901:3-8-01 Criteria and definitions for shellfish processing.

(A) All food processing establishments handling shellstock for interstate distribution shall meet the requirements of Chapter 901:3-8 of the Administrative Code and Chapter 901:3-1 of the Administrative Code to assure the sale or distribution of shellfish from safe sources and to assure shellfish has not been adulterated during cultivating, harvesting, processing, shipping, or handling.

(B) Definitions.

As used in Chapter 901:3-8 of the Administrative Code:

(1) "Air gap" means the unobstructed vertical distance through the free atmosphere between the lowest opening from any pipe or faucet supplying water to a tank, plumbing fixture or other device and the flood level rim of that receptacle.

(2) "Approved" means acceptable to the director or responsible regulatory authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.

(3) "Backflow" means the flow of water or other liquids, mixtures or substances into the distribution pipes of a potable water supply from any source or sources other than the intended source.

(4) "Back siphonage" means the flowing back of used, contaminated or polluted water from a plumbing fixture, vessel or other source into potable water supply pipes because of negative pressure in the water supply pipes.

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

(6) "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.

(7) "Certification" means the issuance of a numbered certificate to a person for a particular activity or group of activities that indicates:

(a) Approval from the director to conduct the activity; and

(b) Compliance with the requirements of this chapter.

(8) "Certification number" means the unique identification number issued by the director to each dealer for each location. Each certification number shall consist of a one to five digit Arabic number preceded by the two letter state abbreviation and followed by a two letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with this chapter using the following terms:

(a) Shellstock shipper (ss);

(b) Shucker-packer (sp);

(c) Repacker (rp);

(d) Reshipper (rs); and

(e) Depuration processor (dp).

(9) "Commingle" means the act of combining different lots of shellstock or shucked shellfish.

(10) "Compliance schedule" means a written schedule that provides a correction time period to eliminate deficiencies.

(11) "Container" means any bag, sack, tote, conveyance or other receptacle used for containing shellfish for holding or transporting.

(12) "Corrosion resistant materials" means materials that maintain their original surface characteristics under normal exposure to the foods being contacted, normal use of cleaning compounds and bactericidal solutions, and other conditions of use.

(13) "Critical control point" means a point, step or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated or reduced to acceptable levels.

(14) "Critical deficiency" means a condition or practice which:

(a) Results in the production of a product that is unwholesome; or

(b) Presents a threat to the health or safety of the consumer.

(15) "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 the identified food safety hazard.

(16) "Cross connection" means an unprotected actual or potential connection between a potable water system and any source or system containing unapproved water or a substance that is not or cannot be approved as safe and potable.

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

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

(19) "Depuration" means the process of reducing the pathogenic organisms that may be present in shellstock by using a controlled aquatic environment as the treatment process.

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

(21) "Director" means the director of the Ohio department of agriculture.

(22) "Direct marketing" means the sale for human consumption of shellfish which:

(a) Does not require depuration or relaying prior to sale; or

(b) Has been subjected to depuration or relaying activities.

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

(24) "Easily cleanable" means a surface which is:

(a) Readily accessible; and

(b) Is made of such materials, has a finish, and is so fabricated that residues may be effectively removed by normal cleaning methods.

(25) "Facility" means a structure.

(26) "FDA" means the United States food and drug administration.

(27) "Food contact surface" means an equipment surface or utensil which normally comes into direct or indirect contact with shucked shellfish.

(28) "Food safety hazard" means any biological, chemical or physical property that may cause a food to be unsafe for human consumption.

(29) "HACCP" is an acronym that stands for hazard analysis and critical control point, a systematic, science-based approach used in food production as a means to assure food safety.

(30) "HACCP plan" means a written document that delineates the formal procedures that a dealer follows to implement the HACCP requirements set forth in Chapter 901:3-7 of the Administrative Code.

(31) "Harvest" means the act of removing shellstock from growing areas and its placement on or in a manmade conveyance or other means of transport.

