GIPSA’s Role GIPSA’s Role in in

Aflatoxin TestingAflatoxin Testing

GIPSA's ObjectiveGIPSA's Objective

Provide the market with rapid, Provide the market with rapid, accurate Aflatoxin testing accurate Aflatoxin testing services. services.

Monitor the official Aflatoxin Monitor the official Aflatoxin testing program in place.testing program in place.

Work with the FDA to safeguard Work with the FDA to safeguard the public's health. the public's health.

GIPSA provides Aflatoxin GIPSA provides Aflatoxin testing service as official testing service as official criteria for corn, sorghum, criteria for corn, sorghum, wheat, and soybeans, as wheat, and soybeans, as official criteria under the official criteria under the United States Grain Standards United States Grain Standards

Act. (USGSA)Act. (USGSA)

Additionally, all corn Additionally, all corn exported from the United exported from the United States is required to be States is required to be tested for Aflatoxintested for Aflatoxin..

As required by the Grain Quality As required by the Grain Quality Incentives Act of 1990 unless buyer Incentives Act of 1990 unless buyer and seller stipulate that Aflatoxin is and seller stipulate that Aflatoxin is not requirednot required

Testing is also provided for Testing is also provided for rice, popcorn, corn meal, corn rice, popcorn, corn meal, corn gluten meal, corn/soy blend, gluten meal, corn/soy blend, and other processed products and other processed products governed by the Agricultural governed by the Agricultural Marketing Act. (AMA)Marketing Act. (AMA)

Number of Grain Number of Grain Aflatoxin InspectionsAflatoxin Inspections

20032003 20042004 20052005GIPSAGIPSA 29,01629,016 32,52632,526 29,39129,391

Official Official Agency/DelegatAgency/Delegated Statesed States 82,24982,249 69,72569,725 67,26467,264

TotalTotal111,26111,26

55102,25102,25

11 96,65596,655

Types of ServiceTypes of Service

Aflatoxin testing services Aflatoxin testing services are are available nationwide, upon request available nationwide, upon request and for a fee,and for a fee,

– as either a as either a qualitativequalitative ( (screening above screening above or below a threshold determined by the or below a threshold determined by the customercustomer) or ) or

– as a as a quantitativequantitative ( (actual results in parts actual results in parts per billionper billion) service using several different ) service using several different types of test kits approved by GIPSA.types of test kits approved by GIPSA.

All official Aflatoxin testing is All official Aflatoxin testing is performed as prescribed in the performed as prescribed in the GIPSA directive by authorized GIPSA directive by authorized employees of GIPSA or licensed employees of GIPSA or licensed

official agency personnel.official agency personnel.

Official Aflatoxin testing Official Aflatoxin testing available at:available at:

56 Private official agencies56 Private official agencies 8 State delegated agencies8 State delegated agencies GIPSA field office locationsGIPSA field office locations

Official Service Providers in Iowa and IllinoisOfficial Service Providers in Iowa and Illinois

Cairo Grain Inspection Agency Cairo 618-734-0689

Central Illinois Grain Inspection Inc. Bloomington 309-827-7121

Central Iowa Grain Inspection Service Iowa Falls 641-648-3467

Champaign-Danville Grain Inspection Departments Inc. Champaign 217-398-0723

D. R. Schaal Agency Belmond 641-444-3122

Decatur Grain Inspection, Inc. Decatur 217-429-2466

Eastern Iowa Grain Inspection and Weighing Service, Inc. Davenport 563-322-7149

Fremont Grain Inspection Department Denison 402-721-1270

John R. McCrea Agency Clinton 815-589-9955

Kankakee Grain Inspection Essex 815-365-2268

Keokuk Grain Inspection Service Keokuk 319-524-6482

Lincoln Grain Inspections Service Hamburg 402-435-4386

Mid-Iowa Grain Inspection Cedar Rapids 319-363-0239

North Dakota Grain Inspection Service Cahokia 618-332-3409

Omaha Grain Inspection Red Oak 402-341-6739

Schneider Inspection Service Lake Village 219-992-2306

Sioux City Inspection and Weighing Service Company Sioux City 712-255-8073

Springfield Grain Inspection Springfield 217-522-5233

Quality Assurance ProgramQuality Assurance Program

The Technical Services Division (TSD), located at the Kansas City Technical Center, conducts an Aflatoxin check sample program for all specified service points and laboratories providing testing services.

