Current through Register Vol. 63, No. 12, December 1, 2024
Domoic acid is a natural toxin that can accumulate in certain
shellfish and fish species and cause amnesic shellfish poisoning, a serious
illness, in consumers. In Oregon, a monitoring and response system for
recreationally and commercially harvested shellfish and Dungeness crab is in
place to protect public health and manage the risk of domoic acid
contamination. The Oregon Department of Agriculture (ODA) analyzes Dungeness
crab and crab viscera samples gathered from the waters of this state and the
Pacific Ocean off Oregon for domoic acid. The Oregon Department of Fish and
Wildlife (ODFW) is responsible for opening and closing the crab fishery as well
as requiring restrictions and reporting on crab harvest and landing.
(1)
Application. These rules
apply to commercial fishing and commercial landings regulated by ODFW pursuant
to Oregon Revised Statutes (ORS) Chapter 509, to licensed food processors
regulated by ODA pursuant to ORS Chapter 616, and to any person, wholesaler or
food processor that purchases or receives crab harvested from the waters of
this state or the Pacific Ocean off Oregon.
(2)
Definitions. For the
purposes of these rules, unless the context requires otherwise.
(a) "Biotoxin management zone" consists of at
least one violative zone and the adjacent buffer zones. A violative zone is a
harvest area with domoic acid test results at or above 30 ppm in crab viscera,
at or above 20 ppm in crab meat, or both, that has been either closed to crab
harvest or where the harvest and landing of crab for commercial purposes has
been prohibited unless it is in accordance with sections 5 and 6 of this rule.
'Buffer zone" is defined below.
(b)
"Buffer zone" means one or more harvest areas adjacent to a violative zone in
which, in order to protect public health from domoic acid concerns, the harvest
of crab for commercial purposes has been prohibited unless it is in accordance
with sections 5 and 6 of this rule. A buffer zone is a part of the biotoxin
management zone. Buffer zones have domoic acid results below 30 ppm in the
viscera.
(c) "Crab sample set"
means all whole crab collected for pre-season testing, routine monitoring, or
during a restriction or closure, during a specific sample gathering event from
multiple depths within a harvest area.
(d) "Crab" means Dungeness crab
(
Cancer magister or Metacarcinus magister) harvested and sold
for commercial purposes from waters of this state or the Pacific Ocean off
Oregon
.
(e)
"Eviscerate" or "Evisceration" means the common processor's action of removing
and discarding the entire intestinal tract, hepatopancreas, all associated
abdominal organs of a crab.
(f)
"HACCP Plan" means a hazard analysis critical control point plan as described
in
21
CFR §
123.6 (2016).
(g) "Harvest" means to fish for, hunt,
pursue, catch, capture or kill, or attempt to fish for, hunt, pursue, catch,
capture or kill.
(h) "Harvest area"
means a section of waters of this state or the Pacific Ocean off Oregon
delineated for crab traceability purposes. Harvest area are defined as the
following geographic areas, including all coastal waters of this state,
intertidal areas, rivers and ports between the following boundaries, over which
the state of Oregon has jurisdiction, and the Pacific Ocean off Oregon:
50-A: OR/WA border to Cape Falcon (latitude
46° 15' N to latitude 45° 46' N) including the Oregon portions of the
Columbia River
50-B: Cape Falcon to
Cape Lookout (latitude 45° 46' N to latitude 45° 20.3' N)
50-C: Cape Lookout to Cascade Head (latitude
45° 20.3' N to latitude 45° 04' N)
50-D: Cascade Head to Cape Foulweather
(latitude 45° 04' N to latitude 44° 46.4' N)
50-E: Cape Foulweather to Waldport (latitude
44° 46.4' N to latitude 44 ° 26' N)
50-F: Waldport to Heceta Head (latitude
44° 26' N to latitude 44° 08.3' N) including the entirety of the Alsea
Bay estuary
50-G: Heceta Head to
Tahkenitch Creek (latitude 44° 08.3' N to latitude 43° 47' N)
50-H: Tahkenitch Creek to North Bend
(latitude 43° 47' N to latitude 43° 25' N)
50-I: North Bend to Bandon (latitude 43°
25' N to latitude 43° 07' N) including the entirety of the Coos Bay and
South Slough estuaries
50-J: Bandon
to Cape Blanco (latitude 43° 07' N to latitude 42° 50' N)
50-K: Cape Blanco to Gold Beach (latitude
42° 50' N to latitude 42° 26' N)
50-L: Gold Beach to OR/CA border (latitude
42° 26' N to latitude 42° 00' N) including the entirety of the Gold
Beach estuary
(i)
"Land", "Landed" or "Landing" means either of the following:
(A) For fisheries where food fish were taken
by use of a vessel, "land, landed or landing" means to begin transfer of food
fish from a vessel. Once transfer begins, all food fish on board the vessel are
counted as part of that landing.
