USDA/GIPSA Proficiency Program

Testing for the Presence of Biotechnology Events in Corn and Soybeans

November 2002 Sample Distribution

 

Date of Report:  February 3, 2003

 

 

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.

 

Program Description

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.

 

GIPSA Proficiency Program Summary Table

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 biotech-lab@usda.gov.


Attachment 1.  GIPSA Proficiency Program Participants:  November 2002

 

The following organizations gave GIPSA permission to identify them as participants in the GIPSA Proficiency Program:

 

Company        Abraxis LLC                                                             

Address           2935 Byberry Road                                                     

                        Hatboro, PA  19040   

Contact            Fernando Rubio                                   

Telephone        215-957-6477                                                

Fax                  215-957-6402

E-mail              frubio@abraxiskits.com

 

Company        Biogenetic Services, Inc.

Address           32nd Avenue

                        Bookings, SD  57006

Contact            Alex Kahler

Telephone        800-423-4263/605-697-8500

Fax                  605-697-8507

E-mail              biogene@brookings.net

 

Company        California Seed and Plant Lab, Inc. 

Address           7877 Pleasant Grove Road

                        Elverta, CA  95626

Contact            Parm Randhawa

Telephone        916-655-1581

Fax                  916-655-1582

E-mail              randhawa@calspl.com

 

Company        GeneScan USA, Inc. 

Address           101 Woodland Highway

                        Belle Chasse, LA  70037

Contact            Frank Spiegelhalter

Telephone        504-398-0940

Fax                  504-398-0945

E-mail              fspiegel@gmotesting.com

 

Company        Genetic ID NA, Inc.  

Address           501 Dimick Drive

                        Fairfield, Iowa  52557 

Contact            Jane Pappin     

Telephone        641-472-9979, ext. 122                                  

Fax                  641-470-1504

E-mail              jpappin@genetic-id.com


GIPSA Proficiency Program Participants:  November 2002

 

Company        Monsanto

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

E-mail              ming.y.deng@monsanto.com

 

Company        OMIC USA Inc.

Address           Laboratory and Inspection

                        1200 NW Naito Parkway

                        Suite 100

                        Portland, OR  97209

Contact            Farin Hajar, DNA Laboratory Manager

Telephone        503-224-5929

Fax                  503-223-9436

E-mail              dna.us@omicnet.com

 

Company        Silliker Laboratories of Iowa

Address           405 8th Ave SE

                        Cedar Rapids, IA  52401

Contact            Dan Wetsch    

Telephone        319-366-3570

Fax                  319-366-4018

E-mail              daniel.wetsch@silliker.com      

                       

Company        Eurofins, Woodson-Tenent Division            

3507 Delaware

                        Des Moines, IA  50313

Contact            David Pinero

Telephone        515-265-1461

Fax                  515-266-5453            

E-mail              davidpinero@eurofinsus.com

 

Company        Agrogene SA 

Address           620, rue Blaise Pascal, Z.I.

                        F-77555 Moissy Cramayel

                        France 

Contact            A Fatmi

Telephone        00 33 1 64 1337 16

Mobile             00 33 7 56 66524

Fax                  00 33 1 64 1331 81

E-mail              kader.fatmi@agrogene.com

 


GIPSA Proficiency Program Participants:  November 2002

 

Company        Behoerde fur Umwelt und Gesundheit

Address           z. Hd. Dr. Norbert Hess

                        Haus 6

                        Marckmannstr.129b

                        D20539 Hamburg

                        Germany

Contact            Norbert Hess, Ph.D.

Telephone        49 40 42845 3629

Fax                  49 40 42845 3840

E-mail              norbert.hess@bug.hamburg.de

 

Company        European Commission DG Joint Research Centre

Address           Via Isola Virginia 14    

                        Bianndronno                                                    

                        VA

                        1-21 024

                        Italy

Contact            Guy Van den Eede

Telephone        +39 (0)332 78 5239

Fax                  +39 (0)332 78 5483

E-mail              guy.van-den-eede@jrc.it

 

Company        FASMAC      

Address           5-1-3 Midorigaoka, Atsugi-shi

                        Kanagawa 243-0041 JAPAN

Contact            Satoshi Futo

Telephone        81 462 9587-87

Fax                  81 462 9437-38

E-mail              sfuto@fasmac.co.jp

 

Company        GeneScan Analytics GmbH, Bremen

Address           Fahrenheitstrasse 1

                        D-28359 Bremen

                        Germany

Contact            Matthias Foth

Telephone        +49-(0)421-202466

Fax                  +49-(0)421-2024689

E-mail              m.foth@genescan.com

 

Company        GeneScan Analytics GmbH, Freiburg

Address           Engesserstrasse 4b

D-79108 Freiburg

                        Germany

Contact            Castor Menendez

Telephone        +49-761-5038-200

Fax                  +49-761-5038-211

E-mail              c.menendez@genescan.com

 

GIPSA Proficiency Program Participants:  November 2002

 

Company        IdentiGEN

Address           Institute of Genetics

                        Trinity College Dublin

                        Dublin 2

                        Ireland

Contact            Ronan Loftus, Ph.D.

