U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Seafood
November 3, 2000
A more recent version of this document
issued in November 2004. Below is an earlier version.
NATIONAL SHELLFISH SANITATION PROGRAM
MODEL ORDINANCE
XV. DEPURATION
(Table of Contents)
Note: In those States where depuration is not practiced, this Chapter may be deleted from
the Ordinance, as well as references to depuration throughout the Ordinance.
Requirements for the Authority.
[Note: The Authority must meet the requirements of this section even if the Authority
does not formally adopt this Chapter in regulation]
A. Prior to authorizing depuration, the Authority shall develop and maintain an
effective program to:
(1) Control shellstock harvesting by special license in accordance with Chapter VIII. B. 01;
(2) Control shellstock transportation between the harvest area and the
depuration facility to prevent shellstock from being illegally diverted to direct marketing;
(3) Approve the design and construction of the depuration facility or
activity including subsequent changes;
B. If shellstock is transported interstate to be depurated, the Authorities in both
States shall execute a memorandum of agreement to provide adequate control measures
to prevent diversion prior to depuration.
C. The Authority shall review and approve the Depuration Plant Operating
Manual prior to granting depuration certification.
D. The Authority shall review the depuration plant performance index and other
records at as part of the monthly inspection to verify that the process and CCP are
effective and the process verification analysis is being performed properly.
E. The Authority shall maintain adequate records for each depuration facility.
The following records for each facility shall be kept for the period of five years:
(1) Inspection reports and reviews of the plant performance in
accordance to §F. (above);
(2) Current Depuration Plant Operation Manuals for each dealer (§.02).
F. The Authority shall assure that each dealer has procedures to assure that no
shellstock which has not been depurated is removed from the depuration facility without
the direct supervision of the Authority.
Requirements for the Dealer.
.01 Critical Control Points.
A. Receiving Critical Control Point -Critical Limits. The dealer shall receive and depurate only
shellstock which is:
(1) Obtained from a licensed harvester who has:
(a) Harvested the shellstock from an Approved or Conditionally
Approved area in the open status as indicated by the tag; and
(b) Identified the shellstock with a tag on each container or
transaction record on each bulk shipment; and
(2) Originates from a dealer who has identified the shellstock with a tag on
each container or transaction record with each bulk shipment; and
(3) Obtained from a special licensed harvester who has:
(a) Harvested or supervised the harvest of shellstock from a
Restricted or Conditionally Restricted area in the open status; and
(b) Identified the shellstock by transaction records which include
the harvest area, the special-licensed harvester's name, harvester license number(s), the
harvest date, and the amount of shellstock shipped in each lot.
B. Processing Critical Control Points -Critical Limits. The dealer shall assure that:
(1) All depuration lots are treated for a minimum of 44 hours; and
(2) The water treatment system is operating to design specifications; and
(3) All critical limits established during verification of the specific depuration process
are being met.
C. Finished Shellstock Storage Critical Control Point -Critical Limits. The dealer shall assure
that:
(1) If wet storage in artificial bodies of water is practiced, water quality
meets the requirements outlined in Chapter X. 08; and
(2) Once placed under temperature control while in the possession of the dealer, shellstock shall
be:
(a) Iced; or
(b) Placed in a storage area or conveyance maintained at 45° Fahrenheit (7.2° Centigrade) or less;
and
(c) Not permitted to remain outside temperature control for more than 2 hours at points of transfer
such as loading docks.
.02 Sanitation
A. Safety of Water for Processing and Ice Production
(1) Water Supply.
(a) Dealers shall provide a potable water supply in accordance with applicable federal, state and
local regulations.
(b) If the water supply is from a private source, the dealer shall make arrangements to have the
water supply sampled by persons recognized by the Authority and tested at laboratories sanctioned
or certified by the Authority:
(i) Prior to use of the water supply;
(ii) Every six months while the water supply is in use; and
(iii) After any water supply has been repaired and disinfected.
(2) Ice production. Any ice used in the processing or storage of shucked shellfish shall:
(a) Be made on-site from potable water in a commercial ice machine; or
(b) Come from a facility approved by the Authority or the appropriate regulatory agency.
