11-35

TITLE 11
DEPARTMENT OF HEALTH
CHAPTER 35
SHELLFISH SANITATION
§11-35-1 	Purpose
§11-35-2 	Definitions
§11-35-3 	Shellfish permit
§11-35-4 	Shellfish and shellfish growing water evaluation
§11-35-5 	Enforcement and penalties
§11-35-6 	Shellfish growing areas
§11-35-7 	Artificial growing systems for shellfish
§11-35-8 	Preparation of shellfish for marketing
§11-35-9 	Harvesting and processing shellstock (shellstock
in the shell)
§11-35-10 	Shucking and packing of shellfish
§11-35-11 	Repacking of shellfish
§11-35-12 	Reshipping of shellfish
§11-35-13 	Sale of shellfish in Hawaii
§11-35-14 	Severability
§11-35-2
Historical Note: 	Chapter 35 	of title 11 	is based substantially on
Public 	Health 	Regulations 	Chapter 	4a, 	Food 	and 	Food 	Products,
Department of Health, State of Hawaii. 	[Eff: 3/25/78; R: 	SEP 1 8 198fl
§11-35-1 	Purpose. 	The 	purpose 	of 	this 	chapter 	is 	to 	establish
sanitary controls for the shellfish industry. 	These provisions shall apply to
the growing area and to all aspects of harvesting, processing, packaging,
storing, and distributing of shellfish. 	[ Eff. 	SEP 1 8 1981 	] 	(Auth: 	HRS
§§321-9, 321-10, 321-11) (Imp: 	HRS §§321-11)
§11-35-2 	Definitions.
"Action leveP' .means the interim limit established for a deleterious
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substance 	present 	in 	a 	product 	or 	an 	environment, 	above 	which level
control or regulatory action may be required to protect public heal th.
"Alert level" means the level of deleterious substance in a product or
an environment indicating degradation and warranting increased monitoring
and sampling.
11 Approved growing area" means an area which has been approved by
the 	department 	for 	growing 	and 	harvesting 	of 	shellfish 	for 	direct
marketing.
11 Artificial growing system for shellfish 11 means a man-made system
with 	definite 	boundaries 	in 	which 	shellfish 	are 	grown 	and 	where
supplemental 	material 	is 	introduced 	for 	ultimate 	utilization 	by 	the
shellfish.
"Blower 11 means the tank or vat used for washing shucked shellfish,
utilizing forced air as a means of agitation.
"Classes of shippers" means (1) reshippers (RS), persons who transship
shucked stock in original containers, or shellstock, from certified shellfish
shippers to other dealers or to final consumers; (2) repackers (RP), persons,
other than the original shucker, who pack shucked shellfish into containers
for 	delivery to the 	consumers; (3) shellstock shippers (SS), persons who
grow, harvest, buy, or sell shellstock and do not shuck shellfish or repack
shucked shellfish; (4) shucker-packers (SP), 	persons who shuck and pack
shellfish.
"Coliform groups 11 means all of the aerobic and facultative anaerobic,
gram-negative, non-spore-forming bacilli which ferment lactose with gas
formation within forty-eight hours at 35°C.
"Culling" means the sorting and removal of dead, inferior or gaping
shellfish.
"Department 11 means the Hawaii state department of health.
"Depuration" means the process of removing microbial contaminants
from live shellfish by placing them in a water environment of low coliform,
low turbidity, and free from chemicals which are detrimental to health.
11 Director 11 means the director of heal th or his designee.
"Dry storage 11 means the storage of shellstock out of water.
"Fecal 	coliform 	group" 	means 	any 	bacteria as 	defined 	under 	the
coliform group which will produce gas in Escherichia coli (E.C.) medium
within twenty-four hours at 44.5°C in a water bath.
"Growing area11 means any offshore ocean, coastal, estuarine or fresh
water 	area 	suitable 	for 	natural 	shellfish 	growth 	or 	artificial 	shellfish
propagation.
"Harvester" means a person who takes shellfish from growing areas
for commercial purposes.
"Internal 	temperature" 	means 	the 	actual 	temperature 	of shucked
shellfish 	in 	the 	container 	or 	of 	shellstock, 	as 	opposed 	to 	the 	air
temperature of the refrigerator in which the shellfish may be stored.
11 Lot of shellstock11 means a 	collection of no more than one day's
production of shellstock harvested from a particular growing area by one or
more harvesters.
"Most probable number (MPN) 11 means a statistical estimate of the
number of bacteria per unit volume which is determined from the number
of positive results in a series of fermentation tubes.
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)
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§11-35-2
"National 	Shellfish 	Sanitation: _Progr:am" .. 111 e&ns 	the 	cooperative
federal, 	state 	and 	industry • program 	f.or 1 the 	certification 	of 	interstate
shellfish shippers as described in Public Health Service Publication Number
33, National Shellfish Sanitation Program Manual of Operations, Parts I and
II, (1965). 	1 	.
"Paralytic 	shellfish 	poisons" 	means 	poisons 	produced 	by 	free-
swim ming, 	one-celled 	marine 	organisms, 	including · the 	dinoflagellates,
Gonyaulax 	catenella, 	Gonyaulax 	tarnarensis, 	Gymnodinium 	breve, 	which
may be temporarily concentrated by shellfish.
"Pathogen" means any disease-producing microorganism or material.
"Person" 	means 	an 	individual, 	firm, 	partnership, 	company,
corporation, trustee, association, or any public or private eritity.
"Processor" ·means a repacker, shellstock shipper, or shucker-packer.
"Prohibited area" 	means a shellfish , growing area where hazardous
levels of toxic material · or pathogens may be found or where a sanitary
survey has not been made.
"Relaying" 	means 	the 	moving 	of 	market 	shellfish 	from 	waters
classified as restricted or grohibited to an approved area for the purpose of
natural purification.
"Restricted 	area" 	means 	a 	shellfish 	growing 	area 	subjected 	to
moderate degrees of ·pollution (total coliform exceeding seventy per one
hundred milliliter (ml), · but not exceeding seven hundred per one hundred
ml) which woUld make it unsafe to harvest shellfish for direct marketing
but from 	which 	shellfish 	may ·be subject to depuration or relaying with
approval of the department.
