216 R.I. Code R. § 216-RICR-50-10-6.4 - General Requirements
6.4.1
General
Requirements
A. Licensure Requirements
1. Types of Licensure Activities
a. Shucker-packer (SP). Any person who
shucks shellfish shall be licensed as a shucker-packer.
b. Repacker (RP)
(1) Any person who repacks shucked shellfish
shall be licensed as a shucker-packer or repacker;
(2) Any person who repacks shellstock shall
be licensed as a shellstock shipper, shucker-packer, or repacker;
(3) A repacker shall not shuck
shellfish.
c. Shellstock
Shipper (SS). Any person who ships and receives shellstock in interstate
commerce shall be licensed as a shellstock shipper, repacker, or
shucker-packer.
d. Reshipper (RS).
Any person who purchases shellstock or shucked shellfish from dealers and sells
the product without repacking or relabeling to other dealers, wholesalers or
retailers shall be licensed as a reshipper. Reshippers are not required to have
a business facility address as required in §6.3.1(J) of this
Part.
2. General
Licensure Requirements
a. No person shall act
as a dealer prior to obtaining licensing.
b. Any person who wants to be a dealer shall:
(1) Make application to the Director for
licensing; and
(2) Have and
implement a HACCP Plan.
B. Shellstock Identification
1. General
a. The dealer shall keep the harvester's tag
affixed to each container of shellstock until the container is:
(1) Shipped; or
(2) Emptied to wash, grade or pack the
shellstock.
b. When the
dealer is also the harvester and he elects not to use a harvest tag, the dealer
shall affix his dealer tag to each container of shellstock.
2. Tags
a
The dealers' tags shall:
(1) Be durable,
waterproof and sanctioned by the Department prior to use; and
(2) Be at least 13.8 square inches [89.03
square cm] in size.
b.
The dealer's tag shall contain the following indelible, legible information in
the order specified below:
(1) The dealer's
name and address;
(2) The dealer's
license number or certification number as assigned by the Department and the
original shellstock shipper's license number, if applicable;
(3) The date of harvest;
(4) The time of harvest (when
appropriate);
(5) The harvest
location, as designated in the Rhode Island Department of Environmental
Management Regulations 250-RICR- 90-00-4, Shellfish, and tagging map located
at: http://www.dem.ri.gov/programs/bnatres/fishwild/pdf/tagmap.pdf,
including the initials for the State of Rhode Island (RI), or the harvest area
it appears on the original dealer's tag, including the initials of the State of
origin; and
(6) When the
shellstock has been taken cross State lines and has been placed in wet storage
in a dealer's operation, the statement: "THIS PRODUCT IS A PRODUCT OF (NAME OF
STATE) AND WAS WET STORED AT (FACILITY LICENSE NUMBER) FROM (DATE) TO
(DATE);"
(7) The type and quantity
of shellfish; and
(8) The following
statement in bold capitalized type on each tag: "THIS TAG IS REQUIRED TO BE
ATTACHED UNTIL CONTAINER IS EMPTY OR IS RETAGGED AND THEREAFTER KEPT ON FILE,
IN CHRONOLOGICAL ORDER, FOR 90 DAYS." "RETAILERS: DATE WHEN LAST SHELLFISH FROM
THIS CONTAINER SOLD OR SERVED (INSERT DATE)"
(9) All shellstock intended for raw
consumption shall include a consumer advisory. The following statement, from
§ 3-603.11 of the 2017 FDA Food Code, or an equivalent statement, shall be
included on all shellstock: "Consuming raw or undercooked meats, poultry,
seafood, shellfish or eggs may increase your risk of foodborne illness,
especially if you have certain medical conditions."
(10) The statement "Keep Refrigerated" or an
equivalent statement must be included on the tag.
(11) If the shellstock is removed from the
original container, the tag on the new container shall meet the requirements in
§§6.4.1(B) through (D) in this part.
C. Tagging
Shellstock during Intermediate Processing
1.
When the shellstock is removed from the original container, the dealer shall:
a. Keep the harvester tag for ninety (90)
days;
b. Keep track of the growing
area and date of harvest for shellstock; and
c. Maintain identity of all shellstock during
any intermediate stage of processing.
2. A dealer receiving bulk tagged lots of
shellstock must have an intermediate processing plan approved by the Department
to ensure that each lot of shellstock is kept separate and identified in a way
which prevents commingling or misidentification.
3. In order for a dealer to tag a lot
container (e.g. a pallet) of shellfish in lieu of meeting the requirement in
§§6.4.1(B), (C), and (D) of this part for a harvester or dealer tag
on each individual container, the dealer shall have an intermediate processing
plan approved by the Department which establishes the procedures the dealer
shall use to tag the lot during the washing, packing or staging of
shellfish.
4. Unless the dealer is
included in the Department's commingling plan, the dealer's intermediate
processing plan for tagging a lot of shellfish during the intermediate stage of
processing shall ensure that each lot of shellfish is separated and identified
in a way which prevents commingling or misidentification. The identification
shall be provided by:
a. A harvester's or
dealer's tag which meets the requirements of §§6.4.1(B), (C), and (D)
of this part; or
b. A tag for each
lot of shellstock which contains the following information:
(1) A statement that "All shellstock
containers in this lot have the same harvest date and area of
harvest;"
(2) Harvest
date;
(3) Harvest time (when
appropriate);
(4) Growing
area;
(5) Original dealer license
or certification number (if applicable); and
(6) Number of individual containers in each
lot of shellstock container (e.g. a pallet) after washing, packing or staging
has been completed.
5. When a dealer has an approved intermediate
processing plan, the dealer shall tag each lot of shellstock in accordance with
the intermediate processing plan while the lot of shellstock is being processed
in the plant.
D.
Transaction Record. If shellstock are sold in bulk, the dealer shall provide a
transaction record prior to shipment. This transaction record shall contain all
the information required in §6.4.1(E) of this Part with the addition of
the name of the consignee.
E.
Shucked Shellfish Labeling
1. All shellfish
intended for raw consumption shall include a consumer advisory. The following
statement, from § 3-603.11 of the 2017 FDA Food Code, or an equivalent
statement, shall be included on all shellfish:
a. "RETAILERS, INFORM YOUR CUSTOMERS"
"Consuming raw or undercooked meats, poultry, seafood, shellfish or eggs may
increase your risk of foodborne illness, especially if you have certain medical
conditions."
2. If the
shucker-packer uses returnable containers to transport shucked shellfish
between dealers for the purpose of further processing or packing, the
returnable containers are exempt from the labeling requirements in this section
of the Regulation. When returnable containers are used, the shipment shall be
accompanied by a transaction record containing:
a. The original shucker-packer's name and
license or certification (if applicable);
b. The shucking date; and
c. The quantity of shellfish per container
and the total number of containers.
3. If the dealer uses master shipping
cartons, the master cartons are exempt from these labeling requirements when
the individual containers within the carton are properly labeled.
4. At a minimum the dealer shall label each
individual package containing fresh or frozen shucked shellfish meat in a
legible and indelible form in accordance with
21 C.F.R. §
161.130 (2012) (not to include
later amendments thereof) and the Federal Fair Packaging and Labeling Act, 15
U.S.C. §§
1451 - 1461.
5.
The dealer shall assure that each package containing less than sixty-four (64)
fluid ounces of fresh or frozen shellfish shall have:
a. The shucker-packer's or repacker's license
or certification number (if applicable) on the label; and
b. A "SELL BY DATE" which provides a
reasonable subsequent shelf-life or the words "BEST IF USED BY" followed by a
date when the product would be expected to reach the end of its shelf-life. The
date shall consist of the abbreviation for the month and number of the day of
the month. For frozen shellfish, the year will be added to the date.
6. The dealer shall assure that
each package containing more than sixty-four (64) fluid ounces of fresh or
frozen shellfish shall have:
a. The
shucker-packer's or repacker's license or certification number (if applicable)
on the label; and
b. A "DATE
SHUCKED" which shall:
(1) For fresh shellfish,
consist of the number of the day of the year or the month and the number of the
day of the month;
(2) For frozen
shellfish, include the year; and
(3) Appear on the lid and sidewall or bottom
of single-use containers.
7. If the dealer thaws and repacks frozen
shellfish, the dealer shall label the shellfish container as previously
frozen.
8. The dealer shall provide
all label information in a legible and indelible form.
9. The dealer shall maintain lot integrity
when shucked shellfish are stored using in-plant reusable containers.
F. Shucked Shellfish If the dealer
(SP, RP) elects to repack shellfish, the dealer shall pack and label all
shellfish in accordance with §§6.4.1(E), (F), and (G) of this Part,
except that the original date of shucking shall be used in establishing the
SELL BY DATE.
G. Buy Boats
1. Boats used to purchase shellfish must be
operated in compliance with all applicable requirements of R.I. Gen. Laws
Chapter 21-14 and this Part, including but not limited to:
a. Hand washing equipment, such as sanitizing
baby wipes or potable water and soap, must be provided on the vessel and used
any time the hands have become contaminated.
b. Boats shall provide overhead protection of
shellstock from exposure to sun, birds, and other adverse conditions.
c. Boats may be cleaned with water from open
harvest areas or a potable water supply.
d. Shellstock shall be placed under
temperature control of forty-five degrees Fahrenheit (45º F) (seven and
two tenths degrees Centigrade (7.2º C)) ambient air temperature (or below)
as soon as possible not to exceed two (2) hours from the time the boat leaves
the harvest area in which it was operating; and
e.
