902 KAR 45:020. Kentucky shellfish dealer
standards and requirements.
RELATES TO: KRS 217.005-217.205, 217.992,
318.130
STATUTORY AUTHORITY: KRS 194A.050,
217.125
NECESSITY, FUNCTION, AND CONFORMITY: KRS
217.125(1) authorizes the Cabinet for Health and Family Services to protect the
public against the adulteration and misbranding of foods. This administrative
regulation establishes minimum sanitary standards for shellfish dealer
certification, for dealers in both interstate and intrastate commerce, based
upon the National Shellfish Sanitation Program Model Ordinance.
(1) "Air gap" means the
unobstructed vertical distance through the free atmosphere between the lowest
opening from any pipe or faucet supplying water to a tank, plumbing fixture, or
other device and the flood level rim of that receptacle.
(2) "AOAC" means the
Association of Official Analytical Chemists.
(3) "APHA" means the American
Public Health Association.
(4) "Approved" means acceptable
to the cabinet or responsible regulatory authority based on a determination of
conformity with principles, practices, and generally-recognized standards that
protect public health.
(5) "Approved classification"
means a classification used to identify a growing area where harvest for direct
marketing is allowed.
(6) "Aquaculture" means the
cultivation of seed in natural or artificial growing areas, or the cultivation
of shellfish other than seed in growing areas.
(7) "Assure" means to make the
best efforts within reasonable limits of manpower and resources to fulfill the
objective of this administrative regulation.
(8) "Backflow" means the flow
of water or other liquids, mixtures. or substances into the distribution pipes
of a potable water supply from any source or sources other than the intended source.
(9) "Back siphonage" means the
flowing back of used, contaminated, or polluted water from a plumbing fixture,
vessel, or other source into potable water supply pipes because of negative
pressure in the water supply pipes.
(10) "Blower" means a receptacle
for washing shucked shellfish which uses forced air as a means of agitation.
(11) "Broker" means any person
who is not a dealer but who arranges the packaging, shipping, sale, or
distribution of molluscan shellfish without taking ownership or physical
custody of the shellfish.
(12) "Cabinet" is defined by
KRS 217.015(3).
(13) "Certified shellfish
dealer" means a person to whom certification is issued for the activities
of shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor.
(14) "Certified shellfish dealer
processing facility" means a structure or vehicle utilized by the
certified shellfish dealer for postharvest shellfish processing, including
shucking, packaging, repackaging, shipping, reshipping, or depuration processing.
(15) "Certification number"
means the unique identification number established in Section 2(10) of this
administrative regulation and issued by the cabinet to a certified shellfish
dealer for each location.
(16) "Commingle" means the act
of combining different lots of shellstock or shucked shellfish.
(17) "Coliform group" means of
the aerobic and facultative anaerobic, gram negative, nonsporeforming,
rod-shaped bacilli which ferment lactose broth with gas formation within
forty-eight (48) hours at ninety-five (95) degrees Fahrenheit.
(18) "Compliance schedule"
means a written schedule, approved by the cabinet, that provides a correction
time period for the certified shellfish dealer to eliminate deficiencies.
(19) "Conditionally approved"
means a classification used to identify a growing area which meets criteria for
the approved classification except under certain conditions described in a
management plan.
(20) "Container" means any bag,
sack, tote, conveyance, or other receptacle used for containing shellfish for
holding or transporting.
(21) "Corrosion-resistant
materials" means materials that maintain their original surface
characteristics under normal exposure to the foods being contacted, normal use
of cleaning compounds and bactericidal solutions, and other conditions of use.
(22) "Critical control point"
means a point, step, or procedure in a food process at which control can be
applied, and a food safety hazard can, as a result be prevented, eliminated or
reduced to acceptable levels.
(23) "Critical deficiency"
means a condition or practice noted as a deficiency on the NSSP Standardized
Shellfish Plan Inspection Form which:
(a) Results in the production of a
product that is unwholesome; or
(b) Presents a threat to the health or
safety of the consumer.
(24) "Critical limit" means the
maximum or minimum value to which a physical, biological, or chemical parameter
must be controlled at a critical control point to prevent, eliminate, or reduce
to an acceptable level the occurrence of the identified food safety hazard.
(25) "Cross connection" means
an unprotected actual or potential connection between a potable water system
and any source or system containing unapproved water or a substance that is
not, or cannot be, approved as safe and potable.
(26) "Cull" means to remove
dead or unsafe shellstock from a lot of shellstock.
(27) "Depuration" means the
process of reducing the pathogenic organisms that may be present in shellstock
by using a controlled aquatic environment as the treatment process.
(28) "Depuration processor" or
"DP" means a person who harvests or receives shellstock from growing
areas in the approved or conditionally-approved, restricted, or
conditionally-restricted classification and submits the shellstock to an
approved depuration process.
(29) "Direct marketing" means
the sale for human consumption of shellfish which:
(a) Does not require depuration or
relaying prior to sale; or
(b) Has been subjected to depuration or
relaying activities.
(30) "Dry storage" means the storage
of shellstock out of water.
(31) "Easily cleanable" means a
surface which is:
(a) Readily accessible; and
(b) Is made of materials, has a finish,
and is so fabricated that residues may be effectively removed by normal
cleaning methods.
(32) "EPA" means the United
States Environmental Protection Agency.
(33) "FDA" means the US Food
and Drug Administration.
(34) "Fecal coliform" means the
portion of the coliform group which will produce gas from lactose in an EC or
A-1 multiple tube procedure liquid medium within twenty-four (24) (plus two
(2)) hours in a water bath maintained at 112 degrees Fahrenheit.
(35) "Food contact surface"
means an equipment surface or utensil which normally comes into direct or
indirect contact with shucked shellfish.
(36) "Food safety hazard" means
any biological, chemical, or physical property that may cause a food to be
unsafe for human consumption.
(37) "Growing area" means any
site which supports, or could support, the propagation of shellstock by natural
or artificial means.
(38) "HACCP" or "Hazard
Analysis and Critical Control Point" means a systematic, science-based
approach used in food production as a means to assure food safety.
(39) "HACCP plan" means a
written document that delineates the formal procedures that a certified
shellfish dealer follows to implement the HACCP requirements set forth in
Section 6 of this administrative regulation.
(40) "Handwashing" means the
process established in Section 11(32) of this administrative regulation.
(41) "Harvest" means the act of
removing shellstock from growing areas and its placement on or in a manmade
conveyance or other means of transport.
(42) "Harvest area" means an
area that contains commercial quantities of shellstock and may include
aquaculture sites and facilities.
(43) "Harvester" means a person
who takes shellstock by any means from a growing area.
(44) "Heat shock" means the
process of subjecting shellstock to any form of heat treatment prior to
shucking, including steam, hot water, or dry heat, to facilitate removal of the
meat from the shell without substantially altering the physical or organoleptic
characteristics of the shellfish.
(45) "ICSSL" or
"Interstate Certified Shellfish Shippers List" FDA publication of
shellfish dealers, domestic and foreign, who have been certified by a state or
foreign authority. The ICSSL is available on-line at the following Web address:
http://vm.cfsan.fda.gov/%7Eear/shellfis.html.
(46) "Importer" means any
certified shellfish dealer who introduces molluscan shellfish into domestic
commerce and has ownership of the shellfish without needing physical custody of
the shellfish.
(47) "Includes" or
"including" means includes or including by way of illustration and
not by way of limitation.
(48) "Key deficiency" means a
condition or practice noted as a deficiency on the NSSP Standardized Shellfish
Processing Plant Inspection Form which may result in adulterated, decomposed,
misbranded, or unwholesome product.
(49) "Label" means a label as
defined by KRS 217.015(26) affixed to, or appearing upon, any package
containing shellfish.
(50) "Lot of shellstock" means
a single type of bulk shellstock, or containers of shellstock, of no more than
one (1) day's harvest from a single defined growing area gathered by one (1) or
more harvesters.
(51) "Lot of shucked shellfish"
means a collection of containers of no more than one (1) day's shucked
shellfish product produced under conditions as nearly uniform as possible, and
designated by a common container code or marking.
(52) "Lot of shucked shellfish for
depuration" means shellstock harvested from a particular area during a
single day's harvest and delivered to one (1) depuration plant.
(53) "Marine biotoxin" means any
poisonous compound produced by marine microorganisms and accumulated by shellstock.
