August 2002 Sample Distribution
Purpose of USDA/GIPSA Proficiency Program
Through the USDA/GIPSA Proficiency Program, USDA seeks to improve the overall performance of testing for biotechnology-derived grains and oilseeds. The USDA/GIPSA Proficiency Program helps organizations identify areas of concern and take corrective actions to improve testing capability and reliability.
In August 2002, USDA/GIPSA’s Technical Services Division mailed samples to thirty-three organizations that voluntarily agreed to participate in the USDA/GIPSA Proficiency Program. Participants included organizations from the U.S., Europe, Asia, and South America. Each participant received twelve ground corn samples and three ground soybean samples (approximately 20 g in each sample). The corn samples were either control samples containing no biotechnology events or fortified samples containing any combination of the following events: T25, CBH351, MON810, GA21, E176, Bt11, and NK603. The soybean samples were either control samples containing no biotechnology event or fortified samples containing the Roundup Ready® event. Each participant received a study description, a Chain of Custody form, and a data report form by regular mail and electronic mail. Participants submitted results by electronic mail, FAX, or regular mail. The participants were asked to provide qualitative results only; i.e., absence or presence of the specific biotechnology event. No methodologies were specified, and organizations used DNA- and protein-based technologies. Thirty-one participating organizations returned results by the agreed date.
The attached GIPSA Proficiency Program Summary Table summarizes the data submitted. The performance of the participant for each event for which data were provided is expressed as percent (%) correct. No distinction was made between false negatives or false positives. For example, the twelve corn samples either contained or did not contain T25, and the percent correct was obtained by dividing the number of correct responses by the total number of responses provided. Those organizations giving GIPSA permission are listed by name in this report (Attachment 1) Those organizations giving GIPSA permission are also listed by name in the Proficiency Program August 2002 Summary Table (Attachment 2); all other organizations were assigned a Participant Identification Number.
General observations from the GIPSA Proficiency Program for August 2002:
1. The Proficiency Program had a total of thirty-three (33) participants: Seventeen (17) from the U.S., eight (8) from Europe, four (4) from Asia, and four (4) from South America.
2. Thirty-one (31) of thirty-three (33) participants submitted results. Two participants did not submit results due to competing demands.
3. Participants used both DNA-based testing (conventional and real time PCR) and protein-based testing (Lateral Flow Strip and Microtiter Well Plate):
· Two (2) organizations used protein-based testing exclusively, seven (7) organizations used a combination of DNA- and protein-based testing, and twenty-two (22) organizations used DNA-based testing exclusively
· Thirteen (13) organizations provided DNA-based results for all corn events (including 35S and NOS) and the soybean event
· Four (4) organizations provided DNA-based results for eight (8) corn events
· Two (2) organizations provided DNA-based results for seven (7) corn events
· Two (2) organizations provided DNA-based results for six (6) corn events
· One (1) organization provided DNA-based results for five (5) corn events
· Three (3) organizations provided DNA-based results for three (3) corn events
· One (1) organization provided DNA-based results for two (2) events
· Three (3) organizations provided DNA-based results for one (1) corn event
· One (1) organization provided a protein-based result for T25
· Four (4) organizations provided a protein-based result for CBH351
· One (1) organization provided a protein-based result for NK603
· Four (4) organizations provided a protein-based result for Cry1Ab
· Twenty-nine (29) organizations provided DNA-based results for the soybean event and eight (8) organizations provided protein-based results for the soybean event
4. Fourteen (14) participants were 100% correct in identifying the presence or absence of all events for which they reported results.
5. A Summary Table has been prepared that shows the performance of participants to analyze for the events using protein-based and/or DNA-based tests.
6. All results reported by participants were scored using the same criteria--% correct. It is important to understand that a negative result where the target analyte is below the limit of detection is not technically wrong or “incorrect,” nor does an incorrect result necessarily imply a fault with the test and/or operator when the analyte level is below the limit of detection. It is always important to consider the limit of detection when interpreting results. A negative result does not mean the sample does not contain the event; it simply means that the sample may not contain the event, or the sample may contain the event at a level below the limit of detection.
