Russia Poultry Laboratory Verification Program
Background
Representatives of the Government of the United States of America and the Government of the Russian Federation met in Washington D.C. on March 21-25, 1996, to discuss the exportation of poultry products from the United States to Russia. At that time, it was agreed that supplemental testing for certain pesticides, antibiotics, heavy metals and Salmonella would be required for the Food Safety and Inspection Service (FSIS) signature of the Veterinary Certificate for Poultry Meat Exported into the Russian Federation.
The tests for pesticides, antibiotics, heavy metals, and Salmonella may be performed either by government or private laboratories with the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) verifying the reliability of test results provided by private laboratories. The verification of the reliability of private laboratory results necessitates the development by AMS of a private laboratory review program. This document outlines the protocol for the Laboratory Verification Program for the Analysis of Poultry Products Destined for Exportation from the United States to Russia.
It must be understood that the approval afforded under this laboratory verification program is only for the testing required on poultry exported to the Russian Federation. Laboratory acceptance into this program does not confer a general USDA laboratory approval nor does it confer approval of the performance of the program analyses on any product other than poultry to be exported to the Russian Federation.
Analytical Requirements
Laboratories applying for entrance into the verification program must be able to analyze poultry products for the following residues by the method indicated:
A. Pesticides, AOAC Official Method 970.52, Organochlorine and Organophosphorus Pesticide Residues
Pesticide Action Level, Fat Tissue
1 BHC 0.30 ppm
2. Chlordane 0.30 ppm
3. Dieldrin 0.30 ppm
4. Aldrin 0.30 ppm
5. DDT and metabolites 5.00 ppm
6. Endrin 0.15 ppm
7. Heptachlor 0.20 ppm
8. Heptachlor epoxide 0.20 ppm
9. Lindane 4.00 ppm
10. Methoxychlor 3.00 ppm
11. Toxaphene 7.00 ppm
12. Hexachlorobenzene 0.50 ppm
B. Heavy Metals, EPA - SW846, Methods for the Evaluation of Solid Waste
Heavy Metal Action Level, Muscle Tissue
1. Mercury 0.03 ppm
2. Lead 0.50 ppm
3. Cadmium 0.05 ppm
C. Antibiotics, AOAC International Official Method 995.09, Chlortetracycline, Oxytetracycline, and Tetracycline in Edible Animal Tissues, Liquid Chromatography Method
Antibiotic Action Level, Muscle Tissue
1. Chlortetracycline 1.00 ppm
2. Oxytetracycline 1.00 ppm
3. Tetracycline 0.25 ppm
D. Salmonella, any AOAC International official status method that specifies: All Foods; Raw, Highly contaminated foods; or Poultry; and tests for all Salmonella (both motile and non-motile)
III. PROGRAM ADMISSION REQUIREMENTS
A. Initial Request for Admission
Any laboratory seeking admittance into the verification program must send a letter requesting admittance to the Technical Services Branch (TSB) of the Science and Technology Division (STD) at the following address:
Shirley J. Wright, Chemist
USDA, AMS, STD, TSB
P.O. Box 96456, Room 3521-South
14th & Independence Avenue, S.W.
Washington, DC 20090-6456
(202) 720-8556
B. Submittance of Completed Admission Kit
AMS will send an admission kit to each laboratory making a written request for admission into the program. The kit will contain the following:
1. A letter stating the parameters of the program, including fees. AMS will set fees based on the cost of laboratory analysis of split samples, the cost of check samples, and administrative costs. The fee for the year of entrance into the program will be higher than that of subsequent years. The fees will be examined yearly to assure that the program is self-supporting.
2. A document specifying the technical details of the program.
3. An application for detailing the education and training of analysts, the physical condition of the laboratory, the capabilities of the laboratory with regard to the required analytical testing, and the poultry plant(s) they will be servicing.
4. A request for a statement from a poultry plant specifying that they will be using the laboratory seeking admittance. The statement must be on company letterhead and signed by an appropriate plant official.
5. A request for submission of standard operating procedures (SOP's) on the maintenance and calibration of equipment and instrumentation, and quality control procedures followed in the laboratory. Also requested is an SOP of the analytical procedure(s) to be performed. A photocopy of a published method is not sufficient. The exact procedure as followed in the laboratory is required.
6. A request for a signed statement from the Laboratory Director stating that the laboratory will only use the methods specified by AMS for the analysis of poultry product for exportation to Russia.
7. A request for designation of the group(s) of residues the laboratory wishes to analyze in the program. A laboratory may be admitted to test any or all of the following groups
(a pesticides,
(b heavy metals,
(c) antibiotics, and
(d) Salmonella.
Note: Partial testing of groups will not be permitted.
C. Review of Documents Submitted
AMS will review the SOP's and make recommendations where necessary. Laboratories must respond to the recommendations before the laboratory is considered for inclusion in the program.
D. Testing of Initial Split Sample
Before acceptance into the program, a split sample for pesticides, heavy metals, and antibiotics must be tested for the residues specified by the program. Check samples for the presence or absence of Salmonella must also be performed before acceptance into the program. All results must conform to the standards of agreement with STD laboratory results as determined by AMS.