(B) For fisheries where food fish were taken
without use of any vessel, "land, landed or landing" means to begin transfer of
food fish from a harvester to a wholesale fish dealer, wholesale fish bait
dealer, or food fish canner, under which the following provisions apply:
(i) When the harvester and the wholesale fish
dealer, wholesale fish bait dealer, or food fish canner are the same person or
entity, transfer occurs when the food fish arrive at the licensed premises of
the wholesale fish dealer, wholesale fish bait dealer, or food fish canner;
and
(ii) Once transfer begins, all
food fish from the harvest area are counted as part of that landing.
(j) "Processor" means
any person engaged in commercial, custom, or institutional processing of fish
or fishery products, in Oregon, in another state, or in a foreign country. A
processor includes any person engaged in the production of any foods that are
to be used in market or consumer tests.
(k) "Processing" means handling, storing,
preparing, heading, eviscerating, freezing, changing into different market
forms, manufacturing, preserving, packing, labeling, dockside unloading or
holding.
(l) "Results" or "domoic
acid test results" means the test results that Oregon Department of Agriculture
obtains by testing crab sample set(s) for domoic acid.
(m) "Sell" includes to offer or possess for
sale, barter, exchange or trade.
(n) "Wholesaler" means any person who buys
crab that is subject to these rules for resale to retailers, other merchants,
or industrial, institution, and commercial users for resale or business
use.
(3)
Procedures for pre-season domoic acid testing
(a) Prior to the opening of the crab fishing
season, ODA will oversee the collection of crab sample set(s) from each harvest
area and will test for domoic acid. ODA will oversee the collection of viscera
and meat samples from each crab in each crab sample set.
(b) Crab viscera samples will be tested
first; if the domoic acid level in any viscera sample is at or above 30 ppm,
meat samples will also be tested. If the domoic acid level in any meat sample
is at or above 20 ppm, ODA will designate the relevant harvest area(s) as
biotoxin management zone(s), and will recommend to ODFW to not open the
biotoxin management zone(s).
(c)
Unrestricted opening of a harvest area at the beginning of the crab season
requires domoic acid test results below 30 ppm in the viscera for all crab in
the crab sample set from that harvest area.
(d) If razor clam test results obtained by
ODA in a particular harvest area show domoic acid levels of 20 ppm or higher or
other indicators show a potential biotoxin concern, ODA may recommend
collection of 2 consecutive crab sample sets at least 7 days apart or another
frequency at ODA's discretion. ODA will recommend unrestricted opening of the
crab fishery only after domoic acid test results indicate domoic acid levels
below 30 ppm in the viscera, and below 20 ppm in the meat, if tested, for all
crab in each sample set.
(e) If one
or more crab domoic acid test results show domoic acid levels at or above 30
ppm in the viscera and below 20 ppm in the meat, ODA will designate the
relevant harvest area(s) as biotoxin management zone(s). ODA will recommend to
ODFW to not open the biotoxin management zone(s), or to open the biotoxin
management zone(s) only in accordance with sections 5 and 6 of this
rule.
(4)
Procedures for in-season crab domoic acid testing.
(a) If domoic acid levels at or above 20 ppm
are detected in razor clams or another indicator raises concern during the crab
fishing season, ODA will oversee the collection of crab sample set(s) every 2
to 4 weeks for domoic acid testing in a harvest area. If no samples are
obtained from a harvest area for 4 weeks during the crab fishing season, ODA
may place evisceration restrictions on crab caught from that area, or ODA may
recommend to ODFW to close the crab fishery in that harvest area.
(b) ODA will oversee the collection of
viscera and meat samples from each crab in each sample set. Viscera samples
will be tested first; if the domoic acid level in any viscera sample is at or
above 30 ppm, meat samples will also be tested.
(c) If the domoic acid level in any single
crab meat sample is at or above 20 ppm:
(A)
ODA will designate a biotoxin management zone and recommend to ODFW that the
harvesting and landing of crab from the violative zone be prohibited starting
from 12:01 am on the date the affected crab sample was harvested. Any crab
already harvested from the violative zone starting from 12:01 am on the harvest
date of the affected crab sample will be considered adulterated and may not be
sold or donated under any circumstance.
(B) ODA will recommend to ODFW to prohibit
the harvest and landing of crab for commercial purposes from buffer zones
unless it is in accordance with sections 5 and 6 of this rule. Buffer zone
restrictions take effect at 12:01 am on the day the test results are
issued.
(C) ODA will supervise
collection of 2 additional crab sample sets from the violative zone and at
least one crab sample set from each adjacent buffer zone. All sample sets must
be gathered at least 7 days apart. A shorter time frame between sample sets may
be allowed at the discretion of ODA.
