Section 70.21. Molluscan shellfish processing.

 

(1)   Definitions. In this section:

(a) "Blower" means a device used for washing shucked shellfish which uses forced air as a means of agitation.

(b) "Broker" means any person who is not a dealer but who arranges the packaging, shipping, sale, or distribution of molluscan shellfish without taking ownership or physical custody of the shellfish.

(c) "Certification" or "certify" means the issuance of a numbered certificate to a licensee dealer for a particular activity or group of activities that indicates approval from the department to conduct the activity and compliance with this chapter.

(d) "Certification number" means the number that conforms to the United States food and drug administration generated-number in the ICSSL.

(e) "Commingle" means the act of combining different lots of food, including shellstock or shucked shellfish.

(f) "Critical limit" means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of an identified food safety hazard.

(g) "Cull" means to remove dead or unsafe shellstock from a lot of shellstock.

(h) "Dealer" means a licensee to whom certification is issued for the activities of shellstock shipper, shucker-packer, repacker, or reshipper.

(i) "Depuration processor" means a person who harvests or receives shellstock from growing areas designated in an approved or conditionally approved, restricted, or conditionally restricted classification by the governing authority and submits such shellstock to an approved depuration process.

(j) "Dry storage" means the storage of shellstock out of water.

(k) "Growing area" means any site which supports or could support the propagation of shellstock by natural or artificial means.

(L) "Harvest area" means a growing area from which commercial quantities of shellstock may be removed and may include aquaculture sites and facilities.

(m) "Harvester" means a person who takes shellstock by any means from a growing area.

(n) "Heat shock" means the process of subjecting shellstock to any form of heat treatment to facilitate shucking, including steam, hot water or dry heat, without substantially altering the physical or organoleptic characteristics of the shellfish.

(o) "ICSSL" means the Interstate Certified Shellfish Shippers List, United States food and drug administration publication of shellfish dealers, domestic and foreign, who have been certified by a state or foreign authority.

(p) "In-shell product" means non-living, processed shellfish with one or both shells present.

(q) "In-shell product packing" means the process of placing in-shell product into containers for introduction into commerce.

(r) "Label" means any written, printed, or graphic matter affixed to, or appearing upon, any package containing shellfish.

(s) "Licensee dealer" means a plant licensed in Wisconsin for the activities of shellstock shipper, shucker-packer, repacker, or reshipper.

(t) "Lot of in-shell product" means a single type of container of in-shell product from no more than one day's harvest from a single defined growing area.

(u) "Lot of shellstock" means a single type of bulk shellstock or containers of shellstock from no more than one day's harvest from a single defined growing area.

(v) "Lot of shucked shellfish" means a collection of containers of no more than one day's shucked shellfish, produced under conditions as nearly uniform as possible and designated by a common container code or marking.

(w) "Molluscan shellfish" means any edible species, whether shucked or in one or 2 shells, of fresh or frozen oysters, clams, mussels, or edible portions of such species, or scallops except when the product consists entirely of the shucked adductor muscle.

(x) "NSSP" means the National Shellfish Sanitation Program.

(y) "Person" means any individual, receiver, trustee, guardian, fiduciary, or representative of any kind, and any partnership, association, corporation, or other entity. "Person" includes the federal government, the state, and any other public or private entity.

(z) "Potable water" means water obtained from a source that meets the requirements of ch. NR 809 .

(za) "Raw shellfish" means shellfish that have not been thermally processed to an internal temperature of at least 145 ° F (62.8 ° C) for at least 15 seconds (or a temperature-time combination of equivalent lethality), or to an extent that the organoleptic characteristics of the shellfish are altered.

(zc) "Repacker" means any licensee dealer, other than the original certified shucker-packer, that repackages shucked shellfish into other containers.

(ze) "Repack shellstock" means the practice of removing shellstock from containers and placing it into other containers.

(zg) "Reshipper" means a licensee dealer that purchases shucked shellfish or shellstock from shellstock shippers, shucker-packers, and repackers and sells the product, without repacking or relabeling, to other dealers, wholesalers, or retailers.

(zi) "Restricted use shellstock" means shellstock that is harvested from growing areas classified by the governing authority as approved under conditions that do not allow the sale of shellstock for direct marketing for raw consumption and is identified with a tag indicating that the shellstock is intended for further processing prior to distribution retail or food service.

(zk) "Shellstock" means live molluscan shellfish in the shell.

(zm) "Shellstock packing" means the process of placing shellstock into containers for introduction into commerce.

(zp) "Shellstock shipper" means a licensee dealer that grows, harvests, buys, repacks, and sells shellstock, or transports shucked shellfish but may not shuck shellfish or repack shucked shellfish.

(zr) "Shucked shellfish" means molluscan shellfish that have one or both shells removed.

(zt) "Shucker-packer" means a licensee dealer that shucks and packs shellfish and may act as a shellstock shipper or reshipper or may repack shellfish originating from other certified dealers.

(zv) "Transaction record" means the form or forms, used to document each purchase or sale of shellfish at the wholesale level, and including shellfish harvest and sales records, ledgers, purchase records, invoices, and bills of lading.

(zx) "Wet storage" means the storage by a licensee dealer of shellstock from growing areas designated in the approved classification or in the open status of the conditionally approved classification by the governing authority, in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater at any permitted land-based activity or facility.

