902 KAR 45:020. Kentucky shellfish dealer standards and requirements

Link to law: http://www.lrc.ky.gov/kar/902/045/020.htm
Published: 2015

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      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.)