Attachment 1 - VS Memo 567.2 v2.pdf

VETERINARY SERVICES MEMORANDUM NO. 567.2

C. Each protocol must state (or a submitted manual covering all of the protocols must contain a blanket statement) that samples for export health certification testing will only be accepted from a Federal or APHIS-accredited veterinarian, a State veterinarian, or personnel appropriately designated and supervised by the veterinarian. The protocol must further state that samples will be accepted for testing only if the following information is included:

1. Name and address of the submitting veterinarian;

2. Name and address of the owner of the aquatic animals being tested;

3. Specific information adequately identifying the location site from which samples are being submitted. Location information should include the farm registration number if samples originate from an APHIS-registered facility;

4. Identification of the animals sampled (including age, species, sex, and other identification such as individual identification numbers, or cage, pond, tank, raceway, and lot numbers);

5. Sample tissue type and preservatives used, if any; and

6. Date of sample collection and submission.

D. Each protocol must state that positive or suspect test results for OIE-notifiable aquatic animal pathogens from assays conducted for any purposes will be reported following reporting requirements as outlined in VS Memorandum

567.6. The protocol must further state that test results will include the date of sample collection and test completion, name and address of the laboratory, the type of assays performed, and the name of the manufacturer of any test kits used.

E. The laboratory should submit sample copies of the diagnostic reports intended for use.

F. The laboratory should develop and maintain appropriate quality assurance and quality control plans.

VI. VS AREA OFFICE RESPONSIBILITIES

A. When a laboratory inquires about APHIS approval, the AVIC will send a copy of attachments 1 and 2 to the requester. The AVIC should discuss the requirements for laboratory approval with the laboratory director or other appropriate individual.

B. Upon receipt of the laboratory’s application for APHIS approval, the AVIC will review and confirm that it contains all required information. If the application is determined to be deficient or incomplete, the AVIC should inform the laboratory of the deficiency and let the laboratory remedy the deficiencies and resubmit the application.

Attachment 1

REQUESTING APPROVAL FOR AQUATIC ANIMAL PATHOGEN TESTING

I. PURPOSE

This document describes procedures for applying for approval by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) to conduct specific pathogen detection and identification assays for aquatic animals, animal parts, embryos, and/or gametes intended for export.

II. ELIGIBILITY

A. All Federal, State, university, and private laboratories are eligible to apply for approval.

B. Laboratories may request to become APHIS-approved for any aquatic animal pathogen assay for which there is an accepted international protocol or for which export health certificates might reasonably be expected of U.S. producers, as determined by the National Veterinary Services Laboratories (NVSL).

III. PROCEDURES AND REQUIREMENTS

A. Contact the Veterinary Services (VS) Area Office in the State and inform the Area

Veterinarian in Charge (AVIC) of your intent to request approval. A list of VS Area Offices may be found at www.aphis.usda.gov/vs/area_offices.htm.

B. Submit an application on your letterhead to the VS Area Office. You may submit an electronic copy or two hard copies. The application should specify the following:

1. Name, physical location, and mailing address, if different from the physical address, of the laboratory;

2. Name of legally responsible official and, if different, the director of the laboratory;

3. A description, including a floor plan, of the laboratory facilities and equipment that will be used in performing pathogen detection assays.

4. A list of the specific diagnostic assays (by individual pathogen) for which approval is requested;

5. A detailed test protocol specific for detecting each pathogen listed in #4 above. Protocols should conform to an internationally recognized standard, such as the current edition of the World Organization for Animal Health (OIE) Manual of Diagnostic Tests for Aquatic Animals, or the current edition of the Standard Procedures for Aquatic Animal Health Inspections section of the Suggested Procedures for the Detection and Identification of Certain Finfish and Shellfish Pathogens, American Fisheries Society, Fish Health Section, Bethesda, Maryland, commonly referred to as the AFS Blue Book (www.afsbooks.org/x70314cxm1.html);

6. A list of the names of individuals performing specific tests and their professional or technical qualifications; and

7. A statement indicating that samples used to conduct assays are held under proper storage conditions in order to repeat the assay with that sample, if necessary, for at least 30 days after results are reported.

