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II. Model Ordinance
XV. Depuration
Guide 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.]
- 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. @.01 C.; |
(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; |
- 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.
- The Authority shall review and approve the Depuration Plant
Operating Manual prior to granting depuration certification.
- The Authority shall review the depuration plant performance index
and other records as part of the monthly inspections to verify that the
process and CCP are effective and the process verification analysis is
being performed properly.
- 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 §D. (above) ; |
(2)
|
Current Depuration Plant
Operation Manuals for each dealer
(§.02). |
- 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.
- 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;
[C] and |
(b) |
Identified the
shellstock with a tag on each container
or transaction record on each bulk shipment; [C] and |
|
(2)
|
Originates from a dealer
who has identified the shellstock
with a tag on each container or transaction record with each bulk
shipment; [C] 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; [C]
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. [C] |
|
- Processing Critical Control Points - Critical Limits. The dealer
shall assure that:
(1) |
All depuration lots are
treated for a minimum of 44 hours; [C] and |
(2)
|
The water treatment system
is operating to design
specifications; [C] 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; [C]
and |
(2)
|
Once placed under
temperature control while in the
possession of the dealer, shellstock shall be:
(a) |
Iced; [C] or
|
(b) |
Placed in a storage
area or conveyance maintained at
45° Fahrenheit (7.2° Centigrade) or less; [C]and
|
(c) |
Not permitted to
remain outside temperature control for
more than 2 hours at points of transfer such as loading docks.[C]
|
|
.02 Sanitation
- 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. [C]
|
(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: [K]
(i) |
Prior to use of
the water supply; [C] |
(ii) |
Every six months
while the water supply is in use; [K] and |
(iii) |
After any water
supply has been repaired and disinfected. [SC/K]
|
|
|
(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; [C] or |
(b) |
Come from a facility
approved by the Authority or the
appropriate regulatory agency. [C] |
|
(3) |
Shellstock washing
(a) |
Water from either a
potable water supply, a growing area
in the approved classification, a saltwater well approved by the
authority, or the restricted area at the time and place of harvest,
shall be used to wash shellstock. [C] |
(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; [K] |
(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; [C] |
(iii) |
Test wash water
daily for bacteriological water
quality; [SC/K] |
(iv) |
Clean, service,
and test disinfection units at the
frequency necessary to ensure effective disinfection. [K]
|
|
(c) |
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); [K] and |
(ii) |
Is measured
using the method in the APHA Standard
Methods for the Examination of Water and Wastewater. [K]
|
|
(d) |
Food contact plumbing
which is designed and installed to
permit effective cleaning and sanitization shall be used. [C]
|
|
(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; [C] 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;
[C] |
(ii) |
If the source
water is a restricted growing area,
then:
- A
study meeting the requirements
of Chapter X. 08 C.(2 )(b) is required; [C]
- The
tank influent produced by
each disinfection
unit is evaluated daily; [C] and
- Source
water prior to final
disinfection must
meet the water quality criteria for restricted for depuration in
accordance with Chapter IV.02. G-H. [C]
|
(iii) |
If the source
water is a recirculating water system,
then:
- A
study meeting the requirements of Chapter
X. 08. C.(2) (b) [C] is required; and
- The
tank influent produced by each disinfection
unit is verified daily. [C]
- A
prohibited growing area may not be used for
source water. [C]
|
|
|
(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; [C] and |
(ii) |
Prevent any
cross-connection between the pressurized potable water supply and water
from an unacceptable source. [C] The dealer shall
install and maintain in good working order devices to protect against
backflow and back siphonage. [K] |
|
(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; [K] |
(ii) |
is
self-draining; [K] and |
(iii) |
meets the
requirements for food contact surfaces; [K] and |
|
(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; [K] |
(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;
[K] |
(iii) |
Shellfish
containers allow process water to flow
freely and uniformity to all shellfish within each container.