§6.4.1(G)(2) of this Part, outlined
below.
2. Disposal of
Human Sewage from Vessels
a. Human sewage
shall not be discharged overboard from a vessel used in the harvesting of
shellstock, or from vessels which buy shellstock while the vessels are in
growing areas.
b. As required by
the Department, in consultation with FDA, an approved marine sanitation device
(MSD), portable toilet or other sewage disposal receptacle shall be provided on
the vessel to contain human sewage.
c. Portable toilets shall:
(1) Be used only for the purpose
intended
(2) Be secured while on
board and located to prevent contamination of shellshock by spillage or
leakage
(3) Be emptied only into a
sewage disposal system
(4) Be
cleaned before being returned to the boat
(5) Not be cleaned in equipment used for
washing or processing food d. Use of other receptacles for sewage disposal may
be approved by the Department if the receptacles are:
(6) Constructed of impervious, cleanable
materials and have a tight-fitting lid;
(7) Indelibly labeled "Human Waste" in
contrasting letters at least three inches (3") in height; and
(8). Meet the requirements of
§6.4.1(G)(2)(c) of this Part.
6.4.2
General
HACCP Requirements
A. Hazard Analysis.
Every dealer shall conduct a hazard analysis to determine the food safety
hazards that are reasonably likely to occur for each kind of shellfish product
processed by that dealer and to identify the preventive measures that the
dealer can apply to control those hazards. Such food safety hazards can be
introduced both within and outside the processing plant environment, including
food safety hazards that can occur before, during, and after harvest. A food
safety hazard that is reasonably likely to occur is one for which a prudent
dealer would establish controls because experience, illness data, scientific
reports, or other information provide a basis to conclude that there is a
reasonable possibility that it will occur in the particular type of shellfish
product being processed in the absence of those controls. In the hazard
analysis, the dealer shall consider the critical control points listed in this
Part.
B. HACCP Plan. Every dealer
shall have and implement a written HACCP plan. A HACCP plan shall be specific
to:
1. Each location where shellfish products
are processed by that dealer; and
2. Each kind of shellfish product processed
by the dealer. The plan may group kinds of shellfish products together, or
group kinds of production methods together, if the food safety hazard, critical
control points, critical limits, and procedures required to be identified and
performed in §6.4.2(C) of this Part are identical for all shellfish
products so grouped or for all production methods so grouped.
C. Contents of the HACCP Plan. The
HACCP plan shall, at a minimum:
1. List the
food safety hazards that are reasonably likely to occur, as identified in
accordance with §6.4.2(A) of this Part and that thus must be controlled
for each shellfish product. Consideration should be given to whether any food
safety hazards are reasonably likely to occur as a result of the following:
a. Natural toxins;
b. Microbiological contamination;
c. Chemical contamination;
d. Pesticides;
e. Drug residues;
f. Unapproved use of direct or indirect food
or color additives; and
g.
Physical hazards.
2.
List the critical control points for each of the identified food safety
hazards, including as appropriate:
a.
Critical control points designed to control food safety hazards introduced
outside the processing plant environment, including food safety hazards that
occur before, during, and after harvest. At a minimum, the critical control
points shall include those identified in §
6.4 of this Part, as
applicable. As an alternative, the dealer may establish other critical control
points which the dealer can demonstrate to the Department provide equivalent
public health protection. If the dealer can demonstrate to the Department
through a hazard analysis that the food safety hazard is not reasonably likely
to occur, the critical control point is not required with the exception of
receiving which shall always be considered as a critical control
point.
b. Critical control points
designed to control food safety hazards that could be introduced in the
processing plant environment. As an alternative, the dealer may establish other
critical control points which the dealer can demonstrate to the Department
provide equivalent public health protection. If the dealer can demonstrate to
the Department through a hazard analysis that the food safety hazard is not
reasonably likely to occur, the critical control point is not required. At a
minimum, the critical control points shall include those identified in §
6.4 of this Part, as
applicable.
3. List the
critical limits that must be met at each of the critical control points. At a
minimum, the critical limits shall include those listed in §
6.4 of this Part, as
applicable. As an alternative the dealer may establish other critical limits
which the dealer has demonstrated provide equivalent public health protection
with the exception of receiving which shall always be considered as a critical
control point. In any case, the critical limits identified in §
6.4 of this Part, shall be
met as components of good manufacturing practices.
4. List the procedures, and frequency
thereof, that will be used to monitor each of the critical control points to
ensure compliance with the critical limits.
5. Include any corrective action plans that
have been developed in accordance with §6.4.2 of this Part to be followed
in response to deviations from critical limits at critical control
points.
6. Provide for a record
keeping system that documents the monitoring of the critical control points.
The records shall contain the actual values and observations obtained during
monitoring.
7. List the
verification procedures, and frequency thereof, that the dealer will use in
accordance with §6.4.2 of this Part.
D. Signing and Dating the HACCP Plan
1. The HACCP plan shall be signed and dated,
either by the most responsible individual on site at the processing facility or
by a higher level official of the dealer. This signature shall signify that the
HACCP plan has been accepted for implementation by the dealer.
2. The HACCP plan shall be signed and dated:
a. Upon initial acceptance;
b. Upon any modification; and
c. Upon verification of the plan.
E. Sanitation.
Sanitation controls may be included in the HACCP plan. However, to the extent
that they are monitored in accordance with this Part, they do not need to be
included in the HACCP plan, and vice versa.
F. Corrective Actions
1. Whenever a deviation from a critical limit
occurs, a dealer shall take corrective action either by:
a. Following a corrective action plan that is
appropriate for the particular deviation, or
b. Following the procedures in §6.4.2 of
this Part.
2. Dealers
may develop written corrective action plans, which become part of their HACCP
plans in accordance with §6.4.2 of this Part, by which they predetermine
the corrective actions that they will take whenever there is a deviation from a
critical limit. A corrective action plan that is appropriate for a particular
deviation is one that describes the steps to be taken and assigns
responsibility for taking those steps, to ensure that:
a. No product enters commerce that is either
injurious to health or is otherwise adulterated as a result of the deviation;
and
b. The cause of the deviation
is corrected.
3. When a
deviation from a critical limit occurs and the dealer does not have a
corrective action plan that is appropriate for that deviation, the dealer
shall:
a. Segregate and hold the affected
product, at least until the requirements of §6.4.2 of this Part are
met;
b. Perform or obtain a review
to determine the acceptability of the affected product for distribution. The
review shall be performed by an individual or individuals who have adequate
training or experience to perform such a review. Adequate training may or may
not include training in accordance with §6.4.2 of this Part;
c. Take corrective action, when necessary,
with respect to the affected product to ensure that no product enters commerce
that is either injurious to health or is otherwise adulterated as a result of
the deviation;
d. Take corrective
action, when necessary, to correct the cause of the deviation;
e. Perform or obtain timely reassessment by
an individual or individuals who have been trained in accordance with
§6.4.2 of this Part, to determine whether the HACCP plan needs to be
modified to reduce the risk of recurrence of the deviation, and modify the
HACCP plan as necessary.
4. All corrective actions taken in accordance
with this section shall be fully documented in records that are subject to
verification in accordance with §6.4.2 of this Part and the record keeping
requirements of §6.4.2 of this Part.
G. Verification
1. Every processor shall verify that the
HACCP plan is adequate to control food safety hazards that are reasonably
likely to occur, and that the plan is being effectively implemented.
Verification shall include, at a minimum:
a. A
reassessment of the adequacy of the HACCP plan whenever any changes occur that
could affect the hazard analysis or alter the HACCP plan in any way or at least
annually. These changes may include: Raw materials or source of raw materials,
product formulation, processing methods or systems, finished product
distribution systems, or the intended use or consumers of the finished product.
The reassessment shall be performed by an individual or individuals who have
been trained in accordance with §6.4.2 of this Part. The HACCP plan shall
be modified immediately whenever a reassessment reveals that the plan is no
longer adequate to fully meet the requirements of §6.4.2 of this
Part.
b. Ongoing verification
activities including:
(1) A review of any
consumer complaints that have been received by the dealer to determine whether
they relate to the performance of critical control points or reveal the
existence of unidentified critical control points;
(2) The calibration of process-monitoring
instruments; and
(3) At the option
of the dealer, the performing of periodic end-product or in-process
testing.
c. A review,
including signing and dating, by an individual who has been trained in
accordance with §6.4.2 of this Part, of the records that document:
(1) The monitoring of critical control
points. The purpose of this review shall be, at a minimum, to ensure that the
records are complete and to verify that they document values that are within
the critical limits. This review shall occur within one (1) week of the day
that the records are made;
(2) The
taking of corrective actions. The purpose of this review shall be, at a
minimum, to ensure that the records are complete and to verify that appropriate
corrective actions were taken in accordance with §6.4.2 of this Part. This
review shall occur within one (1) week of the day that the records are made;
and
(3) The calibrating of any
process monitoring instruments used at critical control points and the
performing of any periodic end-product or in-process testing that is part of
the dealer's verification activities. The purpose of these reviews shall be, at
a minimum, to ensure that the records are complete, and that these activities
occurred in accordance with the processor's written procedures. These reviews
shall occur within a reasonable time after the records are made.
d. Dealers shall immediately
follow the procedures in §6.4.2 of this Part whenever any verification
procedure, including the review of a consumer complaint, reveals the need to
take a corrective action.
e. The
calibration of process-monitoring instruments, and the performing of any
periodic end-product and in-process testing, in accordance with §6.4.2 of
this Part shall be documented in records that are subject to the record keeping
requirements of §6.4.2 of this Part.
