Cleaning and sanitizing of food contact surfaces.
    (a)
    Food contact surfaces of equipment, utensils and containers shall be cleaned and sanitized to prevent contamination of shellfish and other food contact surfaces. The dealer shall:
    (i)
    Provide adequate cleaning supplies and equipment, including three compartment sinks, brushes, detergents, and sanitizers, hot water and pressure hoses shall be available within the plant; [K]
    (ii)
    Sanitize equipment and utensils prior to the start-up of each day's activities and following any interruption during which food contact surfaces may have been contaminated; [K]
    (iii)
    Provide a test kit or other device that accurately measures the parts per million concentration of the chemical sanitizing agent in use; and [K]
    (iv)
    Wash and rinse equipment and utensils at the end of each day. [K]
    (3)
    Containers which may have become contaminated during storage shall be washed, rinsed, and sanitized prior to use or shall be discarded. [K]
    (4)
    Shucked shellfish shall be repacked in clean containers:
    (a)
    Fabricated from food grade materials; and [K]
    (b)
    Stored in a manner which assures their protection from contamination. [K]
    (5)
    If used, the finger cots or gloves shall be:
    (a)
    Made of impermeable materials except where the use of such material is inappropriate or incompatible with the work being done; [O]
    (b)
    Sanitized at least twice daily; [K]
    (c)
    Cleaned more often, if necessary; [K]
    (d)
    Properly stored until used; [K] and
    (e)
    Maintained in a clean, intact, and sanitary condition.[K]

  3. Prevention of Cross Contamination.
    (1)
    Protection of shellfish.
    (a)
    Shucked shellfish shall be protected from contamination. [SC/K]
    (b)
    Equipment and utensils shall be stored in a manner to prevent splash, dust, and contamination. [SK/0]
    (2)
    Employee practices.
    (a)
    The dealer shall assure that all employees working in direct contact with shellfish processing activities or food contact surfaces maintain a high level of personal hygiene and cleanliness. [K]
    (b)
    The dealer shall require all employees to wash their hands thoroughly with soap and water and sanitize their hands in an adequate hand washing facility:
    (i)
    Before starting work; [K]
    (ii)
    After each absence from the work station; [K]
    (iii)
    After each work interruption; and [K]
    (iv)
    Any time when their hands may have become soiled or contaminated. [K]

  4. Maintenance of Hand Washing, Hand Sanitizing and Toilet Facilities.
    (1)
    Hand washing facilities with warm water at a minimum temperature of 110° Fahrenheit (43° Centigrade), dispensed from a hot and cold mixing or combination faucet, shall be provided. [SK/O]
    (2)
    Sewage [C] and liquid disposable wastes [K] shall be properly removed from the facility.
    (3)
    An adequate number of conveniently located, toilets shall be provided. [K]
    (4)
    The dealer shall provide each toilet facility with an adequate supply of toilet paper[K] in a suitable holder. [SK/O]

  5. Protection from Adulterants.
    (1)
    Shellfish shall be protected from contamination while being transferred from one point to another during handling and processing. [K]
    (2) Any lighting fixtures, light bulbs, skylights, or other glass suspended over food storage or processing activities in areas where shellfish are exposed shall be of the safety type or protected to prevent food contamination in case of breakage. [O]
    (3) Food contact surfaces shall be protected from contamination by adulterants by using cleaning compounds and sanitizing agents only in accordance with applicable federal and state laws and regulations. [K]
    (4) Protection of ice used in shellfish processing.
    (a) Any ice, which is not made on site in the shellfish processing facility, shall be inspected upon receipt and rejected if the ice is not delivered in a way so as to be protected from contamination. [SC/K]
    (b) Ice shall be stored in a safe and sanitary manner to prevent contamination of the ice. [SC/K]
    (5) Adequate ventilation shall be provided to minimize condensation in areas where food is stored, processed or packed. [SC/K]

  6. Proper Labeling, Storage and Use of Toxic Compounds.
    (1)
    Storage of toxic compounds.
    (a) The dealer shall assure that only toxic substances necessary for plant activities are present in the facility. [K]
    (b) Each of the following categories of toxic substances shall be stored separately:
    (i) Insecticides and rodenticides; [K]
    (ii) Detergents, sanitizers, and related cleaning agents; and [K]
    (iii) Caustic acids, polishes, and other chemicals. [K]
    (c) The dealer shall not store toxic substances above shellfish or food contact surfaces. [K]
    (2) Use and labeling of toxic compounds.
    (a) When pesticides are used, the dealer shall apply pesticides in accordance with applicable federal and state regulations to control insects and rodents in such a manner to prevent the contamination of any shellfish or repackaging materials with residues. [K]
    (b) Cleaning compounds and sanitizing agents shall be labeled and used only in accordance with applicable federal and state laws and regulations. [K]
    (c) Toxic substances shall be labeled and used in accordance with the manufacturers label directions. [K]

