Florida Administrative Code › 5 - DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES › 5L - Division of Aquaculture › Chapter 5L-1 - THE COMPREHENSIVE SHELLFISH CONTROL CODE › Section 5L-1.002 - Definitions

Current through Reg. 50, No. 138; July 16, 2024
(1) Adulterated - any shellfish harvested
				from closed waters; any shellfish shucked, packed, or otherwise processed in a
				facility which has not been certified by the Department in accordance with the
				requirements of these rules; any shellfish contaminated as determined by
				microbiological or other analysis; any shellfish consisting in whole or in part
				of any filthy, putrid or decomposed substance, or otherwise unfit for food; any
				shellfish prepared, packed, or held under unsanitary conditions where it may
				have become contaminated with filth, or whereby it may have been rendered
				injurious to health.
(2)
				Alternative Processing - any processing done to shellfish which does not follow
				the time-temperature matrix as stated in subparagraphs
				5L-1.008(7)(a)
				1.-3. and paragraph 5L-1.008(7)(b),
				F.A.C.
(3) Approved harvest area -
				an area in which it is indicated by a sanitary survey or other monitoring
				program data that fecal material, pathogenic microorganisms, radio nuclides,
				harmful chemicals, and marine biotoxins are not present in dangerous
				concentrations.
(4) Aquaculture Use
				Zones - legally-defined parcels that are surveyed, describing and indicating
				corners and boundaries, that have been subdivided into individual aquaculture
				leases issued pursuant to Section
				253.68, F.S., and paragraph
				18-21.004(2)(m),
				F.A.C.
(5) Authorized User - an
				Aquaculture Certificate of Registration holder authorized by an aquaculture
				leaseholder to operate on the sovereign submerged state land aquaculture leases
				and listed on a valid Aquaculture Leaseholder and Authorized User
				Acknowledgment form.
(6)
				Certification period - the period of time between July 1 and June 30 of a
				year.
(7) Certified shellfish
				facility - the location, structures and equipment that has been certified
				pursuant to rule Chapter
				5L-1.005, F.A.C., as a
				shellstock shipper, shucker-packer, or repacker. The certified shellfish
				facility shall comply with all laws, rules, and permits applicable to the
				shellfish business operation.
(8)
				Closed area (closed waters) - an area where the harvesting of shellfish is not
				permitted. Closed areas include prohibited and unclassified areas as well as
				temporarily closed approved, conditionally approved, restricted, and
				conditionally restricted harvest areas.
(9) Code - the Comprehensive Shellfish
				Control Code, rule Chapter 5L-1, F.A.C.
(10) Commercial harvester - a person that
				harvests with the intent to sell.
(11) Conditionally approved harvest area - an
				area in which it is indicated by a sanitary survey or other monitoring program
				data that the area is subjected to intermittent microbiological pollution and,
				under such conditions, is temporarily unsuitable as a source of shellfish for
				direct marketing. Such an area shall be managed by an operating procedure that
				will assure that shellfish from the area are not harvested from waters not
				meeting approved area criteria.
(12) Conditionally restricted harvest area -
				an area in which it is indicated by a sanitary survey or other monitoring
				program data that the area is subjected to intermittent microbiological
				pollution and, under such conditions, is temporarily unsuitable as a source of
				shellfish for relaying or depuration. Such an area shall be managed by an
				operating procedure that will assure that shellfish from the area are not
				harvested from waters not meeting restricted area criteria.
(13) Corrective action plan - is a brief
				outline of the deficiency(ies) found during an inspection of a certified
				facility with the corresponding rule deficiencies cited and the time frame in
				which the deficiency(ies) must be corrected.
(14) Critical control point - 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.
(15) Critical
				deficiency - a condition or practice which may result in the production of a
				product that is adulterated. A critical deficiency presents a threat to the
				health or safety of the consumer.
(16) Critical limit - 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.
(17) Deficiency - a condition or practice
				that is not in compliance with the rules governing the operation of the
				facility as outlined in rule Chapter 5L-1, F.A.C., "The Comprehensive Shellfish
				Control Code."
(18) Department -
				the Department of Agriculture and Consumer Services.
(19) Depuration facility (controlled
				purification plant) (DP) - a shellfish processor who obtains shellstock from
				approved, conditionally approved, restricted or conditionally restricted
				harvest area(s) and submits such shellstock to a Department approved controlled
				purification process. The treatment process is designed to purge shellfish of
				bacterial and viral contamination to the extent that such shellfish are
				rendered safe for human consumption.
(20) Designated representative - is the
				individual who supervises all activities associated with the operation of the
				certified shellfish facilty in the absence of the facility owner or facility
				supervisor.