Telephone        +353 1 6083427

Fax                  +353 1 6798558

E-mail              rloftus@tcd.ie

 

Company        Institute of Food Chemistry and Technology

Address           Graz University of Technology

                        Petersgasse 12/2

                        A-8010 Graz

                        Austria

Contact            Ursula Muelleder, Ph.D.

Telephone        43 316 873 6499

Fax                  43 316 873 6971

E-Mail              ursula.muelleder@tugraz.at

 

Company        Landesamt fur Verbraucherschutz und Landwirtschaft

Address           Laborbereich 1 Frankfurt(Oder)

                        Amtliche Labensmitteluberwachung

Fachgebiet 5.03

Ringstrasse 1030

D 15236 Frankfurt(Oder)

Germany

Contact            Dr. Gerhard Neumann

Telephone        +49-033505217-127

Fax                  +49-0335-5217-205

E-mail              gerhard.neumanng@lvl.brandenburg.de

 

Company        Landesuntersuchungsanstalt fur das Gesundheits-und Veterinarwesen Sachsen

Address           Sitz Dresden

                        Amtliche Lebensmitteluberwachung

                        Fachgebiet 6.6

Postfach 2002744

D – 01192 Dresden

Germany

Contact            Gerda Hempel

Telephone        +49-0351-8144-474

Fax                  +49-0351-8144-497

E-mail              gerda.hempel@lua.sms.sachsen.de

 


GIPSA Proficiency Program Participants:  November 2002

 

Company        Landesuntersuchungsamt fur Gesundheits-, Umwelt und Verbraucherschutz

Address           Sachsen-Anhalt

                        Dezernat 33

                        Freiimfelder Str. 66/68

                        D-061112 Halle

                        Germany

Contact            Dietrich Maede, Ph.D.

Telephone        ++49 345 5643 222

Fax                  ++49 345 5643 439

E-mail              maede@lvluahal.ml.lsa-net.de

 

Company        National Laboratory of Foods and Drugs, Department of Health

Address           161-2, Kuen-Yang street, NanKang

Taipei, Taiwan                                     

Contact            Lih-Ching Chiueh         

Telephone        00886-2-26531273

Fax                  00886-2-26531268

E-mail              clc1025@nlfd.gov.tw

 

Company        Niedersachsisches Landesamt fur Verbraucherschutz und Lebensmittelsicherheit

Address           Lebensmittelinstitut Braunschweig

                        Dresdenstrasse 2 + 6

                        38124 Braunschweig

                        Germany

Contact            Manuela Schulze, Ph.D.

Telephone        0531/6804 205

Fax                  0531/6804 201

E-mail              manuela.schulze@lua-bs.niedersachsen.de

 

Company        Nippon Yuryo Kentei Kyokai Yokohama Laboratory

Address           Bankokubashi Bldg 5-26-1

                        Kaigan-dori Naka-ku  

                        Yokohama, Japan

Contact            Kumi Goto

Phone               045-641-1037

Fax                  045-641-1038

E-mail              goto@nykk.or.jp

 

Company        SGS San Lorenzo Laboratory

Address           Neguen 1087

                        S220XAC Sab Kirebzi

                        Santa Fe

                        Argentina

Contact            Pablo Zaltz

Telephone        +54-3476-426254

Fax                  +54-3476-431180

E-mail              pablo_zaltz@sgs.com

 

 

GIPSA Proficiency Program Participants:  November 2002

 

Company        SGS do Brasil Ltda.

Address           Av. Vereador Alfredo das Neves, 480

                        Alemoa

                        Santos-SP

                        11095-510

                        Brazil

Contact            Erica Lui Reinhardt

Phone               55 13 3296-1715

Fax                  55 13 3296-4401

E-mail              erica_reinhardt@sgs.com

 

Company        Sistemas Genomicos S. L.

Address           Valencia Technology Park

                        Benjamin Franklin Avenue 12

                        46980 Paterna (Valencia)

                        Spain, Europe

Contact            Angela Perez   

Telephone        +34-96-199-4266

Fax                  +34-96-199-4265

E-mail              info@sistemasgenomicos.com

 

Company        State Laboratory

Address           Abbotstown

                        Dublin 15

                        Ireland 

Contact            Patricia Bonner

Telephone        +353 1 8025871

Fax                  +353 1 8217320

Email                pbonner@statelab.ie

 

Company        Syngenta Seeds Ltda

Address           Molecular Genetics Lab

                        BR452 Km 142

                        Uberlandia-MG

                        Brazil

                        38405-232

Contact            Cristhiane Abegg Bothona

Phone               55-34-32334510

FAX                55-34-32166537

E-mail              cristhiane.bothona@syngenta.com


Attachment 2.  USDA/GIPSA Proficiency Program November 2002 Summary Table