(54) "MPN" or "Most
probable number" means a statistical estimate of the number of bacteria
per unit volume and is determined from the number of positive results in a series
of fermentation tubes.
(55) "National Shellfish Sanitation
Program" or "NSSP" means the cooperative state-FDA-Industry
Program for the sanitary control of shellfish.
(56) "Other deficiency" means a
condition or practice noted as a deficiency on the NSSP Standardized Shellfish
Processing Plant Inspection Form that is not defined as critical, or key, and
is not in accordance with the requirements of this administrative regulation.
(57) "Person" means any
individual, receiver, trustee, guardian, personal representative, fiduciary, or
representative of any kind, and any partnership, association, corporation, or
other entity.
(58) "Point source" means any
discernible, confined, and discrete conveyance including any pipe, ditch,
channel, tunnel, or conduit that carries pollution.
(59) "Poisonous or deleterious
substance" means a toxic substance occurring naturally, or added to, the
environment for which a regulatory tolerance limit or action level has been
established in shellfish to protect public health.
(60) "Postharvest processing"
means processing of shellfish for the purpose of added safety or quality that
involves hazards not addressed by controls in Sections 11 through 14 of this
administrative regulation.
(61) "Potable water" means
water defined as potable under the provisions of 401 KAR Chapter 8.
(62) "Principal display panel"
means that part of a label that is most likely to be displayed, presented,
shown, or examined under customary conditions of retail sale.
(63) "Private water system" means
a water system as defined in 401 KAR Chapter 8 that is constructed, maintained,
and operated pursuant to applicable requirements of the Kentucky Environmental
and Public Protection Cabinet.
(64) "Process batch" means a
quantity of shellstock used to fill each separate tank or a series of tanks
supplied by a single-process water system for a specified depuration cycle in a
depuration activity.
(65) "Process water" means the
water used in the scheduled depuration process.
(66) "Prohibited Classification"
means a classification used to identify a growing area where the harvest of
shellstock, for any purpose, except depletion or gathering of seed for
aquaculture, is not permitted.
(67) "Public water system"
means a water system as defined in 401 KAR Chapter 8 that is designed,
constructed, maintained, and operated pursuant to applicable requirements of
the Kentucky Environmental and Public Protection Cabinet.
(68) "Raw" means shellfish that
have not been thermally processed:
(a) To an internal temperature of 145
degrees Fahrenheit or greater for fifteen (15) seconds (or equivalent); or
(b) Altering the organoleptic
characteristics.
(69) "Repacker" or
"RP" means any person, other than the original certified
shucker-packer, that repackages shucked shellfish into other containers.
(70) "Repacking shellstock"
means the practice of removing shellstock from containers and placing it into
other containers.
(71) "Reshipper" or
"RS" means a person that purchases shucked shellfish or shellstock
from certified shellfish dealers and sells the product without repacking or
relabeling to other certified shellfish dealers, wholesalers, or retailers.
(72) "Safe materials" means
articles manufactured from or composed of materials that may not reasonably be
expected to, directly or indirectly, become a component of, or otherwise
adversely affect, the characteristics of any food.
(73) "Sanitation control
record" means records that document the monitoring of sanitation practices
and conditions during processing.
(74) "Sanitize" means to
adequately treat food contact surfaces by a process that is effective in:
(a) Destroying vegetative cells of
microorganisms of public health significance;
(b) Substantially reducing the numbers of
other undesirable microorganisms; and
(c) Not adversely affecting the product
or its safety for the consumer.
(75) "Semipublic water supply"
means a water supply as defined in 401 KAR Chapter 8 that is constructed,
maintained, and operated pursuant to applicable requirements of the Kentucky
Environmental and Public Protection Cabinet.
(76) "Shellfish" means all aspects
of:
(a) Oysters, clams, or mussels, whether:
1. Shucked or in the shell;
2. Raw, including postharvest processed;
3. Frozen or unfrozen;
4. Whole or in-part; and
(b) Scallops in any form, except if the
final product form is the adductor muscle only.
(76) "Semipublic water supply"
means a water supply as defined in 401 KAR Chapter 8 that is constructed,
maintained, and operated pursuant to applicable requirements of the Kentucky
Environmental and Public Protection Cabinet.
(77) "Shellstock" means live molluscan
shellfish in the shell.
(78) "Shellstock packing" means
the process of placing shellstock into containers for introduction into
commerce.
(79) "Shellstock shipper" or
"SS" means a certified shellfish dealer who grows, harvests, buys, or
repacks and sells shellstock or ships shucked shellfish and does not shuck
shellfish or repack shucked shellfish.
(80) "Shucker-packer" or
"SP" means a certified shellfish dealer that shucks and packs
shellfish, acts as a shellstock shipper or reshipper, or repacks shellfish
originating from other certified shellfish dealers.
(81) "Swing deficiency" means a
deficiency noted on the NSSP Standardized Shellfish Processing Plant Inspection
Form which, depending upon the severity and circumstance, is either a
"critical" or "key" deficiency.
(82) "Transaction record" means
the form or forms used to document each purchase or sale of shellfish at the
wholesale level, and includes shellfish harvest and sales records, ledgers,
purchase records, invoices, and bills of lading.
(83) "Wet storage" means the
temporary storage, by a certified shellfish dealer, of shellstock from growing
areas in the approved classification or in the open status of the
conditionally-approved classification in containers or floats in natural bodies
of water or in tanks containing natural or synthetic seawater.
(84) "Wholesale" means any sale
to any other person than the ultimate consumer or his or her family.
Section 2. Shellfish Dealer Certification
Requirements. (1) A person shall not act as a shellfish dealer prior to
obtaining certification from the cabinet. A person shall not engage in the
wholesale handling of shellfish, operate, or conduct an establishment for the
shucking, repacking, reshipping, or otherwise processing of shellfish without a
certificate issued by the cabinet.
(2) Certification shall be issued only to
persons who meet the established requirements for certification as established
in this administrative regulation.
(3) A person making application for a
shellfish dealer certification shall:
(a) Make application to the cabinet on
form DFS 200 and complete the application for certification to handle oysters,
clams, mussels, or scallops (DFS 255) and provide all identifying information
required on each application form;
(b) Have and implement a HACCP plan, and
have a program of sanitation monitoring and record keeping in compliance with
Sections 6 and 7 of this administrative regulation, except for the requirement
for harvester identification on a certified shellfish dealer's tag; and
(c) Have a business address at which
inspections of facilities, activities, equipment, records, and vehicles can be
conducted.
(4) Upon receipt of the initial application
for shellfish dealer certification, accompanied by a $100 certification fee,
and upon approval of the certified shellfish dealer processing facility, an
initial certification shall be issued by the cabinet if the applicant meets the
hazard analysis critical control point (HACCP) requirements of this
administrative regulation and complies with the following inspectional
requirements relative to the NSSP standardized shellfish processing plant
inspection form ISSC Form 93-01(A):
(a) Hazard Analysis Critical Control
Point (HACCP) requirements:
1. No critical deficiencies as identified
on the ISSC Form 93-01(A);
2. Not more than two (2) key deficiencies
as identified on the ISSC Form 93-01(A); and
3. Not more than two (2) other
deficiencies as identified on the ISSC Form 93-01(A).
(b) Sanitation items and additional model
ordinance requirements:
1. No critical deficiencies as identified
on the ISSC Form 93-01(A);
2. Not more than two (2) key deficiencies
as identified on the ISSC Form 93-01(A); and
3. Not more than three (3) other
deficiencies as identified on the ISSC Form 93-01(A).
(c) The initial shellfish dealer
certification shall include a compliance schedule to correct any deficiencies
not corrected by the shellfish dealer during the inspection.
(5) Shellfish dealer certifications shall
expire on December 31 following the date of certification and each December 31
thereafter.
(6) Shellfish dealer certifications are
renewable annually upon submittal of application accompanied by an annual fee
of $100, if the dealer is in compliance with this administrative regulation.
(7) The cabinet shall not renew the
certification for any shellfish dealer until the dealer:
(a) Meets the requirements of subsection
(4)a and b of this section. The number of deficiencies allowed under subsection
(4)a and b of this section shall include carry-over deficiencies from an
existing compliance schedule approved by the cabinet and new deficiencies
identified during the certification renewal inspection; and
(b) Agrees to a compliance schedule to
address any new deficiencies not corrected by the shellfish dealer during the
inspection.
