SECTION 241.50. Definitions

The following words and terms, when used in this subchapter of this title, relating to molluscan shellfish, shall have the following meanings unless the context clearly indicates otherwise.

(1) Act--The Texas Health and Safety Code, Chapter 436, Aquatic Life.

(2) Air gap--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.

(3) Application process--The filing of an application for certification with the Texas Department of Health followed by an inspection by an authorized agent confirming compliance with the rules.

(4) Approved area--A classification used to identify a harvest area where harvest for direct marketing is allowed.

(5) Approved source--A source of molluscan shellfish acceptable to the director (commissioner of health).

(6) Aquaculture--The cultivation of seed in natural or artificial growing or harvest areas, or the cultivation of molluscan shellstock other than seed in harvest areas.

(7) Assure--To make certain.

(8) Authorized agent--An employee of the Texas Department of Health who is designated by the commissioner to enforce provisions of these sections.

(9) Backflow--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.

(10) Back siphonage--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.

(11) Blower--A receptacle for washing shucked molluscan shellfish that uses forced air as a means of agitation.

(12) Certificate (molluscan shellfish certificate of compliance)--A numbered document issued by the commissioner which authorizes a dealer to process molluscan shellfish for sale.

(13) Certification or certify--The issuance of a numbered certificate to a person for a particular activity or group of activities that indicates:

(A) permission from the department to conduct the activity; and

(B) initial compliance with the requirements of §§241.50 - 241.71 of this title (relating to Molluscan Shellfish).

(14) Certification number--The unique identification number issued by the commissioner 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 the following terms:

(A) shellstock shipper (SS);

(B) shucker/packer (SP);

(C) repacker (RP); and

(D) depuration processor (DP).

(15) Certified location--A plant or place of business that has been inspected by the Seafood Safety Division of the department and for which a molluscan shellfish certificate of compliance has been issued.

(16) Coliform group--All of the aerobic and facultative anaerobic, gram negative, non spore-forming, rod-shaped bacilli which ferment lactose broth with gas formation within 48 hours at 95 degrees Fahrenheit (35 degrees plus or minus 0.5 degrees Centigrade).

(17) Commingle or commingling--The act of combining different lots of molluscan shell stock or shucked molluscan shellfish.

(18) Commissioner--The commissioner of health for the State of Texas and the executive head of the department.

(19) Compliance schedule--A written schedule that provides a specific time period to correct critical, key and other deficiencies.

(20) Conditionally approved area--A classification used to identify a harvest area which meets the criteria for the approved classification except under certain conditions described in a management plan established by the SSD.

(21) Conditionally restricted area--A classification used to identify a harvest area which meets the criteria for the restricted classification except under certain conditions described in a management plan established by the SSD.

(22) Container--The physical material in contact with or immediately surrounding molluscan shellfish that confines it into a single unit.

(23) Corrosion resistant materials--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.

(24) Critical Control Point (CCP)--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.

(25) Critical deficiency--A condition or practice which:

(A) results in the production of a product that is adulterated, decomposed, misbranded or unwholesome; or

(B) presents a threat to the health or safety of the consumer.

(26) Critical limit--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.

(27) Cross connection--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. Examples include bypass arrangements, jumper connection, removable sections, swivel or change over devices, or other devices through which backflow could occur.

(28) Cull--To remove dead or unsafe molluscan shell stock from a lot of molluscan shell stock.

(29) Dealer--A person to whom certification is issued for the activities of molluscan shell stock shipper, shucker-packer, repacker, or depuration processor.

(30) Deficiency--A condition or practice that is a violation of the Act or rules.

(31) Department--The Texas Department of Health (TDH), 1100 West 49th Street, Austin, Texas 78756, or its successor state agency, having the responsibility for the enforcement of laws concerning the safety of the food supply, including molluscan shellfish growing area classification and certification of molluscan shellfish dealers.

(32) Depletion--The removal, under the direct control of the Texas Parks and Wildlife Department, of all existing commercial quantities of market-size molluscan shellfish from a harvest area classified as prohibited.

(33) Depuration or depurate--The process of reducing the level of bacteria and viruses that may be present in molluscan shellfish by using a controlled aquatic environment as the treatment process.

(34) Depuration plant--A place where depuration of molluscan shellfish occurs.

(35) Depuration Processor (DP)--A person who harvests or receives molluscan shell stock from harvest areas in the approved or conditionally approved, restricted, or conditionally restricted classification and submits such molluscan shell stock to an approved depuration process.