(21) Emergency - any
				unusual incident resulting from natural or unnatural causes which endangers the
				health, safety, or resources of the state, including, but not limited to, a
				hurricane, storm, or red tide; petroleum spill; toxic substance discharge;
				inability of a sewage treatment plant to comply with permit conditions due to a
				breakdown of equipment, power outage, destruction by fire, wind, or by other
				cause.
(22) Facility supervisor -
				an individual who supervises all activities associated with the operation of
				the certified shellfish processing facility.
(23) Food - any raw, cooked, or processed
				edible substance, ice, beverage, or ingredient used or intended for use or for
				sale in whole or in part for human consumption. Shellfish in the shell are
				considered food.
(24) Food contact
				surface - a surface of equipment or utensil which food normally comes into
				contact; or a surface of equipment or utensil from which food may drain, drip,
				or splash into food or onto a surface normally in contact with food.
(25) Food packaging materials - any material
				or container which food normally comes into contact.
(26) Food safety hazard - any biological,
				chemical, or physical property that may cause a food to be unsafe for human
				consumption.
(27) Free liquor -
				that liquid portion of a container that passes through a porous straining
				device when the contents (oyster or clam meats) of the container are
				drained.
(28) HACCP - Hazard
				Analysis and Critical Control Points - A system of inspection, control, and
				monitoring measures initiated by a shellfish processor to identify and control
				microbiological, chemical, or physical food safety hazards which are likely to
				occur in shellfish products produced by the facility.
(29) Harvest - removal and subsequent
				possession of shellstock. Temporary possession of shellfish for the purpose of
				culling shall not constitute harvesting if after culling undersized shellstock
				are immediately returned to the water in the same shellfish harvesting
				area.
(30) Harvester - a person
				engaged in the harvesting of shellfish.
(31) Health authority - the Department or its
				authorized representative.
(32)
				Heat shock - the process of subjecting molluscan 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 molluscan
				shellfish.
(33) ICWW - Intracoastal
				Waterway.
(34) Key deficiency - a
				condition or practice which may result in adulterated, misbrandedor, or
				unwholesome product.
(35) Lot of
				shellstock - a single type of bulk shellstock or container of shellstock of no
				more than one day's harvest from a single harvest area gathered by one or more
				harvesters.
(36) Lot of shucked
				shellfish - a collection of containers of no more than one day's shucked
				product from a single harvest area produced under conditions as nearly uniform
				as possible, and designated by a common container code or marking.
(37) Lot wet storage/depuration - all
				shellfish from a single depuration or wet storage tank or series of tanks
				serviced by a common treatment system.
(38) Mechanical refrigeration - refrigeration
				provided by a compressor in a system where temperature can be adjusted with a
				thermostat and the unit will maintain a temperature of 45ºF or
				less.
(39) Misbranded - any
				shellfish product whose labeling is false or misleading; any shellfish product
				in package form unless it bears labeling including (1) the name and place of
				business of the manufacturer, packer, or distributor; (2) an accurate statement
				of the quantity of the contents in terms of weight, measure, or numerical
				count; and (3) meets labeling requirements of the Department within this
				chapter.
(40) NSSP Model Ordinance
				- the National Shellfish Sanitation Program Guide for the Control of Molluscan
				Shellfish, published by the U.S. Department of Health and Human
				Services.
(41) Other deficiency - a
				condition or practice that is not in accordance with rule requirements and is
				not determined to be a key or critical deficiency.
(42) Pest - refers to any objectionable
				animals or insects, including, but not limited to, dogs, cats, birds, rodents,
				flies, and larvae.
(43) Processing
				- is the handling, unloading, storing, transporting, shucking, freezing,
				preparing, changing into different market form, manufacturing, preserving,
				packing, or labeling of shellfish or shellfish products.
(44) Prohibited harvest area - an area from
				which the taking of shellfish is not permitted.
(45) Public Water System - a system for the
				provision to the public of water for human consumption through pipes or other
				constructed conveyances, if such system has at least fifteen service
				connections or regularly serves an average of at least twenty-five individuals
				daily at least 60 days out of the year. Such term includes: any collection,
				treatment, storage, and distribution facilities under control of the operator
				of such system and used primarily in connection with such system; and any
				collection or pretreatment storage facilities not under such control which are
				used primarily in connection with such system. Such term does not include any
				"special irrigation district." A public water system is either a "community
				water system" or a "non-community water system." See the Code of Federal
				Regulations (C.F.R.), Title 40, Part 141, Section 2, revised as of July 1,
				2015, incorporated in paragraph
				5L-1.001(6)(b),
				F.A.C.
(46) Remote Buying - a
				shellfish processor or designated representative taking possession of shellfish
				at any location different than their certified shellfish processing facility
				location.
(47) Repacker/Repacking
				Facility (RP) - a certified shellfish facility, other than the original
				certified shucker-packer, who repacks shucked shellfish into other containers
				for distribution or sale. A repacker may also purchase, repack and ship
				shellstock. A repacker shall not shuck shellfish.