(3) Shellstock washing
(a) Water from either a potable water supply, or a growing area in the approved classification, or
the restricted area at the time and place of harvest, shall be used to wash shellstock.
(b) If the dealer uses any system to wash shellstock which recirculates water, the dealer shall:
(i) Obtain approval for the construction or remodeling of the system from the Authority;
(ii) Provide a water treatment and disinfection system to
treat an adequate quantity of water to a quality acceptable for shellstock washing, which,
after disinfection, meets the coliform standards for drinking water; and does not leave any
unacceptable residues in the shellstock;
(iii) Test wash water daily for bacteriological water quality;
(iv) Clean, service, and test disinfection units at the frequency necessary to ensure effective
disinfection.
(e) The dealer may use ultra-violet (UV) disinfection in his recirculating wash water system,
provided that the turbidity of the water to be disinfected:
(i) shall not exceed 20 nephelometric turbidity units (NTUs); and
(ii) Is measured using the method in the APHA Standard Methods for the Examination of Water and
Wastewater.
(f) Food contact plumbing which is designed and installed to permit effective cleaning and
sanitization shall be used.
(4) Depuration Process Water.
The dealer shall:
(a) Continuously treat process water with a disinfection system
approved by the Authority that does not leave any unacceptable residue in the shellstock; and
(b) Verify that the disinfection system produces process seawater
with no detectable coliform organisms as measured using an NSSP approved method in
the tank influent according to the following sampling protocols.
(i) If the source water is an approved growing area, approved
well, or other approved source, then the tank influent produced by each disinfection unit
is evaluated once per process batch;
(ii) If the source water is a restricted growing area, then:
(a) A study meeting the requirements of Chapter X. 08C.(2)(b) is required;
(b) The tank influent produced by each disinfection unit is evaluated daily; and
(c) Source water prior to final disinfection must meet the water
quality criteria for restricted for depuration in accordance with Chapter IV. 02G-H.
(iii) If the source water is a recirculating water system, then:
(a) A study meeting the requirements of Chapter X. 08C.(2)(b) is required; and
(b) The tank influent produced by each disinfection unit is verified daily.
(c) A prohibited growing area may not be used for source water.
(5) Plumbing and Related Facilities.
(a) The dealer shall design, install, modify, repair, and maintain all
plumbing and plumbing fixtures to:
(i) Prevent contamination of water supplies; and
(ii) Prevent any cross-connection between the pressurized
potable water supply and water from an unacceptable source. The dealer shall install and
maintain in good working order devices to protect against backflow and back siphonage.
(b) Shellstock storage tanks and related plumbing shall be
fabricated from safe materials, and tank construction shall be such that it :
(i) is easily accessible for cleaning and inspection;
(ii) is self-draining; and
(iii) meets the requirements for food contact surfaces.
(c) Depuration Plant Design and Construction.
The dealer shall ensure that:
(i) Depuration tanks, processing containers, and piping are
fabricated from non-toxic corrosion-resistant materials and are easily cleanable;
(ii) Depuration tank design, hydraulics, and typical container configuration are such that
process water is evenly circulated throughout all the shellfish containers within a given tank;
(iii) Shellfish containers allows process water to flow freely and uniformly to all shellfish
within each container.
(6) Depuration unit
(a) Depuration unit including depuration tanks, all reservoir tanks, and related piping shall be
fabricated from safe materials, and depuration unit construction is such that it:
(i) is easily accessible for cleaning and inspection;
(ii) is self-draining; and
(iii) meets the requirements for food contact surfaces.
B. Condition and Cleanliness of Food Contact Surfaces.
(1) Equipment and utensil construction for food contact surfaces.
(a) Except for equipment in continuous use and placed in service
prior to January 1, 1989, the dealer shall use only equipment which conforms to Shellfish
Industry Equipment Construction Guides (August 1993), U. S. Department of Health and Human
Services.
(b) The dealer shall use only equipment and utensils, including approved plasticware which are:
(i) Constructed in a manner and with materials that can be cleaned, sanitized, maintained or
replaced in a manner to prevent contamination of shellfish products;
(ii) Free from any exposed screws, bolts, or rivet heads on food contact surfaces; and
(iii) fabricated from food grade materials.