(36) Direct marketing--The sale for human consumption of molluscan shellfish which:

(A) does not require depuration or relaying prior to sale; or

(B) have been subjected to depuration or relaying activities.

(37) Director--The executive head (commissioner of health) of the Texas Department of Health.

(38) Dry storage--The storage of molluscan shell stock out of water.

(39) Durable material--Material with the ability to exist for several years without significant deterioration and able to withstand normal daily use associated with molluscan shellfish operations.

(40) Easily cleanable--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.

(41) Facility--A structure.

(42) FDA--The United States Food and Drug Administration or its successor agency, the federal agency in which regulation of foods, including the Cooperative Shellfish Program, is vested.

(43) Food contact surface--An equipment surface or utensil that normally comes into direct or indirect contact with shucked molluscan shellfish.

(44) Food safety hazard--Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

(45) Gatherer--Person who takes molluscan shellfish by any means from a growing area designated by the commissioner for delivery to a depuration plant.

(46) GLO--The Texas General Land Office, 1700 North Congress, Austin, Texas 78701, or its successor agency, the state agency having the responsibility for the enforcement of laws concerning all state lands, including leasing of wetland bottom for private oyster leases.

(47) Growing area--Any site that supports or could support the propagation of molluscan shell stock by natural or artificial means.

(48) HACCP--Hazard Analysis Critical Control Point, a systematic, science-based approach used in food production as a means to assure food safety. The concept is built upon the seven principles identified by the National Advisory Committee on Microbiological Criteria for Foods (1992).

(49) HACCP Plan--A written document that delineates the formal procedures that a dealer follows to implement the HACCP requirements set forth in Title 21, Code of Federal Regulations (CFR), §123.6.

(50) Harvest--The act of removing molluscan shell stock from growing or harvest areas and its placement on or in a manmade conveyance or other means of transport.

(51) Harvest area--An area that contains commercial quantities of molluscan shell stock and may include aquaculture sites and facilities.

(52) Harvester--A person who takes molluscan shell stock by any means from a harvest area.

(53) Heat shock--The process of subjecting molluscan shell stock 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 molluscan shellfish.

(54) ISSC--The Interstate Shellfish Sanitation Conference. The ISSC consists of agencies from molluscan shellfish producing and receiving states, FDA, the molluscan shellfish industry, and the National Marine Fisheries Service of the U.S. Department of Commerce.

(55) Key deficiency--A condition or practice that may result in adulterated, decomposed, misbranded or unwholesome product.

(56) Label--Any written, printed or graphic matter affixed to or appearing upon any package containing molluscan shellfish.

(57) License--The document issued by the Texas Parks and Wildlife Department, under the Texas Parks and Wildlife Code, Chapter 47 or Chapter 76, which authorizes a person to harvest or transport molluscan shell stock for commercial sale.

(58) Lot of molluscan shell stock--A single type of bulk molluscan shell stock or containers of molluscan shell stock of no more than one day's harvest from a single defined harvest area gathered by one or more harvesters.

(59) Lot of molluscan shell stock for depuration--Molluscan shell stock harvested from a particular area during a single day's harvest and delivered to one depuration plant.

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

(61) Marina--Any water area with a structure (docks, basin, floating docks, etc.) which is:

(A) used for docking or otherwise mooring vessels; and

(B) constructed to provide temporary or permanent docking space for more than ten boats.

(62) Marine biotoxin--Any poisonous compound produced by marine microorganisms and accumulated by molluscan shell stock. Examples of toxin producing marine microorganisms include Alexandrium spp. (Proto gonyaulax species) and Karenia breves.

(63) Market shellfish--Molluscan shellfish which are, may be, or have been harvested and/or prepared for sale for human consumption as a fresh or frozen product.

(64) Molluscan shellfish--All species of:

(A) oysters, clams or mussels, whether:

(i) shucked or in the shell;

(ii) fresh or frozen; and

(iii) whole or in part.

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

(65) Monoculture--The culture of a single molluscan shellfish species.

(66) MPN--Most probable number.

(67) Nursery products--Molluscan shellfish which do not exceed 10% of the market weight or that are six months or more growing time from market size.

(68) Open area--A molluscan shellfish growing area where the harvesting for sale, harvesting for transplant, or gathering for depuration of molluscan shellfish is allowed. An open area status may be placed on any one of the classified area designations except for a prohibited area.

(69) Open water aquaculture--The cultivation of molluscan shellfish in natural molluscan shellfish harvest areas.

(70) Other deficiency--A condition or practice that is not defined as critical or key, but is of a public health significance and, if left uncorrected, could result in a key or critical deficiency.