H. Records
1. All records required by §6.4.2 of
this Part shall include:
a. The name and
location of the dealer;
b. The date
and time of the activity that the record reflects;
c. The signature or initials of the person
performing the operation; and
d.
Where appropriate, the identity of the product and the production code, if any.
Processing and other information shall be entered on records at the time that
it is observed.
2. All
records required by §6.4.2 of this Part shall be retained at the
processing facility for at least one (1) year after the date they were prepared
in the case of refrigerated products and for at least two (2) years after the
date they were prepared in the case of frozen products.
3. Records that relate to the general
adequacy of equipment or processes being used by a processor, including the
results of scientific studies and evaluations, shall be retained at the
processing facility for at least two (2) years after their applicability to the
product being produced at the facility.
4. If the processing facility is closed for a
prolonged period between seasonal operations, or if record storage capacity is
limited on a processing vessel or at a remote processing site, the records may
be transferred to some other reasonably accessible location at the end of the
seasonal operations but shall be immediately returned for official review upon
request.
5. All records and HACCP
plans required by §6.4.2 of this Part shall be available for official
review and copying at reasonable times.
6. Tags on containers of shellstock are not
subject to the requirements of this section unless they are used to fulfill the
requirements of §6.4.1 of this Part.
7. The maintenance of records on computers is
acceptable, provided that appropriate controls are implemented to ensure the
integrity of the electronic data and electronic signatures.
I. Training
1. All dealers shall obtain
Department-approved training every five (5) years. The training shall include
required processing, handling, and transportation practices as determined by
the Department.
a. A dealer shall receive
proof of completion of the required training. Proof of training obtained by the
dealer within the past two (2) years shall be presented to the Department prior
to certification, recertification, or licensing.
b. At a minimum, one (1) individual involved
in the shellfish operations shall obtain the required training.
c. The dealer shall maintain the record of
the completed training.
2. At a minimum, the following functions
shall be performed by an individual who has successfully completed training in
the application of HACCP principles to shellfish processing at least equivalent
to that received under standardized curriculum recognized as adequate by the
Department or who is otherwise qualified through job experience to perform
these functions:
a. Developing a HACCP plan,
which could include adapting a model or generic-type HACCP plan that is
appropriate for a specific processor, in order to meet the requirements
§6.4.2 of this Part.
b.
Reassessing and modifying the HACCP plan in accordance within the corrective
action procedures specified in §6.4.2 of this Part and the HACCP plan in
accordance with the verification activities specified in §6.4.2 of this
Part; and.
c. Performing the record
review required by §6.4.2 of this Part.
3. Job experience will qualify an individual
to perform these functions if it has provided knowledge at least equivalent to
that provided through the standardized curriculum as determined by the
Department.
4. The trained
individual need not be an employee of the dealer.
J. Sanitation Monitoring. Each dealer shall
monitor conditions and practices that are both appropriate to the plant and the
food being processed with sufficient frequency to ensure, at a minimum,
conformance with the requirements specified in §6.4.3 of this Part. The
requirements specified in these sections relate to the following sanitation
items:
1. Safety of the water that comes into
contact with food or food contact surfaces, or is used in the manufacture of
ice, hereinafter referred to as: Safety of water for processing and ice
production;
2. Condition and
cleanliness of food contact surfaces, including utensils, gloves, and outer
garments, and from raw product to cooked product, hereinafter referred to as:
Condition and cleanliness of food contact surfaces;
3. Prevention of cross contamination from
unsanitary objects to food, food packaging materials, and other food contact
surfaces, including utensils, gloves, and outer garments, and from raw product
to cooked product, hereinafter referred to as: Prevention of cross
contamination;
4. Maintenance of
hand washing, hand sanitizing, and toilet facilities, hereinafter referred to
as: Maintenance of hand washing, hand sanitizing and toilet
facilities;
5. Protection of food,
food packaging material, and food contact surfaces from adulteration with
lubricants, fuel, pesticides, cleaning compounds, sanitizing agents,
condensate, and other chemical, physical, and biological contaminants,
hereinafter referred to as: Protection from adulterants;
6. Proper labeling, storage, and use of toxic
compounds, hereinafter referred to as: Proper labeling, storage, use of toxic
compounds;
7. Control of employee
health conditions that could result in the microbiological contamination of
food, food packaging materials, and food contact surfaces, hereinafter referred
to as: Control of employees with adverse health conditions; and
8. Exclusion of pests from the food plant,
hereinafter referred to as: Exclusion of pests.
9. While monitoring of those specified
conditions and practices (listed in §§7.10(a) through (h) of this
Part) that are not appropriate to the plant and the food being processed is not
required, compliance with such conditions and practices remains
mandatory.
K. Sanitation
Monitoring Records. Each dealer shall maintain sanitation control records that,
at a minimum, document the monitoring and corrections prescribed by §6.4.2
of this Part.
L. Relationship to
HACCP Plan. Sanitation controls may be included in the HACCP plan. However, to
the extent that they are monitored in accordance with §6.4.2 of this Part,
they need not be included in the HACCP plan, and vice
versa.
6.4.3
Sanitation Requirements (HACCP Key Points of Sanitation)
A. Each dealer shall comply with the
requirements specified in this section that are appropriate to the plant and
the food being processed. Monitoring and record keeping for these conditions
and practices is required.
B.
Safety of Water for Processing and Ice Production
1. Water Supply
a. The dealer 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 Department and tested at laboratories
sanctioned or certified by the Department:
(1)
Prior to use of the water supply;
(2) Every six (6) months while the water
supply is in use; and
(3) After the
water supply has been repaired and disinfected.
c. The dealer shall assure that any steam
used in food processing or that comes in contact with food contact surfaces is
free from any additives, or deleterious substances consistent with Federal and
State laws and Regulations.
2. Ice Production. Any ice used in the
processing, storage, or transport of shellstock or shucked shellfish shall:
a. Be made on-site from potable water in a
commercial ice machine; or
b. Come
from a facility sanctioned by the Department or the appropriate regulatory
agency.
3. Shellstock
Washing. Water from either a potable water supply or a growing area in the
Approved classification shall be used to wash shellstock.
4. Plumbing and Related Facilities. The
dealer shall design, install, modify, repair, and maintain all plumbing and
plumbing fixtures to:
a. Prevent
contamination of water supplies;
b.
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.
5. Shellstock
washing storage tanks and related plumbing shall be fabricated from safe
materials and tank construction shall be such that it:
a. Is easily accessible for cleaning and
inspection;
b. Is self-draining;
and c. Meets the requirements for food contact surfaces.
C. Condition and Cleanliness of
Food Contact Surfaces. Equipment and utensil construction for food contact
surfaces
1. The dealer shall use only
equipment and utensils, including approved plastic ware and finished product
containers which are:
a. Constructed in a
manner and with materials that can be cleaned, sanitized, maintained or
replaced in a manner to prevent contamination of shellfish products;
b. Free from any exposed screws, bolts, or
rivet heads on food contact surfaces; and c. Fabricated from food grade
materials.
2. The dealer
shall assure that all joints on food contact surfaces:
a. Have smooth easily cleanable surfaces; and
b. Are welded.
3. Shucking blocks shall be
provided which are:
a. Easily
cleanable;
b. Fabricated from safe
material;
c. Solid, one (1) piece
construction; and d. Easily removed from the shucking bench unless the block is
an integral part of the bench.
e.
The dealer shall provide a temperature measuring device accurate to +/- two
degrees Fahrenheit (2° F) for use in monitoring product
temperatures.
4. All
equipment used in heat shock processing shall meet the requirements of
§6.4.3 of this Part.
5. All
equipment used to handle ice shall be kept clean and stored in a sanitary
manner, and shall meet the construction requirements in §6.4.3 of this
Part.
6. Wet storage tanks and all
containers used in wet storage tanks shall be kept clean and stored in a
sanitary manner, and shall meet the construction requirements in §6.4.3 of
this Part.
D. Cleaning
and Sanitizing of Food Contact Surfaces
1.
Food contact surfaces of equipment, utensils (including ice shovels), and
containers shall be cleaned and sanitized to prevent contamination of shellfish
and other food contact surfaces. The dealer shall:
a. Provide adequate cleaning supplies and
equipment, including three (3) compartment sinks, brushes, detergents, and
sanitizers, hot water and pressure hoses shall be available within the
plant;
b. Sanitize equipment and
utensils prior to the start-up of each day's activities and following any
interruption during which food contact surfaces may have been contaminated; and
c. Wash and rinse equipment and
utensils at the end of each day.
d.
Provide a test kit or other device that accurately measures the parts per
million concentration of sanitizing solutions.
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.
3. Shellfish shall be protected from
contamination by washing and rinsing shucking containers and sanitizing before
each filling.
4. Containers which
may have become contaminated during storage shall be washed, rinsed, and
sanitized prior to use or shall be discarded.
