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Specific                                  NSSP Guidance Documents, Chapter II

 

Reference:                           

CONSTITUTION BY-LAWS and PROCEDURES of the INTERSTATE SHELLFISH SANITATION CONFERENCE

PROCEDURE XVI. PROCEDURE FOR ACCEPTANCE AND APPROVAL OF ANALYTICAL METHODS FOR

THE NSSP

And:

NATIONAL SHELLFISH SANITATION PROGRAM

2002 MODEL ORDINANCE WORKING DOCUMENT

 

III. LABORATORY

@. 02 Methods.

C. Biotoxin. Methods for the analyses of shellfish and shellfish harvest waters shall be:

(1) The current AOAC and APHA methods used in bioassay for paralytic shellfish poisoning toxins;

 

Text of Proposal/               For many years, there has been an expression of need by regulatory agencies and industry to develop

Requested Action:              a non-animal PSP test to monitor PSP levels with precision and accuracy.

 

The method developed by Jellett Rapid Testing Ltd has been presented to the ISSC and other

regulatory bodies over the past several years. In cooperation with individuals, governments and those

organizations, the analytical method has been refined and improved. The Rapid Test kits have been

tested in several states and foreign countries, and independent papers have been published attesting

to the validity, reproducibility and reliability of these test kits.

 

The CONSTITUTION BY-LAWS and PROCEDURES of the INTERSTATE SHELLFISH SANITATION

CONFERENCE allows the ISSC, through the Laboratory Methods Review Committee, to accept

analytical methods that are sufficiently validated but are not AOAC or APHA methods. This is defined

in the Constitution, PROCEDURE XVI. PROCEDURE FOR ACCEPTANCE AND APPROVAL OF

ANALYTICAL METHODS FOR THE NSSP. Two possible reasons for considering a method are found in

Subdivisions i and ii.

 

Subdivision i. Meets immediate or continuing need;

Subdivision ii. Improves analytical capability under the NSSP as an alternative to other approved or

accepted method(s)

 

The need for alternative methods has been expressed by regulatory agencies, governmental

organizations and industry for many years. The Jellett Rapid Test for PSP has been validated

extensively to demonstrate its simplicity, reliability, precision and accuracy. As a result of ongoing

improvements and demonstrations of efficacy, and the need that has been expressed by industry and

state agencies, the Jellett Rapid Test for PSP is presented as a screening method for the NSSP as a

Type III or Type IV method.

 

Please see attached list of supporting information.

 

Suggested wording:

 

C. Biotoxin. Methods for the analyses of shellfish and shellfish harvest waters shall be:

(1) The current AOAC and APHA methods used in bioassay for paralytic shellfish poisoning toxins;

(2) The Jellett Rapid Test for PSP may be used as a screening method for PSP toxins

by regulatory and industry laboratories.

 

Public Health                        Public Health Significance: {Include appropriate documentation of both the problem and public health

Significance:                         significance such as literature references or data. Inadequate information may result in a

recommendation of “No Action” by the Issue Review Committee or Task Force.}

 

Currently, only data from certified laboratories conducting PSP analyses using the Mouse Bioassay

(MBA) are considered reliable and acceptable. Because of many significant constraints, in practical

terms, this means that only state laboratories (in the US, governmental laboratories in other

countries) can provide acceptable data at this time. However, acceptance of the Jellett Rapid Test for

PSP would allow harvesters, processors, and regulatory agencies to screen for PSP with an accepted

method that provides valid useable data.

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SSC 2003 Summary of Actions                                                                                                                        Page 62

 

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The Jellett Rapid Test for PSP was developed over several years in answer to the oft-stated need for a

rapid, reliable, non-animal analytical method that could be used to supplement the Mouse Bioassay.