  7. Control of Employees with Adverse Health Conditions.
    (1)
    The dealer shall take all reasonable precautions to assure that any employee with a disease in the communicable stage which might be transmissible through food shall be excluded from working in any capacity in which the employee may come in contact with the shellfish or with food contact surfaces. The diseases, which are transmissible from food workers through food, are those determined by the US Centers for Disease Control and Prevention, in compliance with the Americans with Disabilities Act, and published in the Federal Register. [K]
    (2) If an employee with an infected wound keeps it covered with a proper bandage, an impermeable barrier, and a single-use glove for a hand lesion, the dealer may allow the employee to work in the shellfish processing facility without additional restrictions. [K]

  8. Exclusion of Pests. The dealer shall operate his facility to assure that pests which may be a source of shellfish contamination are excluded from his facility and his activities. [K]
.03 Other Model Ordinance Requirements.
  1. Plants and Grounds.
    (1)
    General.
    (a) The physical facilities shall be maintained in good repair. [O]
    (b) Animals or unauthorized persons shall not be allowed in those portions of the facilities where shellfish are stored, handled, processed, or packaged or food handling equipment, utensils, and packaging materials are cleaned or stored. [K]
    (c)
    Air pump intakes shall be located in a protected place. Air filters shall be installed on all blower air pump intakes. Oil bath type filters are not allowed. [O]
    (2) Flooding:
    (a) Facilities in which shellfish are stored, shucked, packed, repacked or reshipped shall be located so that these facilities are not subject to flooding during ordinary high tides. [C]
    (b) If facilities are flooded:
    (i) Shellfish processing, shucking or repacking activities shall be discontinued until the flood waters have receded from the building; and the building is cleaned and sanitized. [C]
    (ii) Any shellfish coming in contact with the floodwaters while in storage shall be destroyed; or discarded in non-food use. [C]
    (3) The dealer shall operate his facility to provide adequate protection from contamination and adulteration by assuring that dirt and other filth are excluded from his facility and activities. [SC/K]
    (4) The dealer shall provide toilet room doors which are tight fitting, self-closing, and do not open directly into a processing area. [K]
    (5) Plant Interior.
    (a) Sanitary conditions shall be maintained throughout the facility. [O]
    (b) All dry area floors shall be hard, smooth, easily cleanable; and [O]
    (c) All wet area floors used in areas to process food and clean equipment and utensils shall be constructed of easily cleanable, impervious, and corrosion resistant materials which:
    (i) Are graded to provide adequate drainage; [O]
    (ii) Have even surfaces, and are free from cracks that create sanitary problems and interfere with drainage; [O]
    (iii) Have sealed junctions between floors and walls to render them impervious to water; and [O]
    (d) Walls and Ceilings. Interior surfaces of rooms where shellfish are stored, handled, processed, or shall be constructed of easily cleanable, corrosion resistant, impervious and packaged materials. [O]
    (6)
    Grounds. Grounds around the facility shall be maintained to be free from conditions which may result in shellfish contamination. These conditions may include:
    (a) Rodent attraction and harborage; and [O]
    (b) Inadequate drainage. [O]

  2. Plumbing and Related Facilities.
    (1)
    Hand washing facilities shall be provided which are:
    (a) Convenient to work areas; [O]
    (b) Separate from the three compartment sinks used for cleaning equipment and utensils; and [K]
    (c) Directly plumbed to an approved sewage disposal system. [SO/K]
    (2) The dealer shall provide at least one hand sink in the packing room. [O]
    (3) The dealer shall provide at each hand washing facility:
    (a) A supply of hand cleansing soap or detergent; [K]
    (b) A conveniently located supply of single service towels in a suitable dispenser or a hand drying device that provides heated air; [O]
    (c) An easily cleanable waste receptacle; and [O]
    (d) Hand washing signs in a language understood by the employees. [O]
    (4) All plumbing and plumbing fixtures shall be designed, installed, modified, repaired, and maintained to provide a water system that is adequate in quantity and under pressure, and includes:
    (a) Cold and warm water at all sinks; and [K]
    (b) Hand washing facilities adequate in number and size for the number of employees, and located where supervisors can observe employee use; [K]
    (5) Adequate floor drainage, including backflow preventers such as air gaps, shall be provided where floors are:
    (a) Used for food holding units (e.g. refrigeration units); [K]
    (b) Cleaned by hosing, flooding, or similar methods; and [K]
    (c) Subject to the discharge of water or other liquid waste including three compartment sinks on the floor during normal activities. [K]
    (6)
    A safe, effective means of sewage disposal for the facility shall be provided in accordance with applicable federal and state laws and regulations; [SC/K]
    (7)
    Installation of drainage or waste pipes over food processing or food storage areas, or over areas in which containers and utensils are washed or stored shall not be permitted. [K]

