Delaware Administrative Code
Title 7 - Natural Resources and Environmental Control
5000 - Division of Watershed Stewardship
7400 - Watershed Assessment Section
7402 - Shellfish Sanitation Regulations
Section 7402-2.0 - Definitions
NOTE: Those definitions primarily relating to the "Policy To Determine Shellfish Growing Area Classification In And Around Wet Slip Basins And Artificial Lagoons" are contained in Appendix 11.
Approved HACCP Plan (see HACCP): An operational plan mandated by Federal law, effective as of December 18, 1997, and defined in the Federal Register in the "Procedures For the Safe and Sanitary Processing and Importation Of Fish and Fishery Products; Final Rule." which includes Part 123: "Fish and Fishery Products Hazards and Controls Guide," and which is approved by DNREC.
Approved HACCP Training Course: A course approved by DNREC in the instruction of HACCP concepts and operational specifications, mandated by Federal law, effective as of December 18, 1997, and defined in the Federal Register in the "Procedures For the Safe and Sanitary Processing and Importation Of Fish and Fishery Products; Final Rule." which includes Part 123: "Fish and Fishery Products Hazards and Controls Guide."
Approved Depuration Process: The process of reducing bacteria and virus levels to acceptable levels in live shellfish by subjecting them to a strictly controlled aquatic environment, as performed only by a certified depuration processor.
Approved Relaying Operation: The harvesting of shellfish from waters classified as other-than-Approved; however not Prohibited, and their subsequent transference to natural bottom, or in approved containers, to Approved shellfish growing areas; however only with written permission of DNREC.
Approved Source of Shellfish: Shellfish meeting all criteria in these Regulations, including the following:
Shellfish which have been handled by certified interstate Shellfish Dealer/Processors whose names appear on the Interstate Shellfish Shippers Certified List; OR shellfish harvested from Delaware waters which have been handled by certified Delaware Intrastate Shellfish Dealer/Processors, and which are available for retail sale to the final customer only in Delaware. 1
Shellfish from Approved waters; OR shellfish from waters classified as other-than-Approved when shellfish harvesting is allowed on a seasonal/conditional basis; OR shellfish subjected to an approved depuration or relay process.
Back Flow/Back Siphonage: Water intended as a potable source; however carrying, or potentially carrying poisonous and/or deleterious substances, because this water flows in the opposite direction of the intended flow due to negative pressure in the potable water supply system.
Business: A shellfish-related business, entity, person, or persons.
Buy Boat/Buy Truck: A boat/truck which is used for the purchasing/shipment of shellfish in the capacity of a certified shellfish dealer/processor.
Certification: The issuance of a numbered license or permit to operate as an intrastate or interstate shellfish dealer/processor.
Certification Number: A number assigned to each certified shellfish dealer/processor by DNREC. The number shall be proceeded by the letters "DE" to indicate Delaware, and followed by a two letter symbols designating the type of operation.
Certified Shellfish Dealer/Processor: A person, persons, or business (including buildings, trucks, boats, and other equipment) which engage in one or more of the following: the sale, shucking, packing, repacking, shipping, reshipping, depurating, freezing, or other handling of shellfish on an interstate and/or intrastate basis, as follows:
Interstate Shellfish Dealer/Processor: A certified shellfish dealer/processor permitted to engage in the shellfish trade across state and international borders.
Intrastate Shellfish Dealer/Processor: A certified shellfish dealer/processor permitted to engage in the shellfish trade only within Delaware. This certification is not recognized outside of Delaware.
Commingling: The act of combining different lots of shucked or unshucked shellfish.
Cross Connection: A potable water supply line constructed to allow either back siphonage, or the attachment of a supply line extension which would allow back siphonage.
DNREC: The Delaware Department of Natural Resources and Environmental Control.
Depuration Plant: A plant certified by the State Shellfish Control Authority as a depuration processor.
Depuration Processor (DP): A shellfish dealer/processor which receives or harvests shellstock from approved sources; OR shellfish from waters classified as Seasonally Approved, Conditionally Approved, or Restricted, and which subjects this shellfish to an approved depuration process thereby rendering the shellfish as approved and fit for human consumption; however only as approved by DNREC.