 

Possible applications for The Jellett Rapid Test for PSP include:

- as a method of screening out negative samples in shellfish regulatory labs;

- as a harvest management tool at aquaculture facilities or in wild shellfish harvest areas

(especially near shore areas) to determine if shellfish are free of PSP and safe to harvest;

- as a quality control tool for shellfish processing plants, distributors and wholesalers to ensure

incoming shellfish are free of PSP toxins before processing or further distribution (this test could

become part of the plant's HACCP program);

- as a tool for water classification for biotoxins;

- to assist in site selection for aquaculture activity;

- as a screening tool for toxic phytoplankton in seawater to provide an early warning for shellfish

growers; and

- as a research tool for broad scale ecological monitoring.

 

The rationale for using the Jellett Rapid Test for PSP is that the kits provide a cost-effective screen

(especially in low-volume laboratories) for PSP that can substantially reduce the need for live animal

testing and the attendant care and disposal considerations. As a harvest management tool, the use of

the Jellett Rapid Test for PSP will supplement regulatory agency efforts and help prevent the harvest

of contaminated product. Having the ability to conduct tests using an accepted method will allow

those processors who choose to use this test to demonstrate that they are truly controlling for PSP

hazards in the harvested shellfish.

 

A simple, rapid, effective, reliable test, available to all harvesters, regulators, and processors, would

increase the monitoring and reduce the chance that shellfish containing PSP toxins above the

regulatory limit would be harvested or marketed.

 

Cost Information                 Each test kit costs $20. It has been reported that each analysis using the Mouse Bioassay costs

(if available):                       approximately the same for a large-volume laboratory, but substantially more for small-volume

laboratories. However, the costs cited do not take into account the costs associated with maintaining

animal care facilities, proper disposal of the test animals, and the dangers associated with injecting

live hand-held animals with toxic materials. In the worst case, it is no more expensive than the Mouse

Bioassay.

 

ACTION BY 2003                  Recommended adoption as a Type IV method with the following restrictions:

LAB METHODS                      i. Method can be used to determine when to perform a mouse bioassay in a previously closed

REVIEW & LAB QA               area.

COMMITTEES                        ii. A negative result can be substituted for a mouse bioassay to maintain an area in the open status.

 

Recommended the Executive Board charge the appropriate committee with reexamination of this

method at the 2005 Conference.

 

Recommended modifying Guidance Document Chapter II Growing Areas Table A. 10. Type III and

Type IV Marine Biotoxin Methods as follows: Insert Type IV under other for Growing Area Survey &

Classification, shellfish with the following footnote: The Jellett Rapid Test for PSP.

 

ACTION BY 2003                  Recommended adoption of Proposal 03-116 as amended by the Laboratory Methods Review

TASK FORCE I                       Committee and Lab Quality Assurance Committee, with the addition of: iii. A positive result can be

used for a precautionary closure.; and Lab Quality Assurance Committee including the checklist

 

ACTION BY 2003                  Adopted recommendations of 2003 Task Force I.

GENERAL ASSEMBLY

 

ACTION BY USFDA                 Concurred with Conference action with the following comments:

 

FDA concurs with adoption of Proposal 03-116 to accept the Jellett rapid PSP test as a tool for states

to use in the control of PSP in shellfish. However, several important caveats placed on use of the

Jellett rapid PSP test were not clearly stated in the Summary of Actions. They are:

 

1. Use of the Jellett PSP test must be based on the currently approved procedure for PSP toxin

extraction. No other extraction procedures have been validated and approved for use under

___________________________________________________________________________________________

ISSC 2003 Summary of Actions                                                                                                                  Page 63

 

___________________________________________________________________________________________

 

the NSSP, including those provided by Jellett Rapid Testing Ltd.

2. When employing only the Jellett rapid PSP test to screen for saxitoxins, the Shellfish Authority

shall make precautionary closures when positive results occur.

 

ACTION BY ISSC                   Concurred with the USFDA.

EXECUTIVE BOARD

 

___________________________________________________________________________________________

ISSC 2003 Summary of Actions                                                                                                                  Page 64