GIPSA’s Role in Aflatoxin Testing

1. GIPSA’s Role in Aflatoxin Testing

2. GIPSA's Objective • Provide the market with rapid, accurate Aflatoxin testing services. • Monitor the official Aflatoxin testing program in place. • Work with the FDA to safeguard the public's health.

3. GIPSA provides Aflatoxin testing service as official criteria for corn, sorghum, wheat, and soybeans, as official criteria under the United States Grain Standards Act. (USGSA)

4. Additionally, all corn exported from the United States is required to be tested for Aflatoxin. • As required by the Grain Quality Incentives Act of 1990 unless buyer and seller stipulate that Aflatoxin is not required

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

6. Number of Grain Aflatoxin Inspections

7. Types of Service • Aflatoxin testing services are available nationwide, upon request and for a fee, • as either a qualitative (screening above or below a threshold determined by the customer) or • as a quantitative (actual results in parts per billion) service using several different types of test kits approved by GIPSA.

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

9. Official Aflatoxin testing available at: • 56 Private official agencies • 8 State delegated agencies • GIPSA field office locations

10. Official Service Providers in Iowa and Illinois

11. Quality 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.

12. Approved Tests • GIPSA has approved 14 quick test kits (7 qualitative and 7 quantitative) that can be used at field locations. All test kits are capable of providing results in 30 minutes or less. • GIPSA also provides High Pressure Liquid Chromatography (HPLC) testing for Aflatoxin. The HPLC testing procedure is performed, upon request, for Board Appeal inspections only.

13. Test Kits Approved for Official Use

14. Test Kits Approved for Official Use

15. 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.

16. Quantitative Test KitsDesign Criteria & Performance Specifications • Time required for analysis • Limit of Detection • Comparative accuracy on naturally contaminated samples • Avoidance of toxic or hazardous substances • Sensitivity to electromagnetic Fields • Temperature sensitivity • Stability • GIPSA Certificate of Conformance

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

18. Sample Requirements • Official Samples • Sample obtained using official personnel , approved methods and equipment. • Entire sample ground to required particle size. • 50 gram test portion cut from whole sample to maintain accuracy.

19. Options • If requested by the applicant, a larger sample size may be obtained. • Approved sampling rates and/or probe patterns established to provide representative sample.

20. Diverter Type Mechanical Sampler (DT)

21. Pelican sampler

22. Ellis Cup

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

24. Submitted 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 same as an official sample. • Not subject to FDA agreement.

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

26. 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.

27. 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.“

28. 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 parts per million (ppm) or Milligrams (mg) per kilogram (kg), or Micrograms (µg) per Kilogram (kg).

29. Review 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.

30. Reinspection Service • The laboratory providing original testing services also provides reinspection services.

31. Appeal Inspection Service • FGIS field offices provide appeal testing services for Aflatoxin.

32. 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.

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

34. FDA RECONDITIONING GUIDELINES • 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.

35. FDA RECONDITIONING GUIDELINES • 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.

36. Additional Information • http://www.gipsa.usda.gov