5. Shucked shellfish shall be packed in clean
containers and stored in a manner which assures their protection from
contamination.
6. If used, the
finger cots or gloves shall be:
a. Made of
impermeable materials except where the use of such material is inappropriate or
incompatible with the work being done;
b. Sanitized at least twice daily;
c. Cleaned more often, if
necessary;
d. Properly stored until
used; and
e. Maintained in a
clean, intact, and sanitary condition.
E. 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. Shucked shellfish
shall be protected from contamination.
c. Shellstock shall not be placed in
containers with standing water for the purposes of washing shellstock or
loosening sediment.
d. Equipment
and utensils shall be stored in a manner to prevent splash, dust, and
contamination.
2.
Employee Practices
a. Where the same employee
works in both the shucking and packing activities, the employee shall wash his
hands thoroughly after entering.
b.
The dealer shall require all employees to wash their hands thoroughly with soap
and water and sanitize their hands in an adequate handwashing facility:
(1) Before starting work;
(2) After each absence from the work
station;
(3) After each work
interruption; and
(4) Any time when
their hands may have become soiled or contaminated.
c. 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: store clothing
or other personal belongings; eat or drink; spit; and use tobacco in any
form.
d. Separation of
Operations
(1) Facilities for shucking and
packing activities shall be separated by use of: separate rooms; partitions; or
sufficient spacing.
(2)
Manufacturing activities which could result in the contamination of the
shellfish shall be separated by adequate barriers.
(3) The dealer shall provide toilet room
doors which are tight fitting, self-closing, and do not open directly into a
processing area.
F. Maintenance of Hand Washing, Hand
Sanitizing and Toilet Facilities
1.
Handwashing facilities with warm water at a minimum temperature of one hundred
ten degrees Fahrenheit (110° F) (forty-three degrees Centigrade (43°
C)), dispensed from a hot and cold mixing or combination faucet, shall be
provided.
2. Handwashing facilities
shall be provided which are:
a. Convenient to
work areas;
b. Separate from the
three (3) compartment sinks used for cleaning equipment and utensils;
c. Directly plumbed to an approved sewage
disposal system.
d. Adequate in
number and size for the number of employees.
3. The dealer shall provide at least one (1)
hand sink in the packing room.
4.
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.
5. Sewage and liquid disposable wastes shall
be properly removed from the facility.
6. An adequate number of conveniently
located, toilets shall be provided.
7. The dealer shall provide each toilet
facility with an adequate supply of toilet paper in a suitable
holder.
G. Protection
from Adulterants
1. Shellfish shall be
protected from contamination while being transferred from one (1) 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 shellfish are exposed shall be of the safety type or protected
to prevent food contamination in case of breakage.
3. Food contact surfaces shall be protected
from contamination by adulterants by using cleaning compounds and sanitizing
agents only in accordance with applicable Federal and State laws and
Regulations.
4. The dealer shall
assure that any steam used in food processing or that comes in contact with
food contact surfaces is free from any additives, or deleterious substances
consistent with Federal and State laws and Regulations.
5. Air pump intakes shall be located in a
protected place. Air filters shall be installed on all blower air pump intakes.
Oil bath type filters are not allowed.
H. Protection of Ice Used in Shellfish
Processing
1. Any ice which is not made on
site in the shellfish processing facility shall be inspected upon receipt and
rejected if the ice is not delivered in a way so as to be protected from
contamination.
2. Ice shall be
stored in a safe and sanitary manner to prevent contamination of the
ice.
3. Adequate ventilation shall
be provided to minimize condensation in areas where food is stored, processed
or packed.
I. Proper
Labeling of Storage of Toxic Compounds
1. The
dealer shall assure that only toxic substances necessary for plant activities
are present in the facility.
2.
Each of the following categories of toxic substances shall be stored
separately:
a. Insecticides and
rodenticides;
b. Detergents,
sanitizers, and related cleaning agents; and
c. Caustic acids, polishes, and other
chemicals.
3. The dealer
shall not store toxic substances above shellfish or food contact
surfaces.
J. Use and
Labeling of Toxic Compounds
1. 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.
2. Cleaning compounds and
sanitizing agents shall be labeled and used only in accordance with applicable
Federal and State laws and Regulations.
3. Toxic substances shall be labeled and used
in accordance with the manufacturer's label directions.
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
42 U.S.C. §
1201 et seq. the Americans with Disabilities
Act, and published in the Federal Register. These include:
a. Norovirus
b. Hepatitis A virus
c. Shigella spp.
d. Enterohemorrhagic or Shiga Toxin-producing
Escherichia coli, or
e. Salmonella
typhi
2. All employees
shall immediately report to the dealer and/or the supervisor information about
their health and activities as they relate to diseases that are transmissible
through food. All employees shall report the information in a manner that
allows the dealer and/or supervisor to reduce the risk of shellfish-borne
disease transmission, including providing necessary additional information,
such as the date of onset of symptoms of an illness, or of a diagnosis without
symptoms, or if the employee:
a. Has any of
the following symptoms:
(1)
Vomiting,
(2) Diarrhea,
(3) Jaundice,
(4) Sore throat with fever, or
(5) A lesion containing pus such as a boil or
infected wound that is open or draining on any part of the body, or
b. Has an illness
diagnosed by a health practitioner due to:
(1) Norovirus
(2) Hepatitis A virus,
(3) Shigella spp.,
(4) Enterohemorrhagic or Shiga
Toxin-producing Escherichia coli, or
(5) Salmonella typhi
c. Had a previous illness, diagnosed by a
health practitioner, within the past three (3) months due to Salmonella typhi,
without having received antibiotic therapy, as determined by a health
practitioner;
d. Has been exposed
to, or is the suspected source of, a confirmed disease outbreak, because the
employee consumed or prepared food implicated in the outbreak, or consumed food
at an event prepared by a person who is infected or ill with:
(1) Norovirus within the past twenty-four
(24) hours of the last exposure:
(2) Enterohemorrhagic or Shiga
toxin-producing Escherichia coli or Shigella spp. Within the past three (3)
days of the last exposure;
(3)
Salmonella typhi within the past fourteen (14) days of the last
exposure;
(4) Hepatitis A virus
within the past thirty (30) days of the last exposure; or
e. Has been exposed by attending or working
in a setting where there is a confirmed disease outbreak, or living in the same
household as, and has knowledge about, an individual that works or attends a
setting where there is a confirmed disease outbreak or living in the same
household as, and has knowledge about, an individual diagnosed with an illness
caused by:
(1) Norovirus within the past
twenty-four (24) hours of the last exposure;
(2) Enterohemorrhagic or Shiga
toxin-producing Escherichia coli, or Shigella spp. Within the past three (3)
days of the last exposure;
(3)
Salmonella typhi within the past fourteen (14) days of the last exposure;
or
(4) Hepatitis A virus within the
past thirty (30) days of the last exposure.
3. 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.
4. The dealer shall notify the State
Shellfish Control Authority and Health Department when notified by an employee
of a diagnosis or exhibits symptoms of hepatitis, and shall ensure that the
employee is excluded from working in any capacity in which the employee may
come in contact with the shellfish or with food contact surfaces or that may
transmit the illness to other employees.
L. Exclusion of Pests. The dealer shall
operate his facility to assure that insects, rodents, and other pests are
excluded from the facility and processing activities. Dogs, cats, birds, and
other animals shall also be excluded.
6.4.4
Other Requirements
A. Each dealer shall comply with the
requirements specified in §6.4.4 of this Part that are appropriate to the
plant and the food being processed. However, monitoring and record keeping for
these conditions and practices is not required, unless specifically
stated.
B. Recalls
1. Dealers shall adopt written procedures for
conducting recalls of adulterated misbranded shellfish products. These written
procedures for conducting recalls shall be based on, and complementary to, the
FDA Enforcement Policy on Recalls.
2. Dealers shall follow their written recall
procedures to include timely notification to the Department of a situation
requiring recall, timely notification of consignee who received the affected
product, and effective removal or correction of the affected product.
C. 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 shellfish are stored, handled, processed, or packaged or food
handling equipment, utensils, and packaging materials are cleaned or
stored.
D.
Flooding
1. Facilities in which shellfish are
stored, shucked, packed, repacked or reshipped shall be located so that these
facilities are not subject to flooding during ordinary high tides.
2. If facilities are flooded:
a. Shellfish processing, shucking or
repacking activities shall be discontinued until the flood waters have receded
from the building; and the building is cleaned and sanitized.
b. Any shellfish 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.
E. Plant Interior
1. Sanitary conditions shall be maintained
throughout the facility.
a. All dry area
floors shall be hard, smooth, easily cleanable; and
b. All wet area floors used in areas to store
shellstock, process food, and clean equipment and utensils shall be constructed
of easily cleanable, impervious, and corrosion resistant materials which:
(1) Are graded to provide adequate
drainage;
(2) Have even surfaces,
and are free from cracks that create sanitary problems and interfere with
drainage;
(3) Have sealed junctions
between floors and walls to render them impervious to water; and
2. Walls and Ceilings.
Interior surfaces of rooms where shellfish are stored, handled, processed, or
packaged shall be constructed of easily cleanable, corrosion resistant,
impervious materials.
3. Grounds.
Grounds around the facility shall be maintained to be free from conditions
which may result in shellfish contamination. These conditions may include, but
not be limited to:
a. Excessively dirty or
dusty parking lots, grounds or roads;
(1)
Rodent, insect, or bird attraction and harborage; and
(2) Inadequate drainage.