(32) "Harvest area" means an area that contains commercial quantities of shellstock and may include aquaculture sites and facilities.

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

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

(35) "ICSSL" is an acronym that stands for Interstate Certified Shellfish Shippers List, an FDA publication of shellfish dealers, domestic and foreign, who have been certified by a state or foreign authority.

(36) "Importer" means any dealer who introduces molluscan shellfish into domestic commerce. An importer has ownership of the shellfish, but need not take physical custody of the shellfish.

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

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

(39) "Lot of shucked shellfish for depuration" means shellstock harvested from a particular area during a single day's harvest and delivered to one depuration plant.

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

(41) "Person" means any individual, receiver, trustee, guardian, personal representative, 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.

(42) "Point source" means any discernible, confined and discrete conveyance including any pipe, ditch, channel, tunnel or conduit that carries pollution.

(43) "Poisonous or deleterious substance" means a toxic substance occurring naturally or added to the environment for which a regulatory tolerance limit or action level has been established in shellfish to protect public health.

(44) "Potable water" means a water supply which meets the requirements of the Ohio environmental protection agency or the local board of health, as applicable.

(45) "Principal display panel" means that part of a label that is most likely to be displayed, presented, shown or examined under customary conditions of retail sale.

(46) "Private water system" as defined in Chapter 3701-28 of the Administrative Code means any water system, other than a public water supply system, for the provision of water for human consumption, if the system has fewer than fifteen service connections and does not regularly serve an average of at least twenty-five individuals daily at least sixty days each year.

(47) "Process batch" means a quantity of shellstock used to fill each separate tank or a series of tanks supplied by a single process water system for a specified depuration cycle in a depuration activity.

(48) "Process water" means the water used in the scheduled depuration process.

(49) "Public water system" means as defined in Chapter 6109. of the Revised Code a system, for the provision to the public of water for human consumption through pipes or other constructed conveyances if the system has at least fifteen service connections or regularly serves at least twenty-five individuals.

(50) "Repacker" means any person, other than the original certified shucker-packer, who repackages shucked shellfish into other containers.

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

(52) "Reshipper" means a person who purchases shucked shellfish or shellstock from dealers and sells the product without repacking or relabeling to other dealers, wholesalers, or retailers.

(53) "Safe materials" means articles manufactured from or composed of materials that may not reasonably be expected to, directly or indirectly, become a component of or otherwise adversely affect the characteristics of any food.

(54) "Sanitation control record" means records that document the monitoring of sanitation practices and conditions during processing.

(55) "Sanitize" means to adequately treat food contact surfaces by a process that is effective in:

(a) Destroying vegetative cells of microorganisms of public health significance;

(b) Substantially reducing the numbers of other undesirable microorganisms; and

(c) Not adversely affecting the product or its safety for the consumer.

(56) "Shellfish" means all aspects of:

(a) Oysters, clams, or mussels, whether:

(i) Shucked or in the shell;

(ii) Fresh or frozen; and

(iii) Whole or in part; and

(b) Scallops in any form, except when the final product form is the adductor muscle only.

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

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

(59) "Shellstock shipper" means a dealer who grows, harvests, buys, or repacks and sells shellstock. A shellstock shipper may also ship shucked shellfish. A shellstock shipper is not authorized to shuck shellfish nor to repack shucked shellfish.

(60) "Shucker-packer" means a person who shucks and packs shellfish. A shucker-packer may act as a shellstock shipper or reshipper or may repack shellfish originating from other certified dealers.

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

(62) "Wet storage" means the temporary storage, by a dealer, of shellstock from growing areas in the approved classification or in the open status of the conditionally approved classification in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater.

R.C. 119.032 review dates: 08/10/2010 and 08/10/2015
Promulgated Under: 119.03
Statutory Authority: 3715.021
Rule Amplifies: 3715.021 , 3715.02
Prior Effective Dates: 6-16-03