"Sanitary survey" means the evaluation of all factors having a bearing
on the sanitary quality ·of a shellfish growing area including sources of
pollution, 	the 	effects of wind, 	tides, 	and 	currents, 	and distribution and
dilution of the polluting materials, and the bacteriological quality of the
water.
"Shellfish" means all edible species of ·oysters, ·clams·, and mussels of
the 	molluscan 	class 	Pelecypoda. 	This 	definition 	excludes 	shellfish 	or
products thereof which, in tlieir final packaging have beerr heat-sterilized
and packaged in hermetically ,sealed containers:
"Shellfish, market" means fresh or frozen shellfish, or parts thereof,
sold for human consumption. • · 	• . .
"Shellstock" means shellfish still in "their shells.
"Shucked shellfish" means shellfish, or parts thereof, ·which have been
removed from their shells. 	·
"Skimmer table" means a shallow, perforated table used in washing
and draining of shucked shellfish.
"Transplanting" 	means 	the 	moving 	of 	shellfish 	from 	one 	area 	to
another 	for · the 	purpose 	of 	propagatibn 	or 	for 	reharvesting 	after 	an
adequate period for acclimatization and growth ·to :market size.
"Wet 	storage" 	means 	the 	temporary 	storage 	of '·shellfish 	from
approved 	sources 	intended 	for 	marketing 	in 	tanks, 	floats 	or in natural
bodies of water. 	[Eff. 	SEP 1 8 1981 	] 	(Auth: 	HRS §§321-9, 	321-10,
321-11, 328-21) (Imp: 	HRS §§321-11, 328-21)
,, 	J
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§11-35-3 	Shellfish 	permit. 	The 	regulations 	governing 	the
requirements for shellfish certification in their several forms (shucker-
packer, shellstock-shipper, reshipper, repacker) in the State of Hawaii shall
equal 	or 	exceed 	the 	requirements 	set 	forth 	by 	the 	Food 	and 	Drug
Administration of the U. S. Department of Health and Human Services, and
the National Shellfish Sanitation Program.
(a) 	No 	person 	in 	the 	State 	of 	Hawaii 	shall 	operate 	a 	plant 	or
business engaged in growing, harvesting, shucking, packing, repacking, or
reshipping fresh or fresh-frozen shellfish for sale to the public for human
consumption without a valid permit issued by the department.
(b) 	Applications 	for 	permit 	shall 	be 	filed 	with the 	department.
Each 	application, 	if 	necessary, 	shall 	be 	accompanied 	with 	sufficient
written data, drawings and descriptions for the department to evaluate the
operation relative to the provisions of this chapter.
(c) 	Authority of department to revoke or suspend a permit.
(1) 	Each 	permit 	issued 	pursuant 	to 	these 	regulations 	may 	be
revoked or suspended by the 	department in accordance with
Chapter 91, HRS, if for any reason the safety of the shellfish as
an article of food is not assured or if the standards set forth
herein are not met, or if the permit was obtained by misrepre-
sentation, or omission of relevant information.
(2) 	A 	permit 	which 	has 	been 	previously 	denied, 	revoked 	or
suspended, may be issued, reissued or reinstated, if violations
are subsequently cleared or corrected to the satisfaction of the
director.
(d) 	A permit issued under these regulations shall be valid for a
period 	not 	to 	exceed 	one 	year 	or 	a 	portion 	thereof, 	with 	automatic
expiration on June 30 of each year. 	An application for renewal of a permit
shall be made on or before June 1. 	Permits are not transfer able.
(e) 	Each permit holder shall notify the department immediately by
telephone 	if there is 	any report 	or 	knowledge 	of 	contamination 	of 	his
shellfish or 	of suspected illness from 	consumption of his shellfish. 	The
harvesting, 	distribution 	and 	sale 	of 	shellfish 	shall 	cease 	immediately
pending 	review 	of 	the 	safety 	of 	the 	product 	and 	approval 	by 	the
department to resume operations.
(f) 	A person who exports shellfish certified by the department shall
be listed on the Interstate Certified Shellfish Shippers List of the U. 	S.
Public 	Health 	Service, 	Food 	and 	Drug 	Administration.
[Eff. 	SEP 1 8 1981 	] (Auth: 	HRS §§321-9, 321-10, 321-11, 328-21) (Imp:
HRS §§321-11, 328-21)
§11-35-4 	Shellfish and shellfish growing water evaluation. 	(a) All
collection 	and 	transportation 	of 	shellfish 	growing 	water 	samples 	and
shellstock 	shall 	be 	performed 	in 	accordance 	with 	the 	"Recommended
Procedures for the Examination of Sea Water and Shellfish" (APHA, 4th
ed., 1970). 	•
(b) 	Analyses 	of 	these 	samples 	for 	bacteriological, 	toxicological,
chemical 	and 	physical 	parameters 	shall 	be 	performed 	by 	a 	laboratory
approved by the department and in accordance with methods recommended
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§11-35-6
in the "Recommended Procedures for 	the Examination of Seawater and
Shellfish" (APHA, Fourth Edition, 1970), "Official Methods of Analysis of
the 	Association ·Of 	Official 	Analytical 	Chemists" 	(AOAC, 	Thirteenth
Edition, 	1980), 	and 	"Standard 	Methods 	for 	Examination 	of 	Water 	and
Wastewater" (APHA, 14th ed., 1975). 	[ Eff. 	SEP 1 8 1981 	] (Auth: 	HRS
§§321-9, 321-10, 321-11, 328-21) (Imp: 	HRS §§321-11, 328-21)
§11-35-5 	Enforcement and penalties. 	(a) 	The taking of any shellfish
from public waters is under the jurisdiction of the state department of land
and natural resources, division of fish and game, and is subject to 	that
department's regulations, enforcement and penalties.
(b) 	Any person who violates any provision of these regulations shall
be guilty of a misdemeanor and upon conviction thereof shall be fined not
more than $500 or imprisoned not more than one year or both, as provided
in §§321-18, HRS. 	Each and every yiol.ation of the provision of these
regulations shall constitute a separate offense. 	[ Eff. 	F 	J
(Auth: 	HRS §§321-9, 321-10, 321-11, 328-21) (Imp: 	HRS §ij;r/1-1/, ~~~!21)
§11-35-6 	Shellfish growing areas. 	(a) No person shall buy sell, off er
for 	sale, 	receive, 	keep, 	transport, 	deliver, 	or 	take 	any 	shellfish 	not
declared by the department 	to be approved 	or 	otherwise fit 	for 	direct
marketing.
