La. Admin. Code tit. 51 § IX-101

Current through Register Vol. 50, No. 11, November 20, 2024
Section IX-101 - Definitions [formerly paragraph 9:001]
A. Unless otherwise specifically provided herein, the following words and terms used in this Part of the Sanitary Code, and all other Parts which are adopted or may be adopted, are defined for the purposes thereof as follows.

Adverse Pollution Conditions-a state or situation caused by meteorological, hydrological, or seasonal events or point source discharges that has historically resulted in elevate fecal coliform levels in a particular growing area.

Approved Area-the classification of a Louisiana shellfish growing area which has been approved by the state health officer with the assistance of the secretary of the Department of Wildlife and Fisheries for growing or harvesting shellfish for direct marketing. The classification of an approved area is determined through a sanitary survey conducted by the Department of Health in accordance with the guidelines set out in this rule and as hereafter amended and duly promulgated. An approved shellfish growing area may be temporarily made a closed area when a public health emergency resulting from, for instance a hurricane or flooding, is declared by the state health officer.

Aquaculture-cultivating shellfish in controlled conditions for human consumption. Cultivation includes propagation and growing of shellfish. These activities may occur in natural or man-made water bodies. These activities include seed collection, production, and cultivation in natural water bodies when shellfish are held off the bottom such as the use of racks, bags, or cages, and when shellfish are held in man-made water bodies such as the use of tanks, ponds, or raceways. These activities do not include depuration or wet storage.

Bacteriological Database-bacteriological analysis organized and used as the basis for the classification of shellfish growing waters.

Central Laboratory, in New Orleans, Public Health Laboratory for the State-Repealed.

Certified Dealer-a person who has been registered with and certified by the Office of Public Health to be a dealer.

Certified Laboratory-a laboratory conducting analysis for the Louisiana Molluscan Shellfish Program that has received a satisfactory rating during an on-site evaluation by the shellfish evaluation officer for the state of Louisiana or the federal Food and Drug Administration (FDA) evaluation officer. The purpose of the evaluation will be to assure the uniform application of standard procedures and methods in the sampling and analytical examination of shellfish growing waters and to determine and assure the adequacy of facilities, equipment, and personnel to perform analytical testing necessary to meet the requirements recommended by the National Shellfish Sanitation Program and found to be acceptable by the Louisiana Molluscan Shellfish Program. This evaluation only certifies that the laboratory facility and its staff meet the specifications of the National Shellfish Sanitation Program at the time of the evaluation.

Closed Area-a growing area where the harvesting of shellfish is temporarily or permanently not permitted. A closed area status is or may be placed on any of four classified area designations-approved, conditionally approved, restricted, or prohibited.

Closed Safety Zone-an area designated by the state health officer for the purpose of lessening the impact of an actual or potential pollution source.

Coliform Group-includes all of the aerobic and facultative anaerobic, gram-negative, non-spore-forming bacilli which ferment lactose with gas formation within 48 hours at 35°C.

Conditional Management Plan-a written management program approved by the state health officer and the secretary of the Department of Wildlife and Fisheries governing classification of shellfish harvesting water classified as conditionally approved.

Conditionally Approved Area-the classification of a Louisiana shellfish growing area determined by the state health officer to meet the approved area criteria for a predictable period. A conditionally approved shellfish growing area is a closed area when the area does not meet the approved growing area criteria and is temporarily closed by the state health officer.

Cull-to remove dead or unsafe shellstock from a lot of shellstock.

Dealer-a person engaged in the purchasing, storing, shipping, and selling of seafood.

Department-the Louisiana Department of Health, Office of Public Health.

Direct Impact-a pollution source or potential source which may have an immediate impact on shellfish harvesting waters. Examples are:

a. any waste directly piped to shellfish harvesting waters;
b. any waste discharged to a property which would drain directly to shellfish harvesting waters;
c. domestic animals penned or confined so the animals have direct contact with the harvesting waters or their waste drain directly to growing waters;
d. marinas;
e. processing waste draining directly to harvesting waters.

Edible Crustaceans-include any edible, commercially distributed shrimp, crab, crayfish, lobster or other member of the animal kingdom classified as crustaceans (Crustacea).

FDA Evaluation Officer-Repealed.

FDA Evaluation Officer-an individual attached to the Department of Health and Human Services, Public Health Service, Food and Drug Administration, Bureau of Food Technology, Shellfish Sanitation Branch for the purpose of conducting on-site evaluations of an officially designated laboratory of the shellfish sanitation laboratory system.

