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Shellfish Sanitation


Published: 2015

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The Oregon Administrative Rules contain OARs filed through November 15, 2015

 

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DEPARTMENT OF AGRICULTURE









 

DIVISION 100
SHELLFISH SANITATION

603-100-0000
Definitions
As used in OAR 603-100-0000
to and including 603-100-0050 and in addition to the definitions set forth in ORS
622.010 and 622.080, the following shall apply:
(1) "Director" means the Director
of the Department of Agriculture or authorized representative.
(2) "Certification Number" means
the number assigned by the Department to each certified shellfish dealer. It consists
of a one-to-five digit number preceded by the two-letter state abbreviation and
followed by the two-letter symbol designating the type of operation certified.
(3) "Dealer" means every person
or peddler engaged in the business of growing, harvesting, processing, or distributing
shellfish. Dealers are certified and assigned a certification number by type of
operation classified as follows:
(a) "Depuration processor (DP)"
means a shellfish dealer who purchases or harvests shell stock from conditionally
approved or restricted growing areas and submits such shell stock to an approved
controlled purification process. Such dealers shall be certified as a shucker-packer
and assigned a certification number designating depuration processor (DP) as the
type of operation;
(b) "Distributor" means a jobber
or wholesaler who furnishes or sells shellfish to retail outlets. Such dealers shall
be certified as a distributor and assigned a certification number designating shellstock
shipper (SS) as the type of operation;
(c) "Grower (GR)" means a dealer
engaged in the business of growing shellfish intended for human consumption. Such
dealers shall be certified as a grower and assigned a certification number designating
(GR) as the type of operation;
(d) "Harvester (HV)" means a
dealer who harvests shellfish intended for human consumption or employs persons
to harvest shellfish intended for human consumption from growing areas. Such dealers
shall be certified as harvesters and assigned a certification number designating
harvester (HV) as type of operation;
(e) "Repackers (RP)" means dealers
other than the original certified shucker-packer who repack shucked shellfish. Such
dealers shall be certified as a shucker-packer, and assigned a certification number
designating repacker (RP) as type of operation;
(f) "Reshippers (RS)" means
dealers who receive shellfish, either shellstock or shucked stock in original containers
from certified shellfish distributors and transship such shellfish to other dealers
or to the final consumer. Such dealers will be certified as distributors, and assigned
a certification number designating shellstock reshipper (RS) as the type of operation;
(g) "Shellstock shippers (SS)"
means dealers who buy, sell, or ship shellstock. Such dealers will be certified
as a distributor and assigned a certification number designating shellstock shipper
(SS) as the type of operation. A shellstock shipper may ship shucked shellfish,
but, is not authorized to shuck or repack shucked shellfish;
(h) "Shucker-packer (SP)" means
dealers who shuck, pack, and repack shellfish. Such dealers will be certified as
a shucker-packer and assigned a certification number designating shucker-packer
(SP) as the type of operation.
(4) "Seed" means shellfish that
are less than market size for human consumption and have a maximum shell length
of:
(a) Thirteen millimeters (1/2
inch) for mussels;
(b) Twenty-five millimeters
(1 inch) for scallops;
(c) Nineteen millimeters (3/4
inch) for Olympia oysters;
(d) Nineteen millimeters (3/4
inch) for Kumomoto oysters;
(e) Fifty-one millimeters (2
inches) for other oyster species;
(f) Thirty-eight millimeters
(1 and 1/2 inch) for geoducks; and
(g) Thirteen millimeters (1/2
inch) for other clam species.
(5) "Shellfish" means:
(a) All edible species of oysters, either shucked or in the
shell, fresh or frozen, whole or in part and intended for human consumption.
(b) All edible species of clams, either
shucked or in the shell, fresh or frozen, whole or in part and intended for human
consumption.
(c) All edible species of mussels,
either shucked or in the shell, fresh or frozen, whole or in part and intended for
human consumption.
(d) All edible species of scallops,
either shucked or in the shell, fresh or frozen, whole or in part, except when the
final product is the shucked adductor muscle only, and intended for human consumption.
(6) "State Waters" means waters
that belong wholly to the state including the Territorial Sea out to the three mile
limit.
Stat. Auth.: ORS 561.190 &
622.180