(2)   Prohibited acts.

(a) In order to ensure that molluscan shellfish in commerce in this state is not adulterated or misbranded as defined in ss. 97.02 and 97.03 , Stats., it is unlawful to process, store, transport, handle, or sell molluscan shellfish or molluscan shellfish products unless the molluscan shellfish is received and tagged as coming from a certified dealer and thereafter protected from contamination and unclean, unhealthy, or insanitary conditions.

(b) No licensee may operate as a licensee dealer without providing the department with a business address at which inspections of facilities, activities, or equipment can be conducted, and obtaining certification from the department.

(c) Only a licensee dealer may handle, receive, store, sort, shuck, repack, or otherwise process molluscan shellfish for interstate commerce.

(d) No person may shuck shellfish for interstate commerce without being certified as a shucker-packer.

(e) No person may repack shucked shellfish for interstate commerce without being certified as a shucker-packer or repacker.

(f) No person may repack shellstock for interstate commerce without being certified as a shellstock shipper, shucker-packer, or repacker.

(g) No person may ship shellstock in interstate commerce without being certified as a shellstock shipper, shucker-packer, or repacker.

(h) No person may purchase shellstock or shucked shellfish from licensee or certified dealers and sell the product in interstate commerce, without repacking or relabeling, to other licensee or certified dealers, wholesalers, or retailers without being certified as a reshipper.

(i) No licensee dealer may commingle, sort, or repack shellstock or shucked shellfish in a way that loses the identity of the lot.

(j) No licensee dealer may handle, store, process, or ship shellstock or shucked shellfish unless it is accompanied by an existing tag or label, or a tag or label that accurately reproduces all information on the original tag or label that accompanied the lot or shipment.

(k) No licensee dealer certified as a reshipper may conduct wet storage activities.

(3)   Licensee dealer certification and enforcement.

(a) A licensee dealer requesting certification shall be subject to a comprehensive, on-site inspection by a standardized department representative not more than 120 days before issuance or renewal of certification, and shall comply with par. (b) or (c) . The department shall ensure that each certification meets all of the following:

1. Certification shall expire annually, with the expiration month set by the department.

2. Only one certification number shall be issued for each licensee dealer.

3. Each certification number shall be unique.

(b) Initial certification shall be given only to a licensee dealer once all of the following requirements have been met:

1. The department has approved any HACCP plans developed by the licensee dealer to meet the requirements of sub. (18) .

2. The department has determined that the licensee dealer is in substantial compliance with subch. II and subs. (5) to (16) and (18) .

3. The department has approved construction, operational, and remodeling plans, if appropriate, for wet storage operations.

(c) Renewal of certification shall be given only to a licensee dealer upon determination by the department that the licensee dealer is in substantial compliance with subch. II and subs. (5) to (16) and (18) .

(d) No licensee dealer may operate as a licensee dealer with a revoked or suspended certification.

(e) Upon certification of a licensee dealer, the department shall notify the United States food and drug administration for the purpose of having the licensee dealer listed in the ICSSL.

(f) Upon suspension or revocation of a licensee dealer's certification, the department shall notify the United States food and drug administration for the purpose of having the licensee dealer removed from the ICSSL.

(g) The department shall inspect licensee dealers as required by one of the following:

1. Within 30 days of the licensee dealer beginning activities if the initial certification was based on a pre-operational inspection.

2. At least monthly for a licensee dealer certified as a depuration processor.

3. At least quarterly for a licensee dealer certified as a shucker-packer or repacker.

4. At least semiannually for a licensee dealer certified for other activities or operation of a wet storage operation.

5. At least annually for a licensee dealer who has demonstrated a history of satisfactory compliance for the past 3 years.

(h) The department shall provide the licensee dealer with a report describing the findings of each inspection, including a listing of deficiencies and corresponding citations of this chapter.

(i) When an inspection detects a deficiency that is critical for the protection of public health, the licensee dealer shall correct the deficiency during that inspection, or cease production affected by the deficiency, or the department shall begin the revocation or suspension of the licensee dealer's certificate.

(j) The department shall notify a licensee dealer, who is certified for wet storage, within 24 hours of any change in growing area classification or status affecting the operation of the wet storage facility.

(4)   Compliance. A licensee dealer shall comply with subch. II and 21 CFR Part 123 .

(5)   Trucks only licensee. A licensee dealer, whose facilities consist of trucks only, shall have either a licensed facility for the storage of shellfish, or arrangements with an appropriately licensed facility for the storage of shellfish and a permanent business address at which records are maintained and inspections of those records can be performed.

(6)   Equipment and facilities.

(a) Before licensing, the department shall review all equipment for conformance with the Shellfish Industry Equipment Construction Guide, Section IV Chapter III .01, of the NSSP (2009). All equipment shall be constructed in a manner, and with materials, that can be cleaned and sanitized, maintained, or replaced in a way that prevents contamination of shellfish products.

(b) A licensee dealer who is a certified shucker-packer shall provide shucking blocks which are solid, of one-piece construction, and easily removed from the shucking bench unless the block is an integral part of the bench. Shucking benches, contiguous walls, and stands or stalls and stools for shuckers shall be made of easily cleanable, corrosion-resistant impervious materials which are free from cracks. Shucking benches shall drain completely and rapidly away from any shellfish on the benches.

