Protocol - submission of concurrence from state of landing

Section IV Guidance Documents Chapter II. Growing Areas .03
Example of Protocol for Onboard Screening and Dockside Testing for
PSP in Closed Federal Waters
Protocol for the Landing of Shellfish from Federally Closed Waters due to PSP
When the harvest of molluscan shellfish is closed in Federal Waters due to Paralytic Shellfish
Poison (PSP), exceptions to the prohibitions may be authorized provided the Authority in the
State of landing in cooperation with appropriate Federal agencies shall develop agreements or
memorandums of understanding between the Authority and individual shellfish harvesters or
individual shellfish dealers. This guidance provides descriptions of the specific information to be
included in the protocol.
A.

Harvest Permit Requirements
The Authority in the landing state will only allow the landing of shellfish from federal
waters closed due to PSP from vessels in possession of an appropriate Exempted Fishing
Permit (EFP) issued by the National Marine Fisheries Service (NMFS). The NMFS shall
receive concurrence from the SSCA in the State of landing.

B.

Training
The Authority shall ensure that all shipboard persons conducting onboard sampling have
been trained by a National Shellfish Sanitation Program (NSSP) Laboratory Evaluation
Officer (LEO) or a US Food and Drug Administration (FDA) marine biotoxin expert to
conduct onboard PSP screening using a NSSP recognized method(s).

C.

Vessel Monitoring
The Authority shall ensure that the harvesting location(s) of each landing vessel has been
appropriately monitored. This requirement may be met by the vessel participating in the
Federal Vessel Monitoring System (VMS).

D.

Identification of Shellfish
Prior to landing each vessel shall provide the Authority with a record identifying each lot
of shellfish as follows: For each harvesting trip the Captain or Mate shall record the
following information on a “Harvest Record.” Electronic logging of this information may
be permitted provided it is made available to the authorized individual at dockside.
1.
2.
3.
4.
5.
6.

Vessel name and Federal Fishing Permit number
Name and telephone number of the vessel Captain and vessel owner
Date(s) of harvest
Number of lots and volume of catch per lot or number of containers per lot
Location(s) of harvest (GPS coordinates or latitude/longitude coordinates in
degrees:minutes:seconds)
Identification of each harvest lot, including cage tag numbers for surfclams and
ocean quahogs, and container numbers or identification codes for other shellfish
species.

7.
8.
9.

Location
(GPS
coordinates
or
latitude/longitude
coordinates
in
degrees:minutes:seconds) of each PSP screening sample
Results of each PSP screening test.
Destination(s) and purchaser(s) of each lot and amount of each lot to each
destination

The Captain or Mate shall sign the “Harvest Record.” The “Harvest Record” shall be
checked by the individual authorized to sample the harvested shellfish. Failure to provide
complete and accurate information will result in revocation or suspension of the NMFS
EFP and rejection of the entire lot(s) of harvested shellfish. Four (4) copies of the
“Harvest Record” shall be prepared. One (1) copy shall remain with the vessel, one (1)
copy shall be provided to the SSCA in the state of landing, one (1) copy shall accompany
the catch to the processing firm(s), and one (1) copy shall be retained by the laboratory
authorized to conduct lot sample analyses.
CONTAINER LABELING:
Each container of shellfish shall be clearly labeled with the following NSSP required
information at the time of harvest:
1.
For surfclams and ocean quahogs existing NMFS tagging requirements
2.
For all other molluscan shellfish (including Stimpson clams also known as Arctic
surfclams) using Tyvek tags:
a. Vessel name
b. Type and quantity of shellfish
c. Date of harvest
d. Harvest lot area defined by GPS coordinates or latitude/longitude coordinates
in degrees:minutes:seconds
E.

Pre-Harvest Sampling
Prior to commercial harvesting of molluscan shellfish, a minimum of five (5) screening
samples shall be collected within each area of intended harvest (lot area) and tested for
PSP toxins in accordance with a NSSP recognized screening method. Each screening
sample shall be collected during a separate and distinct gear tow. Screening sample tows
shall be conducted in a manner that evenly distributes the five (5) samples throughout the
intended harvest area for each area of intended harvest (see Section H.). Only shipboard
officials trained in the use of the designated NSSP screening method may conduct these
tests. Each of the five (5) samples must test negative for PSP toxins. A positive result
from any one (1) sample shall render the “lot area” unacceptable for harvest. The harvest
vessel captain shall immediately report all positive screening test results, by telephone, to
the SSCA within the intended state of landing and the NMFS. The Captain should also
notify other permitted harvest vessels of the positive screening test and advise them to
avoid the questionable area. For each screening test, positive and negative, the remaining
sample material (homogenate) shall be maintained under refrigeration for later use should
the SSCA in the State of landing request confirmatory testing using a NSSP recognized
test method.
Each screening sample shall be comprised of at least twelve (12) whole animals with the
exception of mussels and “whole” or “roe-on” scallops. For mussels each sample shall be
comprised of thirty (30) animals. For “whole” scallops each sample shall be comprised of

twenty (20) scallop viscera and gonads.
comprised of twenty (20) scallop gonads.
F.

For “roe-on” scallops each sample shall be

Submittal of Onboard Screening Homogenates and Test Results
All screening results shall be recorded on the “Harvest Record” as stipulated in Section D.
of this Protocol. Upon landing of the harvest vessel, the “Harvest Record” and screening
homogenates shall be provided to the authority in the State of landing authorized to
sample the harvested shellfish as described in Section G. of this Protocol.

G.

Dockside Sampling
After dockside samples are collected, molluscan shellfish may be processed while
awaiting PSP analytical results. Each lot must be identified and segregated during storage
while awaiting dockside sample test results. Under no circumstances will product be
released from the processor prior to receiving satisfactory paralytic shellfish toxin test
results.
The dockside sampling protocol for molluscan shellfish shall be as follows:
1.