(8) The cabinet shall not issue
certification to a shellfish dealer whose certification has been suspended or
revoked until the shellfish dealer meets the requirements for initial
certification as provided under this administrative regulation.
(9) A shellfish processing facility shall
not operate without a valid shellfish dealer certification issued by the
cabinet. The shellfish dealer certification shall not be transferable with
respect to persons or locations.
(10) The cabinet shall issue only one (1)
certification number to a dealer for a location. A person or dealer may obtain
more than one (1) certification if each business is:
(a) Maintained as a separate entity; and
(b) Is not found at the same location.
(11) A certification number shall consist
of a one (1) to five (5) digit Arabic number preceded by the two (2) letter
state abbreviation and followed by a two (2) letter abbreviation for the type
of activity or activities the dealer is qualified to perform in accordance with
this administrative regulation using the following terms:
(a) Shellstock shipper (SS);
(b) Shucker-packer (SP);
(c) Repacker (RP);
(d) Reshipper (RS); and
(e) Depuration processor (DP).
(12) A person shall not sell, offer for
sale, or have in his or her possession with intent to sell, shellfish which
have been taken from a place classified as "prohibited" or otherwise
closed to harvesting by the pertinent regulatory authorities or from a place
condemned by authorities having supervision at the point of origin of the shellfish.
(13) A person shall not receive or accept
shipment of shellfish for shucking, repacking, shipping, storage, or sale
unless the Kentucky shellfish dealer holds a current certificate issued
pursuant to this administrative regulation. Shellfish originating from
out-of-state sources shall be received from states or countries that have
received the endorsement of the U.S. Food and Drug Administration and the
shellfish dealer shall be listed in the current USFDA Interstate Certified Shellfish
Shippers List.
(14) Food processing establishments
handling shellstock for interstate distribution shall meet the requirements of
this administrative regulation to assure the sale or distribution of shellfish
from safe sources and to assure shellfish has not been adulterated during cultivating,
harvesting, processing, shipping, or handling.
(15) A person who ships and receives
shellstock or shucked shellfish in interstate or intrastate commerce shall be
certified as a certified shellfish dealer. The type of shellfish dealer
certification issued shall be as follows:
(a) A person who shucks shellfish shall
be certified as a shucker-packer.
(b) A person who repacks shucked
shellfish shall be certified as a shucker-packer or repacker.
(c) A person who repacks shellstock shall
be certified as a shellstock shipper.
(d) A person who purchases shellstock or
shucked shellfish from shellfish dealers and sells the product without
repacking or relabeling to other shellfish dealers, wholesalers, or retailers
shall be certified as a reshipper.
(16) After a person is certified, the
cabinet shall make unannounced inspections of the shellfish dealer's
facilities:
(a) During periods of activity; and
(b) At the following minimum frequencies:
1. Within thirty (30) days of beginning
activities if the dealer was certified on the basis of a preoperational
inspection;
2. At least quarterly for shellfish
dealer activities certified as shucker-packer or repacker; and
3. At least semiannually for other
shellfish dealer certifications.
(17) Inspection results shall be recorded
on the NSSP Standardized Shellfish Processing Plant Inspection Form (ISSC Form
93-01A). The cabinet shall provide a copy of the completed inspection forms to
the person in charge at the shellfish facility at the inspection.
Section 3. Transportation. (1) The
harvester, or dealer who transports shellstock from the harvester to the
original dealer, shall assure that a truck used to transport shellstock is
properly constructed, operated, and maintained to prevent contamination,
deterioration, and decomposition.
(2) Storage bins on trucks or other
vehicles used in the transport of shellstock for direct marketing shall be kept
clean with potable water and provided with effective drainage.
(3) Shellstock shall be transported in
refrigerated trucks if the shellstock have been previously refrigerated or if
ambient air temperature and time of travel are such that unacceptable bacterial
growth or deterioration may occur.
(4) Prechilled trucks or other vehicles
shall be used if ambient air temperatures are such that unacceptable bacterial
growth or deterioration may occur.
(5) If mechanical refrigeration units are
used, the units 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 (45) degrees
Fahrenheit or less.
(6) Ice used to cool shellstock during transport
shall meet the requirements of Section 11(10) of this administrative regulation.
(7) There shall not be cats, dogs, and
other animals in any part of the truck or other vehicle where shellstock is
stored.
Section 4. Receiving Shellfish. (1) The certified
shellfish dealer shall reject or discard shellfish shipments which:
(a) Do not originate from a licensed
harvester or dealer; or
(b) Are unwholesome or adulterated,
inadequately protected, or whose source cannot be identified.
(2) Transportation agents or common
carriers used by a certified shellfish 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
administrative regulation;
(b) Ensure that shellstock are not
permitted to remain without ice, mechanical refrigeration, or other approved
means of lowering the internal body temperature of the shellstock to, or
maintaining it at, fifty (50) degrees Fahrenheit or less for more than two (2)
hours at points of 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 (45) degrees
Fahrenheit or less; and
(d) Ensure that frozen shellfish remain
frozen.
(4) All containers used to transport
shellstock shall be:
(a) Constructed to allow for easy
cleaning; and
(b) Operated and maintained to prevent
product contamination.
(5) All containers shall be cleaned with:
(a) Potable water; and
(b) Detergents, sanitizers, and other
supplies acceptable for food contact surfaces.
(6) Containers used for storing shellfish
shall be clean and fabricated from safe materials.
(7) If the entire cargo consists of
shellfish products only, except for bulk shipments, shellstock shipments shall
be shipped on pallets. If the conveyance does not have a channeled floor,
pallets shall be used for all shellfish.
(8) If the conveyance has mixed cargos,
the shellfish may be shipped as part of a mixed cargo of seafood or other food
product only if:
(a) Shellfish products are protected from
contamination by the other cargo;
(b) All cargo is placed on pallets; and
(c) No other cargo is placed on or above
the shellfish unless all cargo is packed in sealed, crush resistant, waterproof
containers.
(9) Ice used to cool shellfish shall meet
the requirements of Section 11(10) of this administrative regulation.
Section 5. Shipping Times. (1) If the
shipping time is four (4) hours or less, the certified shellfish dealer may
provide thermal recorders during shipment, but shall comply with the following
shellfish shipping requirements:
(a) Shellfish shall be shipped well iced
or by using other acceptable means of refrigeration;
(b) If 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 (45) degrees Fahrenheit or less; and
(c) Lack of ice or other acceptable types
of refrigeration shall be considered an unsatisfactory shipping condition.
(2) If the shipping time is greater than
four (4) hours, the certified shellfish dealer shall comply with the following
shellfish shipping requirements:
(a) Shellfish shall be shipped 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 (45) degrees Fahrenheit or less; or
(b) Shipped in containers with an
internal ambient air temperature maintained at or below temperatures of
forty-five (45) degrees Fahrenheit or less; and
(c) Unless the certified shellfish 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.
(3) The initial certified shellfish
dealer shall note the date and time on the temperature-indicating device, if
appropriate.
(4) Each receiving certified shellfish
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.
(5) The final receiving certified
shellfish dealer shall keep the time-temperature recording chart or other
record of time and temperature in a file and shall make it available to the
cabinet upon request.
(6) An inoperative temperature-indicating
device shall be considered as no recording device.
Section 6. HACCP Requirements for
Certified Shellfish Dealers. (1) A certified shellfish 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 or handled by that dealer
and to identify the preventive measures that the certified shellfish dealer can
apply to control those hazards. The dealer shall determine food safety hazards
that can be introduced both within and outside the processing plant
environment, including food safety hazards that can occur before, during, and
after harvest.
(2) A certified shellfish dealer shall
have and implement a written HACCP plan.
(a) A HACCP plan shall be specific to:
Each location where shellfish products
are processed by that dealer and, except as specified in paragraph (b) of this
subsection, each kind of shellfish product processed by the certified shellfish
dealer; and
(b) The HACCP 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 subsection (3) of this
section are identical for all shellfish products so grouped or for all
production methods so grouped.
