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Pistachio Program - Laboratory Approval Procedures - page 2  
A. Initial Request for Admission

 
A letter requesting admission into the program must be submitted to LATD-Laboratory Approval of the S&T program at the following address:

 
Isaac G. Sterling, Program Manager
Laboratory Approval & Testing Division
USDA, AMS, Science &Technology,
1400 Independence Ave. SW
Room 3533-S
Washington, D.C. 20250-0272
Telephone (202)720-5898

 
The Program Manager will then notify the Administrative Committee for Pistachios (ACP) of the laboratory's intent to become an approved laboratory. The ACP then determines if the laboratory has a client and is a legitimate applicant for participation in the program. Their determination is relayed to the LATD Program Manager by telephone or fax. If by telephone, written notification is to follow.

 
If the ACP determines that the laboratory has the necessary client and is a legitimate applicant, the laboratory is sent an admission kit which contains the following items.

 
1. A letter stating the parameters of the program, including the cost of the admittance and maintenance fees.

 
2. A copy of the general laboratory checklist.

 
3. A request for submission of Standard Operating Procedures (SOPs) for sample tracking, issuance of results, Quality Assurance/Quality Control (QA/QC), maintenance and calibration of equipment and instrumentation, and the official method once validated in the laboratory.

 
If the ACP has determined that the laboratory is not a legitimate applicant, the Program Manager will notify the applicant of that determination by letter.

 
B. Submission of Completed Admission Kit

 
The completed admission kit is sent to the Program Manager at the above address.

 
C. Review of Submitted Admission Kit

 
The admission kit is reviewed for completeness and acceptability. If it is incomplete or lacking in any area, recommendations will be made to the laboratory to rectify those areas.

 
D. Required Sample Testing

 
After the admission kit of a prospective laboratory has been determined to be satisfactory, the laboratory must demonstrate its ability to successfully analyze pistachios for aflatoxin. The fees for preparing, shipping, and reviewing sample results for admission to the program must be paid whether the laboratory is accepted into the program or not.

 
1.Testing of Five Samples Containing Known Levels of Aflatoxin

 
Five samples of pistachios containing known (to the applicant) levels of aflatoxin will be shipped to the laboratory. Samples are to be analyzed by the laboratory and results sent to the Program Manager within five working days after receipt. If samples cannot be analyzed within the time allotted, the laboratory must notify the Program Manager to obtain a waiver from the time requirement.

 
The sample results are reviewed by the Program Manager who determines if they are acceptable. In order to be acceptable, each sample result must be within 50-120% for <1 ppb, 70 to 110% for 1 to 10 ppb, and 80 to 110% for >10 ppb of the known value of the sample.

 
If results are not acceptable, the Program Manager will work with the prospective laboratory to determine why the analyses were unsatisfactory. Once the problem(s) is resolved, a second set of known samples may be shipped to the laboratory. If a laboratory fails to successfully analyze the second set of known samples, it may not reapply for admission into the program for at least six months.

 
2.Testing of Five Samples Containing Unknown Levels of Aflatoxin

 
Having successfully tested the five samples of pistachios containing known amounts of aflatoxin, the applicant then moves to the second stage of testing to demonstrate its ability to detect and quantify aflatoxin in pistachios.
Five samples of pistachios containing levels of aflatoxin known to USDA but not to the laboratory will be shipped to the laboratory. (Hereafter called unknown samples.) Samples are to be analyzed by the laboratory and results sent to the Program Manager within five working days after receipt. If samples cannot be analyzed within the time allotted, the laboratory must notify the Program Manager to obtain a waiver from the time requirement.

 
The sample results are reviewed by the Program Manager who determines if they are acceptable. In order to be acceptable, each sample result must be within 50-120% for <1 ppb, 70 to 110% for 1 to 10 ppb, and 80 to 110% for >10 ppb of the known value of the sample.

 
If results are not acceptable, the Program Manager will work with the prospective laboratory to determine why the analyses were unsatisfactory. Once the problem(s) is resolved, a second set of known samples may be shipped to the laboratory. If a laboratory fails to successfully analyze the second set of known samples, it may not reapply for admission into the program for at least six months.

 
E. Initial On-site Laboratory Review

 
S&T personnel will conduct an initial on-site laboratory review after the known and unknown samples have been successfully analyzed for aflatoxin. The review will include:

 
1. A Review of the Analytical Process; The analysis of pistachio samples will be observed in its entirety for adherence to official methodology and for analytical technique.

 
2. A Review of Quality Assurance and Quality Control (QA/QC) Standard Operating Procedures (SOPs); QA/QC SOPs will be reviewed with regard to their application and documentation.

 
3. A Review of SOPs on Sample Tracking and Issuance of Results; Sample tracking and issuance of results SOPs will be reviewed as applied and documented in the laboratory.

 
4. A Review of SOPs on the Maintenance and Repair of Instruments and Equipment; SOPs on the maintenance and repair of laboratory instruments and equipment will be reviewed with regard to the documentation of entries in their respective maintenance and repair logbooks.
Upon completion of the review, the Program Manager will determine whether to accept or reject the laboratory for admission into the program.

 
F. Payment of Admission Fee

 
A non-refundable admission fee of $8,280.00 must be paid in full to S&T before a laboratory is admitted into the program. This fee permits the laboratory to operate as an approved laboratory for the analysis of pistachio nuts for aflatoxin for one year. The fee will be reviewed yearly, and if necessary, adjusted to meet USDA operational costs.

 
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  Suspension or Removal from the Program  
 
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  Complaint and Appeal Process  
 
See Also
 
  LATD - Laboratory Approval Home Page  
 
 
  Last Modified Date: 01/23/2014