7. In the Summary Table for protein-based results, the column “Cry1Ab” reflects the presence of MON810 and/or Bt11 in the samples. Events MON810, E176, and Bt11 all produce the Cry1Ab protein, and, therefore, it is impossible when using a protein-based test to differentiate among these events when a positive result is obtained. In addition, the Cry1Ab protein is produced at varying levels among these events. Event 176 produces very low levels of the Cry1Ab protein, with MON810 and Bt11 producing higher levels. For scoring purposes, the sample was considered positive for the Cry1Ab protein if it contained MON810 and/or Bt11. It is important to recognize that the level of Cry1Ab protein in the proficiency samples may be below the limit of detection for some protein-based tests. Therefore, a negative result for the sample does not indicate the absence of the Cry1Ab protein or necessarily imply a fault with the test or analyst.
November 2002 Sample Distribution
The next distribution of samples is scheduled for November 2002. To obtain additional information on the GIPSA Proficiency Program, contact Don Kendall by phone at US 816-891-0463 or e-mail at firstname.lastname@example.org.
The following organizations gave GIPSA permission to identify them as participants in the GIPSA Proficiency Program:
Hatboro, PA 19040
Contact Fernando Rubio
Company Biogenetic Services, Inc.
Address 32nd Avenue
Bookings, SD 57006
Contact Alex Kahler
Company California Seed and Plant Lab, Inc.
Address 7877 Pleasant Grove Road
Elverta, CA 95626
Contact Parm Randhawa
Address 101 Woodland Highway
Belle Chasse, LA 70037
Contact Frank Spiegelhalter
Address 501 Dimick Drive
Fairfield, Iowa 52557
Contact Jane Pappin
Telephone 641-472-9979, ext. 122
Address 700 Chesterfield Parkway North
Mail Zone: BB5k
St. Louis, MO 63189
Contact Ming Y. Deng, Ph.D.
Phone (636) 737-5854
Fax (636) 737-6134
Company OMIC USA Inc.
Address Laboratory and Inspection
1200 NW Naito Parkway
Portland, OR 97209
Contact Farin Hajar, DNA Laboratory Manager
Company Silliker Laboratories of Iowa
Address 405 8th Ave SE
Cedar Rapids, IA 52401
Contact Dan Wetsch
Contact David Pinero
Address 620, rue Blaise Pascal, Z.I.
F-77555 Moissy Cramayel
Contact A Fatmi
Telephone 00 33 1 64 1337 16
Mobile 00 33 7 56 66524
Fax 00 33 1 64 1331 81
Address: Córdoba 1402 - City: Rosario - Argentina
Zip code: S2000AWV
Contact Juan José Giorda
Telephone 54-341-4211000 e-mail:
Address Via Isola Virginia 14
Contact Guy Van den Eede
Telephone +39 (0)332 78 5239
Fax +39 (0)332 78 5483
Anagawa 243-0041 Japan
Contact Satoshi Futo
Telephone 81 462 9587-87
Fax 81 462 9437-38
Company Food Industry Research Development Institute
Address No. 331 Shih-Pin Road
Contact Wen-Shen Chu
Telephone 886-3-5223191, ext 541
Company GeneScan Analytics GmbH, Bremen
Address Fahrenheitstrasse 1
Contact Matthias Foth
Address Engesserstrasse 4b
Contact Castor Menendez
Address Institute of Genetics
Trinity College Dublin
Contact Ronan Loftus, Ph.D.
Telephone +353 1 6083427
Fax +353 1 6798558
Company National Laboratory of Foods and Drugs, Department of Health
Address 161-2, Kuen-Yang street, NanKang
Contact Lih-Ching Chiueh
Contact Kumi Goto
Address Neguen 1087
S220XAC Sab Kirebzi
Contact Pablo Zaltz
Company Sistemas Genomicos S. L.
Address Valencia Technology Park
Benjamin Franklin Avenue 12
46980 Paterna (Valencia)
Contact Angela Perez
Contact Patricia Bonner
Telephone +353 1 8025871
Fax +353 1 8217320
Address Molecular Genetics Lab
BR452 Km 142
Contact Cristhiane Abegg Bothona