Stats. Implemented: ORS 622.180

Hist.: HD 24-1987, f. &
ef. 11-30-87; AD 22-1993, f. & cert. ef. 12-15-93; Renumbered from 333-190-0000;
DOA 1-2007, f. & cert. ef. 1-2-07; DOA 13-2012, f. 5-29-12, cert. ef. 1-1-13
603-100-0010
Sanitation of Shellfish
Growing Areas and Harvesting, Processing and Distribution of Shellfish
As provided in ORS 622.180, the National
Shellfish Sanitation Program, Guide for the Control of Molluscan Shellfish, 2009
Revision, is hereby adopted as the rules governing this subject matter in Oregon.
The material covered is that governing growing area survey and classification, controlled
relaying, patrol of harvest areas, control of harvesting, aquaculture, laboratory
and administrative procedures. In addition the rules cover the harvesting, handling
and shipping of shellfish; wet storage; shucking and packing shellfish; shellfish
shipping, heat shock, depuration and application of Hazardous Analysis Critical
Control Point (HACCP). These rules are recommended by the Interstate Shellfish Sanitation
Conference and the Food and Drug Administration of Health and Human Services.
[Publications: Publications referenced are
available from the agency.]
Stat. Auth.: ORS 561.190 & 622.180
Stats. Implemented: ORS 622.180
Hist.: HD 24-1987, f. &
ef. 11-30-87; AD 22-1993, f. & cert. ef. 12-15-93; Renumbered from 333-191-0000;
DOA 11-1999, f. & cert. ef. 6-4-99; DOA 1-2007, f. & cert. ef. 1-2-07; DOA
13-2012, f. 5-29-12, cert. ef. 1-1-13; DOA 4-2014, f. & cert. ef. 2-24-14

Shellfish Facilities Plan Review

603-100-0030
Submission of Plans
(1) Plans for a new shellfish plant or storage facility construction or existing plant remodeling shall be submitted to the Department for review and approval at least 90 days prior to actual construction.
(2) Plans shall be submitted as blue-prints, photostats, or original drawing using India ink on substantial drawing paper. The following information shall be included in the plans:
(a) Plot plan of grounds on which building is to be constructed or addition is to be located showing size of area and boundaries;
(b) Floor and elevation plans drawn to scale showing the accurate location of equipment;
(c) Specifications and design detail of equipment, location of plumbing fixtures, and materials used in all processing and storage areas;
(d) If a privately owned public water system is used, plans meeting the specifications of OAR 333-061-0005 through 333-061-0095, Public Water Systems, must be submitted to and approved by the appropriate agency.
Stat. Auth.: ORS 561.190 & ORS 622.180

Stats. Implemented: ORS 622.180

Hist.: HD 24-1987, f. & ef. 11-30-87; AD 22-1993, f. & cert. ef. 12-15-93; Renumbered from 333-198-0010
603-100-0040
Growers and Harvesters
(1) Growers and Harvesters must deliver shellfish intended for human consumption to a shellfish shipper certified by the Oregon Department of Agriculture within 24 hours of harvest.
(2) Growers and Harvesters may only sell shellfish intended for human consumption to shellfish shippers certified by the Oregon Department of Agriculture.
Stat. Auth.: ORS 561.190 & 622.180

Stats. Implemented: ORS 622.180

Hist.: DOA 1-2007, f. & cert. ef. 1-2-07
603-100-0050
Shellstock Harvesting
and Distribution from Non-Interstate Approved Harvest Areas
(1) Each tag of any shellstock
harvested from a non-interstate approved harvest area shall include the following
statement in bold capitalized type, “OREGON DISTRIBUTION ONLY.”
(a) This requirement is in addition
to the Shellstock Identification requirements found in the 2009 Version of the National
Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.
(2) Any person listed in the
Interstate Certified Shellfish Shipper List (ICSSL) shall not sell or possess shellstock
harvested from a non-interstate approved harvest area.
Stat. Auth.: ORS 561.190 &
622.180

