(A) Critical control points.

(1) The dealer shall shuck and pack only shellstock which is from sources certified by the director or listed in the ICSSL; and identified with a tag on each container or a transaction record on each bullk shipment.

(2) The dealer shall ensure that the storage of shellstock once placed under temperature control and until sale to the processor or final consumer, shellstock shall be:

(a) Iced; or

(b) Placed and stored in a storage area or conveyance maintained at forty-five degrees Fahrenheit or less;

(c) Not permitted to remain without ice, mechanical refrigeration or other approved methods of refrigeration for more than two hours at points of transfer such as loading docks; and

(d) Not permitted to be placed in wet storage.

(3) The dealer that processes shall ensure that:

(a) For shellstock refrigerated prior to shucking, shucked meats are chilled to an internal temperature of forty-five degrees Fahrenheit or less within four hours of removal from refrigeration.

(b) If heat shock is used, once heat shocked shellstock is shucked, the shucked shellfish meats shall be cooled to forty-five degrees Fahrenheit or less within two hours after the heat shock process.

(4) The dealer shall store shucked and packed shellfish in covered containers at an ambient air temperature in the storage area of forty-five degrees Fahrenheit or less.

(B) Sanitation.

(1) Safety of water supply for processing and ice production.

(a) Water supply.

The dealer shall provide a water supply approved by the applicable regulatory agency:

(i) For a public water system, the Ohio environmental protection agency; or

(ii) For a private water system, the local board of health.

(b) The dealer shall have the water supply sampled in accordance with the approval of the Ohio environmental protection agency or the local board of health as applicable, and shall maintain sample results on file at the plant.

(c) The dealer shall assure that any steam used in food processing or that comes in contact with food contact surfaces is free from any additives, or deleterious substances.

(d) Any ice used in the processing, storage, or transport of shellstock or shucked shellfish shall:

(i) Be made on-site from potable water in a commercial ice machine; or

(ii) Come from a facility approved by the director or the appropriate regulatory agency.

(e) Shellstock washing.

(i) Water from a potable water supply shall be used to wash shellstock.

(ii) If the dealer uses any system to wash shellstock which recirculates water, the dealer shall:

(a) Obtain approval for the construction or remodeling of the system from the director.

(b) Provide a water treatment and disinfection system to treat an adequate quantity of water to a quality acceptable for shellstock washing which, after disinfection, meets the coliform standards for drinking water, and does not leave any unacceptable residues in the shellstock; and

(c) Test bacteriological water quality daily.

(f) Plumbing and related facilities.

(i) The dealer shall design, install, modify, repair, and maintain all plumbing and plumbing fixtures to:

(a) Prevent contamination of water supplies;

(b) Prevent any cross-connection between the pressurized potable water supply and water from an unacceptable source. The dealer shall install and maintain in good working order devices to protect against backflow and back siphonage.

(ii) Shellstock washing storage tanks and related plumbing shall be fabricated from safe materials and tank construction shall be such that it:

(a) Is easily accessible for cleaning and inspection;

(b) Is self-draining; and

(c) Meets the requirements for food contact surfaces.

(2) Condition and cleanliness of food contact surfaces.

(a) Equipment and utensil construction for food contact surfaces.

(i) Except for equipment in continuous use and placed in service prior to January 1, 1989, the dealer shall use only equipment which conforms to the shellfish industry equipment construction guide in Appendix A of this rule.

(ii) The dealer shall use only equipment and utensils, including approved plastic ware and finished product containers which are:

(a) Constructed in a manner and with materials that can be cleaned, sanitized, maintained or replaced in a manner to prevent contamination of shellfish products;

(b) Free from any exposed screws, bolts, or rivet heads on food contact surfaces; and

(c) Fabricated from food grade materials.

(iii) The dealer shall assure that all joints on food contact surfaces have smooth easily cleanable surfaces; and are welded.

(iv) Shucking blocks shall be provided which are:

(a) Easily cleanable;

(b) Fabricated from safe material;

(c) Solid, one piece construction; and

(d) Easily removed from the shucking bench, unless the block is an integral part of the bench.

(v) All equipment used in heat shock processing shall meet the requirements of paragraph (B)(2)(a)(i), paragraph (B)(2)(a)(ii), and paragraph (B)(2)(a)(iii) of this rule.

(vi) All equipment used to handle ice shall be kept clean and stored in a sanitary manner, and shall meet the construction requirements in paragraph (B)(2)(a)(i), paragraph (B)(2)(a)(ii), and paragraph (B)(2)(a)(iii) of this rule.

(b) Cleaning and sanitizing of food contact surfaces.

(i) 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:

(a) 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;

(b) 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; and

(c) Wash and rinse equipment and utensils at the end of each day.

(ii) 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.

(iii) Shellfish shall be protected from contamination by washing and rinsing shucking containers and sanitizing before each filling.

(iv) Containers which may have become contaminated during storage shall be washed, rinsed, and sanitized prior to use or shall be discarded.