(b) 	A sanitary survey shall be made by the 	department of each
shellfish growing area prior to its classification as 11 approved, 11 "restricted,"
or 11 prohibited. 11 	A sanitary survey shall evaluate all sources of actual and
potential pollution in .the 	area 	including but 	not limited 	to 	pesticides,
industrial 	wastes and 	sewage effluent. 	In addition, 	the 	effect of wind
action, water flow and currents in distributing polluting materials over a
growing area shall be considered.
(c) 	Growing 	areas 	shall 	be 	designated 	as 	approved 	after 	the
sanitary survey conducted by the department indicates 	that 	pathogenic
microorganisms, 	paralytic shellfish poisons, 	heavy metals and pesticides
are 	not 	present 	in 	dangerous 	concentrations 	as 	specified below. 	This
classification 	of the 	growing area shall be verified by laboratory tests
whenever the sanitary survey indicates the need. 	Shellfish from approved
areas may be harvested for direct marketing.
(1) 	Water standards.
(A) 	Fecal coliform median MPN-,-The fecal coliform median
MPN of the water samples shall not exceed fourteen per
one hundred 	milliliters (ml) 	and not 	more than ten per
cent of the samples shall exceed an MPN of forty-three
for a five-:ctube decimal dilution test. 	The fecal coliform
standard 	shall 	be 	used 	as 	the 	primary 	bacteriological
standard 	to 	evaluate 	a 	growing 	area. 	The 	sampling
frequency shall be determined by the director, based on
past 	history 	of 	data 	collected 	and 	the 	results 	of 	the
sanitary survey.
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U=35-
(B) 	Total coliform median MPN-The total coliform 	median
MPN should not exceed seventy per one hundred ml, and
not more than ten per cent of the samples exceed an MPN
of two hundred thirty per one hundred ml for a five-tube
decimal dilution test. 	The total coliform median MPN of
the water samples shall be used as an alert level indicator
of possible fecal pollution.
(C) 	There 	shall 	be 	no 	continual 	or 	periodic 	occurrence 	of
environmental indicators of a potential paralytic shellfish
poisoning 	such 	as 	an 	algal 	bloom 	("red 	tide"), 	animal
mortality (e.g., fish kills, bird kills), intoxicated/sluggish
animals, or irritating/burning aerosols in water.
(2) 	Shellfish meat standards.
(A) 	Fecal coliform-Shellfish meats from an approved growing
area should not exceed a fecal coliform MPN median of
one 	hundred 	thirty 	per 	one 	hundred grams and a 35°C
plate count of one hundred thousand per gram of shellfish
meat.
(B) 	Paralytic 	shellfish 	poisons 	(PSP)-PSP 	content 	of 	the
edible portion of shellfish meat shall not exceed eighty
micrograms of toxin per one hundred grams of meat as
established 	in 	the 	"Recommended 	Procedures 	for 	the
Examination of Seawater 	and Shellfish" (APHA, Fourth
Edition, 1970).
(C) 	Heavy metals-Mercury has an action level of one part
per million. 	The alert levels for zinc, copper, cadmium,
lead and chromium shall be as stated in the "Proceedings-
-Seventh National Shellfish Sanitation Workshop, 1971 11 as
listed below.
Element
Zinc
Copper
Cadmium
Lead
Chromium
Shellfish
(in parts per million)
1,500
100
2
2
2
(D) 	Pesticides"--The 	levels 	of 	pesticides 	in 	shellfish 	in 	an
approved growing area should not 	exceed 	the 	proposed
standards as stated in appendix D of the "Proceedings-
Sixth National Shellfish Sanitation Workshop, 1968, 11 and
as listed in the following table.
Shellfish
Pesticide 	(in parts per million)
Aldrin 	0.20
BHC (Benzenehexachloride) 	0.20
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§11-35-7
Chlordane 	0.03
DDT)
DDE) Any one or all not to exceed 	1.50
DDD)
Dieldrin 	0.20
Endrin 	0.20
Heptachlor 	0.20
Heptachlor Epoxide 	0.20
Lindane 	0.20
Methoxychlor 	0.20
2,4-D(2,4-dichlorophenoxy-
acetic acid) 	0.50
(b) 	Areas shall be classified as restricted when a sanitary survey
indicates· a moderate potential for pollution which would make it unsafe to
harvest shellfish for direct marketing.
(1) 	The total coliform median MPN of the water samples exceeds
seventy per one hundred ml but does not exceed seven hundred
per one hundred ml and not more 	than 	ten per cent 	of the
samples exceed an MPN of two thousand three hundred per one
hundred ml.
(2) 	The fecal coliform median MPN of the water samples exceeds
fourteen per one hundred ml and more than ten per cent of the
samples exceeds an MPN of forty-three for. a five-tube decimal
dilution test.
(c) 	Areas shall be classified as prohibited if the sanitary survey
indicates that the total coliform median MPN of the water exceeds seven
hundred per one hundred ml or more than ten per cent of the samples have
a total coliform MPN in excess of two thousand three hundred per one
hundred ml.
(d) 	Growing areas in which sanitary surveys have not been made
shall be automatically classified as prohibited.
(e) 	The 	taking 	of 	shellfish 	from 	prohibited 	areas 	for 	direct
marketing shall be prohibited. 	[Eff. 	SEP 1 8 1981 	] 	(Auth: 	HRS §§321-
09, 321-10, 321-11, 328-21)(Imp: HRS §§321-11, 328-21)
§11-35-7 	Artificial. growing systems for shellfish. 	(a) 	Artificial
growing 	systems 	for 	shellfish 	shall 	meet 	the 	performance 	criteria 	of
natural growing water systems as stated in §11-35-6(c). 	The operator of an
artificial growing system shall be issued a shellstock shipper's certificate.
Harvesting, processing, packing, storing and shucking operations shall be
the same as for shellfish reared in natural waters (see subsequent sections).
(b) 	Consultation with the department is strongly advised prior to
the construction and operation of an artificial growing system to discuss
construction details, flow diagrams, and sanitary requirements.
