Purpose.
This Ordinance established the minimum requirements necessary to regulate the interstate commerce of molluscan
shellfish and to establish a program to protect the public health of consumers by assuring the sale or distribution of
shellfish from safe sources and assuring shellfish have not been adulterated during cultivating, harvesting, processing,
shipping, or handling.
Definitions.
A. General. The definitions provided below are consistent in intent with
the National Shellfish Sanitation Program.
B. Definition of Terms.
(1) Adverse
pollution condition means a state or situation caused by meteorological,
hydrological or seasonal events or point source discharges that has
historically resulted in elevated fecal coliform levels in a particular
growing area. [In States using total coliform standard, insert "total
coliform" for "fecal coliform".]
(2) 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.
(3) AOAC means
the Association of Official Analytical Chemists.
(4) APHA means
the American Public Health Association.
(5) Approved
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 shellstock other than seed in growing areas.
(7) Authority
means the State or local shellfish control authority or authorities
or its designated agents, which are responsible for the enforcement
of this Code.
(8) Assure means
to make best efforts within the reasonable limits of manpower and resources
to fulfill the objectives of this Ordinance.
(9) 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.
(10) 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.
(11) Blower
means a receptacle for washing shucked shellfish which uses
forced air as a means of agitation.
(12) 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.
(13) Certification or certify means the issuance of a numbered certificate to a person for a particular activity or group of activities that indicates:
(14) Certification number means the unique identification number issued by the Authority to each dealer for each location. Each certification number shall consist of a one to five digit Arabic number preceded by the two letter State abbreviation and followed by a two letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with this Ordinance using the following terms:
(15) Coliform
group means all of the aerobic and facultative anaerobic, gram
negative, nonspore forming, rod shaped bacilli which ferment lactose
broth with gas formation within 48 hours at 95 Fahrenheit (35 + 0.5°Centigrade) .
(16) Commingle
or Commingling means the act of combining different lots of
shellstock or shucked shellfish.
(17) Compliance
schedule means a written schedule that provides a correction
time period to eliminate Key and Other deficiencies.
(18) Conditionally
approved means a classification used to identify a growing
area which meets the criteria for the approved classification except
under certain conditions described in a management plan.
(19) Conditionally
restricted means a classification used to identify a growing
area that meets the criteria for the restricted 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 (CCP) 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 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) Critical
Nonconformity means a deviation of a laboratory requirement
which has the highest likelihood of adversely affecting the quality
of the analytical results if out of conformance.
(26) 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.
Examples are bypass arrangements, jumper connection, removable sections,
swivel or change over devices, or other devices through which backflow
could occur.
(27) Cull means
to remove dead or unsafe shellstock from a lot of shellstock.
(28) Dealer
means a person to whom certification is issued for the activities
of shellstock shipper, shucker-packer, repacker, reshipper, or depuration
processor.
(29) Depletion
means the removal, under the direct control of the Authority,
of shellstock from a growing area classified as prohibited.
(30) Depuration
or depurate means the process of reducing
the pathogenic organisms that may be present in shellstock by using
a controlled aquatic environment as the treatment process.
(31) Depuration
Processor (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 such shellstock
to an approved depuration process.
(32) Direct marketing means the sale for human consumption of shellfish which:
(33) Dry storage means
the storage of shellstock out of water.
(34) Easily cleanable means a surface which is:
(35) EPA means the United
States Environmental Protection Agency.
(36) Facility means
a structure. For other connotations, use person or activity.
(37) Fecal coliform means
that portion of the coliform group which will produce gas from lactose in
an EC or A-1 multiple tube procedure liquid medium within 24 (+ 2) hours
in a water bath maintained at 112 ° Fahrenheit (44.5 ±
0.2 °Centigrade).
(38) FDA means the United
States Food and Drug Administration.
(39) Food contact surface means
an equipment surface or utensil which normally comes into direct or
indirect contact with shucked shellfish.
(40) Food Safety Hazard means
any biological, chemical or physical property that may cause a food
to be unsafe for human consumption.
(41) Geometric Mean means
the antilog (base 10) of the arithmetic mean of the sample result logarithm
(base 10).