4. Plumbing and Related Facilities
a. 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:
(1) Cold and warm water at all sinks;
and
(2) Handwashing facilities
adequate in number and size for the number of employees, and located where
supervisors can observe employee use;
b. Adequate floor drainage, including
backflow preventers such as air gaps, shall be provided where floors are:
(1) Used in shellstock storage;
(2) Used for food holding units (e.g.
refrigeration units); and
(3)
Cleaned by hosing, flooding, or similar methods.
c. A safe, effective means of sewage disposal
for the facility shall be provided in accordance with applicable Federal and
State laws and Regulations;
d.
Installation of drainage or waste pipes over food processing or food storage
areas, or over areas in which containers and utensils are washed or stored
shall not be permitted.
5. Utilities
a. Ventilation, heating, or cooling systems
shall not create conditions that may cause the shellfish products to become
contaminated.
b. The dealer shall
provide lighting throughout the facility that is sufficient to promote good
manufacturing practices.
F. Insect and Vermin Control
1. The dealer shall employ necessary internal
and external insect and vermin control measures to ensure that insects and
vermin are not present in his facility including:
a. Tight fitting, self-closing
doors;
b. Screening of not less
than fifteen (15) mesh per inch; and
c. Controlled air
current.
G.
Disposal of Other Wastes
1. Disposal of waste
materials shall be conducted in accordance with appropriate Federal and State
laws and Regulations.
2. Shell and
other non-edible materials shall be promptly and effectively removed from the
shucking bench or table.
3. 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; and
H. Equipment Construction and Design for
Non-food Contact Surfaces
1. The dealer shall
use only equipment, including approved plastic ware, which is constructed in a
manner and with materials that can be cleaned, sanitized, maintained, or
replaced.
2. The dealer shall use
easily cleanable, corrosion-resistant, durable, impervious materials, free from
cracks to construct:
a. Shucking benches and
contiguous walls; and
b. Stands or
stalls and stools for shucker.
c.
Any non-food contact surfaces in shellfish storage or handling
areas.
3. Shucking
benches shall drain completely and rapidly, and shall drain away from any
shellfish on the benches.
4.
Dealers shall have sufficient refrigeration, capable of cooling and holding
shellfish, as required by this Part.
I. Cleaning Non-food Contact Surfaces
1. Cleaning activities for equipment shall be
conducted in a manner and at a frequency appropriate to prevent contamination
of shellfish 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.
J. Shellfish Storage and Handling
1. The dealer shall:
a. Assure that shellstock is:
(1) Reasonably free of sediment;
and
(2) Culled.
b. Completely empty shucking
buckets at the packing room so that no overage is returned to the
shucker;
c. Inspect incoming
shipments and shall reject dead or inadequately protected shellstock;
d. Not allow the use of dip buckets for hand
or knife rinsing;
e. Not have on
the premises any usable containers or container covers bearing a certification
number different from the one issued for those premises unless documentation
exists to verify the legitimate source of the containers and the containers
contain shellfish from that source;
f. Wash, blow, and rinse all shellfish meats
in accordance with §130 of 21 C.F.R. Part 161.
g. Thoroughly drain, clean as necessary, and
pack shucked shellfish meats promptly after delivery to the packing
room;
h. Conduct packing activities
so as to conform to applicable food additive Regulations;
i. Store packaged shellfish, if they are to
be frozen, at an ambient temperature of zero degrees Fahrenheit (0° F)
(negative seventeen and eight tenths degrees Centigrade (-17.8° C)) or
less; and frozen solid within twelve (12) hours following the initiation of
freezing.
j. Not commingle
shellstock during shucking unless the dealer is included in the Department's
commingling plan.
k. Shellstock
shall not remain outside of temperature control for two (2) or more hours
during processing.
l. Cool oysters
and/or hard clams to an internal temperature of fifty degrees Fahrenheit
(50° F) (ten degrees Centigrade (10° C)) or below within ten (10) hours
after placement into refrigeration during periods when the risk of Vibrio
illness is reasonably likely to occur. When deemed appropriate by the Authority
an exception may be permitted for hard clams to allow for tempering.
K. Heat Shock
1. A dealer may elect to use heat shock to
prepare shellstock for shucking. The dealer shall:
a. Post the schedule for the heat shock
process in a conspicuous location; and
b. Make sure all responsible persons are
familiar with the requirements.
c.
Cool all hot dipped shellstock immediately after the heat shock process. This
cooling shall be accomplished by:
(1) Dipping
in an ice bath; or
(2) Use of
flowing potable water.
2. If a heat shock water tank is used and the
water temperature is maintained at or above one hundred forty degrees
Fahrenheit (140° F) (sixty degrees Centigrade (60° C)), the dealer
shall completely drain and flush the tank at the end of each day's operation so
that all mud and debris which have accumulated in the dip tank are eliminated.
a. If the tank is maintained at or below one
hundred forty degrees Fahrenheit (140° F) (sixty degrees Centigrade
(60° C)), the tank shall be drained and flushed at three (3) hour
intervals.
L.
Supervision
1. Supervisors shall not allow
unauthorized persons in those portions of the facilities where shellfish are
stored, handled, processed, or packaged or food handling equipment, utensils,
and packaging materials are cleaned or stored. 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 shellfish 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
monitor employee hygiene practices, including handwashing, eating, and smoking
at work stations, and storing personal items or clothing.
b. Supervisors to assure that proper sanitary
practices are implemented, including:
(1)
Plant and equipment clean-up;
(2)
Rapid product handling; and
(3)
Shellfish protection from contamination.
c. Employees:
(1) To be trained in proper food handling and
personal hygiene practices, and
(2)
To report any symptoms of illness to their supervisor.
6.4.5
Shipping Documents, Records and Written Recall Procedure/Transportation and
Receiving
A. Trucks or Other Vehicles
Used to Transport Shellfish
1. The dealer who
transports shellstock shall assure that all trucks and other conveyances used
to transport shellstock are properly constructed, operated, and maintained to
prevent contamination, adulteration, cross contamination, deterioration, and
decomposition.
a. Shellfish shall be
transported in refrigerated trucks.
2. Prechilling trucks or other vehicles shall
be required when ambient air temperatures are such that unacceptable bacterial
growth or deterioration may occur.
3. Refrigeration trucks or other conveyances
shall be:
a. Equipped with automatic
controls; and
b. Capable of
maintaining the ambient air temperature in the storage area at temperatures of
forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees
Centigrade (7.2° C)) or less.
4. Any ice used to cool shellstock during
transport shall meet the requirements of §6.4.3(B)(4).
5. Cats, dogs, and other animals shall not be
allowed in any part of the vessel, buy boat, truck or other vehicle where
shellstock is stored.
B.
Transportation Containers
1. All containers
used to transport shellstock shall be:
a.
Constructed to allow for easy cleaning; and
b. Operated and maintained to prevent product
contamination.
C. All containers shall be cleaned with:
1. Potable water; and
2. Detergents, sanitizers, and other supplies
acceptable for food contact surfaces.
D. Shipping Documents
1. Each shellfish shipment shall be
accompanied by a shipping document.
2. The shipping document shall contain:
a. The name, address, and certification
number of the shipping dealer;
b.
The name and address of the major consignee; and
c. The kind and quantity of the shellfish
product.
3. The
receiving dealer shall:
a. Maintain in his
files a copy of the completed shipping document; and
b. Make the shipping document available to
the Department upon request.
4. If the shipment is subdivided to different
dealers, each receiving dealer shall maintain records sufficient to trace his
portion back to the original shipment.
E. Shipment Acceptability
1. Shellfish shipments shall be considered
acceptable when:
a. Shipments are properly
identified with tags and shipping documents;
b. Shellstock is alive and in a conveyance
with an ambient air temperature of forty-five degrees Fahrenheit (45° F)
(seven and two tenths degrees Centigrade (7.2° C)) or less;
c. Shucked shellfish is cooled to a
temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths
degrees Centigrade (7.2° C)) or less, or packed in ice; and
d. The time-temperature indicating device
shows that the ambient air temperature has exceeded forty-five degrees
Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C))
but the shellstock internal body temperature is fifty degrees Fahrenheit
(50° F) (ten degrees Centigrade (10° C)) or less; and
e. All other conditions of shipment in this
Part are met.
F.
Receiving Shellfish
1. The
dealer shall reject or discard any shellfish shipments which:
a. Do not originate from a licensed harvester
or certified dealer; and/or
b.
Shellfish are not properly identified with tags and shipping
documents;
c. The internal
shellstock body temperature exceeds fifty degrees Fahrenheit (50° F)
(fifteen and six tenths Centigrade (15.6° C)) unless the harvest initiation
time is documented and is in compliance with Rhode Island Department of
Environmental Management Regulations, 250-RICR- 40-00-1 Aquaculture of Marine
Species in Rhode Island Waters, and 250-RICR- 90-00-4, Shellfish.
d. Shucked shellfish exceeds forty-five
degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade
(7.2° C)); or
e. Are
unwholesome, inadequately protected, or whose source cannot be
identified.
2.
Transportation agents or common carriers used by a dealer are not required to
be certified.
