Kentucky Administrative Regulations › Title 902 - CABINET FOR HEALTH AND FAMILY SERVICES - DEPARTMENT FOR PUBLIC HEALTH › Chapter 45 - Food and Cosmetics › Section 902 KAR 45:020 - Kentucky shellfish dealer standards and requirements

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS 217.005-217.205,
				217.992,
				318.130
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.
Section 1. Definitions.
(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, non-sporeforming, 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 shell-stock 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.
(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.