E. Issuance of Acceptance
A letter will be issued by AMS to those laboratories attaining acceptance into the program. A copy of this letter must be provided to the FSIS Inspector-In-Charge along with the laboratory's first set of test results on split samples.
IV. CRITERIA FOR MAINTAINING PROGRAM STATUS
To maintain program status a laboratory must analyze poultry products for export to Russia at the intervals specified in the Protocol on Measures for the Fulfillment of the "Veterinary Certificate for Poultry Meat Exported in the Russian Federation", March 25, 1996. Laboratories will only test for those residue groups for which they have been approved.
A. Annual Split Sample Testing for Pesticides, Heavy Metals, and Antibiotics
Split sample testing for the pesticides, heavy metals, and antibiotics listed in Section II. Analytical Requirements will be performed annually on samples collected, deboned, and composited from six individual farms producing poultry for export to Russia. The composited sample will be sent to the following laboratory:
Attn: Lawrence H. Lagman, Chemist
USDA, AMS, STD, Eastern Laboratory
645 Cox Road
Gastonia, North Carolina 28504
Samples must be shipped for next day delivery in a styrofoam container with enough frozen reusable ice packs to insure delivery of a product that is cold to the touch. The sample will be further prepared and split at the AMS Laboratory, with half of the sample being sent to the private laboratory for testing, along with the frozen reusable ice packs, and the remaining half being analyzed by the AMS Eastern Laboratory.
Testing of the split sample by the program laboratory will be done expeditiously and results sent to the program manager at the following address:
Shirley J. Wright, Chemist
USDA, AMS, STD, TSB
P.O. Box 96456, Room 3521-South
Washington, DC 20090-6456
The program laboratory will test the split sample only for those groups of residues for which they have been approved.
B. Twice Yearly Check Sample Testing for Salmonella
Each program laboratory approved for Salmonella testing will be required to correctly analyze two sets of check samples per year for Salmonella. One set will consist of three samples, the second set will consist of two samples.
All split and check sample results must conform to the standards of agreement with the reference AMS laboratory results as determined by AMS. A letter stating laboratory status in the program will be sent by AMS to the laboratory after review of the analytical results. A copy of this letter must be presented to the FSIS Inspector-In-Charge with the next set of laboratory results. In the event that split sample results for pesticides, heavy metals, or antibiotics do not conform to the standards of agreement with the reference AMS laboratory results as determined by AMS, the laboratory will have 30 days to submit a second sample for preparation and splitting by the Eastern laboratory. The split sample will then be tested for those residues that did not meet requirements on the initial sample. If the test results conform to the standards of agreement with the AMS laboratory, the program laboratory will be retained in the program. If they do not, the laboratory will be removed from the program.
In the event that the results of the check sample analysis for Salmonella do not agree with the expected results, a second set of samples will be sent to the participating laboratory for analysis. If these results conform to the expected results, the program laboratory will be retained in the program. If they do not, the laboratory will be removed from the program.
V. REMOVAL FROM THE VERIFICATION PROGRAM
A. Voluntary Removal
A laboratory may voluntarily remove itself from the program at any time by written request to AMS.
B. Involuntary Removal
A laboratory may be involuntarily removed from the verification program for the following reasons:
1. Failure to use methods specified by AMS in Section II. Analytical Requirements.
2. Failure to report required testing results in an expeditious manner.
3. Failure of program laboratory results to agree with AMS laboratory results on both the regularly scheduled sample and the subsequent recheck sample.
Note: A laboratory that has been removed from the program due to poor analytical performance must wait six months before reapplying.
VI. PROGRAM RESPONSIBILITIES
A. Laboratories
It is the responsibility of the laboratory to:
1. Submit all information and forms required in the Admission kit.
2. Promptly pay the initial fee required for acceptance into the program, and the annual fee thereafter.
3. Test samples as required using AMS standard methods only.
4. Report all results of split samples or check samples by the AMS set deadline.
5. Arrange for the plant they are servicing to:
a. Provide product for residue testing. The product is collected, deboned, and composited from individual farms producing poultry for export to Russia.
b. Insure that product for residue testing contain a representative amount of fatty material in that the pesticides specified in the program are stored primarily in the fatty tissue.
c. Ship product for annual split samples to the AMS Eastern laboratory at the following address:
Attn: Lawrence H. Lagman, Chemist
USDA, AMS, STD, Eastern Laboratory
645 Cox Road
Gastonia, North Carolina 28504
B. AMS
It is the responsibility of AMS to:
1. Review admission data and determine which laboratories will be admitted into the program on the basis of that data, and the results of the initial split sample for residue testing and check samples for the determination of the absence or presence of Salmonella.
2. Send a reminder of the split sample requirement one month before the anniversary date of the split sample, and request that product be sent to the AMS Eastern Laboratory on a particular date.
3. Prepare the split sample and ship it to the participating laboratory, setting a deadline date for completion of analytical testing.
4. Prepare check samples for Salmonella testing and mail to the participating laboratory.
5. Analyze split samples for pesticides, antibiotics, and heavy metals and serve as the reference laboratory.
6. Maintain files on each laboratory admitted into the program.
7. Issue all letters pertaining to the status of laboratories in the laboratory verification program.