(c) When monitoring product temperatures, the licensee dealer shall use a temperature measuring device accurate to within 2 ° F (1 ° C).

(d) All equipment used in heat shock processing shall comply with the requirements of subch. II and this subchapter.

(e) All equipment used to handle ice shall be of sanitary design and construction, and kept clean and stored in a sanitary manner.

(f) Shellstock washing storage tanks and related plumbing shall be of sanitary design and construction, easily accessible for cleaning and inspection, self-draining, and cleaned and sanitized in the same manner as other food contact surfaces.

(g) Facilities for shucking and packing activities shall be separated by use of separate rooms, partitions, or sufficient spacing. Other food manufacturing activities which could result in the contamination of shellfish shall be separated by adequate barriers.

(h) 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 prohibited.

(i) All door and window screens shall be not less than 15 mesh per inch.

(7)   Sanitation. A licensee dealer shall comply with the sanitation requirements of subch. II and ensure that all of the following apply:

(a) Any operations water from a private source shall be sampled by a person recognized by the department and tested at a laboratory licensed by the department before use of the water supply, every 6 months while the water supply is in use, and after the water supply has been repaired and disinfected.

(b) Shellstock washing shall only be done using water from a potable water supply. If recirculated water is used to wash shellstock, the licensee dealer shall obtain approval for the construction or remodeling of the system and its operation from the department, treat the water so that it is potable and does not leave any unacceptable residues on the shellstock, and test the microbiological quality of the water daily.

(c) Employees working in both shucking and packing activities shall wash their hands before beginning shucking or packing. Employees shall comply with handwashing requirements of this chapter and after each handwashing shall sanitize their hands in a handwashing facility that meets all of the following requirements:

1. Supplies warm water at a temperature of at least 100 ° F (37.8 ° C), and shall be directly plumbed to an approved sewage disposal system.

2. Contains at least one handwashing sink available in a room used for shellfish packing.

3. Has a posted sign clearly visible to all employees at each handwashing sink that indicates handwashing is required. Each sign shall be translated in one or more languages understood by the employees using the sink.

(d) No clothing or personal belongings shall be stored in any area where shellfish are shucked or packed, and in any area which is used for the cleaning or storage of utensils used to shuck or pack shellfish.

(e) All employees shall immediately report to the licensee dealer any symptoms of disease transmissible through food. This reporting shall be in a manner that allows the licensee dealer to reduce the risk of shellfish-borne disease transmission, including providing information such as previous exposure to shellfish-borne disease, date of symptom onset, description of symptoms, and a diagnosis by a health practitioner. The licensee dealer shall notify the department within one working day when informed by an employee of hepatitis symptoms or diagnosis, and shall take immediate action to ensure that the employee is excluded from working in any capacity in which they may contact shellfish, contact food contact surfaces, or transmit the illness to other employees.

(f) The licensee dealer shall ensure that the only toxic substances present in the facility are those necessary for plant activities. Separate storage shall be provided for pesticides; detergents, sanitizers, and other related cleaning agents; and strong acids, bases, polishes, and other chemicals. No toxic substances shall be stored above shellfish or food contact surfaces.

(g) Chemicals, including those used for cleaning or sanitizing, and toxic substances shall be labeled and used in accordance with the manufacturer's label directions.

(h) Shell and other non-edible materials shall be promptly and effectively removed from the shucking bench or table.

(8)   Supervision and training.

(a) A licensee dealer shall designate an employee to supervise general plant management and activities.

(b) The supervisor shall be trained in proper food handling techniques and principles of food protection, and be knowledgeable of personal hygiene and sanitary practices.

(c) A licensee dealer shall ensure that the supervisor monitors sanitation and employee hygiene practices for compliance with the requirements of this chapter.

(d) A licensee dealer shall ensure that employees are trained in proper food handling, sanitation, and personal hygiene practices necessary for compliance with the requirements of this chapter.

(9)   Receiving.

(a) Shipment acceptability. Fresh molluscan shellfish shipments shall be considered acceptable when all of the following apply:

1. Each shipment is properly identified with tags and shipping documents.

2. All shellstock in the shipment is alive and cooled to an internal shellstock body temperature of 50 ° F (10 ° C) or less.

3. All shucked shellfish in the shipment is cooled to a temperature of 45 ° F (7.2 ° C) or less.

4. If the time-temperature indicating device shows that the ambient air temperature has exceeded 45 ° F (7.2 ° C) but the shellstock internal body temperature is 50 ° F (10 ° C) or less.

5. All other conditions of shipment in this chapter are met.

(b) Shipment rejection. The department shall notify the shipper, the licensee dealer, and the state where the shipment originated, of a shipment's rejection, when the department determines any of the following have occurred:

1. Any molluscan shellfish are not properly identified with tags or shipping documents.

2. Any internal shellstock body temperature exceeds 60 ° F (15.6 ° C).

3. Any shucked shellfish temperature exceeds 50 ° F (10 ° C).

4. Any shellfish purchased as frozen has thawed.

5. Any other reason that the product is adulterated or unsafe for human consumption.

(c) Receiving molluscan shellfish. The licensee dealer receiving molluscan shellfish shall do all of the following:

1. Reject or discard any molluscan shellfish shipments which do not originate from a licensed harvester or dealer listed in the ICSSL, are unwholesome or adulterated, inadequately protected, or whose source cannot be identified.