[K] |
|
|
(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; [K] |
(ii) |
Is
self-draining; [K] and |
(iii) |
Meets the
requirements for food contact surfaces. [K] |
|
|
- 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. [K]
|
(b) |
The dealer shall use
only equipment and utensils,
including approved plastic ware which is:
(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; [K] |
(ii) |
Free from any
exposed screws, bolts, or rivet heads
on food contact surfaces [K] and |
(iii) |
Fabricated from
food grade materials.[K] |
|
(c) |
The dealer shall
assure that all joints on food contact
surfaces:
(i) |
have smooth
easily cleanable surfaces; [K] and |
(ii) |
are welded. [K]
|
|
(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). [K] |
|
(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. [K] |
(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; [K] |
|
(b) |
All conveyances and
equipment which come into contact
with stored shellstock shall be cleaned and maintained in a manner and
a frequency as necessary to prevent shellstock contamination. [O]
|
(c) |
Containers which may
have become contaminated during
storage shall be properly washed, rinsed and sanitized prior to use or
are discarded. [K] |
(d) |
Shellstock depuration
tanks shall be cleaned and
sanitized on a regular schedule as part of a plant sanitation standard
operating procedure. [K] |
|
- 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.
[SC/K] |
(b) |
Shellstock shall not
be placed in containers with
standing water for the purposes of washing shellstock or loosening
sediment; [K] |
|
(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 hand washing facility:
(i) |
Before starting
work; [K] |
(ii) |
After each
absence from the work station; [K] |
(iii) |
After each work
interruption; [K] and |
(iv) |
Any time when
their hands may have become soiled or
contaminated. [K] |
|
|
- Maintenance of Hand Washing, Hand Sanitizing and Toilet
Facilities
(1) |
Hand washing facilities
with warm water at a minimum
temperature of 100° Fahrenheit (38°
Centigrade) ,dispensed from a hot
and cold mixing or combination faucet, shall be provided; [SK/O]
|
(2)
|
Sewage [C] and
liquid disposable wastes [K] shall be properly
removed from the facility. |
(3) |
An adequate number of
conveniently located toilets shall be
provided.[K] |
(4) |
The dealer shall provide
each toilet facility with an
adequate supply of toilet paper [K] in a suitable
holder. [SK/O] |
- Protection from Adulterants.
(1) |
Shellstock shall be
protected from contamination while being
transferred from one point to another during handling and processing; [K]
|
(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. [O]
|
(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. [K]
|
(4) |
Adequate ventilation shall
be provided to minimize
condensation in areas where shellfish are stored, processed or packed. [SK/C]
|
(5) |
Shellstock packing
activities shall be conducted to provide
adequate protection from contamination and adulteration. [K]
|
(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. [SC/K]
|
(b) |
Ice shall be stored in
a safe and sanitary manner to
prevent contamination of the ice. [SC/K]
|
|
- 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. [K]
|
(b) |
Each of the following
categories of toxic substances
shall be stored separately:
(i) |
Insecticides and
rodenticides; [K] |
(ii) |
Detergents,
sanitizers, and related cleaning agents; [K] and |
(iii) |
Caustic acids,
polishes, and other chemicals.
[K] |
|
(c) |
The dealer shall not
store toxic substances above
shellfish or food contact surfaces. [K] |
|
(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.
[K] |
(b) |
Cleaning compounds and
sanitizing agents shall be used
only in accordance with applicable federal and state laws and
regulations. [K] |
(c) |
Detergents,
sanitizers, and other cleaning supplies shall
be used only in strict accordance with the manufacturer's label
instructions. [K] |
(d) |
Toxic substances shall
be used only in strict accordance
with the manufacturer's label instructions. [K] |
|
|
|
- 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. [K]
|
(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. [K]
|
- Exclusion of Pests. The dealer shall operate his facility to
assure that pests are excluded from his facility and his activities.
[K]
.03 Other Model Ordinance Requirements
- Plants and Grounds.
(1) |
General
(a) |
The physical
facilities shall be maintained in good
repair. [O] |
(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. [K] |
|
(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:
[C]
(a) |
Shellstock processing
or repacking activities shall be
discontinued until the floodwaters have receded from the building; and
the building is cleaned and sanitized. [C] |
(b) |
Any shellstock coming
in contact with the floodwaters
while in storage shall be destroyed; or discarded in non-food use.
[C] |
|
(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.
[SC/K] |
(4) |
Separation of operations.
Manufacturing activities which
could result in the contamination of the shellstock shall be separated
by adequate barriers. [K] |
(5) |
Plant Interior.
(a) |
Sanitary conditions
shall be maintained throughout the
facility. [O] |
(b) |
Interior surfaces are
kept in good repair. [O] |
(c) |
All dry area floors
are hard, smooth, easily cleanable
and in good repair; [O] 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; [O] |
(ii) |
Have even
surfaces, and are free from cracks that
create sanitary problems and interfere with drainage; [O]
and |
(iii) |
Have sealed
junctions between floors and walls to
render them impervious to water. [O] |
|
|
(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. [O] |
(7)
|
Grounds. Grounds around the
facility shall be maintained to
be free from conditions which may result in shellfish contamination.