(3) The HACCP plan shall, at a minimum:
(a) List the food safety hazards that are
reasonably likely to occur, as identified in accordance with Section 6(1) of
this administrative regulation for the following:
1. Natural toxins;
2. Microbiological contamination;
3. Chemical contamination;
4. Pesticides;
5. Drug residues;
6. Unapproved use of direct or indirect
food or color additives; and
7. Physical hazards;
(b) List the critical control points for
each of the identified food safety hazards, including as appropriate:
1. 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 Sections 11(1) through (5), 12(1) through (3), 13(1) and (2), and
14(1) through (3) of this administrative regulation;
2. Critical control points designed to
control food safety hazards that could be introduced in the processing plant
environment. At a minimum, the critical control points shall include those
identified in Sections 11(1) through (5), 12(1) through (3), 13(1) and (2), and
14(1) through (3) of this administrative regulation;
(c) 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 Sections 11 through 14 of this administrative
regulation, as applicable. The critical limits identified in Sections 11
through 14 of this administrative regulation, shall be met as components of
good manufacturing practices;
(d) 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;
(e) Include any corrective action plans
that have been developed to be followed in response to deviations from critical
limits at critical control points;
(f) 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; and
(g) List the verification procedures, and
frequency thereof, that the certified shellfish dealer will use in accordance
with subsection (9) of this section.
(4) 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 certified shellfish dealer. This
signature shall signify that the HACCP plan has been accepted for
implementation by the certified shellfish dealer.
(5) The HACCP plan shall be signed and
dated:
(a) Upon initial acceptance;
(b) Upon any modification; and
(c) Upon verification of the plan in
accordance with subsection (9) of this section.
(6) If a deviation from a critical limit
occurs, a certified shellfish 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
subsection (7) of this section.
(7) If a deviation from a critical limit
occurs, and the certified shellfish dealer does not have a corrective action
plan that is appropriate for that deviation, the certified shellfish dealer shall:
(a) Segregate and hold the affected
product, at least until the requirements of paragraphs (b) and (c) of this
subsection 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 been trained
in accordance with subsections (19) through (21) of this section, or
experience, to perform the review;
(c) Take corrective action, if 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, if necessary,
to correct the cause of the deviation; and
(e) Perform or obtain timely reassessment
by an individual or individuals who have been trained in accordance with
subsections (19) through (21) of this section, 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.
(8) All corrective actions taken in
accordance with this section shall be fully documented in records that are
subject to verification in accordance with subsection (9) of this section and
the record-keeping requirements of subsections (12) through (18) of this section.
(9) A certified shellfish dealer 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:
(a) A reassessment of the adequacy of the
HACCP plan if any changes occur that could affect the hazard analysis or alter
the HACCP plan in any way or at least annually. The reassessment shall be
performed by an individual who has been trained in accordance with subsections
(19) through (21) of this section. The HACCP plan shall be modified immediately
if a reassessment reveals that the plan is no longer adequate to fully meet the
requirements of subsection (3) of this section;
(b) Ongoing verification activities
including:
1. A review of consumer complaints that
have been received by the certified shellfish 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 subsections
(19) through (21) of this section, of the records that document:
1. The monitoring of critical control
points. This review shall ensure that the records are complete and verify that
the documents reflect 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. This
review shall ensure that the records are complete and verify that appropriate
corrective actions were taken in accordance with subsections (6) through (8) of
this section. 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 certified shellfish dealer’s verification activities. This review shall
ensure that the records are complete, and that these activities occurred in
accordance with the certified shellfish dealer’s written procedures. These
reviews shall occur within a reasonable time after the records are made.
(10) Certified shellfish dealers shall
immediately follow the procedures in subsections (6) through (8) of this
section, if any verification procedure, including the review of a consumer
complaint, reveals the need to take a corrective action.
(11) The calibration of
process-monitoring instruments and the performing of any periodic end-product
and in-process testing, in accordance with subsection (9)(b)2 and 3 of this
section, shall be documented in records that are subject to the record-keeping
requirements of subsections (12) through (18) of this section.
(12) Records required by this
administrative regulation shall include:
(a) The name and location of the
certified shellfish 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) If appropriate, the identity of the
product and the production code, if any. Processing and other information shall
be entered on records when observed.
(13) Except as provided by subsection
(14) of this section, records required by this administrative regulation shall
be retained at the certified shellfish dealer processing facility for at least
one (1) year after the date they were prepared if refrigerated products, and
for at least two (2) years after the date they were prepared if frozen products.
(14) Records that relate to the general
adequacy of equipment or processes being used by a certified shellfish dealer,
including the results of scientific studies and evaluations, shall be retained
at the certified shellfish dealer processing facility for at least two (2)
years after their applicability to the product being produced at the facility.
(15) If the certified shellfish dealer
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.
(16) Records required by this
administrative regulation, including HACCP plans, shall be available for
official review and copying at reasonable times.
(17) Tags on containers of shellstock are
not subject to the requirements of this administrative regulation unless they
are used to fulfill the requirements of Section 8 of this administrative regulation.
(18) The maintenance of records on
computers is acceptable, if appropriate controls are implemented to ensure the
integrity of the electronic data and electronic signatures.
(19) At a minimum, the following
functions shall be performed by an individual who has successfully completed an
approved training curriculum in the application of HACCP principles to perform
these functions:
(a) Develop a HACCP plan;
(b) Reassess and modify the HACCP plan in
accordance with the corrective action procedures specified in subsection (7)(e)
of this section, and verify the HACCP plan in accordance with the verification
activities specified in subsection (9)(a) and (b) of this section; and
(c) Perform the record review required by
subsection (9)(c) of this section.
(20) An individual described in
subsection (19) of this section shall provide the cabinet, upon request, a copy
of their certificate of completion of training for the application of HACCP
principles for shellfish processing.
(21) Relevant job experience may qualify
an individual to perform the functions specified in subsection (19) of this
section. The trained individual need not be an employee of the certified
shellfish dealer.
Section 7. General Sanitation
Requirements. (1) A certified shellfish dealer shall monitor eight (8) key
areas of sanitation conditions and practices with of sufficient frequency to
ensure, at a minimum, conformance with the applicable requirements contained
within Kentucky’s Food, Drug and Cosmetic Act, KRS Chapter 217, and Sections
11(6) through (54), 12(4) through (42), 13(3) through (44), and 14(4) through
(33) of this administrative regulation. The eight (8) key sanitation areas to
be monitored are:
(a) Safety of the water that comes into
contact with food or food contact surfaces, or is used in the manufacture of
ice;
(b) Condition and cleanliness of food
contact surfaces, including utensils, gloves, and outer garments, and from raw
product to cooked product;
(c) 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;
(d) Maintenance of hand washing, hand
sanitizing, and toilet facilities;
(e) 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;
(f) Proper labeling, storage, and use of toxic
compounds;
(g) Control of employee health conditions
that could result in the microbiological contamination of food, food packaging
materials, and food contact surfaces; and
(h) Exclusion of pests from the food
plant.
(2) A certified shellfish dealer shall
maintain sanitation control records that, at a minimum, document the monitoring
and corrections prescribed by subsection (1) of this section. These records
shall comply with the requirements of Section 6(12) through (18) of this administrative
regulation.
(3) A dealer shall comply with the
pertinent food establishment requirements of the Kentucky Food, Drug and
Cosmetic Act, KRS Chapter 217, and the physical facility requirements contained
in Sections 11 through 14 of this administrative regulation that are applicable
to the plant and the food being processed.
(4) Certified shellfish dealers shall
adopt and follow written procedures for conducting recalls of adulterated or
misbranded shellfish products including: Timely notification of the cabinet of
a situation requiring a recall, timely notification of consignee who received
the affected product, and effective removal or correction of the affected
product.
Section 8. Shellstock Identification. (1)
The certified shellfish dealer shall buy shellfish only from sources certified
by the cabinet or listed in the ICSSL.
(2) The certified shellfish dealer's tags
shall be:
(a) Durable, waterproof, and approved by
the cabinet prior to use; and
(b) At least two and five-eighths (2 5/8)
inches by five and one-fourth (5 1/4) inches in size.
