May 2002 Sample Distribution
Purpose of GIPSA Proficiency Program
Through the GIPSA Proficiency Program USDA seeks to improve the overall performance of testing for biotechnology-derived grains and oilseeds. The GIPSA Proficiency Program helps organizations identify areas of concern and take corrective actions to improve testing capability and reliability.
In May 2002 USDA/GIPSA’s Technical Services Division mailed samples to twenty-seven organizations that voluntarily agreed to participate in the GIPSA Proficiency Program. Participants included organizations from the U.S., Europe, Asian 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.
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 the Summary Report; all other organizations were assigned a Participant Identification Number. Those organizations giving GIPSA permission are identified in the attached document: GIPSA Proficiency Program Participants: May 2002.
General observations from the GIPSA Proficiency Program for May 2002:
1. The Proficiency Program had a total of 27 participants: Fourteen (14) from the U.S., seven (7) from Europe, four (4) from Asia, and two (2) from South America.
2. Twenty-six (26) of twenty-seven (27) participants submitted results. One participant 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):
· Three (3) organizations used protein-based testing exclusively, four (4) organizations used a combination of DNA- and protein-based testing, and nineteen (19) organizations used DNA-based testing exclusively
· Thirteen (13) organizations provided results for all events.
· Four (4) organizations provided results for five (5) corn events, the soybean event, 35S and NOS (one organization did not submit results for NOS).
· Two (2) organizations provided results for four (4) corn events, the soybean event, 35S and NOS.
· Two (2) organizations provided results for three (3) corn events, the soybean event, 35S and NOS.
· Two (2) organizations provided results for two (2) events, the soybean event, 35S and NOS.
· Three (3) organizations provided results using protein-based testing that was both event specific (T25, CBH351 and NK603) and non-event specific (Cry1Ab: MON810, E176 and Bt11)
4. Twelve (12) participants were 100 % correct in identifying the presence or absence of all events for which they reported results.
5. The Summary Table (attached) is color coded to differentiate results generated using protein-based and DNA-based tests:
· Results in Red were generated using protein-based testing
· Results in Blue were generated using DNA-based testing
· Results in Green were generated using both DNA- and protein-based testing
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 a Negative result 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. A column labeled “Cry1Ab” has been added to the Summary Table. 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 theses 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 was below the test limit of detection, and 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 operator.
May Sample Distribution
The next distribution of samples is scheduled for August 2002. To obtain additional information on the GIPSA Proficiency Program, contact Don Kendall by phone at 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 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 7700 Stockwell Road
Lafayette, IN 47909
Contact Huabang Chen
Address 425 Volker Boulevard
Kansas City, MO 64110
Contact Jennifer Hancock
Telephone 816-753-7600, ext. 1447
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 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 Reading Scientific Services Ltd/
The Lord Zuckerman Research Centre
Reading RG6 6LA
Contact Andrew P Tingey
Telephone +44 (0)118 986 8541
Fax +44 (0)118 986 8932