Fecal Coliform Group-includes bacteria of the coliform group which will produce gas from lactose in a suitable multiple tube procedure liquid medium (EC or A-1) within 24 plus/minus two hours at 44.5° plus/minus 0.2°C in a water bath.

Fish-includes any edible, commercially distributed fresh or salt-water member of the animal kingdom classified as fish (Pisces).

Growing Area-an area which supports or could support live shellfish.

Habitable Structure-any structure capable of giving shelter from the environment and producing sewage waste.

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

Harvest Area-an area that contains commercial quantities of shellstock and may include aquaculture sites and facilities.

Harvester-a person who takes shellfish by any means from a growing area.

Hazard Analysis Critical Control Point (HACCP)-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).

Hazard Analysis Critical Control Point Plan-a written document that delineates the formal procedures that a dealer follows to implement the HACCP requirements set forth in 21 Code of Federal Regulations (CFR) 123.6 as adopted by the Interstate Shellfish Sanitation Conference.

Indirect Impact-a discharge or pollution source which could reach shellfish growing waters in a roundabout way. Example: an outfall which discharges to a drainage system which discharges into the immediate area of shellfish growing waters.

In-Shell Product-nonliving, processed shellfish with one or both shells present.

Interstate Shellfish Sanitation Conference (ISCC)-the organization which consists of agencies from shellfish producing and receiving states, FDA, the shellfish industry, NOAA, and the Environmental Protection Agency (EPA). The ISCC provides the formal structure wherein state regulatory authorities, with FDA concurrence, can establish updated guidelines and procedures for sanitary control of the shellfish industry.

Laboratory Evaluation Officer (LEO)-a person from either a state, federal or foreign authority that has met the personnel training requirements for implementing the NSSP.

Louisiana Molluscan Shellfish Laboratory System-all laboratories that have been successfully evaluated during an on-site evaluation by the Laboratory Evaluation Officer for the state of Louisiana and have been consequently officially designated as a shellfish sanitation laboratory for the Louisiana Molluscan Shellfish Sanitation Program.

Louisiana State Shellfish Sanitation Laboratory System-all laboratories that have been successfully evaluated during an on-site evaluation by the shellfish evaluation officer for the state of Louisiana or FDA evaluation officer and have been consequently officially designated as a shellfish sanitation laboratory for the Louisiana State Shellfish Sanitation Program.

Louisiana State Shellfish Sanitation Program, Oyster Water Monitoring Program-Repealed.

Marina-any water area with a structure (docks, basin, floating docks, etc) which is used for docking and constructed to provide temporary or permanent docking space for more than 10 boats.

Marina Policy-the prescribed plan approved by the state health officer to be used in the classification of shellfish harvesting waters in and around marinas.

Marine and Freshwater Animal Food Products-any food products used as food for human consumption which are made from or contains fish, shellfish, edible crustaceans, or any other animal whose normal life span, in whole or part, is spent in fresh, brackish or salt water.

Marine Biotoxin-any poisonous compound produced by marine microorganisms and accumulated by shellstock. Examples include toxins produced by Alexandrium spp [Protogonyaulax species] and Karenia brevis.

Molluscan Shellfish Program-the program which regulates and monitors the growing, harvesting, handling and shipping of shellfish in the state of Louisiana. The program is with the Louisiana Department of Health, Office of Public Health, Sanitation Services Section.

Most Probable Number (abbreviated MPN)-a statistical estimate of the number of bacteria per unit volume and is determined from the number of positive results in a series of fermentation tubes.

Narrative Report-a report submitted by the shellfish evaluation officer for the state of Louisiana or the FDA evaluation officer following an on-site evaluation. The report shall include the identity of the laboratory, the date of evaluation, name of evaluator, information on personnel and procedures and conclusions and shall precisely and accurately describe the conditions which existed during the evaluation, including what recommendations were made to correct deficiencies and proposed timetable for any corrective action necessary to bring the laboratory into substantial conformity with the requirements of the National Shellfish Sanitation Program (NSSP) as approved by the Louisiana Molluscan Shellfish Program.

National Shellfish Sanitation Program (NSSP)-the cooperative State-FDA-Industry program for the certification of interstate shellfish shippers as described in the National Shellfish Sanitation Program for the Control of Molluscan Shellfish. The National Shellfish Sanitation Program for the Control of Molluscan Shellfish guide may be obtained from the Interstate Shellfish Sanitation Conference.

On-Site Evaluation-inspection of a laboratory and all appropriate personnel at the physical laboratory site by the Laboratory Evaluation Officer for the purpose of conducting evaluation according to the NSSP Guide for the Control of Molluscan Shellfish.