Depuration Process Specifications: The controlled conditions (physical and operational specifications) by which shellfish are subjected to a strictly controlled aquatic environment as a means of reducing the levels of bacteria and viruses in live shellfish to acceptable levels, as approved by DNREC.
Depuration Unit: A tank, trough, or similar vessel in which live shellfish are stored temporarily, and subjected to depuration.
Dry storage: The storage of shellstock out of water.
EPA: The United States Environmental Protection Agency.
FDA: The United States Food and Drug Administration.
Food Contact Surface: Those surfaces of equipment and utensils which normally come in contact with food, and those surfaces from which food may drain, drip, or splash back onto surfaces normally in contact with food.
Food-Product Zone: The parts of food equipment, including ancillary structures, such as blower pipes and drain valves, which may contact the food being processed, or may drain into the portion of equipment with which food is in contact.
HACCP (Hazard Analysis Critical Control Points): A method of conducting sanitation assessments of shellfish/seafood dealer/processors, mandated by Federal law, effective as of December 18, 1997, and defined in the Federal Register as the "Procedures For the Safe and Sanitary Processing and Importation Of Fish and Fishery Products; Final Rule." which includes Part 123: "Fish and Fishery Products Hazards and Controls Guide."
Harvester Tag: A tag required to be affixed by a commercial shellfish harvester to an individual unit of shellfish, and meeting specifications contained in Appendix-10.
Harvest Lot: Shellfish harvested from one shellfish growing area during a single harvesting operation by a single shellfish harvester (for example: a harvester's daily take from a single growing area).
Internal Temperature: The actual temperature of shucked shellfish in the container (not necessarily the air temperature of the refrigerator in which the product may be stored).
Intrastate Shellfish Retailer: A shellfish dealer/processor which sells shellfish only in Delaware.
Marine Head: A toilet or other human waste catchment device with retention and/or discharge capability. A marine head may or may not be an MSD. MSD is the term for a Coast Guard approved marine head. See Appendix-11 for a more detailed definition.
Maximum Seed Size: The maximum size that seed can be grown in waters classified as Prohibited before being transported to waters classified as Approved, Seasonally Approved or Conditionally Approved.
National Shellfish Sanitation Program (NSSP): The cooperative State-FDA-Industry Program for certification of foreign and domestic interstate shellfish dealer/processors as described in the "NSSP Model Ordinance."
Person: A person as defined in Title 1, Chapter 3, Section 302, Delaware Annotated Code.
Poisonous or Deleterious Substance: A toxic compound occurring naturally, or which is artificially introduced.
Polluted Waters: Waters which contain human pathogenic organisms and/or indicator organisms and/or other poisonous/deleterious substances at actual or theoretical levels which are determined to render the shellfish growing in the waters unfit for human consumption.
Process Lot: A harvest lot or lots from the same shellfish growing area which are subject to processing.
Process Water: The water in depuration tanks when shellfish are present.
Relay Lot: All shellfish harvested from a single shellfish growing area and transported to another shellfish growing area for natural biological purification.
Relay Operator: A person/business permitted/certified to engage in relaying.
Repacker (RP): A shellfish dealer/processor, other than the original certified shucker-packer, which repacks and ships shucked shellfish into containers other than the original container.
Sanitary Survey: The collection of valid dilution formula loading factors, all elements of a wet slip basin classification survey, and the evaluation of all other actual and potential pollution sources and environmental factors having a bearing on shellfish growing area water quality.
Seed- Juvenile shellfish used in aquaculture operations.
Sewage: Human body wastes and/or other wastes from toilets and other receptacles intended to receive and discharge and/or retain such wastes.