(c) 	System construction guidelines.
(1) 	Artificial growing systems shall be so constructed that they are
not subject to storm .waters and contamination from pollution
sources.
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(2) 	Wastewater 	from 	washing-culling 	operations 	shall 	not
contaminate approved growing areas.
(c) 	Water system.
(1) 	The quality of the water used in the artificial growing system
shall meet the approved growing area standards.
(2) 	Hydraulic appurtenances used in an artificial system shall be
corrosion-resistant and non-toxic to humans and shellfish.
(3) 	There shall be a routine monitoring program by the certificate
holder to assure proper functioning of the water system. 	This
program shall include the monitoring of temperature, salinity,
and fecal and total coliforms of source and effluent waters.
(d) 	Food production of shellfish.
(1) 	Any algal food production facility used in conjunction with an
artificial growing system shall be monitored to insure that the
final shellfish product meets market standards as set forth in
§11-35-13.
(2) 	Monitoring shall include the identification of algal species and
the densities of paralytic poison producing forms.
(e) 	An artificial growing system shall have a program of sanitation,
maintenance 	and 	supervision 	approved 	by 	the 	director 	to 	prevent 	the
contamination of the final shellfish product. 	Plumbing and sewage disposal
shall 	be 	as 	expressed 	for 	a 	packing 	facility 	of 	shellstock.
[Eff. 	SEP 	1 8 1981 	] (Auth: 	HRS §§321-9, 321-10, 321-11, 328-21) (Imp:
HRS §§321-11, 328-21)
§11-35-8 	Preparation of shellfish for marketing. 	(a) 	Relaying.
(1) 	The 	relaying 	of 	market-size 	shellfish 	from 	a 	prohibited 	or
restricted area to an approved area shall be conducted only
with the written permission and under the supervision of the
department. 	Shellfish from public waters shall only be relaid
with 	the 	permission 	of the 	department 	of land 	and 	natural
resources.
(2) 	Shellfish 	relaid 	from 	a 	prohibited 	or 	restricted 	area 	to 	an
approved area shall be kept in such an area for at least fourteen
consecutive days and shall be harvested only with the written
consent from the department and under its supervision. 	Such an
area shall be located and 	marked so that it 	may be readily
identified 	to 	prevent 	accidental 	harvesting 	and 	to 	prevent
shellfish 	in 	adjacent 	approved 	areas 	from 	contamination.
Further need for holding shall be determined by laboratory tests
and evaluation of such data by the department.
(b) 	Depuration.
(1) 	Shellfish from prohibited areas shall not be depurated.
(2) 	Shellfish from a restricted area shall only be harvested with the
permission of the department of land and natural resources (if
public waters) and shall be subjected to an effective depuration
process.
(3) 	The 	department 	shall 	monitor 	the 	sanitary 	quality 	of 	all
harvesting, transporting and depurating operations of shellfish
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§11-35-8
from restricted growing areas. 	Shellfish from a restricted area
shall be depurated for not less than forty-eight hours to achieve
fifty fecal coliforms or less per one hundred grams of meat.
(4) 	An effective depuration facility shall be available in artificial
growing systems if human pathogens have been demonstrated to
-occur in the growing waters. 	All shellfish lots to be marketed
shall be depurated at least twenty-four hours immediately after
harvesting. 	Subsequent lots of shellfish shall be depurated until
the department is satisfied by available monitoring data or a
sanitary 	evaluation 	that 	the 	sources 	of 	contamination 	are
absent.
(5) 	Construction of a depuration facility.
(A) 	Consultation with the department is advised prior to the
construction and operation of a depuration plant.
(B) 	Plants in which shellfish are depurated shall be so located
that they are not subject to flooding by high tides, storm
waters, and other pollution sources.
(C) 	A 	depuration 	facility 	shall 	be 	so 	constructed 	that
depurated shellstock are not recontaminated or are not
accidentally commingled with shellstock to be depurated.
(D) 	Process 	tanks 	and 	shellstock 	containers 	used 	for
depuration purposes shall be of sufficient size and shape,
constructed of corrosion-resistant material, kept in good
repair 	at 	all 	times, 	and 	not 	subject 	to 	external
con ta mina tion~
(E) 	Regulations 	for 	storage, 	processing, 	sewage 	facilities
shall be in accordance with §11-35-9.
(6) 	Seawater system.
(A) 	Hydraulic appurtenances shall be corrosion-resistant and
non-toxic to shellfish and humans.
(B) 	Water used in a depuration facility shall meet approved
growing 	water 	standards 	and 	should 	favor 	maximum
physiological 	activity 	of the 	shellfish so as to achieve
purification.
(C) 	Water used in the depuration facility shall be subjected to
an effective sterilization process such as ultraviolet (UV)
light or ozonization, unless the water is obtained from a
protected well 	source and 	if the fecal coliform 	is less
than two per one hundred ml.
(7) 	Plant operations.
(A) 	Washing and culling-,-Shellfish shall be washed to remove
matter 	which 	would 	contaminate 	the 	water 	of 	the
depuration facility, and culled to provide proper disposal
of broken-shelled, 	dead or gaping shellfish. 	After 	the
depuration process, shellstock shall be washed to remove
the feces produced by the shellfish during the process and
culled to dispose of dead or gaping shellfish which may
have been missed on the first washing and culling.
(B) 	Process tanks and shellstock containers shall be cleaned
and sanitized after each depuration process.
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(C)
(D)
Monitoring of plant operations-Accurate and up-to-date
records of the quality and the flow rate of the water shall
be 	kept. 	Physiochemical 	parameters 	of untreated and
treated water should be monitored so as to determine the
efficiency of the treatment units.
A 	record 	shall 	be 	kept 	of 	the 	amount 	of 	shellfish
depurated, the period of time the shellfish were depurated
and 	the 	person to 	whom the shellfish were sold. 	Such
records 	shall 	be 	made 	available 	to 	the 	director 	upon
request. 	[ Eff. 	SEP 1 8 1981 	J 	(Auth: 	HRS §§32i-9,
321-10, 321-11, 328-21) (Imp: 	HRS §§321-11, 328-21)
§11-35-9 	Harvesting and processing shellstock (shellfish in the shell).