(D) ODA will only lift the biotoxin
management zone designation and recommend that ODFW harvest restrictions be
removed after the violative zone(s) have 2 crab sample sets with domoic acid
test results from all meat below 20 ppm and at least one sample set from each
buffer zone shows all viscera results below 30 ppm. If results from the crab
sample sets show domoic acid levels below 20 ppm in all meat samples but at or
above 30 ppm in any viscera sample, a biotoxin management zone designation will
remain in place, consistent with subsection (4)(d) of this rule.
(d) If domoic acid test results
from a crab sample set show domoic acid levels at or above 30 ppm in any
viscera sample and below 20 ppm in all meat samples:
(A) ODA will designate a biotoxin management
zone(s) and recommend to ODFW to either prohibit harvest and landing of crab
for commercial purposes from the
violative zone(s) or to prohibit
harvest and landing of crab for commercial purposes from the
violative
zone(s) unless it is in accordance with sections 5 and 6 of this rule.
ODA will recommend to ODFW to begin these prohibitions starting from 12:01 am
on the date the affected crab sample was harvested. Any crab already harvested
from the violative zone starting from 12:01 am on the harvest date of the
affected crab sample will be considered adulterated and under no circumstance
may be sold or donated unless it is sold in accordance with sections 5 and 6 of
this rule.
(B) ODA will recommend
to ODFW to prohibit the harvest and landing of crab for commercial purposes
from buffer zones unless it is in accordance with sections 5 and 6 of this
rule. Buffer zone restrictions take effect at 12:01 am on the day the test
results are issued.
(C) ODA will
supervise collection of 2 additional crab sample sets from the violative zone
and at least one crab sample set from each adjacent buffer zone. All sample
sets must be gathered at least 7 days apart. A shorter time frame between
sample sets may be allowed at the discretion of ODA.
(D) ODA will only lift the biotoxin
management zone designation and recommend that ODFW harvest restrictions be
removed after the violative zone(s) have 2 crab sample sets with domoic acid
test results from all viscera below 30 ppm and at least one sample set from
each buffer zone shows all viscera results below 30 ppm.
(5) All crab harvested from waters
of this state or the Pacific Ocean off Oregon must comply with ODFW's rules OAR
635-005-0466 and 635-006-0201.
(6)
Prohibition on uneviscerated crab sales to consumers. If
pre-season or in-season testing conducted as described in Sections 3 and 4 of
these rules detects domoic acid at or above 30 ppm in crab viscera but below 20
ppm in the meat in 1 or more harvest areas, and the conditions in Section 5 are
met and ODA recommends the biotoxin management zone(s) open or remain open with
prohibitions on uneviscerated crab sales, no person, processor, or wholesaler
shall donate, hold, offer for sale or sell Dungeness crab from the biotoxin
management zone unless the following conditions are met.
(a) The crab is conveyed or sold to a food
processing establishment licensed by ODA or to a licensed food processor that
eviscerates and processes crab consistent with subsection (6)(e).
(b) The crab is conveyed or sold to a
wholesaler that in turn sells all crab subject to these rules to a food
processor that is licensed by ODA or to a licensed processor.
(c) In no case may uneviscerated crab be
conveyed, sold or donated to retailers or directly to consumers unless it is
processed as described in subsection (6)(d).
(d) Food processors or wholesalers are
prohibited from selling or offering for sale to retailers or to consumers crab
as described in this section unless:
(A) The
licensed processor conducts its activities consistent with a seafood HACCP
plan; and
(B) The crab is
eviscerated.
(e) If any
of the landed crab in a landing from a fishing vessel came from a biotoxin
management zone, the entire landing shall be subject to the requirements of
this section. Landings for which the harvest area is unspecified shall be
subject to the requirements of this section. Failure of a producer or
wholesaler to notify processors that crab originated from a biotoxin management
zone and so must be processed consistent with this section before it is
donated, held, offered for sale or sold to consumers will be considered a
violation of ORS 616.215(1).
(7)
Penalties.
Whenever it is found that any crab as described in subsection (6) is sold,
offered for sale, or donated to any person in a manner that is inconsistent
with these rules, the crab is considered adulterated food, and the holding, or
offering for sale of crab is prohibited as provided in ORS
616.215(1). If
any person violates these rules, ODA may proceed with any lawful remedy
including, but not limited to:
(a) Seeking
the district attorney to institute proceedings in the proper courts to be
prosecuted in the manner required by law;
(b) Enjoining violations of law in a summary
proceeding;
(c) Embargo, seizure or
detention consistent with the provisions of ORS
561.605 -
630; and
(d) Imposing civil penalties up to $10,000
for each violation as provided in ORS
616.997.
Statutory/Other Authority: ORS
616.215, ORS
616.225, ORS
616.235, ORS
561.190