(v) Shucked shellfish shall be packed in clean containers and stored in a manner which assures their protection from contamination.

(vi) 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;

(b) Sanitized at least twice daily;

(c) Cleaned more often, if necessary;

(d) Properly stored until used; and

(e) Maintained in a clean, intact, and sanitary condition.

(3) Prevention of cross contamination.

(a) Protection of shellfish.

(i) Shellstock shall be stored in a manner to protect shellstock from contamination in dry storage and at points of transfer.

(ii) Shucked shellfish shall be protected from contamination.

(iii) Shellstock shall not be placed in containers with standing water for the purposes of washing shellstock or loosening sediment.

(iv) Equipment and utensils shall be stored in a manner to prevent splash, dust, and contamination.

(b) Employee practices.

(i) Where the same employees work in both the shucking and packing activities, the employees shall wash their hands thoroughly after entering.

(ii) 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:

(a) Before starting work;

(b) After each absence from the work station;

(c) After each work interruption; and

(d) Any time when their hands may have become soiled or contaminated.

(4) Maintenance of hand washing, hand sanitizing, and toilet facilities.

(a) Hand washing facilities with warm water at a minimum temperature of one hundred ten degrees Fahrenheit, dispensed from a hot and cold mixing or combination faucet, shall be provided.

(b) Sewage and liquid disposable wastes shall be properly removed from the facility.

(c) An adequate number of conveniently located toilets shall be provided.

(d) The dealer shall provide each toilet facility with an adequate supply of toilet paper in a suitable holder.

(5) Protection from adulterants.

(a) Shellfish shall be protected from contamination while being transferred from one point to another during handling and processing.

(b) 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.

(c) Food contact surfaces shall be protected from contamination by adulterants by using cleaning compounds and sanitizing agents only in accordance with manufacturer label directions.

(d) Protection of ice used in shellfish processing.

(i) 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.

(ii) Ice shall be stored in a safe and sanitary manner to prevent contamination of the ice.

(e) Ventilation shall be provided to minimize condensation in areas where food is stored, processed, or packed.

(6) Proper labeling, storage, and use of toxic compounds.

(a) Storage of toxic compounds.

(i) The dealer shall assure that only toxic substances necessary for plant activities are present in the facility.

(ii) Each of the following categories of toxic substances shall be stored separately:

(a) Insecticides and rodenticides;

(b) Detergents, sanitizers, and related cleaning agents; and

(c) Caustic acids, polishes, and other chemicals.

(iii) The dealer shall not store toxic substances above shellfish or food contact surfaces.

(b) Use and labeling of toxic compounds.

(i) When pesticides are used, the dealer shall apply pesticides in accordance with Chapter 921. of the Revised Code and the rules adopted thereunder to control insects and rodents in such a manner to prevent the contamination of any shellfish or packaging materials with residues.

(ii) Cleaning compounds and sanitizing agents shall be properly labeled and used only in accordance with the manufacturer's label directions.

(iii) Toxic substances shall be labeled and used in accordance with the manufacturer's label directions.

(7) Control of employees with adverse health conditions.

(a) 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.

(b) An employee with an infected wound shall keep it covered with a proper bandage, an impermeable barrier, and a single-use glove for a hand lesion.

(8) The dealer shall operate the facility to assure that pests are excluded from the facility and processing activities.

(C) Physical facilities.

(1) Plants and grounds.

(a) General.

(i) The physical facilities shall be maintained in good repair.

(ii) 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.

(iii) 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.

(b) Separation of operations.

(i) Facilities for shucking and packing activities shall be separated by use of:

(a) Separate rooms;

(b) Partitions; or

(c) Sufficient spacing.

(ii) Manufacturing activities which could result in the contamination of the shellfish shall be separated by adequate barriers.

(c) The dealer shall provide toilet room doors which are tight fitting, self closing, and do not open directly into a processing area.

(d) Plant interior.

(i) Sanitary conditions shall be maintained throughout the facility.

(ii) All dry area floors shall be hard, smooth, easily cleanable;

(iii) All wet area floors used in areas to store shellstock, process food, and clean equipment and utensils shall be constructed of easily cleanable, impervious, and corrosion resistant materials which:

(a) Are graded to provide adequate drainage;

(b) Have even surfaces, and are free from cracks that create sanitary problems and interfere with drainage; and

(c) Have sealed junctions between floors and walls to render them impervious to water.

(iv) Walls, ceilings, and interior surfaces of rooms where shellfish are stored, handled, processed, or packaged shall be constructed of easily cleanable, corrosion resistant, impervious materials.

(e) Grounds around the facility shall be maintained to be free from rodent attraction and harborage, and inadequate drainage conditions which can result in shellfish contamination.

(2) Plumbing and related facilities.

(a) Hand washing facilities shall be provided which are:

(i) Convenient to work areas;

(ii) Separate from the three compartment sinks used for cleaning equipment and utensils; and

(iii) Directly plumbed to an approved sewage disposal system.