(3) The certified shellfish dealer's tag
shall contain the following indelible, legible information in the order
specified below:
(a) The certified shellfish dealer's name
and address;
(b) The certified shellfish dealer's
certification number as assigned by the cabinet and the original shellstock
shipper's certification number;
(c) The date of harvest (if depurated,
the date of depuration processing);
(d) The most precise identification of
the harvest location as is practicable including the initials of the state of
harvest, and the designation of the growing area by indexing, administrative or
geographic designation. If growing areas have not been indexed, an appropriate
geographical or administrative designation shall be used, and if depurated, the
depuration cycle or lot number shall be included;
(e) If the shellstock has been placed in
wet storage in a certified shellfish dealer's operation, the statement:
"This product is a product of (name of state) and was wet stored at
(facility certification number) from (date) to (date)";
(f) The type and quantity of shellstock;
(g) The following statement in bold,
capitalized type: "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS
EMPTY OR IS RETAGGED AND THEREAFTER KEPT ON FILE FOR 90 DAYS"
(h) Shellstock intended for raw
consumption shall include a consumer advisory. The following statement, or an
equivalent statement, shall be included on all shellstock: "RETAILERS
INFORM YOUR CUSTOMERS" "Consuming raw or undercooked meats, poultry,
seafood, shellfish, or eggs may increase your risk of food-borne illness,
especially if you have certain medical conditions"; and
(i) The statement "Keep
Refrigerated" or an equivalent statement.
(4) If both the certified shellfish dealer
and harvester tags appear on the container, the certified shellfish dealer's
tag shall not be required to duplicate the information on the harvester's tag.
(5) If the shellstock is removed from the
original container, the tag on the new container shall meet all applicable
labeling and shellstock identification requirements of this administrative
regulation.
(6) If shellstock are sold in bulk, the
certified shellfish dealer shall provide a transaction record prior to
shipment. This transaction record shall contain the information required in
Section 10(5) through (10) of this administrative regulation with the addition
of the name of the consignee.
Section 9. Shucked Shellfish Labeling.
(1) If the shucker-packer uses returnable containers to transport shucked
shellfish between dealers for the purpose of further processing or packing, the
returnable containers shall be exempt from the labeling requirements in this administrative
regulation. If returnable containers are used, the shipment shall be accompanied
by a transaction record containing:
(a) The original shucker-packer's name
and certification number;
(b) The shucking date; and
(c) The quantity of shellfish per
container and the total number of containers.
(2) If the certified shellfish dealer
uses master shipping cartons, the master cartons shall be exempt from these
labeling requirements if the individual containers within the carton are
properly labeled.
(3) At a minimum, the certified shellfish
dealer shall label each individual package containing fresh or frozen shucked
shellfish meat in a legible and indelible form in accordance with the following:
(a) 21 C.F.R. Part 101 Nutrition Labeling
of Food;
(b) Federal Fair Packaging and Labeling
Act, 15 U.S.C. Chapter 39;
(c) 21 C.F.R. 161.30;
(d) 21 C.F.R. 161.130; and
(e) 21 C.F.R. 161.136.
(4) The certified shellfish 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
certification number 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 if 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 shall be added
to the date.
(5) The certified shellfish dealer shall
assure that each package containing sixty-four (64) or more fluid ounces of
fresh or frozen shellfish shall have:
(a) The shucker-packer's or repacker's
certification number 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 disposable containers.
(6) If the certified shellfish dealer
thaws and repacks frozen shellfish, the dealer shall label the shellfish
container as previously frozen.
(7) The certified shellfish dealer shall
provide label information in a legible and indelible form.
(8) If the certified shellfish dealer
elects to repack shellfish, the dealer shall pack and label shellfish in
accordance with this section except that the original date of shucking shall be
used in establishing the sell by date.
Section 10. Shipping Documents and
Records. (1) A 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 certified shellfish
dealer shall:
(a) Maintain in a file a copy of the
completed shipping document; and
(b) Make the shipping document available
to the cabinet upon request.
(4) If the shipment is subdivided to
different certified shellfish dealers, a receiving certified shellfish dealer
shall maintain records sufficient to trace the portion received back to the
original shipment.
(5) A certified shellfish dealer shall
have a business address at which transaction records are maintained.
(6) A certified shellfish dealer shall
maintain complete, accurate, and legible records of the cabinet’s required
information.
(7) Transaction records shall be
sufficient to:
(a) Document that the shellfish are from
a source authorized under this administrative regulation;
(b) Permit a container of shellfish to be
traced back to the specific incoming lot of shucked shellfish from which it was
taken; and
(c) Permit a lot of shucked shellfish or
a lot of shellstock to be traced back to the growing area, date of harvest,
and, if possible, the harvester or group of harvesters.
(8) Purchase and sales shall be recorded:
(a) In a permanently-bound ledger book;
or
(b) In retrievable electronic computer
files or discs.
(9) The transaction records shall be
retained as follows:
(a) If fresh shellfish, for a minimum of
one (1) year; and
(b) If In the case of frozen shellfish,
for at least two (2) years or the shelf-life of the product, whichever is
longer.
Section 11. Requirements for Certified
Shellfish Dealers Engaged in Shucking and Packing. (1) The certified shellfish
dealer shall shuck and pack only shellstock which is from sources certified by
the cabinet or listed in the ICSSL; and identified with a tag on each container
or a transaction record on each bulk shipment.
(2) The certified shellfish dealer shall
ensure upon receipt that shellfish has been transported iced or in a conveyance
maintained at or below an ambient air temperature of forty-five (45) degrees
Fahrenheit.
(3) The certified shellfish dealer shall
ensure that the storage of shellstock, once placed under temperature control
and until sale to the processor or final consumer, shall be:
(a) Stored in ice; or
(b) Placed and stored in a storage area
or conveyance maintained at forty-five (45) degrees Fahrenheit or less;
(c) Not permitted to remain without ice,
mechanical refrigeration, or other approved methods of refrigeration for more
than two (2) hours at points of transfer such as loading docks; and
(d) Not permitted to be placed in wet storage.
(4) The certified shellfish dealer that
processes shall ensure that:
(a) For shellstock refrigerated prior to
shucking, shucked meats are chilled to an internal temperature of forty-five
(45) degrees Fahrenheit or less within four (4) hours of removal from refrigeration;
and
(b) If heat shock is used, once
heat-shocked shellstock is shucked, the shucked shellfish meats shall be cooled
to forty-five (45) degrees Fahrenheit or less within two (2) hours after the
heat shock process.
(5) The certified shellfish dealer shall
store shucked and packed shellfish in covered containers at an ambient air
temperature in the storage area of forty-five (45) degrees Fahrenheit or less,
or covered in ice to maintain the internal product temperature of forty-five
(45) degrees Fahrenheit.
(6) The certified shellfish dealer shall
provide a water supply that is potable, adequate, and from an approved public
supply of a municipality or water district, if available.
(7) If a public water supply of a
municipality or a water district is not available, the supply for the certified
shellfish dealer processing facility shall be developed and approved pursuant
to applicable requirements of 401 KAR Chapter 8, Public Water Supply.
(8) The certified shellfish dealer shall
have the water supply sampled in accordance with the provisions of 401 KAR
Chapter 8, as applicable, and shall maintain sample results on file at the
plant.
(9) The certified shellfish dealer shall
assure that steam used in food processing or that comes in contact with food
contact surfaces is free from any additives or deleterious substances.
(10) 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 which holds a
valid permit to operate as an ice manufacturer.
(11) Water from a potable water supply
shall be used to wash shellstock.
(12) If the certified shellfish dealer
uses a system to wash shellstock which recirculates water, the dealer shall:
(a) Obtain approval from the cabinet for
the construction or remodeling of the system by submitting construction plans
for approval prior to construction or renovation;
(b) 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 unacceptable residues in the
shellstock; and
(c) Test bacteriological water quality
daily.
(13) The certified shellfish dealer shall
design, install, modify, repair, and maintain all plumbing and plumbing
fixtures to:
(a) Prevent contamination of water supplies;
and
(b) Prevent cross-connection between the
pressurized potable water supply and water from an unacceptable source in
accordance with 815 KAR Chapter 20, State Plumbing Code. The certified
shellfish dealer shall install and maintain in good working order devices to protect
against backflow and back siphonage.
(14) Shellstock washing storage tanks and
related plumbing shall be fabricated from safe materials and tank construction
that:
(a) Is easily accessible for cleaning and
inspection;
(b) Is self-draining; and
(c) Meets the requirements for food
contact surfaces in accordance with subsection (16) of this section.
(15) Except for equipment in continuous
use and placed in service prior to January 1, 1989, the certified shellfish
dealer shall use only equipment which conforms to the Shellfish Industry
Equipment Construction Guide.
(16) Food contact surfaces of equipment
and utensils used by the certified shellfish dealer, including plastic ware and
finished product containers, shall be:
(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 exposed screws, bolts, or
rivet heads on food contact surfaces; and
(c) Fabricated from food grade materials.
(17) The certified shellfish dealer shall
assure that all joints on food contact surfaces have smooth, easily cleanable
surfaces and are welded.