C. Each protocol must state (or a submitted manual covering all of the protocols must contain a blanket statement) that samples for export health certification testing will only be accepted from a Federal or APHIS-accredited veterinarian, a State veterinarian, or personnel appropriately designated and supervised by the veterinarian. The protocol must further state that samples will be accepted for testing only if the following information is included:

1. Name and address of the submitting veterinarian;

2. Name and address of the owner of the aquatic animals being tested;

3. Specific information adequately identifying the location site from which samples are being submitted. Location information should include the farm registration number if samples originate from an APHIS-registered facility;

4. Identification of the animals sampled (including age, species, sex, and other identification such as individual identification numbers, or cage, pond, tank, raceway, and lot numbers);

5. Sample tissue type and preservatives used, if any; and

6. Date of sample collection and submission.

D. Include in the protocol a statement that positive or suspect test results for the OIE notifiable aquatic animal pathogens from assays conducted for any purposes will be reported following reporting requirements as outlined in VS Memorandum

567.6. The protocol must further state that test results will include the date of sample collection and test completion, name and address of the laboratory, the type of assays performed, and the name of the manufacturer of any test kits used.

E. Submit sample copies of the diagnostic reports intended for use.

F. Develop and maintain appropriate quality assurance and quality control plans.

IV. APPROVAL

A. The AVIC and other VS staff will designate appropriate personnel to schedule and conduct a site visit and confirm that information in the laboratory’s application is correct.

B. NVSL will provide oversight and approval of the laboratory procedures on a case-by-case basis. Biennial site visits of approved laboratories by the AVIC or designated personnel are required. During these site visits, ongoing compliance with this memorandum will be reviewed, in particular that all approved protocols are the only protocols used for export testing purposes. To verify this, the AVIC may request supporting pathogen detection and identification assay documentation for results used to support specific export health certificates that were endorsed through the relevant VS Area Office. User fees will apply as specified in title 9 of the Code of Federal Regulations, parts 130 and 156.

C. APHIS will inform laboratories of their approval status and will add them to VS’ online list of approved laboratories.

V. CHANGES TO LABORATORY PROTOCOL

To propose a change in assay protocols, submit the proposed changes in advance in writing to the AVIC, who will forward them to NVSL for review. NVSL will ensure that proposed protocols meet the standards in III.B.5. and will determine if approval is warranted. If the modification to the protocol is approved, NVSL will notify the laboratory, AVIC, the Director of ASEP, and the relevant VS Regional Director of such changes and approvals. Laboratories that generate results based on modified protocols that have not received written approval from NVSL risk losing approval status.

VI. REMOVAL OF LABORATORY APPROVAL

The AVIC may withdraw laboratory approval when a laboratory requests removal or upon the recommendation of NCIE, the Director of NVSL, or the Director of ASEP when any of the criteria for approval are no longer met. If the laboratory is approved to perform pathogen detection assays for more than one pathogen, removal may apply either to specified assays or to all assays for which the laboratory is approved.

Laboratories voluntarily requesting removal should do so in writing to the AVIC. The AVIC will forward the request directly to NVSL for removal from the list. If APHIS recommends the removal of the laboratory, the laboratory will be informed of the removal of approved status and the reasons for doing so in a letter signed by the Associate Administrator for VS. Laboratories whose approval is withdrawn may re-apply when all deficiencies have been addressed.

Attachment 2

SITE VISIT CHECKLIST

Laboratory Inspection for Aquatic Animal Diagnostic Testing for Export

Laboratory name:________________________________________________________

Laboratory Director:______________________________________________________

Laboratory contact (if different from Laboratory Director):_______________________

Telephone no.________________________ Fax no.____________________________

Laboratory address (physical location):

Mailing address (if different from above):

Shipping address for supplies and proficiency tests (if different from above):

Name of person or persons and job title that accompanied the APHIS VS Inspector during the inspection

List laboratory personnel and the testing methods for aquatic animal pathogen detection conducted in the laboratory (use additional sheet if necessary).