Stat. Implemented: ORS 622.180

Hist.: DOA 13-2012, f. 5-29-12,
cert. ef. 1-1-13
Fees
603-100-0100
Certificate
Fees; Rules
As provided in ORS
622.080, the Oregon Department of Agriculture establishes the following fees for
persons engaged in the growing, production, harvesting or distribution of shellfish:
(1) Persons
who receive $50,000 or less in annual gross income from all shellfish operations
shall pay:
(a) $300
for a certificate of shellfish sanitation as a shucker-packer, or repacker. For
a person operating a shellfish shucking, packing or repacking plant for the distribution
of shellfish;
(b) $200
for a certificate of shellfish sanitation as a grower. For a person engaged in the
business of growing shellfish;
(c) $200
for a certificate of shellfish sanitation as a distributor, reshipper, or shellstock
shipper. For any jobber or wholesaler who furnishes or sells shellfish to retail
outlets;
(d) $125
for a certificate of shellfish sanitation as a commercial harvester. For any person
harvesting clams or mussels for commercial purposes.
(2) Persons
who receive more than $50,000, but not more than $500,000 in annual gross income
from all shellfish operations shall pay:
(a) $600
for a certificate of shellfish sanitation as a shucker-packer, or repacker. For
a person operating a shellfish shucking, packing or repacking plant for the distribution
of shellfish;
(b) $400
for a certificate of shellfish sanitation as a grower. For a person engaged in the
business of growing shellfish;
(c) $450
for a certificate of shellfish sanitation as a distributor, reshipper, or shellstock
shipper. For any jobber or wholesaler who furnishes or sells shellfish to retail
outlets;
(d) $200
for a certificate of shellfish sanitation as a commercial harvester. For any person
harvesting clams or mussels for commercial purposes.
(3) Persons
who receive more than $500,000 in annual gross income from all shellfish operations
shall pay:
(a) $1,200
for a certificate of shellfish sanitation as a shucker-packer, or repacker. For
a person operating a shellfish shucking, packing or repacking plant for the distribution
of shellfish;
(b) $800
for a certificate of shellfish sanitation as a grower. For a person engaged in the
business of growing shellfish;
(c) $900
for a certificate of shellfish sanitation as a distributor, reshipper, or shellstock
shipper. For any jobber or wholesaler who furnishes or sells shellfish to retail
outlets;
(d) $250
for a certificate of shellfish sanitation as a commercial harvester. For any person
harvesting clams or mussels for commercial purposes.
Stat. Auth.: ORS
561.190 & 622.080

Stat. Implemented:
ORS 622.080

Hist.: DOA
25-2012, f. 10-30-12, cert. ef. 1-1-13
603-100-0110
Annual Fees
As provided in ORS
622.290, the Oregon Department of Agriculture establishes the following annual cultivation
fees for the use of state lands to cultivate oysters, clams, or mussels:
(1) For growing
areas that have been classified as prohibited, persons shall pay $5 per year for
each acre claimed pursuant to Chapter 675, Oregon Laws 1969, or claimed pursuant
to a plat made subsequent thereto.
(2) For growing
areas that have been classified as approved, conditionally approved, restricted,
or conditionally restricted shall pay $14 per year for each acre claimed pursuant
to Chapter 675, Oregon Laws 1969, or claimed pursuant to a plat made subsequent
thereto.
Stat. Auth.: ORS
561.190 & 622.290

Stat. Implemented:
ORS 622.290

Hist.: DOA
25-2012, f. 10-30-12, cert. ef. 1-1-13
Civil Penalties
603-100-0900
Purpose
The Oregon Department
of Agriculture Food Safety Program licenses and inspects all facets of Oregon’s
food distribution system, except restaurants, to ensure food is safe for consumption.
Education and technical assistance are vital to the prevention, correction, and
abatement of food safety violations, and are preferred over regulatory action. However,
regulatory action may be necessary to deter violations of food safety laws and rules,
to educate persons about the consequences of such violations, and to compel compliance
with food safety laws for the protection of consumers. The Department intends to
initiate civil penalty actions when educational measures, technical assistance,
warning letters, compliance agreements or other remedial measures fail to achieve
compliance.
Stat. Auth.: ORS
561.190 & 622.996

Stat. Implemented:
ORS 622.996

Hist.: DOA
2-2013, f. & cert. ef. 2-7-13
603-100-0910
Definitions
As used in OAR 603-100-0920
through 603-100-0930, unless otherwise required by the context, the following terms
will be construed to mean:
(1) “Interference”
means hindering or impeding an activity or process, which includes, but is not limited
to any harassment, unreasonable delay, threat, concealment, deceit, or obstruction.
(2) “Major,”
with respect to violations, means an incident, or series of incidents that cause
a reasonable probability that serious adverse health consequences or death will
occur.
(3) “Minor,”
with respect to violations, means an incident, or series of incidents that are not
likely to cause adverse health consequences.
(4) “Moderate,”
with respect to violations, means an incident, or series of incidents that may cause
temporary or medically reversible adverse health consequences, or where the probability
of serious adverse health consequences is remote.
(5) "Repeat
violation" means the recurrence of the same violation for each 24-hour period after
a notice of noncompliance or assessment of civil penalty was issued within the preceding
three years. It does not include a violation if the previous notice is the subject
of a pending appeal or if the notice has been withdrawn or successfully appealed.
(6) “Same,”
with respect to violations, means an identical recurrence, exact repetition, or
a continuation of a previous violation.
(7) "Violation"
means the failure to comply with any requirement of ORS 622.010 to 622.180, or any
rule adopted thereunder.
Stat. Auth.: ORS
561.190 & 622.996