Shellfish: All edible species of oysters, clams, mussels and scallops* either shucked or in the shell, fresh or frozen, whole or in part. The term "shellfish" may be used interchangeably with "shellstock" unless otherwise specified in these Regulations. Some of the common bivalves included in this definition are:
Common Name Scientific Name
Cockle Clinocardium nuttalli
Cardium corbis (Pacific)
Geoduck Panope generosa
Freshwater clam Rangia cuneata
Soft shell clam Mya arenaria
Hard or quahog clam Mercenaria mercenaria
Mercenaria campechiensis
Surf clam Spisula solidissima
Mahogany clam or Ocean quahog Arctica islandica
Gaper or Horse clam Tresus nuttalli
Tresus capax
Razor clam Solen resaceus
Ensis directus (Atlantic)
Solen viridis
Tagelus plebeius
Siliqua patula (Pacific)
Bent-nose clam Macoma nasuta
Pismo clam Tivela stultorum
Butter clam Saxidomus giganteus
Calico clam Macrocallista maculata
Sunray venus Macrocallista nimbosa
Pacific littleneck clam Protothaca tenerrima
Protothaca staminea
Manilla clam Tapes semidecussata
Pacific (Japanese) oyster Crassostrea gigas
Eastern oyster Crassostrea virginica
Olympia or yaquina oyster Ostrea lurida
European oyster Ostrea edulis
Blue or bay mussel Mytilus edulis
Ribbed mussel Geukensia demissa
California sea mussel Mytilus californianus
Green lipped mussel Perna canaliculus
*Scallops are excluded if the final product is the shucked adductor muscle only.
Shellfish Growing Areas (Waters): Naturally-occurring subaqueous or intertidal areas which support or could support live shellfish.
Shellfish Growing Area Classification: A designation which reflects the suitability of an area for shellfish harvesting relating to the fitness of the shellfish therein for human consumption. The following are the classifications that Delaware may use:
Approved" Shellfish Growing Area: An area approved for the harvesting of shellfish for any human food purposes with no seasonal restrictions or conditions.
Seasonally Approved" Shellfish Growing Area: An area where the harvesting of shellfish is allowed conditionally, as per a specified season.
Conditionally Approved" Shellfish Growing Area: An area where the harvesting of shellfish is allowed based on one or more specified conditions.
Prohibited" Shellfish Growing Area: An area where the taking of shellfish is prohibited, except for scientific research purposes with written permission of DNREC.
Shellfish Handler: Any person, persons, or business engaged in the growing, harvesting, buying, treating, packing, selling, shipping or other processing of shellfish.
Shellfish Handling: Any manual, mechanical, chemical manipulation or alteration of shellfish relating to its growing, harvesting, buying, treating, packing, selling, shipping, or other processing.
Shellfish Harvester (Catcher, Taker, Tonger, etc.): A person who removes shellfish from any waters by any means for any purpose.
Shellfish Harvesting (Catching, Taking, Tonging, Raking, etc.): The removal of shellfish by any means from a shellfish growing area for any purpose.
Shellfish Processing: The process undertaken when shellfish are shipped, reshipped, shucked, frozen, packed, repacked, depurated, or otherwise handled.
Shellstock: Shellfish in the shell.
Shellstock-Shipper (SS): A shellfish dealer/processor which grows, and/or harvests, and/or buys, and sells/ships shellstock.
Shellstock Shipper Tag: A tag required to be affixed by a shellstock shipper, repacker, or shucker-packer, to an individual unit of shellfish (as defined in these Regulations), and meeting specifications contained in Appendix 10.
Shucked Shellfish: Shellfish, whole or in part, from which one or both shells have been removed.
Shucker-Packer (SP): A shellfish dealer/processor which shucks and packs shellfish, and may also act as a SS or RS.
State Shellfish Control Authority (SSCA): The State agency or agencies having legal authority to classify shellfish growing areas and issue permits for the interstate shipment of shellfish in accordance with the provisions of the "NSSP Model Ordinance." Foreign shellfish control authorities having effective agreements with the FDA are considered State Shellfish Control Authorities for the purposes of these Regulations. DNREC is the State Shellfish Control Authority for Delaware.
Transaction Record: Forms used to document each purchase or sale of shellfish at the wholesale level.
Wet Storage: The temporary storage of shellfish intended for marketing in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater.
Wet Slip: A place in the water where a boat may be docked or otherwise moored to a fixed or floating structure, including but not limited to a dock, pier, mooring or anchorage.
Wet Slip Basin: A natural waterway and/or artificial lagoon and/or demarcated portions thereof containing more than ten wet slips.
1 Sales made to the final consumer are not required to be made by certified shellfish dealer/processors. However, all shellfish must at some time be handled by a certified shellfish dealer/processor prior to being sold/transferred to the final consumer.