(48) Repeat Critical deficiency - is the same
				"critical" deficiency that has been listed on the corrective action plans for
				the same facility anytime during the preceding 180 days.
(49) Repeat Key deficiency - is the same
				"key" deficiency that has been listed on the corrective action plans for the
				same facility anytime during the preceding 180 days.
(50) Repeat Other deficiency - is the same
				"other" deficiency that has been listed on the corrective action plans for the
				same facility anytime during the preceding 180 days.
(51) Restricted harvest area - an area in
				which it is indicated by a sanitary survey or other monitoring program data
				that fecal material, pathogenic microorganisms, radio nuclides, harmful
				chemicals, and marine biotoxins are not present in dangerous concentrations
				such that shellfish harvested from such an area and subjected to a suitable and
				effective purification process are safe for human consumption.
(52) Restricted Use Shellstock - shellstock
				that is harvested from harvest areas classified as approved or conditionally
				approved in the open status and under conditions that do not allow the sale of
				shellstock for direct marketing for raw consumption. Restricted use shellstock
				is identified with a green tag indicating the shellstock is intended for
				shucking by a certified processing facility or post harvest processing
				only.
(53) Retail sale - sale to
				the ultimate consumer or to a person who will not resell the product.
(54) Sanitize - the effective bactericidal
				treatment of clean food contact surfaces of equipment and utensils by a process
				using only those safe sanitizing agents that have an available field test for
				strength and effectiveness, and is effective to yield a reduction of 5 logs,
				which is equal to a 99.999% reduction of representative disease microorganisms
				of public health importance. Such treatment shall not adversely affect the
				product and shall be safe for the consumer.
(55) Shellfish - all edible species of
				oysters, clams, mussels, and whole or roe-on scallops either shucked or in the
				shell, fresh, or frozen.
(56)
				Shellfish Processor - a shellstock shipper, shucker-packer, or repacker who
				possesses a shellfish processing facility certification from the
				Department.
(57) Shellfish Relaying
				- the transfer of shellfish from an aquaculture lease closed for the harvest of
				shellfish to a certified depuration facility or another aquaculture lease open
				for the harvest of shellfish, pursuant to Rule
				5L-1.009, F.A.C.
(58) Shellstock - shellfish which remain in
				their shells.
(59) Shellstock
				shipper/Shellstock shipping facility (SS) - a certified shellfish facility
				which buys, repacks and sells shellstock. A shellstock shipper is not
				authorized to shuck shellfish nor to repack shucked shellfish but may also buy
				and sell sealed containers of shucked shellfish.
(60) Shuck date - the date shucked shellfish
				are initially removed from their shells.
(61) Shucked shellfish - shellfish or parts
				thereof which have been removed from their shells.
(62) Shucker-packer/Shucker-packer facility
				(SP) - a certified shellfish facilty which shucks and packs shellfish. SPs may
				act as a shellstock shipper and/or repacker.
(63) Swing deficiency - a deficiency that
				could either be a "critical" or a "key" deficiency, or it could be either a
				"key" or an "other" deficiency, depending on the location, severity and
				circumstances.
(64) Time of Harvest
				- is defined as the time when shellfish are first removed from the water and
				placed on or in a manmade conveyance or other means of transport.
(65) Time of Refrigeration - is defined as
				the time when shellfish are first placed within an ambient environment of
				45ºF degrees or less.
(66)
				Unclassified area - an area for which no recent sanitary survey exists. Harvest
				of shellfish is not permitted.
(67)
				Unwholesome - shellfish which are not in sound condition, unclean, or otherwise
				not suitable for human consumption.
(68) UV - Ultraviolet.
(69) Violation and deficiency - are used
				interchangeably within these rules. The meaning of both is that a facility is
				not in compliance with the rules governing their operation as outlined in rule
				Chapter 5L-1, F.A.C., "The Comprehensive Shellfish Control Code."
(70) Warning letter - a warning letter
				includes a notice of non-compliance.
(71) Wet storage - the temporary storage of
				shellfish harvested from an approved sources or in the open status
				conditionally approved harvest area and placed in tanks containing water that
				meets approved or open status conditionally approved shellfish harvesting area
				water quality standards.
(72)
				Wholesale - any sale to any person or business other than the final
				consumer.
Rulemaking Authority 597.020 FS. Law Implemented 597.020
					 FS.
New 1-4-87, Amended 5-21-87, 8-10-88, 7-9-89, 11-5-92,
					 5-20-93, Formerly 16R-7.003, Amended 7-3-95, 5-8-96, 2-6-97, 6-23-99, Formerly
					 62R-7.003, Amended 8-9-00, 5-29-02, 3-23-17, 4-2-19,
					 1-18-23.