Field offices are responsible for routine supervision to assure all laboratories in their circuit provide accurate results and that all sampling and sample handling protocols are followed.

Approved TestsApproved Tests

GIPSA has approved 14 quick test kits (7 GIPSA has approved 14 quick test kits (7 qualitative and 7 quantitative) that can be qualitative and 7 quantitative) that can be used at field locations. All test kits are capable used at field locations. All test kits are capable of providing results in 30 minutes or less.of providing results in 30 minutes or less.

GIPSA also provides High Pressure Liquid GIPSA also provides High Pressure Liquid Chromatography (HPLC) testing for Aflatoxin. Chromatography (HPLC) testing for Aflatoxin. The HPLC testing procedure is performed, The HPLC testing procedure is performed, upon request, for Board Appeal inspections upon request, for Board Appeal inspections only.only.

Test Kits ApprovedTest Kits Approved for Official Use for Official Use

QualitativeQualitative

AflacardTAflacardT20 20

AflaCupAflaCup

AgraStripAgraStrip

AgriScreeAgriScreenn

QuicktoxQuicktox

RevealRevealROSA®ROSA®

Test Kits ApprovedTest Kits Approved for Official Use for Official Use

QuantitativeQuantitative

Veratox-ASTVeratox-AST

VeratoxVeratox

MycoMycoRidascreen Fast Ridascreen Fast SCSC

AflatestAflatest

FluoroquantFluoroquant

ROSAROSA

Qualitative Test KitsRapid Test Performance

Evaluation Program

The rapid test manufacturer submits a data package supporting their claims.

The GIPSA staff reviews the data submitted by the manufacturer.

If the data package is complete and the claims of the rapid test are supported by the data, GIPSA conducts an in-house performance verification of the rapid test.

If the manufacturer's claims are verified by the GIPSA in-house performance testing, a Certificate of Performance is issued to the manufacturer for the rapid test.

Quantitative Test KitsDesign Criteria &

Performance Specifications Time required for analysisTime required for analysis Limit of DetectionLimit of Detection Comparative accuracy on naturally Comparative accuracy on naturally

contaminated samplescontaminated samples Avoidance of toxic or hazardous Avoidance of toxic or hazardous

substancessubstances Sensitivity to electromagnetic FieldsSensitivity to electromagnetic Fields Temperature sensitivityTemperature sensitivity StabilityStability GIPSA Certificate of Conformance GIPSA Certificate of Conformance

Official Sampling MethodsOfficial Sampling Methods

Same Sampling Methods and Same Sampling Methods and Equipment as used for obtaining Equipment as used for obtaining official grade results or other official grade results or other official criteria.official criteria.

Sample RequirementsSample Requirements

Official Samples Official Samples – Sample obtained using official personnel Sample obtained using official personnel

, approved methods and equipment., approved methods and equipment.– Entire sample ground to required Entire sample ground to required

particle size.particle size.– 50 gram test portion cut from whole 50 gram test portion cut from whole

sample to maintain accuracy.sample to maintain accuracy.CarrierCarrier Min. Amount (lbs.)Min. Amount (lbs.)Barges/SublotsBarges/Sublots 1010

RailcarsRailcars 33

TrucksTrucks 22

Options

If requested by the applicant, a If requested by the applicant, a larger sample size may be larger sample size may be obtained.obtained.

Approved sampling rates and/or Approved sampling rates and/or probe patterns established to probe patterns established to provide representative sample. provide representative sample.

Diverter Type Diverter Type Mechanical Sampler Mechanical Sampler (DT)(DT)

Pelican samplerPelican sampler

Ellis CupEllis Cup

Probe Probe

Double-tubed compartmented Probe Double-tubed compartmented Probe appropriately sized to the carrier.appropriately sized to the carrier.