(42) Growing area means
any site which supports or could support the propagation of shellstock
by natural or artificial means.
(43) HACCP is an acronym
that stands for Hazard Analysis Critical Control Point, a systematic, science-based
approach used in food production as a means to assure food safety. The concept
is built upon the seven principles identified by the National Advisory Committee
on Microbiological Criteria for Foods (1992).
(44) HACCP Plan means
a written document that delineates the formal procedures that a dealer
follows to implement the HACCP requirements set forth in 21 CFR 123.6
as adopted by the Interstate Shellfish Sanitation Conference.
(45) Harvest means the
act of removing shellstock from growing areas and its placement on or
in a manmade conveyance or other means of transport.
(46) Harvest area means
an area that contains commercial quantities of shellstock and may include
aquaculture sites and facilities.
(47) Harvester means
a person who takes shellstock by any means from a growing area.
(48) 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.
(49) Importer means any
dealer who introduces molluscan shellfish into domestic commerce. An
importer has ownership of the shellfish, but need not take physical
custody of the shellfish.
(50) Includes or including means
includes or including by way of illustration and not by way of limitation.
(51) Inspection item means
one of the standard criteria listed in the NSSP Plant Inspection Form
under which single or multiple observations of specific critical , key
or other deficiencies can be debited. [Note: term "item" appears several
places in the Ordinance with a larger connotation than this definition.
In the section addressing the use of the inspection form, however, the
Ordinance uses the term "inspection item" hence that is provided here
as the defined term.]
(52) Interstate Certified Shellfish
Shippers List (ICSSL) means a FDA publication of shellfish
dealers, domestic and foreign, who have been certified by a state or
foreign Authority as meeting the public health control measures specified
in this Ordinance.
(53) Interstate Shellfish Sanitation
Conference (ISSC) means the organization which consists of agencies
from shellfish producing and receiving States, FDA, the shellfish industry,
the National Marine Fisheries Service of the U.S. Department of Commerce,
and the U.S. Environmental Protection Agency. The ISSC provides the formal
structure wherein State regulatory authorities, with FDA concurrence, can
establish updated guidelines and procedures for sanitary control of the
shellfish industry.
(54) Key deficiency means
a condition or practice which may result in adulterated, decomposed,
misbranded or unwholesome product.
(55) Key Nonconformity means
a deviation of a laboratory requirement has a significant potential
to adversely affect the quality of the analytical results if out of
conformance.
(56) Label means any written,
printed or graphic matter affixed to or appearing upon any package containing
shellfish.
(57) License means the
document issued by the Authority to a person to harvest or transport
shellstock for commercial sale. [In those States issuing permits as
opposed to licenses, the term license would be replaced with the term
"permit" which would be defined the same as "license".]
(58) Lot of shellstock means
a single type of bulk shellstock or containers of shellstock of no more
than one day's harvest from a single defined growing area gathered by
one or more harvesters.
(59) Lot of shellstock for depuration
means shellstock harvested from a particular area during a
single day's harvest and delivered to one depuration plant.
(60) Lot of shucked shellfish
means a collection of containers of no more than one day's
shucked shellfish product produced under conditions as nearly uniform
as possible, and designated by a common container code or marking.
(61) Marina means any
water area with a structure (docks, basin, floating docks, etc.) which
is:
(62) Marine biotoxin means
any poisonous compound produced by marine microorganisms and accumulated
by shellstock. Examples include Alexandrium spp. [Protogonyaulax
species], and Karenia brevis.
(63) May means discretionary
and is not mandatory or required.
(64) Milliliter (ml)
means a unit of measurement equal to the 0.001 portion of a liter.
(65) Monoculture means
the culture of a single bivalve species.
(66) MPN (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.
(67) National Shellfish Sanitation
Program (NSSP) means the cooperative state-FDA-Industry
program for the sanitary control of shellfish that is adequate to insure
that the shellfish produced in accordance with these guidelines will
be safe and sanitary.
(68) Open water aquaculture means
the cultivation of bivalve shellfish in natural shellfish growing areas.
(69) Other deficiency means
a condition or practice that is not defined as critical or key and is
not in accordance with the requirements of this Model Ordinance.
