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Peanut Aflatoxin Program - Laboratory Approval Procedures  

 

 
The request must include a letter(s) from one or more handlers (shellers) stating their intent to use the laboratory to analyze peanuts. The laboratory is then sent an admission kit which contains the following items.

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

 
A copy of the general laboratory checklist.

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

 
The completed admission kit is sent to Lingsu Zhang, Program Manager. Upon receipt, it 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.

 
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 peanuts 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 peanuts 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 and determined if they are acceptable. In order to be acceptable, each sample result must be within 80-110% of the known value of the sample.

 
If results are not acceptable, the Program Manager will work with the 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 peanuts 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 peanuts.

 
Five samples of peanuts 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 and determined if they are acceptable. In order to be acceptable, each sample result must be within 80-110% of the known value of the sample.

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

 
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 peanut 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 Standard Operating Procedures (QA/QC 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.

 
Payment of Admission Fee

 
A non-refundable fee of $7,200.00 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 peanuts for aflatoxin for one year. The fee will be reviewed yearly and, if necessary, adjusted to meet USDA operational costs.

 
Descriptive Word Phrase of the Approved Methodology Listed for Official Certificates

 
Each laboratory approved for the USDA peanut aflatoxin program must insert a descriptive word phrase of the methodology for which it is approved on each official peanut aflatoxin analysis certificate that it issues. This phrase must indicate a complete description (not an official methodology citation) of the analytical method used for the total aflatoxin (sum of B1+ B2 + G1 + G2) determination. The word phrase denoting the method of analysis is limited to one of the following choices on each official certificate issued:

 
1. An immunoaffinity column with direct fluorometry method of analysis.
2. Water Slurry Method with thin-layer chromatography (TLC) analysis, designated as the Alternative Best Foods (BF) method of analysis.
3. An immunoaffinity column cleanup with high performance liquid chromatography (HPLC) method.
4. Verotox® Quantitative Aflatoxin Single Test (AST) competitive direct enzyme-linked immunosorbent assay method of analysis.

 
Administrative Definition of Negative Aflatoxin Test Result Included

 
Each approved laboratory in the USDA Aflatoxin in Peanuts Domestic Laboratory Approval Program must have an administrative definition of a negative aflatoxin test result on each official peanut analysis certificate it issues to read as follows:

 
The designation of Aflatoxin Negative is defined as the average analytical result of 15 parts per billion (ppb) or less aflatoxin and applies to product distributed within the United States under 7 CFR Part 996.

 
Scope of the Laboratory Approval Denoted

 
Due to the specific applicability of the approved total aflatoxin determination methods for only United States or domestic trade, a USDA-approved laboratory testing under 7 CFR Part 996, must place on each official certificate it issues a phrase denoting the limitation of the laboratory approval as follows:

 
USDA laboratory approved to test for total aflatoxin content in samples for domestic and imported peanuts marketed in the United States.

 
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Additional Information image
 
  Background  
 
  Laboratory Approval Procedures  
 
  Maintaining Program Status  
 
  Removal from the Program  
 
  Readmission to the Program  
 
  Complaint and Appeal Process  
 
See Also
 
  LATD - Laboratory Approval Home Page  
 
 
  Last Modified Date: 02/04/2014