3. The dealer shall:
a. Inspect incoming shellfish shipments to
assure that the shipments are received under the conditions required in this
Part;
b. Ensure that shellstock are
not permitted to remain without ice, mechanical refrigeration, or other
approved methods of storage, as required [wet storage, iced, at or below
forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees
Centigrade (7.2° C))] for more than two (2) hours at points of processing
or transfer such as loading docks;
c. Ensure that shucked shellfish are not
permitted to remain without ice, mechanical refrigeration, or other approved
means of maintaining shellfish temperature at forty-five degrees Fahrenheit
(45° F) (seven and two tenths degrees Centigrade (7.2° C)) or
less;
d. Ensure that frozen
shellfish remain frozen.
G. Shipping Times
1. Shipping Time is No More Than Four (4)
Hours
a. When the shipping time is four (4)
hours or less, the dealer shall ship under temperature control.
b. When mechanical refrigeration units are
used, the units shall be equipped with automatic controls and shall be capable
of maintaining the ambient air in the storage area at temperatures of
forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees
Centigrade (7.2° C)) or less.
c. The dealer shall not be required to
provide thermal recorders during shipment.
2. Shipping Time is Greater Than Four (4)
Hours
a. When the shipping time is greater
than four (4) hours, the dealer shall ship all shellfish in mechanically
refrigerated conveyances which are equipped with automatic controls and capable
of maintaining the ambient air in the storage area at temperatures of
forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees
Centigrade (7.2° C)) or less; or
b. Unless the dealer has an approved HACCP
plan with an alternate means of monitoring time-temperature, the initial dealer
shall assure that a suitable time-temperature recording device accompanies each
shipment of shellfish.
c. The
initial dealer shall note the date and time on the temperature indicating
device, if appropriate.
d. Each
receiving dealer shall write the date and time on the temperature indicating
device, if appropriate, when the shipment is received and the doors of the
conveyance or the containers are opened.
e. The final receiving dealer shall keep the
time-temperature recording chart or other record of time and temperature in his
files and shall make it available to the Department upon request.
f. An inoperative temperature indicating
device shall be considered as no recording device.
3. Transaction and Shipping Records
a. Each dealer shall have a business address
at which transaction records are maintained.
b. Each dealer shall maintain complete,
accurate and legible records of the Department's required information in a form
authorized by the Department.
c.
Transaction records shall be sufficient to:
(1) Document that the shellfish are from a
source authorized under these requirements;
(2) Permit a container of shellfish to be
traced back to the specific incoming lot of shucked shellfish from which it was
taken;
(3) Permit a lot (or
commingled lots) of shucked shellfish or a lot of shellstock to be traced back
to the growing area(s), date(s) of harvest, harvest time (when directed by the
Department) and the harvester or group of harvesters.
(4) Trace the wet storage history of the
shellfish including, original harvest site, original harvest date, original
harvest time (when directed by the Department) wet storage site(s) and
dates.
d. Purchase and
sales shall be recorded:
(1) In a permanently
bound ledger book; or
(2) Using
shipping/sales documents as required in §6.4.5(D) of this Part and to
include the harvest area, harvest date and harvest time (when directed by the
Department); or
(3) Using other
recording methods acceptable to and authorized by the Department within
seventy-two (72) hours of any purchase or sales.
e. The transaction records shall be retained:
(1) In the case of fresh shellfish, for a
minimum of one (1) year; and
(2) In
the case of frozen shellfish, for at least two (2) years or the shelf-life of
the product, whichever is longer.
f. If computer records are maintained, the
Department shall approve the format and its use.
6.4.6
Post-Harvest Processing
A. A
dealer may elect to use a process to reduce Vibrio vulnificus levels in
shellfish. The dealer shall have a HACCP plan approved by the Department for
the process which includes:
1. An end point
criteria for the process as non-detectable (less than three (< 3) MPN/gram)
to be determined by use of the Vibrio vulnificus FDA approved EIA procedure of
Tamplin, et al, as described in Chapter 9 of the "Bacteriological Analytical
Manual," 8th Edition, Revision A (2004) as required by the 2019 Model Ordinance
available online at:
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070830.htm;
and
2. A sampling program to
demonstrate that the end point criteria is met.
B. Package and label all shellfish in
accordance with all requirements contained in this part. This includes the
labeling all shellfish which has been subjected to the process but which is not
frozen in accordance with applicable shellfish tagging and labeling
requirements in §§6.4.1(B) through (F) of this Part.
C. Keep records in accordance with
§§6.4.1(E) and (F) of this Part.
D. A dealer who meets the requirements of
§6.4.6 of this Part may label product which has been subjected to the
reduction process as "Processed to reduce Vibrio vulnificus to non-detectable
levels."
E. Processed Products with
Labeling Claims for Safety. All certified dealers processing products with
labeling claims for safety shall:
1. Consult
with and adhere to advice from the U.S. Food and Drug Administration for all
special labeling claims.
2. Meet
all applicable requirements of R.I. Gen. Laws Chapter 21-14.3. For the purposes
of refrigeration, if the end product is dead, treat the product as shucked
product. If the end product is live it shall be treated as shellstock for the
purposes of refrigeration; and,
3.
Shall ensure through controls in their HACCP Plan that claims are
met.
6.4.7
Shucking and Packing
A. Heat
Shock
1. The dealer shall submit for approval
the scheduled process for heat shock. The schedule may be developed by the
Department or qualified persons with adequate facilities for conducting the
appropriate studies.
2. The dealer
shall assure that the critical factors which may affect the heat shock process
have been adequately studied and provided for in establishing the process. The
critical factors shall include:
a. Type and
size of shellfish;
b. Time and
temperature of exposure;
c. Type of
process;
d. Size of tank, tunnel or
retort;
e. Water to shellfish
ratios in tanks; and
f.
Temperature and pressure monitoring devices;
3. The dealer shall assure that heat shock
process does not:
a. Change the physical and
organoleptic properties of the species;
b. Kill the shellfish prior to shucking; and
c. Increase microbial
deterioration of the shucked shellfish.
4. The dealer shall retain records covering
all aspects of the establishment of the heat shock process.
B. Critical Control Points
1. Receiving Critical Control Point -
Critical Limits. The dealer shall shuck and pack only shellstock which is:
a. Obtained from a licensed harvester who
has:
(1) Harvested the shellstock from an
Approved or Conditionally Approved area in the open status as indicated by the
tag; and
(2) Identified the
shellstock with a tag on each container or transaction record on each bulk
shipment; or
b. Obtained
from a dealer other than the original harvester who has identified the
shellstock with a tag on each container or transaction record with each bulk
shipment.
(1) Shipped the shellstock in a
conveyance at or below forty-five degrees Fahrenheit (45° F) (seven and two
tenths degrees Centigrade (7.2° C)) ambient air temperature; or fifty
degrees Fahrenheit (50° F) (ten degrees Centigrade (10° C)) internal
temperature or less;
(2) Identified
the shellstock with a tag on each container or transaction record with each
bulk shipment.
(3) All shipments of
shellstock shall be accompanied with documentation indicating the time of
shipment and that all shipping conveyances comply with the requirements of
§6.4.7 of this Part.
c. Shucked shellfish is received in a
conveyance with an ambient temperature of forty-five degrees Fahrenheit
(45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less or
adequately iced.
d. Harvested in
compliance with the time temperature requirements as described in Rhode Island
Department of Environmental Management Regulations, 250-RICR- 40-00-1
Aquaculture of Marine Species in Rhode Island Waters, and 250-RICR- 90-00-4,
Shellfish.
2. Shellstock
Storage Critical Control Point - Critical Limits. The dealer shall ensure that:
a. If wet storage is practiced, water quality
meets the requirements outlined in §6.4.11 of this Part; and
b. Once placed under temperature control and
until sale to the processor or final consumer, shellstock shall be;
(1) Iced; or
(2) Placed and stored in a storage area or
conveyance maintained at forty-five degrees Fahrenheit (45° F) (seven and
two tenths degrees Centigrade (7.2° C)) or less; and
(3) Not permitted to remain without ice,
mechanical refrigeration or other approved methods of refrigeration, as
required in §§6.4.9(B)(1) and (2) of this Part, for more than two (2)
hours at points of transfer such as loading docks.
3. Processing Critical Control
Point - Critical Limits. The dealer shall ensure that:
a. For shellstock which has not been
refrigerated prior to shucking, shucked meats are chilled to an internal
temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths
degrees Centigrade (7.2° C)) or less within three (3) hours of
shucking.
b. For shellstock
refrigerated prior to shucking, shucked meats are chilled to an internal
temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths
degrees Centigrade (7.2° C)) or less within four (4) hours of removal from
refrigeration.
c. If heat shock is
used, once heat shocked shellstock is shucked, the shucked shellfish meats
shall be cooled to forty-five degrees Fahrenheit (45° F) (seven and two
tenths degrees Centigrade (7.2° C)) or less within two (2) hours after the
heat shock process.
d. When heat
shock shellstock are cooled and held under refrigeration for later shucking,
the heat shocked shellstock shall be cooled to an internal temperature of
forty-five degrees Fahrenheit (45° F) (seven and two tenths degrees
Centigrade (7.2° C)) within two (2) hours from time of heat
shock.