(a) 	Harvesting and transporting of shellstock.
(1) 	All boats and trucks used in connection with a shellfish business
shall 	be 	constructed, 	operated, 	and 	maintained 	to 	prevent
contamination 	or 	deterioration 	of the shellfish, and shall be
kept clean.
(2) 	No boat shall discharge sewage overboard in areas in which
shellfish are grown for public consumption.
(3) 	All shovels, wheelbarrows, containers, or other equipment used
in the harvesting and transporting of shellfish shall be cleaned
prior to use.
(4) 	Shellstock shall be protected from the sun to prevent spoilage
and shall be refrigerated within six hours after harvesting.
(5) 	Harvesters shall sell shellstock only to certified dealers and
provide them with the following information:
(A) 	Area where shellfish were harvested.
(B) 	Amount of shellstock harvested.
(C) 	Date of harvesting.
(b) 	Packing and shipping of shellstock.
(1) 	A shellstock-shipper shall deal only in shellfish which are still in
the shell. 	The holder of such a 	certificate 	shall 	not 	shuck
shellfish or repack shucked shellfish.
(2) 	Shellstock 	shall 	be 	washed 	free 	of 	bottom 	sediments 	and
detritus as soon after harvesting as practicable. 	Water used for
shellstock washing shall be obtained from an approved growing
area, or from other sources approved by the department.
(3) 	Dry storage of shellstock.
(A) 	The 	floor 	of 	the 	storage 	area 	shall 	be 	constructed of
materials impervious to water, be of a smooth surface and
graded to drain.
(B) 	Walls of shellstock storage rooms and hoppers shall be
smooth and of material which will not deteriorate under
repeated washing.
(C) 	Shellstock storage areas shall be constructed so that they
will not receive floor drainage water from other portions
of the plant. 	The shellstock shall be stored on racks to
prevent them from coming into contact with the floor or
35-10

§11-35-10
with water which might accumulate on the floor. 	Shell-
stock from different sources shall be kept separated from
each other. 	Shellstock storage areas shall be protected
against sewage backflow by the installation of an airgap
in the waste line or by provision of a separate drainage
system.
(D) 	Conveyances or devices used in the transport of shellstock
shall be constructed so that they may be easily cleaned
and sanitized.
(E) 	Shellstock kept in storage overnight or for a longer period
prior to packing (or shucking) shall be refrigerated to a
temperature of at least 45°F (7°C).
(4) 	Wet storage. 	Shellfish in wet storage shall be protected against
fecal contamination. 	Wet storage shall not be used by a shipper
unless a written request is made to the department annually.
The request for approval shall include a sketch, drawn to scale,
showing the location of the storage area, floats or the water
intake 	for 	the 	wet-storage 	tanks, 	and 	a 	discussion 	of 	the
potential hazards to which the stored shellfish may be exposed.
A sanitary survey of the wet storage facility shall be made by
the department prior to approval.
(5) 	The certificate holder shall keep records of purchases and sales,
and tag shellstock shipments so that 	they can be identified.
The tag shall be securely fastened to each shipping container
and 	bear 	the 	number 	of 	the 	license 	holder, 	his 	name 	and
address, 	and 	the 	kind 	and 	quantity 	of 	shellstock 	in 	the
container. 	Tags shall be at least two and 	one-half by 	five
inches 	in 	size and 	shall 	be 	made 	of substantial, 	waterproof
material. 	Bulk shipments of shellstock to a certified shipper
require 	only 	a 	single 	tag 	or 	bill 	of lading. 	The 	necessary
information may be printed on the shipping container rather
than on a tag.
(6) 	The provisions of §11-35-10, Shucking and packing of shellfish,
are also applicable to the packing and shipping of shellstock,
specifically (a)(7)(A), 	(a)(8)(A,D,F ,G,H,I,K), (a)(9), (a)(l2)(A,C),
(b)(l)(A,B), 	(c)(l), 	and (d). 	[.Eff. 	SE p 1 8 1981 	] 	(Auth:
HRS 	§§321-9, 	321-10, 321-11, 	328-21) (imp: 	• HRS §§321-11,
328-21)
§11-35-10 	Shucking and packing of shellfish. 	(a) 	Facilities.
(1) 	Plant arrangement.
(A) 	Plants in which shellfish are shucked and packed shall be
located so that they will not be subject to flooding. 	Any
shellstock 	subjected 	to 	flooding 	shall 	be 	relayed,
depurated .or destroyed.
(B) 	Shucking and 	packing operations shall 	be 	conducted 	in
separate 	rooms. 	A window 	shall 	be 	installed 	in 	the
partition between the shucking and packing rooms. 	The
window shall be equipped with a corrosion-resistant shelf
2n2

§11-35-10
draining 	toward 	the 	shucking 	room 	and, 	if 	necessary,
curbed on the packing room side. 	Fly control screening
may 	be 	accepted 	in 	lieu 	of a solid 	wall 	between 	the
shucking and packing rooms, 	provided that 	the 	packing
room 	is 	situated 	so 	that 	there 	is 	no likelihood of the
shucked 	product 	or 	packing 	room 	equipment 	being
contaminated by splash from the shucking room.
(C) 	Packing rooms shall be large enough to permit sanitary
handling of shellfish and thorough cleaning of equipment.
(D) 	A separate room or rooms, or lockers shall be provided for
storing employees' street clothing and personal articles.
(2) 	Wet and dry storage of shellfish prior to shucking shall meet the
requirements of §11-35-9(b)(3) and (b)(4).
(3) 	The floors of all rooms in which shellfish are shucked or packed,
or 	in 	which 	utensils 	are 	washed, 	shall 	be 	constructed 	of
materials impervious to water, well maintained, and graded to
drain.
(4) 	The interior surfaces of rooms in which shellfish are shucked or
packed, 	or 	in 	which 	utensils 	are 	washed, 	shall 	be 	smooth,
washable, light-colored, durable, and well maintained.
(5) 	Natural or artificial light shall be provided in all working and
storage rooms to produce at least the intensity indicated below:
Type of Area
Foot Candles of Illumination
(measured as incident light)
Working surfaces in
packing rooms.
Shucking benches and
utensil washing areas.
Storage rooms, including
cold-storage rooms.
25
15
5
Light shields shall be provided to protect workers and food stuff
from shattered glass.