2. Place molluscan shellfish under temperature control within 2 hours after receipt from the harvester or when the shipper is also the harvester, when shellstock reaches the shipper's facility.

3. Ensure that once shellstock is placed in storage under temperature control and until sale to the processor or final consumer, it shall meet all of the following conditions:

a. The shellstock shall be iced or placed and stored in a storage area or conveyance with ambient air temperature maintained at 45 ° F (7.2 ° C) or colder.

b. The shellstock shall not be permitted to remain without ice, mechanical refrigeration, or other approved methods of refrigeration for more than 2 hours at points-of-transfer such as loading docks.

c. The shellstock shall not be permitted to be placed in wet storage.

4. Ensure that frozen shellfish remains frozen.

(10)   Shellstock identification.

(a) The licensee dealer shall buy shellstock only from sources listed in the ICSSL.

(b) The licensee dealer shall keep the harvester's tag affixed to each container of shellstock until the container is either shipped, or emptied to wash, grade, or pack the shellstock.

(c) The identification tags of the licensee dealer shall be durable, waterproof, and approved by the department prior to use, at least 13.8 square inches in area, and contain all of the following indelible, legible information in the order specified below:

1. The licensee's name, address, and certification number as assigned by the department.

2. The original shellstock shipper's license or certification number. If the shellstock has been depurated, the original shellstock shipper's certification number is not required.

3. The date of harvest, or date of depuration processing, the original harvest date, and any harvest date from wet storage.

4. The wet storage or depuration cycle or lot number, if the shellstock has been wet stored or depurated. The wet storage lot number shall begin with the letter "w."

5. The most precise identification of the harvest location as is practicable including the capital initials of the state of harvest, and the designation of the growing area by indexing, administrative, or geographic designation.

6. When the shellstock has been transported across state lines and placed in wet storage in a licensee dealer's operation, the statement "This product is a product of (name of state) and was wet stored at (facility certification number) from (date) to (date)."

7. The type and quantity of shellstock.

8. In bold capitalized type on each tag, the statement "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY OR IS RETAGGED AND THEREAFTER KEPT ON FILE FOR NINETY DAYS . "

9. All shellstock intended for raw consumption shall include a consumer advisory with the statement "Retailers, inform your customers of the following: Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness, especially if you have certain medical conditions" or an equivalent statement.

10. The statement "Keep Refrigerated" or an equivalent statement.

(d) When both the licensee dealer and harvester tags appear on the container, the licensee dealer's tag is not required to duplicate the information on the harvester's tag.

(e) If the shellstock is removed from the original container, the tag on the new container shall meet the requirements in par. (c) . If the shellstock is received bearing a restricted use tag, all restricted use language shall be transferred to the new shipping tag.

(f) When shellstock intended for retail sale is packed in containers of not more than 5 pounds, and shipped in a master container which includes a tag in compliance with this chapter, the individual containers are not required to be tagged, but may be labeled in some other manner with indelible, legible information which is adequate for tracing the shellfish back to the lot of shellstock from which it originated.

(11)   Tagging of shellstock lots during intermediate processing.

(a) When the shellstock is removed from the original container, the licensee dealer shall do all of the following:

1. Keep the harvester tag for 90 days.

2. Keep a record of the growing area and date of harvest for shellstock.

3. Maintain the lot identity of all shellstock during any intermediate stage of processing.

(b) A licensee dealer receiving bulk tagged lots of shellstock shall have an intermediate processing plan approved by the department to ensure that each lot of shellstock is kept separate and identified in a way which prevents commingling or misidentification.

(c) In order for a licensee dealer to tag a lot container of shellstock, instead of meeting the requirement in sub. (10) (c) , for a harvester or licensee tag on each individual container, the licensee dealer shall have an intermediate processing plan approved by the department which establishes the procedures the licensee dealer shall use to tag the lot during the washing, packing, or staging of molluscan shellfish.

(d) Unless the licensee dealer is included in a commingling plan approved by the department, the licensee dealer's intermediate processing plan for tagging a lot of shellstock during the intermediate stage of processing shall ensure that each lot of shellstock is separated and identified in a way which prevents commingling or misidentification. The identification shall be provided by a harvester's or licensee dealer's tag which meets the requirements of this chapter, or a tag for each lot of shellstock that contains all of the following:

1. The statement "All shellstock containers in this lot have the same harvest date and area."

2. The harvest date and growing area.

3. The original dealer certification number.

4. The number of individual containers in each lot of shellstock unit after washing, packing, or staging has been completed.

(e) When a licensee dealer has an intermediate processing plan approved by the department, the licensee dealer shall tag each lot of shellstock in accordance with the intermediate processing plan while the lot of shellstock is being processed in the licensee dealer's facility.

(f) All restricted use shellstock shall include a tag containing all information required in this chapter and specific language indicating the intended use of the shellstock.

(g) If shellstock is sold in bulk, the licensee dealer shall provide a transaction record prior to shipment. This transaction record shall contain the name of the consignee and all information specified in sub. (10) (c) .