(70) Other Nonconformity
means a deviation of a laboratory requirement which does not normally
compromise the quality of the analytical results, but generally serve
to enhance the overall operation of the laboratory.
(71) Person means any
individual, receiver, trustee, guardian, personal representative, fiduciary,
or representative of any kind, and any partnership, association, corporation
or other entity. Person includes the federal government, the State,
and any other public or private entity.
(72) Point source means
any discernible, confined and discrete conveyance including any pipe,
ditch, channel, tunnel or conduit that carries pollution.
(73) 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.
(74) Polyculture means the cultivation of:
a. Two or more species of shellfish; or
b. Shellfish with other species in a common environment.
(75) Post Harvest Processing means processing of shellfish for the purpose of added safety or quality that involve hazards not addressed by controls in NSSP Model Ordinance Chapters XI. through XIV.
(76) Potable water means
a water supply, which meets the requirements of the Safe Drinking Water
Act, as, administered by the EPA, and any applicable state or local
requirements.
(77) 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.
(78) 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.
(79) Process water means
the water used in the scheduled depuration process.
(80) Prohibited 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.
(81) Raw means shellfish that have not been thermally processed:
(82) Relay means to transfer
shellstock from a growing area classified as restricted or conditionally
restricted to a growing area classified as approved or conditionally
approved for the purpose of reducing pathogens as measured by the coliform
indicator group or poisonous or deleterious substances that may be present
in the shellstock by using the ambient environment as the treatment
process.
(83) Remote status means
a designation applied to a shellfish growing area that has no human
habitation and is not impacted by any actual or potential pollution
sources.
(84) Repacker (RP) means
any person, other than the original certified shucker-packer, who repackages
shucked shellfish into other containers.
(85) Repacking Shellstock means
the practice of removing shellstock from containers and placing it into
other containers.
(86) Replicate is defined
as two (2) filters for tdh analysis from the same homogenate at
the same dilution.
(87) Reshipper (RS) means
a person who purchases shucked shellfish or shellstock from dealers
and sells the product without repacking or relabeling to other dealers,
wholesalers, or retailers.
(88) Restricted means
a classification used to identify a growing area where harvesting shall
be by special license and the shellstock, following harvest, is subjected
to a suitable and effective treatment process through relaying or depuration.
(89) 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.
(90) Sanitation control record
means records that document the monitoring of sanitation practices
and conditions during processing.
(91) Sanitary survey means
the written evaluation report of all environmental factors, including
actual and potential pollution sources, which have a bearing on the
water quality in a shellfish growing area.
(92) Sanitize means to adequately treat food contact surfaces by a process that is effective in:
(93) Seed means shellstock
which is less than market size.
(94) Shall means mandatory
and required.
(95) Shellfish means all species of:
(96) Shellstock means
live molluscan shellfish in the shell.
(97) Shellstock packing means
the process of placing shellstock into containers for introduction into
commerce.
(98) Shellstock Shipper (SS) means
a dealer who grows, harvests, buys, or repacks and sells shellstock.
They are not authorized to shuck shellfish nor to repack shucked shellfish.
A shellstock shipper may also ship shucked shellfish.
(99) Should means recommended
but is not required.
(100) Shucker-Packer (SP) means
a person who shucks and packs shellfish. A shucker-packer may act as
a shellstock shipper or reshipper or may repack shellfish originating
from other certified dealers.
(101) Standardization means
a process in which applicable staffs from the FDA and the Authority
conduct evaluations using standard criteria in a uniform manner.
(102) State shellfish standardization
inspector means a person that has successfully completed the
FDA standardization training course (or one deemed acceptable by the
FDA and the field evaluation phase of shellfish plant inspection
with either an FDA standardization officer or a state standardization
officer.
(103) State shellfish standardization
officer means a person that has successfully completed the
FDA standardization training course and the field evaluation phase of
shellfish plant inspection with an FDA standardization officer.
(104) Swing deficiency means
a deficiency noted on the NSSP Standardized Shellfish Processing Plant
Inspection Form which, depending upon the severity and circumstances,
can be either a "Critical" or a "Key" deficiency.
(105) 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.
(106) Wet storage means
the temporary storage, by a 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.