(6) 	Working rooms shall be ventilated to reduce condensation and
mold.
(7) 	Water supply.
(A) 	The 	water 	supply 	shall 	be 	adequate 	and 	of 	safe 	and
sanitary quality.
(B) 	All shellstock storage rooms, shucking and packing rooms,
and utensil washrooms shall be provided with sufficient
water outlets.
(C) 	An automatically regulated hot-water system which has
sufficient capacity to furnish water with a temperature of
at least 130°F (54°C), during all hours of plant operation
shall be provided.
(D) 	Sufficient 	water 	shall be available for 	all plant needs.
Non-pressure supplies shall not constitute compliance.
35-12

§11-35-10
(E) 	Hot (at least 100°F) (38°C) and cold wa.ter outlets sha.ll be
provided at each sink compartment, 	except 	that 	warm
water may be acceptable at handwashing sinks.
(8) 	Plumbing and related facilities.
(A) 	Plumbing 	sha.11 	be. 	installed 	in 	compliance 	with 	loca.l
plumbing codes.
(B) 	There sh~ be. no cross-connection between the approved
pressure 	water 	supply 	and 	water 	from 	a 	non-approved
source, and no fixtures or connections through which the
approved pressure supply might be contaminated by back-
siphonage.
(C) 	Conveniently located, separate toilets sha.11 be provided
for 	each sex. 	Separate 	facilities 	are 	not 	required 	in
family operations or when the plant has fewer than ten
employees.
(D) 	Hand washing facilities sha.11 be convenient to the work
areas, 	and 	so 	located 	that 	the 	person 	responsible 	for
supervision can readily observe that employees wash their
hands before beginning work after each interruption.
(E) 	The lavatories sha.ll be provided with hot water (at least
100°F) (38°C).
(F) 	Supplies of soap and single-service hand towels sha.ll be
available near the lavatory.
(G) 	The toilet rooms sha.ll be kept clean and in good repair.
(H) 	Toilet doors sha.11 be tight-fitting and self-closing.
(I) 	A supply of toilet paper sha.ll be available in the toilet
rooms.
(J) 	At. 	least 	five-foot-candle 	illumination 	(natural 	or
artificial 	light) 	sha.11 be provided 	in 	toilet 	rooms, 	and
toilet rooms sha.ll be ventilated by direct opening to the
outer air, 	or by a 	mechanical ventilating system. 	Air
vents should be screened or have self-closing louvers.
(K) 	No drainpipes or 	wastepipes sha.11 be located over food
processing 	or 	storage 	areas, 	or 	over 	areas 	in 	which
containers or utensils are stored or washed.
(9) 	Sewage 	sha.11 	be 	discharged 	into 	public 	sewers 	wherever
possible. 	Where 	private 	sewage-disposal 	systems 	must 	be
utilized, they sha.11 be constructed and operated according to
the applicable public, health regulations and county ordinances,
rules and regulations. 	All sewage disposal facilities sha.ll be
constructed and maintained so that waste will be inaccessible
to flies and rodents.
(10) 	Construction of shucking benches and tables.
(A) 	Shucking benches and contiguous wa.lls to a height of at
least two feet above the bench tops sha.11 be of smooth
concrete, corrosion-resistant meta.I or other durable, non-
absorbent material, free from cracks.
(B) 	Benches sha.ll drain completely and rapidly, and drainage
sha.11 be directed away from any shellfish on the benches.
35-13
252

(C) 	Shucking stools and blocks shall be constructed so as to be
easily cleaned.
(11) 	Construction of utensils and equipment.
(A) 	All 	utensils 	and 	equipment 	coming 	into 	contact 	with
shucked 	shellfish, 	or 	ice 	used 	for 	direct 	cooling 	of
shellfish, 	shall be of corrosion-resistant, 	non-absorbent,
non-toxic and smooth material.
(B) 	There shall be no exposed screw, bolt, or rivet heads in
the parts touching or draining to the food, and all joints
shall 	be 	welded 	or 	soldered 	flush 	and 	have 	a smooth
surface.
(C) 	Tanks, tubs and shucked shellfish storage containers shall
be so located that their top rim is at least two feet above
the floor.
(D) 	All utensils and equipment shall be in good repair.
(E) 	The 	blower 	drain shall 	not 	be directly connected to a
sewer.
(12) 	Vermin control measures.
(A) 	The plant shall be constructed and maintained so as to
prevent rodent entrance and infestation.
(B) 	All outer openings to toilet and washrooms, shucking and
packing rooms, storage rooms and locker rooms shall be
screened 	or 	constructed 	to 	prevent 	the 	entrance 	of
vermin. 	Effective in-plant vermin control measures shall
be used to eradicate vermin which may enter the plant
despite the screening. 	Doors should open outward and be
self-closing.
(C) 	Only such 	toxic 	materials 	as 	are 	required 	to 	maintain
sanitary 	conditions 	shall 	be 	used 	in 	a 	shellfish 	plant.
These toxic materials shall be identified, stored and used
in such 	a 	manner 	as 	to 	prevent 	contamination 	of 	the
product or ingredients, and to cause no heal th hazards to
employees.
(b) 	Sanitation.
(1) 	General cleanliness.
(A) 	Premises 	shall 	be 	kept 	clean 	and 	free 	of 	litter 	and
rubbish. 	Miscellaneous and unused equipment and articles
which are not necessary to plant operations shall not be
stored 	in rooms 	used 	for 	shellstock 	storage, 	shucking,
packing or repacking.
(B) 	No animals shall be permitted in a shellfish processing
plant.
(C) 	Shellstock storage, shucking, and packing portions of the
plant, 	when 	in 	operation, 	shall 	be 	restricted 	to 	the
handling of shellfish.
(D) 	Shuckers shall not go into or through the packing room
without 	wearing 	a 	clean 	apron 	and 	washing 	hands
thoroughly.
(2) 	Cleaning of buildings and equipment.
(A) 	Wash sinks shall be large enough to permit the complete
35-14

§11-35-10
immersion of the largest utensil to be sink-washed. 	A
second 	compartment 	shall 	be provided 	in 	the 	sink 	for
clear-water 	rinsing 	between 	washing 	and 	bactericidal
treatment, 	unless some other 	method, such as a spray
rinse, is provided.