(12)   Bulk tagging shellstock lots for sales between licensee dealers.

(a) When a single lot of shellstock is sold, multiple containers may be placed on a wrapped pallet, in a tote, in a net bailer, or another container, and the unit tagged with a single tag in accordance with sub. (10) (c) .

(b) This bulk tagging provision shall not apply to sales to re-shippers.

(c) The shipment shall be accompanied by a transaction record stating the name of the consignee who shall be a certified dealer.

(d) The unit tag shall include the statement "All shellstock containers in this lot have the same harvest date and area of harvest," the number of individual containers in the unit, and the requirements specified in sub. (10) (c) .

(13)   Processing.

(a) Shellstock processing. When processing shellstock, a licensee dealer shall do all of the following:

1. For shellstock refrigerated prior to shucking, chill the shucked meats to an internal temperature of 45 ° F (7.2 ° C) or less, within 4 hours of removal from refrigeration.

2. Ensure that shellstock for shucking is reasonably free of sediment and is not placed in containers with standing water for the purposes of washing shellstock or loosening sediment.

3. Cull to remove any dead or damaged shellstock.

4. Wash, blow, and rinse all shellfish meats in accordance with 21 CFR Part 161.130 .

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

6. Not commingle shellstock lots during shucking unless all shellfish is from licensee dealers included in a commingling plan approved by the department.

7. Not allow the use of dip buckets for hand or knife rinsing, or sanitizing.

8. A licensee dealer that uses heat shock to prepare shellstock for shucking shall do all of the following:

a. Use only a scheduled heat shock process approved by the department. The scheduled process may be developed by the department or qualified persons with adequate facilities conducting the appropriate studies of critical factors including the type and size of shellfish, time and temperature of exposure, type of process, size of tank, tunnel, or retort, water-to-shellfish ratios in tanks, and temperature and pressure monitoring devices.

b. Post the schedule for the heat shock process in a conspicuous location.

c. Make sure all responsible persons are familiar with the requirements.

d. Cool all hot shellstock immediately after the heat shock process by either dipping in an ice bath or using flowing potable water.

e. If a heat shock water tank is used, and the water is maintained at or above a temperature of 140 ° F (60 ° C), completely drain and flush the tank at the end of each day's operation so that all mud and debris in the dip tank are removed. If the temperatures are maintained below 140 ° F (60 ° C), completely drain and flush the tank at not less than 3 hour intervals.

(b) Shucked shellfish processing. When processing shucked shellfish, a licensee dealer shall do all of the following:

1. If heat shock is used, once heat shocked shellstock is shucked, cool the shucked shellfish meats to 45 ° F (7.2 ° C) or less, within 2 hours after the heat shock process.

2. Wash, blow, and rinse all specified shucked shellfish meats in accordance with 21 CFR Part 161.130 .

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

4. Completely empty shucking buckets at the packing room so no overage is returned to the shucker.

5. Store shucked and packed shellfish in covered containers in the storage area at an ambient air temperature of 45 ° F (7.2 ° C) or less.

6. Store packaged shellfish, if they are to be frozen, at an ambient air temperature of 0 ° F (-18 ° C) or less, so that they freeze solid within twelve hours following the start of freezing.

(c) Repacking shucked shellfish. When repacking shucked shellfish, a licensee dealer shall do all of the following:

1. Maintain repacked fresh or thawed shucked shellfish, including any portion of frozen shellfish for repacking at an internal temperature of 45 ° F (7.2 ° C) or less.

2. Store repacked, shucked shellfish in covered containers at an ambient air temperature of 45 ° F (7.2 ° C) or less.

(d) Wet storage of shellstock. A licensee dealer conducting wet storage of shellstock shall do all of the following:

1. Follow a plan approved by the department. The plan shall include procedures for ensuring water quality, washing and culling of shellstock before wet storage begins, and segregation of shellstock species and lots of shellstock.

2. Use only shellstock harvested from areas classified by the governing authority as approved or conditionally approved in the open status.

3. Comply with requirements in subs. (9) and (10) .

4. Store depurated shellstock only within the facility in which the shellstock was depurated.

5. Store and handle shellstock before wet storage to protect against conditions which adversely affect shellstock survival.

6. Maintain shellstock in a sanitary condition.

7. Harvest, process, package, and label shellstock from wet storage in compliance with requirements of this chapter.

8. Keep complete and accurate records to enable a lot of shellstock to be traced back to the original harvest location and wet storage location, and include the dates the shellstock was held in wet storage. The records shall be maintained for at least one year.

9. Not commingle lots of shellstock unless in accordance with a commingling plan approved by the department. If 2 or more lots of shellstock are in wet storage at the same time, the identity of each lot of shellstock shall be maintained.

(14)   Labeling shucked shellfish.

(a) The licensee dealer shall maintain lot integrity when shucked shellfish are stored using in-plant reusable containers.

(b) If the licensee dealer uses returnable containers to transport shucked shellfish to other licensee dealers in Wisconsin or certified dealers in other states for the purpose of further processing or packing, the returnable containers are exempt from the labeling requirements in this subsection. When returnable containers are used, the shipment shall be accompanied by a transaction record containing the original shucker-packer's name and license or certification number, the shucking date, and the quantity of shellfish per container, and the total number of containers.