(b) The dealer shall provide at least one hand sink in the packing room.

(c) The dealer shall provide at each hand washing facility:

(i) A supply of hand cleansing soap or detergent;

(ii) A conveniently located supply of single service towels in a suitable dispenser or a hand drying device that provides heated air;

(iii) An easily cleanable waste receptacle; and

(iv) Hand washing signs in a language understood by the employees;

(d) 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:

(i) Cold and warm water at all sinks; and

(ii) Hand washing facilities adequate in number and size for the number of employees, and that are located where supervisors can observe employee use;

(e) Adequate floor drainage, including backflow preventers such as air gaps, shall be provided where floors are:

(i) Used in shellstock storage;

(ii) Used for food holding units;

(iii) Cleaned by hosing, flooding, or similar methods; and

(iv) Subject to the discharge of water or other liquid waste on the floor during normal activities.

(f) A safe, effective means of sewage disposal for the facility shall be provided;

(g) 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.

(3) Ventilation, heating, or cooling systems shall not create conditions that may cause the shellfish products to become contaminated.

(4) To insure that insects and vermin are not present in the facility, the dealer shall employ necessary internal and external insect and vermin control measures including but not limited to tight fitting, self-closing doors; screening of not less than fifteen mesh per inch; and controlled air currents.

(5) Disposal of waste materials, shell and other non-edible materials shall be promptly and effectively removed from the shucking bench or table. 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.

(6) Equipment construction for non-food contact surfaces.

(a) 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.

(b) The dealer shall use easily cleanable, corrosion resistant, impervious materials, free from cracks to construct:

(i) Shucking benches and contiguous walls; and

(ii) Stands or stalls and stools for shucker;

(iii) Any non-food contact surfaces in shellfish storage or handling areas.

(c) Shucking benches shall drain completely and rapidly, and shall drain away from any shellfish on the benches.

(7) Cleaning non-food contact surfaces.

(a) Cleaning activities for equipment shall be conducted in a manner and at a frequency appropriate to prevent contamination of shellfish and food contact surfaces.

(b) 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.

(8) Shellfish storage and handling.

The dealer shall:

(a) Assure that shellstock is:

(i) Reasonably free of sediment; and,

(ii) Culled.

(b) Completely empty shucking buckets at the packing room so that no overage is returned to the shucker.

(c) Inspect incoming shipments and shall reject dead or inadequately protected shellstock.

(d) Not allow the use of dip buckets for hand or knife rinsing.

(e) 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.

(f) Wash, blow, and rinse all shellfish meats in accordance with 21 CFR 161.130 (2018).

(g) Thoroughly drain, clean as necessary, and pack shucked shellfish meats promptly after delivery to the packing room.

(h) Conduct packing activities so as to conform to applicable food additive regulations.

(i) Store packaged shellfish, if they are to be frozen, at an ambient temperature of zero degrees Fahrenheit or less; and frozen solid within twelve hours following the initiation of freezing.

(j) Not commingle shellstock during shucking.

(9) A dealer that uses heat shock to prepare shellstock for shucking shall:

(a) Post the schedule for the heat shock process in a conspicuous location; and

(b) Make sure all responsible persons are familiar with the requirements.

(c) Cool all hot dipped shellstock immediately after the heat shock process. This cooling shall be accomplished by:

(i) Dipping in an ice bath; or

(ii) Use of flowing potable water.

(d) If a heat shock water tank is used, the dealer shall completely drain and flush the tank at three hour intervals or less so that all mud and debris which have accumulated in the dip tank are eliminated.

(10) Any employee handling shucked shellfish shall be required to:

(a) Wear effective hair restraints;

(b) Remove any hand jewelry that cannot be sanitized or secured;

(c) Wear finger cots or gloves if jewelry cannot be removed;

(d) Wear clean outer garments, which are rinsed or changed as necessary to be kept clean; and

(e) In any area where shellfish are shucked or packed and in any area which is used for cleaning or storage of utensils, the dealer shall not allow employees to:

(i) Store clothing or other personal belongings;

(ii) Eat or drink;

(iii) Spit; or

(iv) Use tobacco in any form.

(11) Supervision.

(a) A reliable, competent individual shall be designated to supervise general plant management and activities.

(b) Cleaning procedures shall be developed and supervised to assure cleaning activities do not result in contamination of shellfish or food contact surfaces.

(c) All supervisors shall be:

(i) Trained in proper food handling techniques and food protection principles; and

(ii) Knowledgeable of personal hygiene and sanitary practices.

(d) The dealer shall require:

(i) Supervisors to monitor employee hygiene practices, including hand washing, eating, and smoking at work stations, and storing personal items or clothing;

(ii) Supervisors to assure that proper sanitary practices are implemented, including:

(a) Plant and equipment clean-up;

(b) Rapid product handling; and,

(c) Shellfish protection from contamination.

(iii) Employees to be trained in proper food handling and personal hygiene practices, and to report any symptoms of illness to their supervisor.

View Appendix