(c) The dealer shall assure that all joints on food contact surfaces:
(i) have smooth easily cleanable surfaces; and
(ii) are welded.
(d) All equipment used to handle ice shall be kept clean and stored in a sanitary manner, and shall
meet the construction requirements in §.02 B (1) (a), (b), and (c).
(2) Cleaning and sanitizing of food contact surfaces.
(a) Food contact surfaces of the depuration units, equipment and
containers shall be cleaned and sanitized to prevent contamination of shellstock and food
contact surfaces. The dealer shall:
(i) Provide applicable adequate cleaning supplies and
equipment, brushes, detergents, and sanitizers, hot water and pressure hoses .
(ii) Wash, rinse and sanitize equipment prior to the start-up
of each day's activities and following any interruption during which food contact surfaces
may have been contaminated;
(b) All conveyances and equipment which come into contact with
stored shellstock in such a manner and such a frequency shall be cleaned and maintained
as necessary to prevent shellstock contamination.
(c) Containers which may have become contaminated during
storage shall be properly washed, rinsed and sanitized prior to use or are discarded.
(d) Shellstock depuration tanks shall be cleaned and sanitized on a regular schedule as
part of a plant sanitation standard operating procedure.
C. Prevention of Cross Contamination.
(1) Protection of shellfish.
(a) Shellstock shall be stored in a manner to protect shellstock
from contamination in dry storage and at points of transfer.
(b) Shellstock shall not be placed in containers with standing
water for the purposes of washing shellstock or loosening sediment;
(2) Employee practices.
(a) The dealer shall require all employees to wash their hands thoroughly with
soap and water and sanitize their hands in an adequate handwashing facility:
(i) Before starting work;
(ii) After each absence from the work station;
(iii) After each work interruption; and
(iv) any time when their hands may have become soiled or contaminated.
D. Maintenance of Hand Washing, Hand Sanitizing and Toilet Facilities
(1) Handwashing facilities with warm water at a minimum temperature of
110° Fahrenheit (43° Centigrade), dispensed from a hot and cold mixing or combination
faucet, shall be provided;
(2) Sewage and liquid disposable wastes shall be properly removed from the facility.
(3) An adequate number of conveniently located toilets shall be provided.
(4) The dealer shall provide each toilet facility with an adequate supply of toilet paper in a
suitable holder.
E. Protection from Adulterants.
(1) Shellstock shall be protected from contamination while being
transferred from one point to another during handling and processing;
(2) Any lighting fixtures, light bulbs, skylights, or other glass suspended
over food storage or processing activities in areas where shellstock are exposed shall be
of the safety type or protected to prevent food contamination in case of breakage.
(3) Conveyances or devices used to transport shellstock shall be
constructed, maintained and operated to prevent contamination of the shellstock. If
overhead monorails or conveyors are used, the dealer shall take precautions to assure that
hydraulic fluids or lubricants do not leak or drip onto the shellstock or conveyance surfaces.
(4) Adequate ventilation shall be provided to minimize condensation in
areas where shellfish are stored, processed or packed.
(5) Shellstock packing activities shall be conducted to provide adequate
protection from contamination and adulteration.
(6) Protection of ice used in shellstock shipping.
(a) Any ice which is not made on-site in the depuration facility
shall be inspected upon receipt and rejected if the ice is not delivered in a way so as to be
protected from contamination.
(b) Ice shall be stored in a safe and sanitary manner to prevent contamination of the ice.
F. Proper Labeling, Storage and Use of Toxic Compounds.
(1) Storage of toxic compounds.
(a) The dealer shall assure that only toxic substances necessary for plant activities are present
in the facility.
(b) Each of the following categories of toxic substances shall be stored separately:
(i) Insecticides and rodenticides;
(ii) Detergents, sanitizers, and related cleaning agents; and
(iii) Caustic acids, polishes, and other chemicals.
(c) The dealer shall not store toxic substances above shellfish or food contact surfaces.
(2) Use and labeling of toxic compounds.