(c) If the licensee dealer uses master shipping cartons, the master cartons are exempt from the labeling requirements in this subsection when the individual containers within the carton are properly labeled.

(d) The licensee dealer shall label each individual package containing fresh or frozen shucked shellfish meat in a legible and indelible form and in accordance with applicable requirements for declaration of quantity and drained weight specified in 21 CFR Parts 161.30 and 161.130 .

(e) Each package containing less than 64 fluid ounces of fresh or frozen shellfish shall have the certification number on the label, and a "sell by date" which provides a reasonable subsequent shelf-life or the words "best if used by" followed by a date when the product would be expected to reach the end of its shelf-life. The date shall consist of the abbreviation for the month and number of the day of the month. For frozen shellfish, the year shall be added to the date.

(f) Each package containing more than 64 fluid ounces of fresh or frozen shellfish shall have the certification number on the label, and the "date shucked."

1. The date shucked for fresh shellfish shall consist of the number of the day of the year or the month and the number of the day of the month.

2. The date shucked for frozen shellfish shall include the number of the day of the year or the month and the number of the day of the month, and the year.

3. The date shucked shall appear on the lid and sidewall, or bottom of disposable containers.

(g) If the licensee dealer thaws and repacks frozen shellfish, the licensee dealer shall label the shellfish container as previously frozen.

(h) If the licensee dealer freezes fresh shucked shellfish, the licensee dealer shall label all frozen shellfish as frozen in type of equal prominence immediately adjacent to the type of shellfish and the year shall be included in the date on the label.

(i) The licensee dealer shall include on each package of fresh or frozen shucked shellfish a consumer advisory with the statement "Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness, especially if you have certain medical conditions."

(j) The licensee dealer shall provide all label information in a legible and indelible form and in accordance with applicable requirements for declaration of quantity and drained weight specified in 21 CFR Parts 161.30 and 161.130 .

(k) If the licensee dealer elects to repack molluscan shellfish, the licensee dealer shall pack and label all shellfish in accordance with this subsection, except that the original date of shucking shall be used in establishing the sell by date.

(15)   Labeling of in-shell product.

(a) Licensee dealers, packing any container holding in-shell product, shall label the container with tags that are legible and indelible and indicate all of the following:

1. The licensee dealer's name, address, and certification number assigned by the department.

2. The original shellstock shipper's certification number. If the shellfish has been depurated, the original shellstock shipper's certification number is not required.

3. The depuration cycle number or lot number, if the shellfish has been depurated.

4. The most precise identification of the harvest location as is practicable, including the capital initials of the state of harvest, and that state authority's designation of the growing area by indexing, administrative, or geographic designation.

5. When in-shell product has been transported across state lines and placed in wet storage in a licensee dealer's operation, the statement "This product is a product of (name of state) and was wet stored at (facility certification number) from (date) to (date)."

6. A "sell by date" which provides a reasonable subsequent shelf-life or the words "best if used by" followed by a date when the product would be expected to reach the end of its shelf-life. The date shall consist of the abbreviation for the month and number of the day of the month. For frozen shellfish, the year shall be added to the date.

7. The type and quantity of in-shell product.

8. In bold capitalized type on each tag, the statement "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY OR IS RETAGGED AND THEREAFTER KEPT ON FILE FOR 90 DAYS."

9. The statement "Keep Refrigerated" or an equivalent statement.

(b) The container for all in-shell products intended for raw consumption shall bear a consumer advisory with the statement: "Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness, especially if you have certain medical conditions."

(c) If the in-shell product is removed from the original container, the tag on the new container shall meet the requirements of par. (a) .

(d) When in-shell product intended for retail sale is packed in containers of 5 pounds or less, and shipped in a master container which includes a tag complying with par. (a) , then labeling of the individual containers is not required to comply with par. (a) , but may be labeled in some other manner with indelible, legible information which is adequate to trace the in-shell shellfish back to the lot [from] which it was derived. The consumer advisory required in part (b) shall be included on each individual retail package.

(16)   Shellfish storage and handling. When storing and handling shellfish, the licensee dealer shall do all of the following:

(a) Assure that shellstock is reasonably free of sediment and culled.

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

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

(d) Assure that no usable containers or container covers bearing a certification number different from the one issued for those premises are present unless documentation exists to verify the legitimate source of the containers or container covers, and the containers contain shellfish from that source.

(e) Maintain shellfish received frozen in the frozen condition during storage.

(f) Assure that no shellstock is commingled during shucking unless all shellfish is from licensee dealers in Wisconsin or certified dealers outside Wisconsin included in a commingling plan approved by the department.

(17)   Transportation.

(a) Transportation of shellstock. Trucks or other vehicles used to transport shellstock shall meet all of the following requirements:

1. All trucks used to transport shellstock shall be properly constructed, operated, and maintained by the harvester, or person who transports shellstock from the harvester to the original licensee dealer to prevent contamination, deterioration, and decomposition of shellstock.

2. Storage bins on trucks or other vehicles used in the transport of shellstock for direct marketing shall be kept clean with potable water; and provided with effective drainage.

3. Shellstock shall be transported in refrigerated trucks when the shellstock has been previously refrigerated or when ambient air temperature and time of travel are such that unacceptable bacterial growth or deterioration may occur.