Opening/Closing Line-a boundary drawn on a map to delineate the classification of shellfish grown waters.

Open Water Aquaculture-the cultivation of bivalve shellfish in natural shellfish growing areas.

Person-includes any individual, partnership, corporation, association or other legal entity.

Point Source-any discernible, confined and discrete conveyance including but not limited to any pipe, ditch, channel, tunnel, or conduit that carries pollution.

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 shellfish to protect public health.

Pollution-the contamination of the shellfish waters by the discharge of microbiological substances into these waters (chemicals, bacterial, or biotoxins).

Post-Harvest Processing (PHP)-any process which has been validated using NSSP validation procedures which reduces levels of pathogenic hazards to below the appropriate FDA action level or in absence of such a level, below the appropriate level as determined by the ISCC.

Processing-any activity associated with the handling, shucking, freezing, packing, labeling or storing of shellfish in preparation for distribution. This would include the activities of a shellstock shipper, shucker packer, repacker, reshipper, or depuration processor.

Prohibited Area-Louisiana waters that have been classified by the state health officer as prohibited for the harvesting of shellfish for any purpose except depletion and production of seed for aquaculture. A prohibited shellfish growing area is a closed area for the harvesting of shellfish at all times. Harvesting of shellfish from a closed area may result in criminal charges pursuant to R.S. 56:424.

Relaying-the transfer of shellfish from restricted areas to approved areas for natural biological cleansing using the ambient environment as a treatment system.

Restricted Area-a classification used to identify a growing area where harvesting shall be by special permit and the shellstock, following harvest, is subjected to a suitable and effective treatment process.

Sanitary Survey-the written evaluation report of all \environmental factors, including actual and potential pollution sources, which have a bearing on shellfish growing area water quality.

Satisfactory Rating-Repealed.

Seafood-includes but is not limited to fish, shellfish, edible crustaceans, marine and freshwater animal food products.

Seed-shellstock which is less than market size.

Shellfish-all edible species of oysters, clams, or mussels, either shucked or in the shell, fresh or frozen; whole or in part. Some of the common bivalves included in this definition are:

Common Name

Scientific Name

Cockle

Clinordium nuttalli

Cardium corbis (Pacific)

Geoduck

Panope generosa

Fresh water clam

Rangia cuneata

Soft shell clam

Mya arenaria

Hard or quahog clam

Mercenaria mercenaria

Mercenaria campechiensis

Surf clam

Spisula solidissima

Mahogany or Ocean quahog, clam

Artica islandica

Gaper or Horse clam

Tresus nuttalli and T. capax

Razor clam

Solen resaceus, Ensis directus

(Atlantic)

Solen viridis, Tagelus plebeius, and 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 and

Protothaca staminea

Manila 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

California sea mussel

Mytilus californianus

Green lipped mussel

Perna canaliculus

(New Zealand)

Shellfish Evaluation Officer for the State of Louisiana- state health officer or his/her designee approved by letter by the federal Department of Health and Human Services, Public Health Service, Food and Drug Administration, Bureau of Food Technology, Shellfish Sanitation Branch to conduct on-site evaluations of laboratories deserving official recognition as a member of the shellfish sanitation laboratory system other than the certified laboratory. Official approval is based upon the individual meeting the requirements of Shellfish Sanitation Interpretation S.S. 35 entitled "Evaluation of Laboratories by State Shellfish Laboratory Evaluation Officers."

Shellstock-live molluscan shellfish in the shell.

State Shellfish Patrol Agency-the enforcement agents of the Louisiana Department of Wildlife and Fisheries having the responsibility for the enforcement of lines concerning harvesting of shellfish.

State Waters-waters that belong wholly to the state of Louisiana, including the Territorial Sea.

Transplanting-the moving of shellfish from one area to another area for improving growth, stocking depleted area and leases, and for other aquaculture purposes.

Worst Pollution Conditions-Repealed.

La. Admin. Code tit. 51, § IX-101

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1289 (June 2002), amended LR 28:1591 (July 2002), LR 31:2895 (November 2005), LR 34:2175 (October 2008), Amended by the Department of Health, Office of Public Health, LR 481844 (7/1/2022), Amended LR 482132 (8/1/2022).
AUTHORITY NOTE: The first source of authority for promulgation of the sanitary code is in R.S. 36:258.B, with more particular provisions found in Chapters 1 and 4 of Title 40 of the Louisiana Revised Statutes. This Part is promulgated in accordance with the specific provisions of R.S. 40:4.A(1), R.S. 40:5.A(2)(3)(5)(7)(9)(15)(17)(19)(20) and R.S. 40:5.3.