4. Shucked Meat
Storage Critical Control Point - Critical Limit. The dealer shall store shucked
and packed shellfish in covered containers at an ambient air temperature in the
storage area of forty-five degrees Fahrenheit (45° F) (seven and two tenths
degrees Centigrade (7.2° C)) or less or covered with ice.
6.4.8
Repacking of
Shucked Shellfish
A. Receiving
Critical Control Point - Critical Limits. The dealer shall repack only
shellfish which:
1. Originated from a dealer;
and
2. Shipped the shellfish in a
conveyance at or below forty-five degrees Fahrenheit (45° F) (seven and two
tenths degrees Centigrade (7.2° C)) ambient air temperature or covered in
ice; and
3. Are identified with a
label as outlined in §§6.4.1(E) and (F) of this Part.
4. Was harvested in compliance with the time
temperature requirements as described in Rhode Island Department of
Environmental Management Regulations, 250-RICR- 40-00-1 Aquaculture of Marine
Species in Rhode Island Waters, and 250-RICR- 90-00-4, Shellfish.
5. Are accompanied with documentation
indicating the time of shipment, that shellfish has been shipped adequately
iced or in a conveyance pre-chilled at or below forty-five degrees Fahrenheit
(45° F) (seven and two tenths degrees Centigrade (7.2° C)) ambient air
temperature.
B.
Processing Critical Control Point - Critical Limits. The dealer shall ensure
that repacked shellfish do not exceed an internal temperature of forty-five
degrees Fahrenheit (45° F) (seven and two tenths degrees Centigrade
(7.2° C)) for more than two (2) hours.
C. Shucked Meat Storage Critical Control
Point - Critical Limit. The dealer shall store repacked shellfish in covered
containers at an ambient air temperature of forty-five degrees Fahrenheit
(45° F) (seven and two tenths degrees Centigrade (7.2° C)) or less or
covered with ice.
6.4.9
Shellstock Shipping
A. Receiving
Critical Control Point - Critical Limits
1.
The dealer shall ship or repack only shellstock which is obtained from a
licensed harvester who has:
a. Harvested the
shellstock from an Approved or Conditionally Approved area in the open status
as identified by the tag; and
b.
Identified the shellstock with a tag on each container or transaction record on
each bulk shipment; or
c. Obtained
from a dealer who has identified the shellstock with a tag on each
container.
d. Harvested the
shellstock in compliance with the time temperature requirements as described In
Rhode Island Department of Environmental Management Regulations, 250-RICR-
40-00-1 Aquaculture of Marine Species in Rhode Island Waters, and 250-RICR-
90-00-4, Shellfish.
2.
Obtained from a dealer other than the original harvester who has:
a. Identified the shellstock with a tag on
each container or transaction record with each bulk shipment.
b. Shipped the shellstock in a conveyance at
or below forty-five degrees Fahrenheit (45° F) (seven and two tenths
degrees Centigrade (7.2° C)) ambient air temperature; or fifty degrees
Fahrenheit (50° F) (ten degrees Centigrade (10° C)) internal
temperature or less;
c. All
shipments of shellstock shall be accompanied with documentation indicating the
time of shipment and that all shipping conveyances comply with the requirements
of §6.4.7 of this Part.
B. Shellstock Storage Critical Control Point
- Critical Limits. The dealer shall ensure that:
1. If wet storage in artificial bodies of
water is practiced, water quality meets the requirements outlined in
§§6.4.11(C) and (D)(1) of this Part; and
2. Once placed under temperature control and
until sale to the processor or final consumer, shellstock shall be:
a. Iced; or
b. Placed in a storage area or conveyance
maintained at forty-five degrees Fahrenheit (45° F) (seven and two tenths
degrees Centigrade (7.2° C)) or less; and
c. Not permitted to remain without ice,
mechanical refrigeration or other approved methods of refrigeration, as
required in §6.4.9(A) of this Part for more than two (2) hours at points
of transfer such as loading docks.
3. The dealer shall store shucked and packed
shellfish in covered containers at an ambient temperature of forty-five degrees
Fahrenheit (45° F) (seven and two tenths degrees Centigrade (7.2° C))
or less or covered with ice.
4. A
dealer may receive shellstock from a dealer who has elected to ship shellstock
without the shellstock meeting the receiving requirements of §6.4.8 of
this Part if the product is accompanied with documentation indicating:
a. Shellstock has been cooled to an internal
temperature of fifty degrees Fahrenheit (50° F) (ten degrees Centigrade
(10° C)) or less; or
b. All
shipments of shellstock have been accompanied with documentation indicating the
time of shipment and that all shipping conveyances comply with the requirements
of §6.4.8 of this Part. This documentation must include a notice of all
shellstock harvested under the requirements of §6.4.9(A)(4) of this
Part.
5. A dealer may
receive shellstock from a dealer who has elected to ship shellstock without the
shellstock meeting the receiving requirements of §6.4.9 of this Part if
the product is accompanied with a time/temperature recording device indicating
and documenting that continuing cooling has occurred. Shipments of four (4)
hours or less will not be required to have a time/temperature device.
6. Shellstock that is received
bearing a restricted use tag shall only be shipped to a certified dealer and
shall include specific language detailing the intended use of the shellstock.
The transaction record shall indicate the quantity of restricted use shellstock
containers.
7. All oysters
harvested under State Vibrio Control Plans other than those labeled for a
restricted use shall meet the following temperature requirements:
a. Oysters and/or hard clams must be cooled
to an internal temperature of fifty degrees Fahrenheit (50° F) (ten degrees
Centigrade (10° C)) or below within ten (10) hours or less after placement
into refrigeration during periods when the risk of Vibrio illness is reasonably
likely to occur.
b. The dealer's
HACCP Plan shall include controls necessary to ensure, document and verify that
the internal temperature of oysters and/or hard clams has reached fifty degrees
Fahrenheit (50° F) (ten degrees Centigrade (10° C)) or below within ten
(10) hours or less after placement into refrigeration.
c. When deemed appropriate by the Department
an exception may be permitted for hard clams to allow for tempering. Oysters
and/or hard clams without proper HACCP records demonstrating compliance with
this cooling requirement shall be diverted to PHP or labeled "for shucking
only," or other means to allow the hazard to be addressed by further
processing.
8. The
effectiveness of the Plan should be evaluated yearly. The Vibrio Control Plan
may be modified when the evaluation shows the Plan is ineffective, or when new
information is available or new technology makes this prudent as determined by
the Department.
9. Product intended
for relay, wet storage or depuration, or either geoduck clams (Panopea
generose), or Mercenaria sp which are being cooled utilizing a
Department-approved tempering plan are exempt from the Vibrio Control Plan
requirement.
6.4.10
Reshipping
A. Receiving Critical Control Point -
Critical Limits. The dealer shall reship only shellfish which:
1. Originated from a dealer;
2. Are identified with a tag as outlined in
§6.4.1 of this Part or a label as outlined in §6.4.1 of this
Part.
3. Has been shipped in
compliance with §6.4.9 of this Part.
B. Shellstock Storage Critical Control Point
- Critical Limits. The dealer shall ensure that once placed under temperature
control and until sale to the processor or final consumer, shellstock shall be:
1. Iced; or
2. Placed in a storage area or conveyance
maintained at forty-five degrees Fahrenheit (45° F) (seven and two tenths
degrees Centigrade (7.2° C)) or less; and
3. Not permitted to remain without ice,
mechanical refrigeration, or other approved means of refrigeration for more
than two (2) hours at points of transfer such as loading docks.
C. Shucked Meat Storage Critical
Control Point - Critical Limit. The dealer shall store shucked shellfish at a
temperature of forty-five degrees Fahrenheit (45° F) (seven and two tenths
degrees Centigrade (7.2° C)) or less or covered with
ice.
6.4.11
Wet
Storage in Approved and Conditionally Approved Growing Areas
A. Requirements for the Dealer: Source of
Shellstock
1. The dealer shall wet store
shellstock harvested only from areas classified as Approved, or Conditionally
Approved, when in the open status.
2. Shellstock shall be harvested, identified
and shipped to the wet storage operation in accordance with the requirements of
§6.4.5 of this Part.
B. General Requirements
1. Wet storage may be used to store,
condition, remove sand or to add salt to shellstock. Wet storage shall be
deemed a processing activity, however licensees are not subject to any
additional license fees and therefore not required to obtain a separate
Department food processor license.
2. Wet storage of depurated product shall
occur only within the facility in which it was depurated. The shellstock shall
be packed and labeled according to the requirements of this Part.
3. Wet storage shall be practiced only by a
dealer in strict compliance with the provisions in the written approval for the
wet storage activity given by the Department.
4. While awaiting placement in a wet storage
operation, shellstock shall be protected from physical, chemical or thermal
conditions which may compromise the shellstock's survival, quality or activity
during wet storage.
5. Conditions
and water quality during wet storage shall be sufficient to minimize the
potential for compromising the sanitary quality of the shellstock during
storage.
6. For the purpose of
certification, each wet storage site or operation shall be evaluated annually.
The evaluation shall include an inspection of the near shore storage site and
floats, or the wet storage operation.
7. Shellstock from a wet storage operation
shall be harvested, identified and shipped according to the requirements of
§§6.4.2 and 6.4.5 of this Part. Any dealer who wet stores shellstock
from another State and ships the shellstock as a product of the State where the
shellstock was wet stored shall be required to:
a. Have an operational plan approved by the
Department which describes how this labeling change will be employed in
assuring that shellstock can be traced to its source; and
b. Meet the requirements of §6.4.5 of
this Part.