(18) 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.
(19) The certified shellfish dealer shall
provide a temperature measuring device accurate to plus or minus two (2)
degrees Fahrenheit for use in monitoring product temperatures.
(20) Equipment used in heat shock
processing shall meet the requirements of subsection (15) through (17) of this
section.
(21) Equipment used to handle ice shall
be kept clean and stored in a sanitary manner, and shall meet the construction
requirements in subsections (15) through (17) of this section.
(22) Food contact surfaces of equipment,
utensils and containers shall be cleaned and sanitized to prevent contamination
of shellfish and other food contact surfaces. The certified shellfish 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 interruption during
which food contact surfaces may have been contaminated;
(c) Wash and rinse equipment and utensils
at the end of each day; and
(d) Provide a test kit or other device
that accurately measures the parts per million concentration of the chemical
sanitizing agent in use.
(23) 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.
(24) Shellfish shall be protected from
contamination by washing and rinsing shucking containers and sanitizing before
each filling.
(25) Containers which may have become
contaminated during storage shall be washed, rinsed, and sanitized prior to use
or shall be discarded.
(26) Shucked shellfish shall be packed in
clean, covered containers and stored in a manner which assures their protection
from contamination.
(27) If used, the finger cots or gloves
shall be:
(a) Made of impermeable materials except
if the use of this 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.
(28) Shellstock shall be stored in a
manner to protect shellstock from contamination in dry storage and at points of
transfer.
(29) Shucked shellfish shall be protected
from contamination.
(30) Shellstock shall not be placed in
containers with standing water for the purposes of washing shellstock or
loosening sediment.
(31) Equipment and utensils shall be
stored in a manner to prevent splash, dust, and contamination.
(32) Handwashing shall include the
following:
(a) Wetting hands and forearms with
running water at a temperature of 110-120 °F;
(b) Applying antibacterial or
antimicrobial soap and thoroughly distributing over hands and forearms;
(c) Rubbing hands vigorously for at least
twenty (20) seconds, covering all surfaces of the hands, forearms, and fingers,
paying special attention to the thumbs, backs of fingers, and spaces between
the fingers;
(d) Rinsing hands and forearms thoroughly
to remove residual soap;
(e) Drying hands and forearms with paper
towels dispensed from a sanitary dispenser or by utilizing a hand drying device
that provides heated air; and
(f) Application of an approved hand
sanitizer.
(33) If the same employee works in both
the shucking and packing areas, the employee shall wash their hands immediately
and thoroughly after entering each work area.
(34) The certified shellfish dealer shall
require all employees to wash their hands in an approved hand washing facility:
(a) Before starting work;
(b) After each absence from the work station;
(c) After each work interruption; and
(d) If their hands may have become soiled
or contaminated.
(35) Hand washing facilities with warm
water at a minimum temperature of 110 degrees Fahrenheit, dispensed from a hot
and cold mixing or combination faucet, under pressure, shall be provided.
(36) Sewage and liquid disposable wastes
shall be properly removed from the facility.
(37) Toilets shall be provided and
conveniently located in accordance with 815 KAR Chapter 20, State Plumbing
Code.
(38) The certified shellfish dealer shall
provide toilet facilities with an adequate supply of toilet paper in a suitable
holder.
(39) Shellfish shall be protected from
contamination while being transferred from one point to another during handling
and processing.
(40) The certified shellfish dealer shall
provide lighting throughout the facility that is sufficient to promote good
manufacturing practices.
(41) 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 shielded to
prevent food contamination in case of breakage.
(42) Food contact surfaces shall be
protected from contamination and adulteration by using cleaning compounds and
sanitizing agents in accordance with manufacturer label directions.
(43) Ice that is not made on site in the shellfish
processing facility shall be inspected upon receipt and rejected if the ice may
have been subject to contamination.
(44) Ice shall be stored in a safe and
sanitary manner to prevent contamination of the ice.
(45) Ventilation shall be provided to
minimize condensation in areas where food is stored, processed, or packed.
(46) The certified shellfish dealer shall
assure that only toxic substances necessary for plant activities are present in
the certified shellfish dealer processing facility.
(47) 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.
(48) The certified shellfish dealer shall
not store toxic substances above shellfish or food contact surfaces.
(49) If pesticides are used, the
certified shellfish dealer shall apply pesticides in full compliance with the
manufacturer’s labeling and in a manner to prevent the contamination of any
shellfish or packaging materials with residues.
(50) Cleaning compounds and sanitizing
agents shall be properly labeled and used in accordance with the manufacturer's
label directions.
(51) Toxic substances shall be labeled
and used in accordance with the manufacturer's label directions.
(52) The certified shellfish dealer shall
take all reasonable precautions to assure that an employee with a communicable
disease that can be transmitted through food, shall be excluded from working in
any capacity in which the employee may come in contact with shellfish or with
food contact surfaces.
(53) An employee with an open, exposed,
or infected wound shall keep it covered with a proper bandage, an impermeable
barrier, and a single-use glove for a hand lesion.
(54) The certified shellfish dealer shall
operate the certified shellfish dealer processing facility to assure that pests
are excluded.
(55) The physical certified shellfish
dealer processing facility shall be maintained in good repair.
(56) The certified shellfish dealer shall
operate the certified shellfish dealer processing facility to provide
protection from contamination and adulteration by assuring that dirt and other
filth are excluded from the facility or activities.
(57) Animals or unauthorized persons
shall not be allowed in portions of the certified shellfish dealer processing
facility where shellfish are stored, handled, processed or packaged, or where
food handling equipment, utensils, and packaging materials are cleaned or
stored.
(58) 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 shall not be used.
(59) The shucking and packing operation
shall be separated by use of:
(a) Separate rooms;
(b) Partitions; or
(c) Spacing which is sufficient to
protect product from adulteration or cross-contamination.
(60) Manufacturing activities which could
result in the contamination of shellfish shall be separated by adequate barriers.
(61) The certified shellfish dealer shall
provide toilet room doors which are tight fitting, self closing, and do not
open directly into a processing area.
(62) Sanitary conditions shall be
maintained throughout the shellfish processing facility.
(63) Dry area floors shall be hard,
smooth, easily cleanable, and in good repair.
(64) 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:
(a) Are graded to provide adequate drainage;
(b) Have even surfaces and are free from
cracks that create sanitary problems and interfere with drainage; and
(c) Have sealed junctions between floors
and walls to render them impervious to water.
(65) Walls, ceilings, and interior
surfaces of rooms where shellfish are stored, handled, processed, or packaged
shall be constructed of easily cleanable, corrosion resistant, impervious materials.
(66) Grounds around the facility shall be
maintained to be free from rodent attraction and harborage, and inadequate
drainage conditions.
(67) Hand washing 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; and
(c) Plumbed to an approved sewage
disposal system in accordance with 815 KAR Chapter 20, State Plumbing Code.
(68) The certified shellfish dealer shall
provide at least one (1) conveniently located hand sink in the packing room.
(69) The certified shellfish dealer shall
provide at each hand washing 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, covered waste receptacle;
(d) Approved hand sanitizer; and
(e) Hand washing signs in a language
understood by the employees;
(70) Plumbing and plumbing fixtures shall
be designed, installed, modified, repaired, and maintained in accordance with
815 KAR Chapter 20, State Plumbing Code, to provide a water system that is adequate
in quantity and under pressure, and includes:
(a) Cold and warm water at all sinks; and
(b) Hand washing facilities adequate in
number and size for the number of employees and that are located where
supervisors can observe employee use.
(71) Adequate floor drainage, including
backflow preventers, such as air gaps, shall be provided if floors are:
(a) Used in shellstock storage;
(b) Used for food holding units;
(c) Cleaned by hosing, flooding, or
similar methods; and
(d) Subject to the discharge of water or
other liquid waste on the floor during normal activities.
(72) A safe, effective means of sewage
disposal for the certified shellfish dealer processing facility shall be
provided. Sewage shall be disposed of into a public sewerage system, if
available. If a public sewerage system is not available, disposal shall be made
into a private system designed, constructed, and operated pursuant to 902 KAR
10:060 through 110, Kentucky On-site Sewage Disposal Systems, or 401 KAR
Chapter 5, Water Quality.
(73) drainage or waste pipes shall not be
installed over food processing or food storage areas, or over areas in which
containers and utensils are washed or stored.