(a) When pesticides are used, the dealer shall apply pesticides in accordance with applicable
federal and state regulations to control insects and rodents in such a manner to prevent the
contamination of any shellfish or packaging materials with residues.
(b) Cleaning compounds and sanitizing agents shall be used only
in accordance with applicable federal and state laws and regulations.
(c) Detergents, sanitizers, and other cleaning supplies shall be
used only in strict accordance with the manufacturer's label instructions.
(d) Toxic substances shall be used only in strict accordance with
the manufacturer's label instructions.
(e) The dealer shall not store toxic substances above shellfish or food contact surfaces.
G. Control of Employees with Adverse Health Conditions.
(1) The dealer shall take all reasonable precautions to assure that
any employee with a disease in the communicable stage which might be transmissible
through food shall be excluded from working in any capacity in which the employee may
come in contact with the shellfish or with food contact surfaces. The diseases which are
transmissible from food workers through food are those determined by the US Centers
for Disease Control and Prevention, in compliance with the Americans with Disabilities
Act, and published in the Federal Register.
(2) If an employee with an infected wound keeps it covered with a proper
bandage, an impermeable barrier, and a single-use glove for a hand lesion, the dealer may
allow the employee to work in the shellfish processing facility without additional restrictions.
H. Exclusion of Pests. The dealer shall operate his facility to assure that pests
are excluded from his facility and his activities.
.03 Other Model Ordinance Requirements
A. Plants and Grounds.
(1) General
(a) The physical facilities shall be maintained in good repair.
(b) Animals or unauthorized persons shall not be allowed in those
portions of the facilities where shellstock are stored, handled, processed, or packaged and
food handling equipment and packaging materials are cleaned or stored.
(2) Flooding. Facilities in which shellstock are stored, packed, or
repacked shall be located so that these facilities are not subject to flooding during
ordinary high tides. If facilities are flooded:
(a) Shellstock processing or repacking activities shall be discontinued until the flood waters
have receded from the building; and the building is cleaned and sanitized.
(b) Any shellstock coming in contact with the flood waters while
in storage shall be destroyed; or discarded in non-food use.
(3) The dealer shall operate his facility to provide adequate protection from contamination and
adulteration by assuring that dirt and other filth are excluded from his facility and
activities.
(4) Separation of operations. Manufacturing activities which could result
in the contamination of the shellstock shall be separated by adequate barriers.
(5) Plant Interior.
(a) Sanitary conditions shall be maintained throughout the facility.
(b) Interior surfaces are kept in good repair.
(c) All dry area floors are hard, smooth, easily cleanable and in good repair; and
(d) All wet area floors used in areas to store shellstock, food processing, and cleaning equipment
are constructed of easily cleanable, impervious, and corrosion resistant materials which:
(i) Are graded to provide adequate drainage;
(ii) Have even surfaces, and are free from cracks that create sanitary problems and interfere with
drainage;
(iii) Have sealed junctions between floors and walls to render them impervious to water; and
(iv) Are maintained in good repair.
(6)Walls and Ceilings. Interior surfaces of rooms where shellstock are stored, handled,
processed, or packaged and food handling equipment and packaging materials shall be
constructed of easily cleanable, corrosion resistant, impervious and light colored materials.
(7) Grounds.
(a) Grounds around the facility shall be maintained to be free
from conditions which may result in shellfish contamination. These conditions may include:
(i) Rodent attraction and harborage;
(ii) Excessively dusty yards, roads or parking lots; and
(iii) Inadequate drainage.
(b) The dealer shall operate his facility to assure that dirt and other filth which may
be a source of shellfish contamination are excluded from his facility and his activities.
B. Plumbing and Related Facilities.
(1) Handwashing facilities shall be provided which are:
(a) Convenient to work areas;
(b) If applicable, separate three compartment sinks; and
(c) Directly plumbed to an approved sewage disposal system.
(2) The dealer shall provide at each handwashing facility:
(a) A supply of hand cleansing soap or detergent;
(b) A conveniently located supply of single service towels in a
suitable dispenser or a hand drying device that provides heated air;
(c) An easily cleanable waste receptacle; and
(d) Handwashing signs in a language understood by the employees;
(3) All plumbing and plumbing fixtures shall be designed, installed,
modified, repaired, and maintained to provide a water system that is adequate in quantity
and under pressure, and includes:
(a) Cold and warm water at all sinks; and
(b) Handwashing facilities adequate in number and size for the
number of employees, and are located where supervisors can observe employee use.