  3. Utilities.
    (1)
    The dealer shall ensure that ventilation, heating, or cooling systems do not create conditions that may cause the shellfish products to become contaminated. [SC/K]
    (2) The dealer shall provide lighting throughout the facility that is sufficient to promote good manufacturing practices. [SC/K]

  4. Insect and Vermin Control.
    (1)
    The dealer shall employ necessary internal and external insect and vermin control measures to insure that insects and vermin are not present in his facility including:
    (a) Tight fitting, self-closing doors; [K]
    (b) Screening of not less than 15 mesh per inch; and [K]
    (c) Controlled air currents. [K]

  5. Disposal of Other Wastes.
    (1)
    Disposal of waste materials shall be conducted in accordance with appropriate federal and state laws and regulations. [O]
    (2) All areas and receptacles used for the storage or conveyance of waste shall be operated and maintained to prevent attraction, harborage, or breeding places for insects and vermin. [O]

  6. Equipment Construction for Non-food Contact Surfaces.
    (1)
    The dealer shall use only equipment, including approved plastic ware, which is constructed in a manner and with materials that can be cleaned, sanitized, maintained, or replaced; and [O]
    (2) The dealer shall use easily cleanable, corrosion-resistant, impervious materials, free from cracks to construct any non-food contact surfaces in shellfish storage or handling areas. [O]

  7. Cleaning Non-food Contact Surfaces.
    (1)
    Cleaning activities for equipment and utensils shall be conducted in a manner and at a frequency appropriate to prevent contamination of shellfish and food contact surfaces. [K]
    (2) All conveyances and equipment which come into contact with stored shellstock shall be cleaned and maintained in a manner and frequency as necessary to prevent shellstock contamination. [O]

  8. Shellfish Storage and Handling.
    (1)
    The dealer shall:
    (a) Not commingle shellfish from different lots; [K]
    (b) Repack shucked shellfish meats only into containers labeled with the authorized certification number; [K]
    (c) Not have on the premises any usable containers or container covers bearing a certification number different from the one issued for those premises unless documentation exists to verify the legitimate source of the containers and the containers contain shellfish from that source. [K]
    (d) Wash, blow, and rinse all shellfish meats in accordance with 21 CFR 161§130. [K]
    (e) Thoroughly drain, clean as necessary, and repack [K] shucked shellfish meats promptly;
    (f)
    Conduct repacking activities so as to conform to applicable food additive regulations; [K]
    (g)
    Store packaged shellfish, if they are to be frozen, at an ambient temperature of 0° Fahrenheit (-17.8° Centigrade) or less and frozen solid within twelve hours following the initiation of freezing. [SK/O]

  9. Heat Shock. N/A.

  10. Personnel. Any employee handling shucked shellfish shall be required to:
    (1)
    Wear effective hair restraints; [O]
    (2) Remove any hand jewelry that cannot be sanitized or secured; [O]
    (3) Wear finger cots or gloves if jewelry cannot be removed. [O]
    (4) Wear clean outer garments, which are rinsed or changed as necessary to be kept clean. [O]
    (5) In any area where shellfish are shucked or packed and in any area that is used for the cleaning or storage of utensils, the dealer shall not allow employees to:
    (a) Store clothing or other personal belongings; [K]
    (b) Eat or drink; [K]
    (c) Spit; and [K]
    (d) Use tobacco in any form. [K]

  11. Supervision.
    (1)
    A reliable, competent individual shall be designated to supervise general plant management and activities; [K]
    (2) Cleaning procedures shall be developed and supervised to assure cleaning activities do not result in contamination of shellfish or food contact surfaces. [K]
    (3) All supervisors shall be:
    (a) Trained in proper food handling techniques and food protection principles; and [K]
    (b) Knowledgeable of personal hygiene and sanitary practices. [K]
    (4) The dealer shall require:
    (a) Supervisors to monitor employee hygiene practices, including hand washing, eating, and smoking at work stations, and storing personal items or clothing. [K]
    (b) Supervisors to assure that proper sanitary practices are implemented, including:
    (i) Plant and equipment clean-up; [K]
    (ii) Rapid product handling; and [K]
    (iii) Shellfish protection from contamination. [K]
    (c) Employees
    (i) to be trained in proper food handling and personal hygiene practices, and [K]
    (ii) to report any symptoms of illness to their supervisor. [K]

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