(71) Pack (packing)--All activities involved in placing molluscan shellfish in containers.

(72) Person--Any individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind, government or governmental subdivision or agency, partnership, association, corporation or other legal entity.

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

(74) Polyculture--The cultivation of:

(A) two or more species of molluscan shellfish; or

(B) molluscan shellfish with other species in a common environment.

(75) Potable water--A water supply that is suitable for human consumption.

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

(77) Process batch--A quantity of molluscan shell stock 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.

(78) Process water--The water used in the scheduled depuration process.

(79) Prohibited area--A classification used to identify a harvest area where the harvest of molluscan shell stock for any purpose, except depletion or gathering of seed for aquaculture, is not permitted.

(80) Records--Written documents required to be maintained under this chapter.

(81) Relaying--Transferring of shellstock from a growing area classified as restricted or conditionally restricted to a growing area classified as approved or conditionally approved for the purpose of reducing pathogens, as measured by the coliform indicator group or poisonous or deleterious substances that may be present in the shellstock, by using the ambient environment as the treatment process.

(82) Repacker (RP)--A dealer who buys, repacks and sells molluscan shellfish. Repackers are not authorized to shuck shellfish.

(83) Repacking molluscan shellstock--The practice of removing molluscan shell stock from containers and placing it into other containers.

(84) Restricted area--A classification used to identify a harvest area where harvesting shall be by special license and the molluscan shell stock, following harvest, is subjected to a suitable and effective treatment process through transplanting or gathering for depuration.

(85) Safe materials--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.

(86) Sanitation control record--Records that document the monitoring of sanitation practices and conditions.

(87) Sanitize--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.

(88) Seed--Molluscan shell stock which is less than market size.

(89) Sewage--Refuse liquids or waste matter, including hand sink drainage.

(90) Sewer--An artificial, usually subterranean, conduit to carry off sewage and/or surface water.

(91) Sewerage--The removal and disposal of sewage and surface water by sewers.

(92) Shell stock--Live molluscan shellfish in the shell.

(93) Shell stock packing--The process of placing molluscan shell stock into containers for introduction into commerce.

(94) Shellstock Shipper (SS)--A dealer who grows, harvests, buys, or repacks and sells molluscan shell stock. They are not authorized to shuck molluscan shellfish or to repack shucked molluscan shellfish. A shellstock shipper may also ship shucked molluscan shellfish.

(95) Shucked shellfish--Molluscan shellfish, whole or in part, from which one or both shells have been removed.

(96) Shucker/Packer (SP)--A person who shucks and packs molluscan shellfish. A shucker-packer may act as a shellstock shipper or may repack molluscan shellfish originating from other certified dealers.

(97) SSD--The Seafood Safety Division of the Texas Department of Health to which responsibility to classify molluscan shellfish growing areas and to regulate harvesting, processing, and/or shipping of molluscan shellfish is delegated.

(98) Take--Catch, hook, net, snare, trap, kill, or capture by any means, including the attempt to take.

(99) Temperature Control--The management of the environmental temperature of shellstock by means of ice, mechanical refrigeration or other approved means that is capable of lowering the temperature of the shellstock and maintaining it at 45 degrees Fahrenheit (7.2 degrees Centigrade) or less.

(100) TDA--The Texas Department of Agriculture, 1700 North Congress, Austin, Texas 78701, or its successor state agency having responsibility for enforcement of laws concerning licensing of aquaculture.

(101) TCEQ--The Texas Commission on Environmental Quality, 12100 Park 35 Circle, Austin, Texas 78753, or its successor state agency having the responsibility for the enforcement of laws concerning water supplies and discharges of water or wastewater in Texas.

(102) TPWD--The Texas Parks and Wildlife Department, 4200 Smith School Road, Austin, Texas 78744, or its successor state agency having the responsibility for the enforcement of laws concerning harvesting and depletion of molluscan shellfish resources.

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

(104) Transplant (transplanting)--To transfer molluscan shell stock from a harvest area classified as restricted or conditionally restricted or from a conditionally approved area in the closed status to a harvest area classified as approved or conditionally approved for the purpose of reducing pathogens, as measured by the coliform indicator group or poisonous or deleterious substances that may be present in the molluscan shell stock, by using the ambient environment as the treatment process.

(105) Water closet--A toilet bowl and its accessories surrounded by walls or partitions.

(106) Wet storage--The temporary storage, by a dealer, of molluscan shell stock from harvest 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.

Source Note: The provisions of this §241.50 adopted to be effective March 20, 2003, 28 TexReg 2346