Stat. Implemented:
ORS 622.996

Hist.: DOA
2-2013, f. & cert. ef. 2-7-13
603-100-0920
Schedule
of Civil Penalties
In addition to any
penalty available under ORS 561.190 or 622.992, the Department may impose a civil
penalty with respective amounts for:
(1) Acting
as a dealer without the certificate or certificates of shellfish sanitation issued
by the Department as explained in ORS 622.020. Penalty — $5,000 to $10,000.
(2) Operating
outside of the geographic area specified in a validated certificate of shellfish
sanitation as explained in ORS 622.040. Penalty — $5,000 to $10,000.
(3) A dealer
failing to display the certificate of a dealer or certificates of shellfish sanitation
in accordance with the rules of ORS Chapter 622. Penalty — $100.
(4) A dealer
sending or accepting any shellfish without a signed statement in accordance with
ORS 622.160. Penalties:
(a) Minor
— $1,000 to $4,000;
(b) Moderate
— $4,001 to $7,000; or
(c) Major
— $7,001 to $10,000.
(5) A dealer
who gathers or receives shellfish from any source other than designated in the certificate
or certificates of shellfish sanitation and fails to keep accurate records of the
amount and source of such shellfish, fails to retain the records for at least 90
days, or fails to provide access to the Department for inspection as explained in
ORS 622.170. Penalties:
(a) Minor
— $1,000 to $4,000;
(b) Moderate
— $4,001 to $7,000; or
(c) Major
— $7,001 to $10,000.
(6) Interference
with a lawful inspection under ORS 622.180(2)(a). Penalty -- $5,000 to $10,000.
(7) Interference
with the taking of samples as requested by the Department under ORS 622.180(2)(b).
Penalties:
(a) Minor
— $1,000 to $4,000;
(b) Moderate
— $4,001 to $7,000; or
(c) Major
— $7,001 to $10,000.
(8) Interference
with the Department’s condemnation, removal from sale, or destruction of any
shellfish that are unfit for consumption, from an uncertified source, or are improperly
certified as explained in ORS 622.180(1)(c). Penalty — $5,000 to $10,000.
(9) Violation
of any requirement for dealers or harvesters found in the National Shellfish Sanitation
Program, Guide for the Control of Molluscan Shellfish, 2009 Revision. Penalties:
(a) Minor
— $1,000 to $4,000;
(b) Moderate
— $4,001 to $7,000; or
(c) Major
— $7,001 to $10,000.
(10) Failure
of a grower or harvester to deliver shellfish intended for human consumption to
a certified shellfish shipper within 24 hours of harvest as explained in OAR 603-100-0040.
Penalties:
(a) Minor
— $1,000 to $4,000;
(b) Moderate
— $4,001 to $7,000; or
(c) Major
— $7,001 to $10,000.
(11) Failure
to tag shellstock harvested from non-interstate approved harvest areas pursuant
to OAR 603-100-0050. Penalties:
(a) Minor
— $1,000 to $4,000;
(b) Moderate
— $4,001 to $7,000; or
(c) Major
— $7,001 to $10,000.
Stat. Auth.: ORS
561.190 & 622.996

Stat. Implemented:
ORS 622.996

Hist.: DOA
2-2013, f. & cert. ef. 2-7-13
603-100-0930
Penalty factors;
procedure
(1) In imposing
a penalty pursuant to the schedule adopted pursuant to ORS 621.995, the Department
shall consider the following factors, which are listed in prioritized order:
(a) The immediacy
and extent to which the violation threatens the public health or safety.
(b) Any prior
violations of statutes, rules or orders pertaining shellfish.
(c) The past
history of the person incurring a penalty in taking all feasible steps or procedures
necessary or appropriate to correct any violation.
(d) The economic
and financial conditions of the person incurring the penalty, including any financial
gains resulting from the violation.
(2) Each
24-hour period a violation continues after the period of time established for compliance
will be considered a separate violation unless the Department finds a different
period of time is more appropriate to describe the specific violation event.
(3) Repeat
violations of OAR 603-024-0910 will be assessed as three times the penalty amount
in OAR 603-024-0910, not to exceed $10,000.
(4) A civil
penalty imposed under this rule will comply with ORS 183.745, except that the written
application for a hearing must be received by the Department no later than 10 days
after the mailing or personal service of the notice of civil penalty.
Stat. Auth.: ORS
561.190 & 622.996

Stat. Implemented:
ORS 622.996

Hist.: DOA
2-2013, f. & cert. ef. 2-7-13

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