(4) Adequate floor drainage, including backflow preventers such as air gaps, shall be provided
where floors are:
(a) Used in shellstock storage;
(b) Used for food holding units (e. g. refrigeration units);
(c) Cleaned by hosing, flooding, or similar methods; and
(d) Subject to the discharge of water or other liquid
waste, including, if applicable, three compartment sinks, on the floor during normal activities;
(5) A safe, effective means of sewage disposal for the facility shall be
provided in accordance with applicable federal and state laws and regulations;
(6) Installation of drainage or waste pipes over processing or storage
areas, or over areas in which containers and utensils are washed or stored shall not be permitted.
C. Utilities.
Ventilation, heating, or cooling systems shall not create conditions that
may cause the shellstock to become contaminated.
D. Insect and Vermin Control.
The dealer shall employ necessary internal and external insect and
vernmin control measures to assure that insects and vermin are not present in the facility,
including:
(1) Tight fitting, self-closing doors;
(2) Screening of not less that 15 mesh per inch; or
(3) Controlled air currents.
E. Disposal of Wastes.
(1) Disposal of waste materials shall be conducted in accordance with
appropriate federal and state laws and regulations.
(2) All areas and receptacles used for the storage or conveyance of waste
shall be operated and maintained to:
(a) Minimize odors;
(b) Prevent attraction,
(c) Avoid the creation of nuisance conditions.
F. Equipment Construction for Non-food Contact Surfaces.
(1) The dealer shall use only equipment which is constructed in a manner
and with materials that can be cleaned, sanitized, maintained or replaced in a manner to
prevent contamination of shellstock.
(2) The dealer shall use easily cleanable, corrosion resistant, impervious materials, free from
cracks, to construct any non-food contact surfaces in shellfish storage or handling areas.
G. Cleaning and Sanitizing of Non-food Contact Surfaces.
(1) Cleaning activities for the depuration unit and equipment shall be
conducted in a manner and at a frequency appropriate to prevent contamination of
shellstock and food contact surfaces.
(2) All conveyances and equipment which come into contact with stored
shellstock shall be cleaned and maintained in a manner and frequency as necessary to prevent
shellstock contamination
H. Shellstock Storage and Handling.
(1) The dealer shall assure that shellstock is:
(a) Reasonably free of sediment; and
(b) Culled
(2) Shellstock shall be stored in a protected location which assures
complete and rapid drainage of water away from the shellstock by:
(a) Placing shellstock at an adequate height off the floor; or
(b) Grading the floor.
(3) Any mechanical refrigeration equipment used for shellstock storage shall be adequate in size
and are equipped with:
(a) An automatic temperature regulating control; and
(b) Installed thermometers to accurately measure temperature within the storage compartments.
(4 ) Inspect incoming shipments and shall reject dead or inadequately protected shellstock.
(5) Ensure that separate dry storage facilities are provided for depurated and undepurated shellfish;
and
(6) Cull and wash the shellstock prior to loading into the depuration tanks. This process may occur
before the shellstock is received at the facility by;
(a) Licensed harvester(s) at the harvest site; or
(b) Certified dealer(s) at their certified facility.
(7) Assure that culled shellfish are destroyed or disposed of in such a manner as to prevent their
use for human food.
(8) Transport, store, and handle shellstock so that:
(a) Shellstock potential for normal physiological activity during depuration is not compromised;
and
(b) Shellstock quality is not degraded.
(9) Assure that different harvest lots of shellfish are not commingled
during washing, culling, processing, or packing. If more than one harvest lot of shellfish
are being processed at the same time, the identity of each harvest lot is maintained throughout the
stages of depuration.
(10) Wash and cull shellstock after depuration and pack the shellstock in clean shipping containers
fabricated from safe materials;
(11) Depurated packaged shellstock shall be protected from contamination
at all times and be held at an ambient temperature not to exceed 45° Fahrenheit (7.2° Centigrade).