Submitted SampleSubmitted Sample

– Analysis based on the sample submitted by the applicant for service.

– Does not represent the lot (carrier), only the amount of grain in the sample.

– Qualified certificate.– Minimum size 500 grams preferably Minimum size 500 grams preferably

same as an official sample.same as an official sample.– Not subject to FDA agreement.Not subject to FDA agreement.

CertificationCertification

Upon the request of the applicant, separate certificates may be issued for grade and for Aflatoxin when both are determined on the same lot.

Certification of Qualitative Testing

Certify results as being equal to or less than a threshold. – If a quantitative method is used the

actual result can be recorded on the work record but the results are certified like a qualitative method was used.

Certification of Quantitative Testing

When test results indicate that Aflatoxin is present at a level of less than 5 ppb, certify the results as "Aflatoxin does not exceed 5 ppb.“

Certify test results that are between the lower testing range (5 ppb) and the upper testing range (e.g., 80 ppb) to the nearest whole ppb. "Aflatoxin (result rounded to the nearest whole number) ppb.“

Test results greater than the upper testing limit of the test kit are certified as exceeding the test kit range unless a supplemental analysis is performed. "Aflatoxin exceeds 80 ppb.“

Optional Certification Statements

At the request of the applicant, use the following statement when Aflatoxin is not detected (0 ppb). "Aflatoxin not detected."

Can also be shown converted to Can also be shown converted to parts per million (ppm) or parts per million (ppm) or Milligrams (mg) per kilogram (kg), or Micrograms (µg) per Kilogram (kg).

Review InspectionsReview Inspections

Review inspection services for Aflatoxin are provided on either a new sample or the file sample. Board appeal inspection services are limited to the analysis of file samples.

Applicants may request either qualitative or quantitative analysis unless the original test was quantitative. Then, only a quantitative analysis is available.

Reinspection Service

The laboratory providing original testing services also provides reinspection services.

Appeal Inspection Service

FGIS field offices provide appeal testing services for Aflatoxin.

Board Appeal Inspection Services

Limited to the file sample and are provided by the Board of Appeals and Review (BAR) in Kansas City.

The HPLC method is also available for determining Aflatoxin in Board appeal samples. The applicant must specify the HPLC method as the desired determination method.

Reporting Lots Exceeding Reporting Lots Exceeding FDA Action Levels FDA Action Levels

Under the provisions of the Under the provisions of the Memorandum of Understanding (MOU), Memorandum of Understanding (MOU), GIPSA and officially GIPSA and officially delegated/designated agencies report delegated/designated agencies report to FDA, on a lot-by-lot basis, each lot to FDA, on a lot-by-lot basis, each lot that, during the course of an official that, during the course of an official sample-lot inspection, exceed the sample-lot inspection, exceed the action limits.action limits.

FDA RECONDITIONING FDA RECONDITIONING GUIDELINESGUIDELINES

The Food and Drug Administration (FDA) will permit reconditioning of Aflatoxin-contaminated corn lots at export locations by mechanical cleaning under the following conditions:– a. Only one attempt at reconditioning is

allowed. The analytical results from the reconditioned lot will be the final determination for disposition of the entire lot.

– b. To assure proper reconditioning, the grain company must mechanically clean the lot at a rate not to exceed 50 percent of the rated cleaner capacity.

FDA RECONDITIONING FDA RECONDITIONING GUIDELINESGUIDELINES

– c. FGIS must oversee the cleaning process, sample the reconditioned lot (cleaned corn) using a diverter-type mechanical sampler, and analyze the samples for Aflatoxin.

– d. FGIS must sample the cleanings/screenings using the most practical procedures available and test the cleanings and/or screenings for Aflatoxin contamination.

At interior locations, the local FDA office may modify the reconditioning procedures to provide for a cost effective process.

http://www.gipsa.usda.govhttp://www.gipsa.usda.gov

Additional InformationAdditional Information