GIPSA Proficiency Program

Testing for the Presence of Biotechnology Events in Corn and Soybeans

May 2002 Sample Distribution

 

Date of Report:  August 2, 2002

 

 

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.

 

Program Description

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.

 

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 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 biotech-lab@usda.gov.

 


GIPSA Proficiency Program Participants:  May 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            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

 

Company            Indiana Crop Improvement 

Address            7700 Stockwell Road

                        Lafayette, IN  47909  

Contact            Huabang Chen

Telephone            766-523-2535

Fax                  766-523-2536        

E-mail              chen@indianacrop.org

 

Company            Midwest Research Institute         

Address            425 Volker Boulevard

                        Kansas City, MO  64110

Contact            Jennifer Hancock

Telephone            816-753-7600, ext. 1447

Fax                  816-753-1014        

E-mail              jhancock@mriresearch.org

GIPSA Proficiency Program Participants:  May 2002

 

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            Woodson-Tenent Laboratories              

3507 Delaware

                        Des Moines, IA  50313

Contact            David Pinero

Telephone            515-265-1461

Fax                  515-266-5453        

E-mail              davidpinero@eurofins.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

 

Company            Bolsa de Comercio de Rosario

Address:             Córdoba 1402 - City: Rosario - Argentina

Zip code: S2000AWV  

Contact              Juan José Giorda 

Telephone             54-341-4211000 e-mail:

Fax                  54-341-4241019

E-mail              jjgiorda@bcr.com.ar  

 

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

 

 

 

 

 

 

GIPSA Proficiency Program Participants:  May 2002

 

Company            FASMAC      

Address            5-1-3-Midorigaoka

                        Atsugi-shi

                        Anagawa 243-0041  Japan

Contact            Satoshi Futo

Telephone            81 462 9587-87

Fax                  81 462 9437-38

E-mail              sfuto@fasmac.co.jp

 

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            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:  May 2002

 

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            Reading Scientific Services Ltd. 

Address            Reading Scientific Services Ltd/

The Lord Zuckerman Research Centre

Whiteknights

Reading RG6 6LA

United Kingdom

Contact            Andrew P Tingey

Telephone            +44 (0)118 986 8541

Fax                  +44 (0)118 986 8932

E-mail             andrew.p.tingey@rssl.com