I. Personnel. Any employee handling shucked shellfish shall be required to:
(1) Wear effective hair restraints;
(2) Remove any hand jewelry that cannot be sanitized or secured;
(3) Wear finger cots or gloves if jewelry cannot be removed;
(4) Wear clean outer garments, which are rinsed or changed as necessary to be kept clean.
(5) In any area where shellfish are shucked or packed and in any area
which is used for the cleaning or storage of utensils, the dealer shall not allow employees to:
(a) Store clothing or other personal belongings;
(b) Eat or drink;
(c) Spit; and
(d) Use tobacco in any form.
J. Supervision.
(1) A reliable, competent individual shall be designated to supervise general plant management and
activities;
(2) Cleaning procedures shall be developed and supervised to assure
cleaning activities do not result in contamination of shellstock or food contact surfaces.
(3) All supervisors shall be:
(a) Trained in proper food handling techniques and food protection principles; and
(b) Knowledgeable of personal hygiene and sanitary practices.
(4) The dealer shall require:
(a) Supervisors to assure employees follow proper hygiene practices.
(b) Supervisors to assure that proper sanitary practices are implemented, including:
(i) Plant equipment clean-up;
(ii) Rapid product handling; and
(iii) Shellstock protection from contamination.
(c) Employees
(i) to be trained in proper food handling and personal hygiene practices, and
(ii) to report any symptoms of illness to their supervisor.
K. Plant Operating Manual.
The dealer shall prepare a written Depuration Plant Operations Manual (DPOM)
according to Minimum Requirements of a Depuration Plant Operations Manual (below);
and update the DPOM as necessary. A copy of the DPOM shall be kept in a location
readily accessible to the trained personnel responsible for the depuration activity. The
minimum requirements for a Depuration Plant Operating Manual shall address:
(1) Introduction including;
(a) Status of document (to create, revise, or update DPOM);
(b) Ownership and principal(s) involved with operation of facility;
(c) Address and phone number of owners and principles; and
(d) Summary of proposed use of the depuration facility including
statement of objectives of the operation of the plant, species to be processed, proposed
periods of facility operation, proposed sources of shellfish, including potential harvest
areas, and maximum capacity of plant.
(2) Description of the Facility including;
(a) Site plan drawings;
(b) Facility layout including detailed schematic of the entire depuration system;
(c) Schematic drawing of process;
(d) Product flow diagram showing product movement through facility (may be combined with §B.
(3);
(e) Statement that construction materials and fabrication will meet
the requirements of §.04, §.08, and §.09; and
(f) Schematic of seawater delivery and distribution system.
(3) Design Specifications of Depuration Unit including;
(a) Depuration tank diagram including tank dimensions and construction details, influent and
effluent locations, operating water level, and typical container configuration;
(b) Process water system describing type of system (flow-through or recirculating),
pretreatment and filtration systems, disinfection system, and hydraulic schematic;
(c) Shellfish containers construction and material meets §.04 and §.08 of this Chapter;
and
(d) List of equipment including washing, culling, and packing
equipment, material handling equipment, and cleaning and sanitation equipment.
(4) Laboratory to be utilized for microbial analyses (in house, government agency, private
commercial);
(5) Depuration process monitoring including:
(a) Sampling protocols including frequency of sampling, number of samples, sampling locations,
and methodology for process water analyzing , incoming shellstock, depurated shellstock, and
growing waters;
(b) Monitoring equipment maintenance and calibration procedures and copy of activity
log forms that will be used for data entry;
(c) Process water monitoring protocol for physical and chemical parameters; and
(d) Data analysis and evaluation.
(6) Standard Operating Procedure for:
(a) Receiving and holding;
(b) Washing, culling, and placement of undepurated product in process tanks;
(c) Depuration unit operation;
(d) Monitoring of depuration unit operation;
(e) Removal of depurated product from process tanks;
(f) Storage parameters and procedures;
(g) Labeling/ tagging procedures;
(f) Plant cleaning and sanitation; and
(g) Data analysis.
(h) Recall procedures.
(7) Record Keeping. List categories of information that will be recorded.