8. The wet
storage operator shall keep complete and accurate records to enable a lot of
shellstock to be traced back to the original harvest location and wet storage
location, and include the dates the shellstock were held in wet storage. The
records shall be maintained for at least one (1) year.
a. Different lots of shellfish shall not be
commingled during wet storage. If more than one (1) lot of shellstock is being
held in wet storage at the same time, the identity of each lot of shellstock
shall be maintained.
C. Wet Storage Sites in Natural Bodies of
Water
1. Natural bodies of waters used for wet
storage in containers and floats shall meet the requirements for classification
as Approved or Conditionally Approved while shellstock is being held in
storage. Areas classified as Conditionally Approved may be used only when in
the open status. When an area classified as Conditionally Approved is placed in
a status other than its open status, any shellstock in wet storage in that area
shall be:
a. Subjected to relaying or
depuration prior to human consumption; or
b. Held in the wet storage site until the
area is returned to the open status.
2. Site evaluations of natural bodies of
water shall include:
a. The sanitary survey of
the storage site, with special consideration of potential intermittent sources
of pollution;
b. The location of
near shore storage sites and floats; and c. The examination of the construction
of shellstock containers, if used, to ensure the free flow of water to all
shellstock; and d. A review of the operation's plan and operating procedures
for an offshore activity as submitted by the dealer.
D. Wet Storage in Artificial
Bodies of Water (Land-Based)
1. General
a. If the dealer chooses to practice wet
storage in artificial bodies of water, the dealer shall also meet the
requirements of §§6.4.11(A) through (C) of this Part
b. For the purpose of permitting, each wet
storage site or operation shall be evaluated at intervals not to exceed six (6)
months. The evaluation shall include the operation's plan and operating
procedures for an onshore activity as submitted by the dealer.
c. Prior to commencing construction, all
plans for construction or remodeling of onshore wet storage facilities or
operations shall be reviewed and authorized by the Department.
d. The wet storage facility or operation
evaluation shall include a review of:
(1) The
purpose of the wet storage activity, such as holding, conditioning or
increasing the salt content of shellstock;
(2) Any species specific physiological
factors that may affect design criteria; and
(3) The plan giving the design of the
land-based wet storage facility, source and quantity of process water to be
used for wet storage, and details of any process water treatment
system.
2.
Operation Specifications
a. Each land-based
wet storage activity shall meet the following design, construction, and
operating requirements.
b.
Effective barriers shall be provided to prevent entry of birds, animals, and
vermin into the area.
c. Storage
tanks and related plumbing shall be fabricated of safe material and shall be
easily cleanable. This requirement shall include:
(1) Tanks constructed so as to be easily
accessible for cleaning and inspection, self-draining and fabricated from
non-toxic, corrosion resistant materials; and
(2) Plumbing designed and installed so that
it can be cleaned and sanitized on a regular schedule, as specified in the
operating procedures.
d.
Storage tank design, dimensions, and construction are such that adequate
clearance between shellstock and the tank bottom shall be maintained.
e. Shellstock containers, if used, shall be
designed and constructed so that the containers allow the free flow of water to
all shellstock within a container.
f. When a building is used for the wet
storage activity:
(1) Floors, walls, and
ceilings shall be constructed in compliance with the applicable provisions of
§6.4.4 of this Part; and
(2)
Lighting, plumbing, water and sewage disposal systems shall be installed in
compliance with applicable provisions of §6.4.4 of this Part.
g. When the wet storage activity
is outdoors or in a structure other than a building, tank covers shall be used.
Tank covers shall:
(1) Prevent entry of
birds, animals or vermin; and
(2)
Remain closed while the system is in operation except for periods of tank
loading and unloading, or cleaning.
3. Wet Storage Source Water
a. General
(1) Except for wells, the quality of the
surface source water prior to treatment shall meet, at a minimum, the
bacteriological standards for the restricted classification and water
classified as Prohibited or Conditionally Restricted when in the Closed Status
shall not be used as source water.
(2) Any well used as source water for wet
storage shall meet the requirements (with the exception of the salt content in
saltwater wells).
(3) Except when
the source of the water is a growing area in the Approved classification, a
water supply sampling schedule shall be included in the dealer's operating
procedures and water shall be tested according to the schedule.
(4) Results of water samples and other tests
to determine the suitability of the source water supply shall be maintained for
at least two (2) years.
(5)
Disinfection or other water treatment such as the addition of salt cannot leave
residues unless they are Generally Recognized as Safe (GRAS) and do not
interfere with the shellstock's survival, quality or activity during wet
storage.
(6) Disinfected process
water entering the wet storage tanks shall have no detectable levels of the
coliform group as measured by a recognized multi-tube MPN test per one hundred
(100) ml. for potable water and acceptable for use with marine water and follow
the protocol of the Decision Tree (Section IV. Guidance Documents Chapter III.
05. of the 2019 NSSP Model Ordinance).
(7) When the laboratory analysis of a single
sample of disinfected process water entering the wet storage tanks shows any
positive result for the coliform group daily sampling shall be immediately
instituted until the problem is identified and eliminated.
(8) When the problem that is causing
disinfected process water to show positive results for the coliform group is
eliminated, the effectiveness of the correction shall be verified on the first
operating day following correction through the collection, over a twenty-four
(24) hour period, of a set of three (3) samples of disinfected process
water.
(9) For water that is
disinfected by ultra-violet treatment, turbidity shall not exceed twenty (20)
nephelometric turbidity units (NTUs) measured in accordance with Standard
Methods for the Examination of Water and Wastewater (Jenkins, David, Joseph J.
Connors, and Arnold E. Greenberg. Standard Methods for the Examination of Water
and Wastewater. Washington, D.C: American Public Health Association, 1981) (not
to include later amendments thereof)).
(10) The disinfection unit(s) for the process
water supply shall be cleaned and serviced as frequently as necessary to assure
effective water treatment.
4. Continuous Flow-through System
a. If the system is of continuous
flow-through design, water from a growing area classified as:
(1) Approved may be used, without
disinfection, in wet storage tanks provided that the near shore water source
used for supplying the system meets the Approved classification bacteriological
criteria at all times that shellstock are being held in wet storage;
or
(2) Conditionally Approved in
the Closed Status, Restricted or Conditionally Restricted in the Open Status
may be used if the source water is continuously subjected to disinfection and
it is sampled and analyzed daily following disinfection
b. When a source classified as other than
Approved is used, a study shall be required to demonstrate that the
disinfection system will consistently produce water that tests negative for the
coliform group under normal operating conditions. The study shall:
(1) Include five (5) sets of three (3)
samples from each disinfection unit collected for five (5) consecutive days at
the outlet from the disinfection unit or at the inlet to at least one (1) of
the wet storage tanks served by the disinfection system;
(2) Include one (1) sample daily for five (5)
consecutive days from the source water prior to disinfection;
(3) Use NSSP recognized methods to analyze
the samples to determine coliform levels;
(4) Require all samples of disinfected water
to be negative for the coliform group; and
(5) Be repeated if any sample of disinfected
water during the study is positive for the coliform group.
c. Once sanctioned for use, the water system
shall be sampled daily to demonstrate that the disinfected water is negative
for the coliform group.
d. When
other than Approved water is located between the intake of a flow-through wet
storage system and the land-based facility then the Department may require
periodic verification of the system's integrity to ensure that the other than
approved water does not infiltrate into the intake pipe.
5. Recirculating Water System
a. A study shall be required to demonstrate
that the disinfection system for the recirculating system will consistently
produce water that tests negative for the coliform group under normal operating
conditions. The study shall meet the requirements in §6.4.11(D)(4) (b) of
this Part.
b. Once sanctioned for
use, the recirculating water system shall be sampled weekly to demonstrate that
the disinfected water is negative for the coliform group.
c. When make-up water of more than ten
percent (10%) of the water volume in the recirculating system is added from a
growing area source classified as other than Approved, a set of three (3)
samples of disinfected water and one (1) sample of the source water prior to
disinfection shall be collected within a twenty-four (24) hour period to
reaffirm the ability of the system to produce water free from the coliform
group or viable bacteria.
d. When
ultra-violet treatment is used as the water disinfectant, each time a bulb
change is required either to replace a burned out bulb or for servicing, new
ultraviolet bulbs shall be installed and old bulbs discarded, and the weekly
disinfected process water sample shall be collected and analyzed.
e. Failure to meet the weekly water sampling
requirements of §6.4.11(D)(5)(b) of this Part may result in termination of
the system, pending approval of the Department.
6. Shellstock Handling
a. Shellstock shall be thoroughly washed with
water from an approved source and culled prior to wet storage in tanks. Due to
the adverse effects of culling on mussel physiology, culling of mussels may be
done after wet storage, subject to permission from the Department.
b. Unless the dealer is in the Department's
commingling plan, different lots of shellstock shall not be commingled during
wet storage in tanks. If more than one (1) lot of shellstock is being held in
wet storage at the same time, the identity of each lot of shellstock shall be
maintained.
c. Bivalve mollusks
shall not be mixed with other species in the same tank. Where multiple tank
systems use a common water supply system for bivalve mollusks and other
species, wet storage water shall be effectively disinfected prior to entering
tanks containing the bivalve mollusks.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.