(74) Ventilation, heating, or cooling
systems shall not create conditions that may cause shellfish products to become
contaminated.
(75) To insure that insects and vermin
are not present in the facility, the dealer shall employ necessary internal and
external insect and vermin control measures including tight-fitting,
self-closing doors; screening of not less than fifteen (15) mesh per inch; and
controlled air currents.
(76) Disposal of waste materials, shell,
and other nonedible materials shall be promptly and effectively removed from
the shucking bench or table. 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.
(77) Nonfood contact surfaces of
equipment and utensils utilized by the certified shellfish dealer, including
plastic ware, shall be designed and fabricated for durability under conditions
of normal use and shall be resistant to denting, buckling, pitting, chipping,
and crazing and be made from materials that can be cleaned, sanitized, maintained,
or replaced.
(78) The certified shellfish dealer shall
use easily cleanable, corrosion resistant, impervious materials, free from
cracks to construct:
(a) Shucking benches and contiguous
walls;
(b) Stands or stalls and stools for
shuckers; and
(c) Nonfood contact surfaces in shellfish
storage or handling areas.
(79) Shucking benches shall drain
completely and rapidly, and shall drain away from any shellfish on the benches.
(80) Cleaning activities for equipment
and utensils shall be conducted in a manner and at a frequency appropriate to
prevent contamination of shellfish and food contact surfaces.
(81) 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.
(82) The certified shellfish 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 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 shellfish meats
in accordance with 21 C.F.R. 161.130;
(g) Thoroughly drain, clean as necessary,
and pack shucked shellfish meats promptly after delivery to the packing room;
(h) Conduct packing activities to conform
to applicable food additive requirements contained in KRS Chapter 217, and 21
C.F.R. Part 170 through 189;
(i) Store packaged shellfish, if they are
to be frozen, at an ambient temperature of zero degrees Fahrenheit or less, and
frozen solid within twelve (12) hours following the initiation of freezing; and
(j) Not commingle shellstock during shucking.
(83) A certified shellfish dealer that
uses heat shock to prepare shellstock for shucking shall:
(a) Post the schedule for the heat shock
process in a conspicuous location; and
(b) Make sure responsible persons are
familiar with the requirements;
(c) Cool 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; and
(d) If a heat shock water tank is used,
the certified shellfish dealer shall completely drain and flush the tank at
three (3) hour intervals or less so that mud and debris which have accumulated
in the dip tank are eliminated.
(84) An employee handling shucked
shellfish shall:
(a) Wear effective hair restraints;
(b) Remove hand jewelry that cannot be
sanitized or secured;
(c) Wear finger cots or gloves if jewelry
cannot be removed; and
(d) Wear clean outer garments, which are
rinsed or changed as necessary to be kept clean.
(85) In an area where shellfish are
shucked or packed and in an area which is used for cleaning or storage of
utensils, the certified shellfish dealer shall not allow employees to:
(a) Store clothing or other personal
belongings;
(b) Eat or drink;
(c) Spit; or
(d) Use tobacco in any form.
(86) A reliable, competent individual
shall be designated to supervise general plant management and activities and
monitor compliance with this administrative regulation.
(87) Cleaning procedures shall be
developed and supervised to assure that cleaning activities do not result in
contamination of shellfish or food contact surfaces.
(88) Supervisors shall be:
(a) Trained in proper food handling
techniques and food protection principles; and
(b) Knowledgeable of personal hygiene and
sanitary practice requirements contained within 21 C.F.R. Part 110, Current
Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.
(89) The certified shellfish dealer shall
require that supervisors:
(a) Monitor employee hygiene practices,
including hand washing, eating, and smoking at work stations, and the storage
of personal items or clothing;
(b) Assure that proper sanitary practices
are implemented, including:
1. Plant and equipment clean-up;
2. Rapid product handling; and
3. Shellfish protection from contamination;
and
(c) Require employees to:
1. Be trained in proper food handling;
and personal hygiene practices; and
2. Report any symptoms of illness.
Section 12. Requirements for Certified
Shellfish Dealers Engaged in Repacking of Shucked Shellfish.
(1) The certified shellfish dealer
receiving shellfish shall repack only shellfish which:
(a) Originated from a certified shellfish
dealer;
(b) Are identified with a label as
specified in Section 8 of this administrative regulation; and
(c) Has been transported iced or in a
conveyance maintained at or below an ambient air temperature of forty-five (45)
degrees Fahrenheit.
(2) The certified shellfish dealer processing
shellfish shall ensure that repacked shellfish:
(a) Do not exceed an internal temperature
of forty-five (45) degrees Fahrenheit for more than two (2) hours during
processing; and
(b) Are maintained at a temperature less
than forty-five (45) degrees Fahrenheit in any portion of frozen shellfish
thawed for repacking.
(3) The certified shellfish dealer shall
store repacked, shucked shellfish in covered containers at an ambient air
temperature of forty-five (45) degrees Fahrenheit or less, or covered in ice to
maintain an internal product temperature of forty-five (45) degrees Fahrenheit
or less.
(4) The certified shellfish dealer shall
comply with Section 11(6) through (10), (13), (15) through (17), (19), (21),
(22), (25), (27), (29), (31), (32), (34) through (58), (61) through (75), (77),
(80), (81), and (84) through (89) of this administrative regulation.
(5) Shucked shellfish shall be repacked
in clean containers:
(a) Fabricated from food grade materials;
and
(b) Stored in a manner which assures
their protection from contamination.
(6) The certified shellfish dealer shall
assure that employees working in direct contact with shellfish processing
activities or food contact surfaces maintain a high level of personal hygiene
and cleanliness.
(7) Disposal of waste materials shall not
create a public health hazard or nuisance.
(8) 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.
(9) The certified shellfish dealer shall
use easily cleanable, corrosion resistant, impervious materials, free from
cracks to construct nonfood contact surfaces in shellfish storage or handling areas.
(10) The certified shellfish dealer
shall:
(a) Not commingle shellfish from
different lots;
(b) Repack shucked shellfish meats only
into containers labeled with the authorized certification number;
(c) Not have on the premises 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;
(d) Wash, blow, and rinse shellfish meats
in accordance with 21 C.F.R. 161.130;
(e) Thoroughly drain, clean as necessary,
and repack shucked shellfish meats promptly;
(f) Conduct repacking activities to
conform to applicable food additive requirement contained in KRS Chapter 217,
and 21 C.F.R. Parts 170 through 189; and
(g) Store packaged shellfish, if they are
to be frozen, at an ambient temperature of zero degrees Fahrenheit or less and
frozen solid within twelve (12) hours following the initiation of freezing.
Section 13. Requirements for Certified
Shellfish Dealers Engaged in Shellstock Shipping. (1) The certified shellfish
dealer receiving shellstock shall ship or repack only shellstock which is obtained
from:
(a) Sources certified by the cabinet or
listed in the ICSSL;
(b) A certified shellfish dealer who has
transported the shellfish iced or in a conveyance maintained at an ambient air
temperature at or below forty-five (45) degrees Fahrenheit;
(c) A licensed harvester who has:
1. Harvested the shellstock from an
approved or conditionally-approved area in the open status as identified by the
tag; and
2. Identified the shellstock with a tag
on each container or transaction record on each bulk shipment; or
(d) A certified shellfish dealer who has
identified the shellstock with a tag on each container.
(2) The certified shellfish dealer
storing shellstock shall ensure that once placed under temperature control and
until sold to the processor or final consumer, shellstock shall be:
(a) Iced; or
(b) Placed in a storage area or
conveyance maintained at forty-five (45) degrees Fahrenheit or less;
(c) Not permitted to remain without ice,
mechanical refrigeration, or other approved methods of refrigeration, as
required in paragraphs (a) and (b) of this subsection for more than two (2)
hours at points of transfer such as loading docks; and
(d) Not permitted to be placed in wet storage.
(3) The certified shellfish dealer shall
comply with Section 11(6) through (17), (19), (21), (22), (25), (27) through
(32), (34) through (57), (61) through (67), (69), (70) through (75), (77), (80),
(81), and (85) through (89) of this administrative regulation.
(4) Shellstock shall be packed in clean
containers.
(5) The certified shellfish dealer shall
operate the certified shellfish dealer processing facility to provide adequate
protection from contamination and adulteration by assuring that dirt and other
filth are excluded from the certified shellfish dealer processing facility.