Aquatic Pathogen Laboratory Personnel Testing Method

Inspector: _____________________________ Title:_____________________________

Date: _____________________

Telephone Number of Inspector:_____________________________________________

Signature of Laboratory Director: ____________________________________________

Laboratory Site Visit

Section Item Yes No Notes

Laboratory Separate rooms or areas are used when appropriate.

Note specific usage on report (e.g. DNA/RNA extraction, etc.)

Adequate bench space is available to perform test (s) without compromising the integrity of assays performed within or adjacent to dedicated workspace.

Sink is available in work areas with hot and cold running water.

Laboratory temperature is maintained at all times between 68 and 77°F (20 and 25°C).

Laboratory equipment is clean and neatly stored Laboratory design, biosecurity, and equipment are appropriate for containment of the specific pathogens handled during testing.

Personnel Signed bench logs are kept for all approved assays indicating the identity of the technician performing the assay.

Training records noting specific courses (or other required or elective training instruction) are kept for technicians performing approved assays.

Laboratory Supplies and Equipment

Individual written protocols were reviewed with staff to determine that supplies and equipment are available to perform the tests on a pathogen-specific basis.

Equipment required to perform the tests is present as described in the protocol previously submitted to and approved by NVSL.

Equipment is monitored for performance and accurate calibration, and routine maintenance logs are maintained.

Logs are maintained for equipment and supplies indicating expiration dates of time-sensitive materials. No outdated reagents are present in the laboratory.

Control of Specimens and Reporting

Required of all approved laboratories

Receiving area is separate from laboratory where testing is being done.

Laboratory assigns a unique accession number to each sample in a logbook or file, which is readily accessible.

Specimens that are not appropriately identified or in poor condition are not tested.

Specimens are received with proper identification according to section V.C. 1 through 6 of VS Memorandum 567.2.

A temperature log is maintained for all samples indicating temperature on receipt at the laboratory, and subsequent temperature at which samples were maintained until testing.

The identification of the specimen is maintained on the worksheets and on test samples in permanent ink.

The test results for each sample are recorded on a worksheet in permanent ink.

The test results are recorded in a reporting format easily and clearly identifiable as described in section V.D. of VS Memorandum 567.2.

Specimens are held under proper storage conditions for at least 30 days after results are reported.

Test Procedure The procedure that is outlined in the approved test protocol is being followed.

Reagents are stored appropriately.

Tests in progress (if applicable) should be reviewed during the inspection process to ascertain that the protocols are being followed and properly recorded.

Records of any required or elective proficiency testing or other quality control procedures should be reviewed and summarized in the report.

Building The building is in good repair.

The laboratory is separated from the office and other storage areas by partitions with doors.

Adequate lighting is available―1000 lumens per square meter (min.) of bench space is recommended.

Restrooms are available, clean, and in good repair.

Cleanliness Laboratories are free of rodents, insects, and other pests.

Appropriate disposal equipment (receptacles, sinks, etc.) are located in ways to minimize laboratory cross-contamination. Note number and location of these on report.

All refuse is placed in proper containers and removed daily.

Clean laboratory clothes (coats) are provided and being worn. Latex gloves are used for all assays.

Only laboratory equipment and supplies are within the laboratory; NO animals, personal clothing, eating utensils, household goods, etc., are present in the laboratory.

All floors, benches, equipment, etc., are clean and disinfected regularly.

Biosecurity Laboratory has written biosecurity protocols covering biological containment, fire, flood, loss of power, and other emergency procedures.

ADDITIONAL REMARKS:

Laboratory is: Satisfactory Unsatisfactory (circle one)

APHIS VS Inspector’s signature Date

APHIS VS Inspector’s name (printed)

APHIS VS Area Office Contact’s signature Date

APHIS VS Area Office Contact’s name (printed)