These conditions may include:
(a) |
Rodent attraction and
harborage; [O]
|
(b) |
Inadequate drainage. [O]
|
|
- Plumbing and Related Facilities.
(1) |
Hand washing facilities
shall be provided which are:
(a) |
Convenient to work
areas; [O] |
(b) |
Separate from the
three compartment sinks used for
cleaning equipment and utensils[K]; and |
(c) |
Directly plumbed to
an approved sewage disposal system.
[SO/K] |
|
(2)
|
The dealer shall provide at
each hand washing facility:
(a) |
A supply of hand
cleansing soap or detergent; [K] |
(b) |
A conveniently located
supply of single service towels in
a suitable dispenser or a hand drying device that provides heated air;
[O] |
(c) |
An easily cleanable
waste receptacle; [O] and |
(d) |
Hand washing signs in
a language understood by the
employees; [O] |
|
(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; [K] and |
(b) |
Hand washing
facilities adequate in number and size for
the number of employees, and are located where supervisors can observe
employee use. [K] |
|
(4) |
Adequate floor drainage,
including backflow preventers such
as air gaps, shall be provided where floors are:
(a) |
Used in shellstock
storage; [K] |
(b) |
Used for food holding
units (e.g. refrigeration units);
[K] |
(c) |
Cleaned by hosing,
flooding, or similar methods; [K] and |
(d) |
Subject to the
discharge of water or other liquid waste,
including, if applicable, three compartment sinks, on the floor during
normal activities; [K] |
|
(5) |
A safe, effective means of
sewage disposal for the facility
shall be provided in accordance with applicable federal and state laws
and regulations; [SC/K] |
(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. [K]
|
- Utilities.
Ventilation, heating, or cooling systems shall not create conditions
that may cause the shellstock to become contaminated. [SC/K]
- Insect and Vermin Control.
The dealer shall employ necessary internal and external insect and
vermin control measures to assure that insects and vermin are not
present in the facility, including:
(1) |
Tight fitting, self-closing
doors; [K] |
(2)
|
Screening of not less that
15 mesh per inch; [K] or |
(3) |
Controlled air currents.
[K] |
- Disposal of Wastes.
(1) |
Disposal of waste materials
shall be conducted in accordance
with appropriate federal and state laws and regulations. [O]
|
(2)
|
All areas and receptacles
used for the storage or conveyance
of waste shall be operated and maintained to prevent attraction,
harborage, or breeding places for insects and vermin. [O]
|
- 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.
[O] |
(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. [O]
|
- 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.
[K] |
(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. [O]
|
- Shellstock Storage and Handling.
(1) |
The dealer shall assure
that shellstock is:
(a) |
Reasonably free of
sediment; [O] and |
(b) |
Culled. [K]
|
|
(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; [K]or |
(b) |
Grading the floor.
[O] |
|
(3) |
Any mechanical
refrigeration equipment used for shellstock
storage shall be adequate in size and are equipped with:
(a) |
An automatic
temperature regulating control; [K] and |
(b) |
Installed thermometers
to accurately measure temperature
within the storage compartments. [K] |
|
(4) |
Inspect incoming shipments
and shall reject dead or
inadequately protected shellstock. [K] |
(5) |
Ensure that separate dry
storage facilities are provided for
depurated and undepurated shellfish. [K] |
(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; [K] or |
(b) |
Certified dealer(s) at
their certified facility. [K] |
|
(7)
|
Assure that culled
shellfish are destroyed or disposed of in
such a manner as to prevent their use for human food. [K] |
(8)
|
Transport, store, and
handle shellstock so that:
(a) |
Shellstock potential
for normal physiological activity
during depuration is not compromised; [K] and |
(b) |
Shellstock quality is
not degraded. [K] |
|
(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 is being processed at the same time,
the identity of each harvest lot is maintained throughout the stages of
depuration. [K] |
(10)
|
Wash and cull shellstock
after depuration and pack the
shellstock in clean shipping containers fabricated from safe materials.