(B) 	All shelves, tables, and other equipment in the shucking
and packing rooms shall be clean.
(C) 	Wash tanks, blowers, and shellfish meat containers should
be 	flushed 	or. spray-rinsed 	with 	tap 	water 	after 	each
emptying. 	Periodic 	clean-water 	flushing 	of 	shucking
benches, 	utensils, 	table 	surfaces, 	and 	other 	equipment
during working periods is recommended.
(3) 	Bactericidal treatment of utensils and equipment.
(A) 	All utensils and equipment in the shucking and packing
rooms 	which 	come into contact 	with 	shucked 	shellfish
shall be subjected to an effective bactericidal process at
the end of each day's operation.
(B) 	Returnable shipping containers shall be subjected to an
effective bactericidal treatment process prior to reuse.
(C) 	All utensils and other equipment shall be treated by a
method 	of 	bactericidal 	treatment 	approved 	by 	the
department.
(4) 	Equipment 	and 	utensils 	which 	have been 	cleaned 	and given
bactericidal treatment shall be stored so as to be protected
against contamination.
(c) 	Shucking and packing processes.
(1) 	All 	shellfish 	to be 	shucked shall be obtained from 	a source
conforming to the provisions of these regulations.
(2) 	Shucking of shellfish.
(A) 	Shellstock shall be reasonably free of mud when shucked.
Water 	used 	in 	washing 	shellstock 	shall 	be 	from 	an
approved source.
(B) 	Only live shellstock shall be shucked.
(C) 	Shucking knives shall be cleaned and sanitized prior to use
and after any prolonged break (e.g~, lunch breaks).
(Df 	Empty shells shall not accumulate and shall be removed
promptly from the shucking room.
(3) 	Sorting and packing of shucked shellfish.
(A) 	Shucked shellfish shall be graded, 	sized 	and packed in
accordance with Title 21 	Code 	of Federal 	Regulations
(CFR) §161.350-161.145.
(B) 	Shucked shellfish shall not remain on the shucking bench
for more than one hour.
(C) 	Skimmer 	tables 	shall 	be located 	so 	that 	they 	do 	not
receive drainage from the delivery window.
(D) 	Shuckers 	shall 	not 	place 	shucking 	containers 	on 	the
skimmer tables.
(E) 	Shucking containers shall be rinsed with running tap water
before each filling.
35-15

(F) 	Shucked 	shellfish 	shall 	be 	packed 	in 	clean 	containers
without exposing them to contamination.
(G) 	Each individual package or container or fresh or frozen
shucked shellfish shall have recorded on the package or
label to be easily visible, the name and address of the
packer, repacker, or distributor and certification number,
and the date of packing-repacking.
(4) 	Refrigeration of shucked shellfish. 	Shucked shellfish shall be
cooled to an internal temperature of 45°F (7°C) or less within
two hours after packing, and stored and shipped under similar
temperature conditions. 	Packaged shellfish to be frozen shall
be properly stacked to insure rapid freezing and shall be frozen
at an ambient air temperature of 0°F 	(-18°C) 	or less. 	The
packages should be frozen solid within twelve hours after the
start of freezing. 	Frozen shellfish shall be handled in such a
manner to remain frozen solid and held at 0°F (-18°C) or less at
all times.
(5) 	Ice shall be obtained from a source approved by the department
and shall be stored and handled in a clean manner.
(d) 	Each shucker-packer, repacker, shellstock shipper or reshipper
shall establish and maintain a record system satisfactory to the department
indicating from whom shellfish were purchased, the date of purchase, the
area of harvest and the names and addresses of persons or firms to whom
the shellfish were sold.
(e) 	Personnel.
(1) 	A person known to be infected with any communicable disease
or who has an infected wound or open lesion on any exposed
portion 	of his 	body, 	shall be 	excluded from 	the handling or
processing of shellfish.
(2) 	The 	certificate 	holder 	shall 	designate 	and 	identify 	to 	the
department 	the 	individual 	who 	has 	the 	management
responsibility 	for 	compliance 	with 	the 	items 	of 	these
regulations having to do with plant and personnel cleanliness.
(3) 	Employees shall wash their hands with soap and water before
beginning work and again after each interruption. 	When manual
handling 	of 	shucked 	shellfish 	becomes 	necessary, 	sanitized
rubber gloves shall be worn, or the hands shall be washed and
disinfected immediately before such manual handling.
(4) 	Effective hair restraints shall be used by employees engaged in
the shucking/packing of shellfish.
(5) 	Employees shall 	not 	eat, 	drink or smoke in the shucking or
packing rooms. 	[ Eff. 	EP 1 8 	J (Auth: 	HRS §§3 21-9,
321-10, 321-11, 328-21) (Imp: 	HRS §§321-11, 328-21)
§11-35-11 	Repacking 	of 	shucked 	shellfish. 	When 	repacking
(packaging of shucked shellfish in plants other than those in which they
were originally shucked) is practiced, it shall be done in accordance with
the requirements of §11-35-10 and the following provisions of this section:
(a) 	Repacking of shucked shellfish.
35-16

§11-35-13
(1) 	All 	shucked 	shellfish 	shall 	be 	received 	in 	containers 	which
prevent contamination.
(2) 	Shellfish 	shall 	be 	received 	from 	certified 	sources 	at 	a
temperature 	of 	45°F 	(7°C) 	or 	less 	and 	maintained 	at 	this
temperature during repacking.
(3) 	Frozen shellfish which have thawed shall not be repacked nor
shall frozen shellfish be thawed during the repacking process.
(b) 	Returnable shipping containers shall be thoroughly cleaned and
sanitized before use.
(c) 	A repacker may also act as a shellstock shipper if that person
has 	the 	necessary 	facilities 	according 	to 	these 	regulations. 	[ Eff .