4. A pre-chilling truck or other refrigerated vehicle is required when ambient air temperatures are such that unacceptable bacterial growth or deterioration may occur.

5. When any mechanical refrigeration unit is used, the unit shall be equipped with automatic controls, and capable of maintaining the ambient air temperature in the storage area at a temperature of 45 ° F (7.2 ° C) or less.

6. No animals shall be allowed in any part of any truck or other vehicle where shellstock is stored.

7. Transportation agents or common carriers used by a shipper are not required to be certified.

(b) Transportation storage containers. Transportation storage containers shall meet all of the following requirements:

1. Containers used to transport shellstock shall be clean, constructed of food-contact grade material, and free of any substance or organisms that may cause the shellstock to become adulterated.

2. Any container to be used more than one time to store and transport shellstock shall be constructed to allow easy cleaning, maintained to prevent product contamination, and cleaned with potable water and a detergent, other cleaning chemical, or sanitizer acceptable for food contact surfaces and used according to the manufacturer's specifications.

(c) Shipment protection from cross contamination. Molluscan shellfish shipments shall be protected from cross contamination and meet all of the following requirements:

1. Except for bulk shipments, when the entire shipment consists of molluscan shellfish products, shellstock shall be shipped on pallets. If the conveyance does not have a channeled floor, pallets shall be used for all shellfish.

2. When the conveyance has mixed shipments, the molluscan shellfish shall be shipped only when molluscan shellfish products are protected from contamination by the other cargo, all cargo is placed on pallets, and no other cargo is placed on or above the molluscan shellfish unless all cargo is packed in sealed, crush resistant, leak-proof, and waterproof containers.

(d) Shipping times. When shipping molluscan shellfish or shellstock, the shipper must ensure all of the following conditions are met:

1. When the expected shipping time for any molluscan shellfish or shellstock is 4 hours or less, the shipper shall use ice or mechanical refrigeration to maintain the required temperature of the molluscan shellfish or shellstock. Mechanical refrigeration units shall be equipped with automatic controls and capable of maintaining the ambient air in the storage area at temperatures of 45 ° F (7.2 ° C) or less. The shipper is not required to provide thermal recorders during shipment. Lack of ice or other acceptable types of refrigeration shall be considered an unsatisfactory shipping condition.

2. When the expected shipping time is greater than 4 hours, the shipper shall ship all shellfish in mechanically refrigerated conveyances which are equipped with automatic controls and capable of maintaining the ambient air in the storage area at a temperature of 45 ° F (7.2 ° C) or less, or in containers, the internal ambient air temperature of 45 ° F (7.2 ° C) or less.

a. Unless the shipper has a HACCP plan approved by the department with an alternate means of monitoring time-temperature, the shipper shall ensure that a suitable time-temperature recording device accompanies each shipment of shellfish.

b. The shipper shall note the date and time shown on the temperature-indicating device.

c. Each shipment receiver shall record the date and time shown on the temperature-indicating device when the shipment is received, and the doors of the conveyance or the containers are opened.

d. The final shipment receiver shall keep the time-temperature recording chart or other record of time-temperature in a file and shall make it available to the department upon request.

e. An inoperative temperature-indicating device shall be considered a failure to provide the required recording device.

(18)   HAACP plan.

(a) Prior to licensing and certification as a licensee dealer, each applicant shall develop any necessary HACCP plans to comply with subch. II and 21 CFR Part 123 , addressing food safety hazards in its operations. HACCP plans shall be approved by the department as part of the license application process. The HACCP plan for shellfish processing shall include all of the following:

1. For a shellstock shipper, the critical control point of shellstock shipping.

2. For a shucker-packer, repacker, or reshipper, the critical control points of receiving, shellstock or in-shell product storage, processing, and shucked meat storage, and shipping, as appropriate.

3. A HACCP plan which includes the receiving critical control point shall include critical limits for the receiving critical control point that ensure all of the following:

a. Shellstock is obtained from a licensed harvester who has harvested the shellstock from an approved area or a conditionally approved area in the open status as indicated by the tag, and identified the shellstock with a tag on each container or transaction record on each bulk shipment.

b. Shellstock, if obtained from a dealer other than the original harvester, is shipped adequately iced, or in a conveyance at or below 45 ° F (7.2 ° C) ambient air temperature, or with an internal temperature of 50 ° F (10 ° C) or less, or in a conveyance capable of lowering the temperature of the shellstock and maintaining it at 50 ° F (10 ° C) or less, and is identified with a tag on each container or transaction record with each bulk shipment.

c. In-shell product is obtained from a dealer who has shipped the in-shell product adequately iced, or in a conveyance with an ambient air temperature at or below 45 ° F (7.2 ° C), or with an internal temperature of 45 ° F (7.2 ° C) or less, and the in-shell product is identified with a tag on each container.

4. A HACCP plan which includes the shellstock or in-shell product storage critical control point shall include critical limits for the shellstock or in-shell product storage critical control point that ensure any of the following:

a. Shellstock, once placed under temperature control and until sale to the processor or final consumer, shall be iced or placed and stored in a storage area or conveyance with ambient air temperature maintained at 45 ° F (7.2 ° C) or less, and not permitted to remain without ice, mechanical refrigeration, or other methods of refrigeration approved by the department for more than 2 hours at points-of-transfer such as loading docks.

b. In-shell products shall be iced or placed and stored in a storage area or conveyance with ambient air temperature maintained at 45 ° F (7.2 ° C) or less.

