November 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 November 2002, USDA/GIPSA’s Technical Services Division mailed samples to forty-one organizations that voluntarily agreed to participate in the USDA/GIPSA Proficiency Program. Participants included organizations from the Africa, Asia, Australia, Europe, South America, and the U.S. 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-five participating organizations returned results by the established date for submitting reuslts.
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 November 2002 Summary Table (Attachment 2); all other organizations were assigned a Participant Identification Number.
General observations from the GIPSA Proficiency Program for November 2002
1. The Proficiency Program had a total of forty-one (41) participants: Nineteen (19) from the U.S., fourteen (14) from Europe, three (3) from Asia, three (3) from South America, one (1) from Africa, and one (1) from Australia.
2. Thirty-five (35) of the forty-one (41) participants submitted results. Six participants did not submit results for a variety of reasons, i.e., competing demands, staff shortages, etc.
3. Participants used both DNA-based testing (conventional and real time PCR) and protein-based testing (Lateral Flow Strip and Microtiter Well Plate)
· Thirty-three (33) organizations reported DNA-based testing results
· Seven (7) organizations reported protein-based testing results
· Two (2) organizations used protein-based testing exclusively, five (5) organizations used a combination of DNA- and protein-based testing, and twenty-eight (28) organizations used DNA-based testing exclusively
· Thirty-two (32) organizations reported results for 35S and thirty (30) organizations reported results for NOS
· Nineteen (19) organizations reported DNA-based results for all corn events, i.e., T25, CBH351, MON810, GA21, E176, Bt11 and NK603
· Three (3) organizations reported DNA-based results for six (6) corn events
· Two (2) organizations reported DNA-based results for five (5) corn events
· Two (2) organizations reported DNA-based results for four (4) corn events
· One (1) organization reported DNA-based results for three (3) corn events
· One (1) organization reported DNA-based results for two (2) corn events
· Three (3) organizations provided DNA-based results for one (1) corn events
· Two (2) organization provided DNA-based results for no specific corn events (they did report results for the 35S and NOS)
· Two (2) organization reported a protein-based result for T25
· Four (4) organizations reported a protein-based result for CBH351
· Three (3) organizations reported a protein-based result for NK603
· Three (3) organizations reported a protein-based result for Cry1Ab (MON810/Bt11)
· Thirty-two (32) organizations reported DNA-based results for the soybean event
· Six (6) organizations reported protein-based results for the soybean event
4. Accuracy of reported results among the participants using DNA-based testing
· Of the nineteen (19) organizations that reported DNA-based results for all corn and soybean events, eleven (11) correctly classified all samples for all events
· Six (6) organizations correctly classified all samples for all events for which they reported results
· Twenty-two (22) of thirty-three (33) organizations that reported DNA-based results for corn and soybeans events correctly classified the samples greater than 80 % of the time
5. Accuracy of reported results among participants using protein-based testing
· T25 event: Two (2) organizations using the Lateral Flow Strip tests to test for this event correctly classified 66.7 % of the samples
· CBH351 event:
- Two (2) organizations using the Lateral Flow Strip tests to test for this event correctly classified 100 % of the samples
- Three (3) organizations using the ELISA Plate tests to test for this event correctly classified 100 % of the samples
· NK603 event:
- Three (3) organizations used the Lateral Flow Strip tests to test for this event; one organization correctly classified 50 % of the samples, one organization correctly classified 66.7 % of the samples, and one organization correctly classified 100 % of the samples
- One (1) organization using the ELISA Plate tests to test for this event correctly classified 100 % of the samples
· MON810, Bt11 and E176 all produce the Cry1Ab protein, but because E176 produces a very small amount a sample was deemed to be positive for the Cry1Ab protein if it contained MON810 and/or Bt11:
- Two (2) organizations used the Lateral Flow Strip tests to test for this event; one organization correctly classified 75 % of the samples and the other organization correctly classified 83.3 % of the samples
- One (1) organization using the ELISA Plate tests to test for this event correctly classified 100 % of the samples
· Soybean event:
- Three (3) organizations using the Lateral Flow Strip tests to test for this event correctly classified 100 % of the samples
- Four (4) organizations using the ELISA Plate tests to test for this event correctly classified 100 % of the samples
6. Attachment 1 lists the organizations giving GIPSA permission to identify them as participants in the USDA/GIPSA Proficiency Program.
7. Attachment 2 is the USDA/GIPSA Proficiency Program November 2002 Summary Table. Participants giving GIPSA permission are identified by organization name in this table; all other organizations are identified by a Participant Identification Number.
8. 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.
9. 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 assessment 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.
February 2003 Sample Distribution
The next distribution of samples is scheduled for February 2003. The USDA/GIPSA Proficiency Program may be expanded to offer participants the opportunity to obtain samples for quantitative testing. Participants will be advised prior to the distribution of samples.
To obtain additional information on the USDA/GIPSA Proficiency Program, contact Donald C. Kendall, Biotechnology Program Manager, by phone at US 816-891-0463, or by e-mail at email@example.com.
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 z. Hd. Dr. Norbert Hess
Contact Norbert Hess, Ph.D.
Telephone 49 40 42845 3629
Fax 49 40 42845 3840
Address Via Isola Virginia 14
Contact Guy Van den Eede
Telephone +39 (0)332 78 5239
Fax +39 (0)332 78 5483
Address 5-1-3 Midorigaoka, Atsugi-shi
Kanagawa 243-0041 JAPAN
Contact Satoshi Futo
Telephone 81 462 9587-87
Fax 81 462 9437-38
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 Institute of Food Chemistry and Technology
Address Graz University of Technology
Contact Ursula Muelleder, Ph.D.
Telephone 43 316 873 6499
Fax 43 316 873 6971
Company Landesamt fur Verbraucherschutz und Landwirtschaft
Address Laborbereich 1 Frankfurt(Oder)
D 15236 Frankfurt(Oder)
Contact Dr. Gerhard Neumann
Company Landesuntersuchungsanstalt fur das Gesundheits-und Veterinarwesen Sachsen
Address Sitz Dresden
D – 01192 Dresden
Contact Gerda Hempel
Company Landesuntersuchungsamt fur Gesundheits-, Umwelt und Verbraucherschutz
Freiimfelder Str. 66/68
Contact Dietrich Maede, Ph.D.
Telephone ++49 345 5643 222
Fax ++49 345 5643 439
Company National Laboratory of Foods and Drugs, Department of Health
Address 161-2, Kuen-Yang street, NanKang
Contact Lih-Ching Chiueh
Address Lebensmittelinstitut Braunschweig
Dresdenstrasse 2 + 6
Contact Manuela Schulze, Ph.D.
Telephone 0531/6804 205
Fax 0531/6804 201
Contact Kumi Goto
Address Neguen 1087
S220XAC Sab Kirebzi
Contact Pablo Zaltz
Address Av. Vereador Alfredo das Neves, 480
Contact Erica Lui Reinhardt
Phone 55 13 3296-1715
Fax 55 13 3296-4401
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