.SF fl 18 JQA 1 ] 	(Auth: 	HRS §§321-9, 321-10, 321-11, 328-21) (Imp: 	HRS
§§3:21- 1, 32"8'"-21)
§11 -35-12 	Reshipping of shellfish. 	Persons who reship shellfish from
certified 	shell.stock 	shippers, 	shucker-packers 	or 	repackers 	to 	other
certified shippers or to final consumers shall be certified as reshippers. 	A
reshipper 	is 	not 	permitted 	to 	shuck 	shellfish, 	nor 	to 	repack 	shucked
shellfish. 	If 	shellstock 	is 	handled, 	the 	applicable 	requirements 	for
shell.stock dealers in §11-35-9(b) shall be met. 	If only shucked shellfish is
handled, the applicable requirements of "Shucking and packing of shellfish"
(§11-35-10) shall be met. 	[Eff. 	SEP 1 8 1981 	] 	(Auth: 	HRS §§321-9,
321-10, 321-11, 328-21) (Imp: 	HRS §§321-11, 328-21)
§11-35-13 	Sale of shellfish in Hawaii. 	(a) 	Shellfish shipped into
Hawaii.
(1)
(2)
(b)
(1)
(2)
Market 	shellfish shipped 	into 	Hawaii from 	outside 	the state
shall be 	from 	approved growing 	areas 	and 	certified 	by 	the
appropriate agency of the state or county of origin and shall be
acceptable to the Hawaii state department of health.
Each certified shipper shall be listed on the current issue of the
Interstate Certified Shellfish Shippers List of the U. S. Public
Health Service-Food and Drug Administration.
Storage of shellfish.
Dry storage. 	Shellfish shall be kept in storage in their original
containers properly refrigerated at a temperature of at least
45°F (7°C). 	Shellstock shall be kept at least four inches off the
floor.
Wet storage.
(A) 	Wet 	storage 	shall 	not 	be 	practiced 	without 	written
approval 	from 	the 	department. 	The 	request 	for 	an
approval shall include a sketch drawn to scale showing the
location 	of 	the 	storage 	area, 	water . source 	and 	all
potential hazards to which the stored shellfish might be
exposed.
(B) 	Approval shall be immediately terminated if any heal th
hazard is deemed to exist.
35..,.17
252

(c)
(1)
(2)
(C) 	Water 	storage 	of 	shellfish 	in 	fill-and-draw 	tanks
continuously recirculated, may be practiced provided the
following conditions are met:
(i) 	Tanks 	are 	constructed 	of 	easily 	cleaned 	material
and supplied with 	water of salinity approximately
equal to that of the waters in which the shellfish
were grown originally.
(ii) 	An approved treatment system shall be used to treat
the water to meet approved growing area standards.
(iii) 	Water used in the tanks shall be refrigerated to a
temperature of 45°F (7°C) or less.
(iv) 	The 	sidewalls 	of such 	tanks shall 	extend at least
three 	feet 	above 	the 	surrounding 	floor 	level 	to
protect the shellfish from contamination.
(v) 	Tanks shall be maintained in a clean and sanitary
condition at all times.
( vi) 	The 	opera tor 	of such 	holding 	tanks 	shall 	provide
samples of waters and shellfish meats for laboratory
analysis as requested by the department.
Retailing and wholesaling of shellfish.
The 	department 	shall 	maintain 	a 	shellfish 	receiver 	agency
program aimed at protecting the health of the public by the
following means:
(A) 	Identify 	inventory 	and 	make 	periodic 	inspections 	of
various 	wholesale 	and 	retail 	dealers 	in 	the 	State 	of
Hawaii.
(B) 	Certify 	all 	shippers 	shipping 	shellfish 	intrastate 	or
interstate 	according 	to 	their 	activities 	as 	reshipper,
repacker, 	shellstock 	shipper, 	or 	shucker-packer, 	and 	if
appropriate, place them on the U. S. Interstate Shellfish
Shippers List.
(C) 	Develop 	the 	laboratory 	and 	inspection 	capabilities 	to
sample 	shellfish 	from 	certified 	shippers 	arriving 	at
wholesale markets periodically.
(D) 	Laboratory results 	of samples which are 	below 	market
standards (see next 	section) shall 	be 	for warded 	to 	the
regional food and drug administration office and to the
appropriate state control agency as quickly as possible for
corrective action.
(e) 	If violations are found in two successive samples from the
same shipper, future shipments by this shipper shall not be
allowed into Hawaii until the department is satisfied that
the problems at the point of origin have been eliminated.
The 	following 	standards shall 	apply to 	all certified shellfish
meat at the market level:
(A) 	Satisfactory-A fecal coliform density of not more than
two hundred thirty MPN per one hundred grams and 	a
35°C 	aerobic 	plate count (APC) of not 	more 	than 	five
hundred thousand per gram of sample will be acceptable.
35-18

§11-35-19
(B) 	Conditional-A fecal coliform density of more than two
hundred 	thirty 	MPN 	per 	one 	hundred 	grams 	or 	35°C
aerobic plate count of more than five hundred thousand
per gram shall constitute a conditional sample and may be
rejected by the department.
(C) 	Shellfish found to contain human pathogens shall not be
sold.
(D) 	Any shellfish found to be adulterated, e.g., decomposed
gaping, shall not be marketed and shall also be subject to
the requirements of §11-35-13(c)(6).
(3) 	Shellfish shall be displayed for retain sale in a refrigerated area
at a temperature of 45°F (7°C) or less or on ice. 	If ice is used,
it shall be made from potable water and manufactured, stored,
transported and/or handled in a sanitary manner. 	Adequate
drainage shall be provided.
( 4) 	If shellstock are repacked into trays for retail sale, a label shall
accompany each tray with the following information:
(A) 	Name of product.
(B) 	Weight statement.
(C) 	Name of distributor or packer and his address.
(5) 	Adequate records shall be kept by wholesalers and retailers to
verify the source of the shellfish being sold.
(6) 	Mislabeled, adulterated or uncertified shellfish may be subject
to embargo and possible seizure in accordance with §328-25,
HRS. 	[Eff. 	SEP 1 8 1981 	] 	(Auth: 	HRS §§321-9, 	321-10,
321-11, 328-21) (Imp: 	HRS §§321-11, 328-21)
§11-35-14 	Severability. 	If any provision of these regulations. or the
application thereof to any person or circumstance, is held invalid, other
applications, and the remainder of these regulations shall not be affected
hereby. 	[Eff. 	SEP 1 8 1981 	] (Auth: 	HRS §§321-9, 321-10, 321-11, 328-
21) (Imp: 	HRS §§321-11, 328-21)
35-19