5. A HACCP plan which includes the processing critical control point shall include critical limits for the processing critical control point that ensure any of the following:

a. Shucked molluscan shellfish from shellstock that has not been refrigerated before shucking shall be chilled to an internal temperature of 45 ° F (7.2 ° C) or less, within 3 hours of shucking.

b. Shucked molluscan shellfish from shellstock that has been refrigerated before shucking shall be chilled to an internal temperature of 45 ° F (7.2 ° C) or less, within 4 hours of removal from refrigeration.

c. Shucked molluscan shellfish from heat shocked shellstock shall be chilled to an internal temperature of 45 ° F (7.2 ° C) or less, within 2 hours after the heat shock process.

d. Heat shocked shellstock that are cooled and held under refrigeration for later shucking shall be chilled to an internal temperature of 45 ° F (7.2 ° C) or less, within 2 hours after the heat shock process.

e. In-shell product is processed such that the internal temperature of the shellfish meat shall not exceed 45 ° F (7.2 ° C) for more than 2 hours during processing.

f. Shucked shellfish that are received and repacked shall not exceed an internal temperature of 45 ° F (7.2 ° C) for more than 2 hours.

6. A HACCP plan which includes the shucked meat storage critical control point shall include critical limits for the shucked meat storage critical control point that ensure shucked and packed shellfish are stored in covered containers at an ambient air temperature of 45 ° F (7.2 ° C) or less, or covered with ice.

7. A HACCP plan which includes the shellstock shipping critical control point shall include critical limits for the shellstock shipping critical control point that ensure the shellstock containers are labeled and tagged in compliance with the requirements in sub. (10) .

8. If a licensee dealer will be using heat shock, the licensee dealer shall include heat shock as a critical control point in the HAACP plan and ensure that heat shock does not change the physical and organoleptic properties of the species, kill the shellfish prior to shucking, or increase microbial deterioration of the shucked shellfish.

(19)   Shipping documents and transaction records.

(a) Shipping documents. Each licensee dealer shall maintain shipping documents that meet the following requirements:

1. Each shellfish shipment shall be accompanied by a shipping document which contains the name, address, and certification number of the shipping licensee dealer, the name and address of the receiving facility, and the kind and quantity of the shellfish product.

3. The licensee dealer shall maintain in a file, a copy of the completed shipping document, and make the shipping document available to the department upon request.

4. If the shipment is subdivided to different facilities, each receiving facility shall maintain records sufficient to trace the portion received back to the original shipment.

5. Shellstock that is shipped bearing a restricted use tag shall only be shipped to a licensed shucker-packer and shall include specific language detailing the intended use of the shellstock.

(b) Transaction records. Each licensee dealer shall maintain transaction records that meet the following requirements:

1. Each licensee dealer shall have a business address at which transaction records are maintained.

2. Each licensee dealer shall maintain complete, accurate, and legible records of the required information.

3. Transaction records shall be sufficient to do all of the following:

a. Document that the shellfish are from an authorized source.

b. Permit a container of shucked shellfish to be traced back to the specific incoming lot of shucked shellfish or shellstock from which it was taken.

c. Permit a lot, or commingled lots, of shucked shellfish or a lot of shellstock to be traced back to the growing area, date of harvest, date and location of wet storage, if applicable, and if possible, the harvester or group of harvesters.

4. Purchases and sales shall be recorded in a permanently bound ledger book or using other recording methods acceptable to and approved by the department.

5. The transaction records shall be retained for at least one year in the case of fresh shellfish, and for at least 2 years or the shelf-life of frozen shellfish, whichever is longer.

6. If computer records are maintained, the records shall be made available for inspection by the department.

(20)   Illness outbreaks associated with shellfish.

(a) At any time shellfish are potentially implicated in an illness outbreak involving at least 2 persons not from the same household (or at least one person in the case of paralytic shellfish poisoning), the department shall determine whether an epidemiological association exists between the illness and the shellfish consumption by reviewing each consumer's food intake history and the shellfish handling practices of the consumer and retailer.

(b) When the department has determined an epidemiological association exists between an illness outbreak and shellfish consumption, the department shall conduct an investigation of the outbreak within 24 hours to determine whether the illness is related to the shellfish growing area or to post-harvest contamination or mishandling.

(c) Upon completion of the investigation, the department shall notify receiving states and the United States food and drug administration of the findings, and take appropriate steps in cooperation with the licensee dealer to recall the affected product and, if necessary, inform consumers about the outbreak and associated product.

CR 12-037 : cr. May 2013 No. 689, eff. 6-1-13; (1) (za) to (zx) renumbered from (1) (aa) to (kk) under s. 13.92 (4) (b) 1., Stats., Register May 2013 No. 689 .

Note

A copy of the Shellfish Industry Equipment Construction Guide is on file with the department and the legislative reference bureau. You may also obtain a copy from the following website: http://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006754.htm . Microsoft Windows NT 6.1.7601 Service Pack 1 The bracketed word was inadvertently omitted and will be inserted in future rulemaking. Microsoft Windows NT 6.1.7601 Service Pack 1