(6) Disposal of waste materials shall not
create a public health hazard or nuisance.
(7) 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.
(8) The certified shellfish dealer shall
use easily cleanable, corrosion resistant, impervious materials, free from
cracks to construct any nonfood contact surfaces in shellstock storage or
handling areas.
(9) The certified shellfish dealer shall:
(a) Assure that shellshock is:
1. Alive;
2. Reasonably free of sediment; and
3. Culled; and
(b) Not commingle shellstock during repacking.
(10) The certified shellfish dealer shall
inspect incoming shipments and shall reject dead or inadequately-protected shellstock.
(11) A certified shellfish dealer whose
activity consists of trucks or docking facilities only shall:
(a) Have a permanent business address at
which records are maintained and inspections can be performed; and
(b) Not repack shellstock.
(71) A certified shellfish dealer who
stores or repacks shellstock shall have:
(a) A facility for proper storage or
repacking of shellstock; or
(b) Arrangements with a facility approved
by the cabinet for the storage or repacking of shellstock.
Section 14. Requirements for Certified
Shellfish Dealers Engaged in Reshipping. (1) The certified shellfish dealer
shall reship only shellfish received which at receiving:
(a) Are from sources certified by the
cabinet or listed in the ICSSL;
(b) Are identified with a tag as
specified in Section 8 of this administrative regulation or a label as
specified in Section 9 of this administrative regulation; and
(c) Originated from a certified shellfish
dealer who has transported the shellstock iced or in a conveyance maintained at
or below an ambient air temperature of forty-five (45) degrees Fahrenheit.
(2) The certified shellfish dealer shall
ensure that, once placed under temperature control and until sold to the
processor or final consumer, shellstock shall be:
(a) Iced; or
(b) Placed in a storage area or
conveyance maintained at forty-five (45) degrees Fahrenheit or less;
(c) Not permitted to remain without ice,
mechanical refrigeration, or other approved means of refrigeration, as required
in paragraphs (a) and (b) of this subsection, for more than two (2) hours at
points of transfer such as loading docks; and
(d) Not permitted to be placed in wet storage.
(3) The certified shellfish dealer shall
store shucked shellfish at a temperature of forty-five (45) degrees Fahrenheit
or less.
(4) The certified shellfish dealer shall
comply with Section 11(6), (7), (8), (10), (13), (28), (29), (31), (32), (34)
through (43), (45) through (57), (61) through (67), (69) through (75), (77),
(78), (80), (81), and (85) through (89) of this administrative regulation.
(5) Equipment used to handle ice shall be
kept clean and stored in a sanitary manner and shall meet the construction
requirements in Section 11(15) through (17) of this administrative regulation.
(6) Disposal of waste materials shall not
create a public health hazard or nuisance.
(7) 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.
(8) The certified shellfish dealer shall:
(a) Buy shellfish only from sources
holding a valid certification issued by the cabinet or listed in the most
current ICSSL; and
(b) Add the dealer's name and
certification number to the package.
(9) The certified shellfish dealer shall
not:
(a) Commingle, sort, or repack shellstock
or shucked shellfish; or
(b) Remove or alter any existing tag or label.
(10) A certified shellfish dealer whose
activity consists of trucks only shall have:
(a) A facility for the storage of
shellfish; or
(b) Arrangements with a facility that
meets the minimum sanitation requirements for a refrigerated or frozen food
storage warehouse in accordance with KRS Chapter 217; and
(c) A permanent business address at which
records are maintained and inspections can be performed.
Section 15. Plan Review of Future
Construction. If a certified shellfish dealer processing facility is
constructed or extensively remodeled, or plumbing relocated, or additional
plumbing added, or if an existing structure is converted for use as a certified
shellfish dealer processing facility; properly prepared plans and specifications
for the construction, renovation, or alteration; showing layout, arrangements,
size, location and type of facilities and a plumbing riser diagram shall be
submitted to the cabinet for approval before work is begun.
Section 16. Denial, Suspension,
Revocation or Nonrenewal of Shellfish Dealer Certification. (1) The cabinet,
after notice to the applicant, shall deny initial shellfish dealer
certification for failure to comply with the requirements of this administrative
regulation.
(2) The cabinet, after notice to a
certificate holder, and after an opportunity for a conference, may suspend,
permanently revoke, or deny certificate renewal for failure to comply with the
requirements of this administrative regulation. Following conference proceedings,
a certificate holder may request a formal hearing pursuant to KRS Chapter 13B.
(3) If the cabinet has substantial reason
to believe that an imminent public health hazard exists, or if the certificate
holder has interfered with the cabinet in the performance of its duties, after
the cabinet agents have duly and officially identified themselves, the
certification shall be suspended immediately upon notice to the certificate
holder without a conference. In this event, the certificate holder may request a
conference on form DFS-212. If requested, the conference shall be granted as
soon as practical, or in any event, not to exceed seven (7) days.
(4) In all other cases, a shellfish
dealer’s certification shall not be renewed or reinstated until the shellfish
dealer complies with the requirements for initial certification found in
Section 2 of this administrative regulation and is able to demonstrate
substantial compliance with other pertinent requirements of this administrative
regulation specific to the particular type of certification being sought.
(5) If an inspection reveals the presence
of a critical deficiency as identified on the ISSC Form 93-01(A):
(a) The deficiency shall be corrected
during that inspection; or (b) The certified shellfish dealer shall cease
production in areas of the facility affected by deficiency.
(6) If the certified shellfish dealer
fails to comply with subsection (5) of this section, the cabinet shall
immediately begin actions to suspend or revoke the certified shellfish dealer’s
certification.
(7) If the cabinet has reason to believe
that a critical deficiency may have resulted in product contamination, the
cabinet shall take appropriate action to prevent contaminated or adulterated
product from reaching consumers. If necessary the cabinet shall:
(a) Quarantine undistributed lots of
shellfish that may have been adulterated;
(b) Coordinate with the certified
shellfish dealer a recall of distributed shellfish; and
(c) Immediately notify the appropriate
federal and state health authorities where the product was distributed and the
ISSC.
(8) If an inspection detects any key or
other deficiencies as identified on the ISSC Form 93-01(A) that are not already
covered in a compliance schedule, the cabinet, working with the certified
shellfish dealer, shall develop a compliance schedule to correct the new key or
other deficiencies.
(9) If a certified shellfish dealer has
failed to meet a compliance schedule for the correction of objectionable
conditions noted during a previous inspection, the cabinet shall:
(a) If unique circumstances prevail,
consider revising the compliance schedule;
(b) Seek suspension or revocation of the
shellfish dealer’s certification; or
(c) Seek other administrative remedies as
provided by KRS Chapter 217.
(10) If an inspection detects four (4) or
more new key deficiencies as identified on the ISSC Form 93-01(A), the cabinet
shall initiate the following enforcement action towards the certified shellfish
dealer:
(a) Revise the existing compliance schedule;
(b) Suspend or revoke the shellfish
dealer’s certification; or
(c) Seek other administrative remedies as
provided by KRS Chapter 217.
(11) Any shellfish dealer whose shellfish
dealer certification has been suspended may make a request in writing for
reinstatement of the certification.
Section 17. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Appendix B.1., Mulluscan
Shellfish Model Ordinance-Shellfish Industry Equipment Construction
Guide", 2003;
(b) "DFS-200, Facility
Profile", 7-01;
(c) "DFS-255, Application for
Certification to Handle Oysters, Clams, Mussels or Scallops", 2005;
(d) "Shellfish Dealer Certification",
2005;
(e) "DFS-220, Food Plant Inspection
Form", 04-04;
(f) "ISSC Form 93-01 (A), NSSP
Standardized Shellfish Processing Plant Inspection Form", 2000;
(g) "DFS-214, Enforcement Notice",
8-96;
(h) "DFS-212, Request for
Conference";
(i) "DFS-213, Notice of Conference";
and
(j) "DFS-215, Application for
Reinstatement of Shellfish Dealer Certification", (2-95).
(2) This material may be inspected,
copied, or obtained, subject to applicable copyright law, at the Kentucky
Cabinet for Health and Family Services, 275 East Main Street, Frankfort,
Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m. (FDC-6; 1 Ky.R. 534;
eff. 3-12-75; Am. 20 Ky.R. 1413; 1843; eff. 1-10-94; 22 Ky.R. 2450; eff.
8-1-96; 32 Ky.R. 1155; 1405; eff. 3-2-2006.)