[K] |
(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). [K] |
- Heat Shock. N/A
- Personnel. Any employee handling shucked shellfish shall be
required to:
(1) |
Wear effective hair
restraints; [O] |
(2)
|
Remove any hand jewelry
that cannot be sanitized or secured; [O] |
(3) |
Wear finger cots or gloves
if jewelry cannot be removed; [O] |
(4) |
Wear clean outer garments,
which are rinsed or changed as necessary to be kept clean. [O]
|
(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 belongs; [O] |
(b)
|
Eat or drink; [K]
|
(c) |
Spit; and [K]
|
(d) |
Use tobacco in any
form. [K] |
|
- Supervision.
(1) |
A reliable, competent
individual shall be designated to
supervise general plant management and activities; [K]
|
(2)
|
Cleaning procedures shall
be developed and supervised to
assure cleaning activities do not result in contamination of shellstock
or food contact surfaces. [K] |
(3) |
All supervisors shall be:
(a) |
Trained in proper food
handling techniques and food
protection principles; [K] and |
(b) |
Knowledgeable of
personal hygiene and sanitary practices.
[K] |
|
(4) |
The dealer shall require:
(a) |
Supervisors to assure
that proper sanitary practices are
implemented, including:
(i) |
Plant equipment
clean up; [K] |
(ii) |
Rapid product
handling; [K] and |
(iii) |
Shellstock
protection from contamination. [K] |
|
(b) |
Employees
(i) |
to be trained in
proper food handling and personal
hygiene practices, [K] 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; |
(h) |
Plant cleaning and
sanitation; and |
(i) |
Data analysis. |
(j) |
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; |
|
- Process Verification.
The Dealer shall continually:
(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 90th
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 coliform 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. |
(e) |
For the purpose of
making calculations, fecal
coliform counts that signify the upper or lower limit of sensitivity of
the test (MPN or ETCP) shall be increased or decreased by one
significant figure. Thus, <9.0 becomes 8.9, <17 becomes 16 and
>248 becomes 250. Individual plates which are too numerous to count
(TNTC) are considered to have >100 colonies per plate. A sample
containing "TNTC" plates is collectively rendered as having a count of
10,000. |
|
(2)
|
Conditional Protocol
Verification. If the depuration
performance indices 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 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. |
|
(e) |
When in Conditional
Protocol Verification due to a
failure of an established harvest area to meet the above Indices for
Depuration Plant Performance, determine daily, or as results become
available, the depuration performance indices defined as the geometric
mean and 90th percentile of fecal coliform (FC) from
assay data of the most recent ten (10) consecutive end product samples
for each species depurated and for each harvest area used
(i) |
Compare these
depuration performance indices with
the above Critical Limits for the Indices of Depuration Plant
Performance for this species. |
(ii) |
If these
depuration performance indices are less
than or equal to the above Critical Limits for the Indices of
Depuration Plant Performance for this species, the process is then
considered to be verified for this species from this particular harvest
area; and the process reverts to the Process Verification protocol in
.03L(1) . |
(iii) |
If either the
geometric mean or the 90th
percentile values exceed the above Critical Limits for the Indices of
Depuration Plant Performance for this species, the process shall remain
in Conditional Protocol Verification for this species from this
particular harvest area until the above Indices of Depuration Plant
Performance are attained. |
|
(f)
|
When in Conditional
Protocol Verification due to the
use of a new harvest area as the source of shellfish or if a new
depuration process has generated less than 10 process batches of data,
determine daily, or as results become available, the depuration
performance indices defined as the geometric mean and 90th
percentile of fecal coliform (FC) from assay data of the most
recent ten (10) consecutive harvest lots for each species depurated and
for each harvest area used.
(i) |
Compare these
depuration performance indices with
the above Critical Limits for the Indices of Depuration Plant
Performance for this species. |
(ii) |
If these
depuration performance indices are less
than or equal to the above Critical Limits for the Indices of
Depuration Plant Performance for this species, the process is then
considered to be verified for this species from this particular harvest
area; and the process reverts to the Process Verification protocol in
XV. 03 L . (1). |
(iii) |
If less than 10
process batches of data have been
collected or either the geometric mean or the 90th
percentile values exceed the above Critical Limits for the Indices of
Depuration Plant Performance for this species, from this particular
harvest area, the process shall remain in Conditional Protocol
Verification for this species from this particular harvest area until
10 batches of data have been collected and the above Indices of
Depuration Plant Performance are attained. |
|
|
(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 least 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. |
|