2.
3.

H.

For each lot of molluscan shellfish, a minimum of seven (7) composite samples, each
comprised of at least twelve (12) whole animals, shall be taken at random by the
individual authorized to sample, with the following exceptions:
a. For each lot of mussels, a minimum of seven (7) composite samples, each
comprised of at least thirty (30) whole animals, shall be taken at random by the
individual authorized to sample.
b. For each lot of “whole” scallops, a minimum of seven (7) composite samples,
each comprised of twenty (20) scallop viscera and gonads, shall be taken at
random by the individual authorized to sample.
c. For each lot of “roe-on” scallops, a minimum of seven (7) composite samples,
each comprised of twenty (20) scallop gonads, shall be taken at random by the
individual authorized to sample.
Shellfish samples collected in accordance with G.1 shall be tested for the presence of
paralytic shellfish toxins using NSSP recognized methods.
Laboratory test results for each lot of shellfish shall be forwarded to the SSCA in the
state in which the shellfish is being held prior to the product being released by the
SSCA.

Holding and Lot Separation
A harvest lot is defined as all molluscan shellfish harvested during a single period of
uninterrupted harvest activity within a geographic area not to exceed three (3) square
miles. Once harvesting has ceased and the harvest vessel moves to another location,
regardless of the distance, a new harvest lot will be established. Any harvest vessel
containing more than one lot shall clearly mark and segregate each lot while at sea, during
off loading, and during transportation to a processing facility. Prior to harvesting in
Federal waters, each harvest vessel shall submit to the NMFS a written onboard lot
segregation plan. The SSCA in the intended state of landing and the FDA Regional
Shellfish Specialist must approve the proposed lot segregation plan.

I.

Disposal of Shellfish

If test results of any one (1) of the seven (7) samples collected in accordance with G.1
equal or exceed 80ug of paralytic shellfish toxins/100g of shellfish tissue (n=7, c=0), the
entire lot must be discarded or destroyed at the cost of the harvester under the supervision
of the SSCA in accordance with state laws and regulations except when:
A lot of “whole” or “roe-on” scallops equals or exceeds 80ug paralytic shellfish
toxins/100g of tissue, the adductor muscle may be shucked from the viscera and/or
gonad and marketed. The remaining materials (viscera and/or gonad) must be
discarded or destroyed under supervision of the SSCA in accordance with state laws
and regulations.
Confirmatory PSP analyses shall be according to NSSP recognized methods and shall be
conducted by laboratories certified in accordance with NSSP guidelines. Private
laboratories may be used if certified by a Federal or state shellfish Laboratory Evaluation
Officer (LEO) in accordance with NSSP guidelines.
J.

Notification Prior to Unloading
Prior to the issuance of an EFP, the harvester shall be responsible for notifying the SSCA
in the state of landing and in a manner approved by the SSCA that molluscan shellfish is
being harvested for delivery to the intended receiving processor.
Each vessel shall give at least twelve (12) hours notice to the individual authorized to
sample prior to unloading shellfish. Notice of less than twelve (12) hours may be
approved by the authorized individual at his/her discretion. SSCAs may approve
industry sampling and sample transport to the NSSP certified testing laboratory in
accordance with the practices and procedures used by the SSCA under the NSSP. Such
procedures may be approved by the SSCA only when sample collection and sample
transport training is provided by the SSCA.
Shellfish from a federally closed harvest area must be kept separate and not sold until so
authorized by the SSCA.
Failure to comply with the provisions of this Protocol will result in the suspension or
revocation of the vessel’s EFP.

K.

Unloading Schedule
Unloading shall take place between 7:00 A.M. and 5:00 P.M. Monday through Friday,
unless otherwise mutually agreed upon by the individual authorized to sample, the
processing plant manager, the harvest vessel captain, and the SSCA in the state of
landing, sample testing, and processing.

L.

Access for Dockside Sampling
Individuals authorized to sample shall be provided access to the catch of shellfish.

M.

Record Keeping
Record keeping requirements shall be as follows:

1. The vessel shall maintain Harvest Records for at least one (1) year.
2. The processor(s) shall maintain Harvest Records for at least one (1) year or two (2)
years if the product is frozen.
3. The SSCA in the State of landing shall retain Harvest Records for at least two (2)
years.
N.

Early Warning/Alert System
PSP sample data acquired as a result of onboard screening and dockside testing shall be
transmitted to a central data register to be maintained by the FDA. These data, both
screening and confirmatory, shall be transmitted to the FDA by the NSSP certified
laboratory conducting PSP analyses of the sampled lot(s) within one week of the
completion of the PSP analyses. The data provided shall include the following:
1.
2.
3.
4.
5.

shellfish species
harvest location name and coordinates (GPS or latitude/longitude)
harvest date
onboard screening test method, date, and results
laboratory test date and test results

Results of all samples having acceptable levels of paralytic shellfish toxins (<80ug/100g)
shall immediately be reported to the SSCA in the state of landing. If the results of any
one (1) sample equal or exceed 80ug/100g the testing laboratory shall immediately notify
the FDA Regional Shellfish Specialist, the SSCA, and the processor by telephone. The
FDA shall notify the NMFS. The NMFS shall notify permitted harvesters to advise them
to cease fishing in the affected area(s).
NOTE: Due to the resources necessary to meet the requirements of this Protocol, State Shellfish
Control Authorities (SSCAs) may find it necessary to require industry to fund associated costs.
These costs may include sample collection, screening, transportation, analysis, inspection,
enforcement, and other related expenses.