Include copies of proposed forms to be used in each category. A single form may be
used for several categories if properly designed.
(a) Shipping and receiving records;
(b) Plant Operation Log, including provisions for recording the values for chemical and physical
parameters;
(c) Maintenance and Sanitation Log(s);
(d) Laboratory records;
L. Process Verification.
The Dealer shall continously:
(1) Perform process verification on a continuous basis according to the following protocol:
(a) Following completion of a minimum of 44 hours of depuration, collect and assay at least one
end-product sample from each lot of shellstock to be depurated in the depuration unit.
(b) Determine daily, or as results become available, the depuration
performance indices defined as the geometric mean and 90 th percentile of fecal coliform
(FC) from assay data of the most recent ten (10) consecutive harvest lots for each species
depurated and for each restricted harvest area used.
(c) Compare daily, or as a results become available, the depuration performance indices with the
following Critical Limits for the Indices of Depuration Plant Performance.
Limits for Verification of Depuration Plant Performance
Fecal coliforms per 100 grams |
| Species |
Geometric Mean |
90th Percentile |
| Soft Clams (Mya arenaria) |
|
50 |
130 |
| Hard Clams (Mercenaria mercenaria) |
20 |
70 |
|
| Oysters |
20 |
70 |
|
| Manilla Clams |
20 |
70 |
|
| Mussels |
20 |
70 |
|
(d) If the depuration performance indices for a specific species
from a specific growing area are less than or equal to the above Critical Limits for the
Indices of Depuration Plant Performance, then the process is considered verified for that
species from that growing area.
(2) Conditional Protocol Verification. If the depuration performance
indicies for a specific growing area fail to meet the Critical Limits for the Indices of
Depuration Plant Performance, or if a new restricted growing area is used as a source of
shellfish for depuration, or if a new depuration process has generated less than 10 process
batches of data, the process is considered to be unverified and the dealer shall adhere to
the following conditional protocols:
(a) The depuration processor shall collect and assay at least one
zero hour and three end-product samples from each harvest lot;
(b) Environmental parameters including process water
temperature, salinity, dissolved oxygen, and turbidity and/ or other operational conditions
may be inhibit the physiological process and must be identified. The conditions(s), once
identified and quantified, become critical control points (CCP) for specific species in the
specific plant and the hazard analysis and HACCP plan shall be revised accordingly
(c) Shellstock which are processed during this conditional
protocol must meet the following release criteria before they may be released to market:
(i) Geometric mean (from three samples) of soft clams not to
exceed 110 and no single sample to exceed 170; or
(ii) Geometric mean (from three samples) of other clam
species, mussels, or oysters not to exceed 45 and no single sample to exceed 100.
(d) If the harvest lot fails to meet the release criteria, the
depuration processor may choose to subject the product to additional depuration
processing whereupon the shellfish can be resampled for release criteria or the disposition
of the shellfish shall be as follows:
(i) The Authority, in consultation with the depuration
processor, may order the destruction of the shellfish; or
(ii) The Authority, in consultation with the depuration
processor, may allow non-food use of the shellfish; or
(iii) The Authority, in consultation with the depuration
processor, may allow the shellfish to be relayed in accordance with Chapter V.
(3) When depuration units with multiple tanks are used, it is necessary to
determine whether the individual tanks are similar.
(a) Tanks are considered similar if the difference between physical
tank dimensions and process water flow rate is less than 10%.
(b) If they are not similar, then the process verification protocols
contained in Section .03 (1) -(2) must be employed for each tank.
(4) The dealer shall ensure that all microbiological assays of end-point samples of shellstock:
(a) Are analyzed by a laboratory which has been evaluated and
approved pursuant to the requirements in Chapter III, using an NSSP-approved method;
(b) Sample size consists of a pool of at leasts 12 shellfish selected
at random from each designated container (more than 12 individuals may be required in the case of
smaller shellfish); and
(c) Samples are collected at locations within the depuration unit
that are considered to be most compromised as regards shellfish activity, based on the
sampling plan contained in the Depuration Plant Operations Manual.
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Hypertext updated by dav/ear 2006-OCT-05