Updated: 2005-11-29
BACKGROUND:
The FDA program activity involving aflatoxin in domestic peanut products is directed
toward products intended for direct consumption and not raw peanut products. The
USDA has a comprehensive program involving raw peanuts which can be expected
to result in proper processing or destruction of any high aflatoxin raw peanuts.
The USDA will provide FDA with a copy of the certificate of analysis and the name of the
applicant for each lot found to exceed 25 ppb aflatoxin *(MOU, FDA 225-96-2001).*
Also, some districts have been detaining shipments of U.S. raw peanuts returned
from Canada because Canadian officials had found them to contain aflatoxin in
excess of the Canadian limit.
POLICY:
The FDA offers no objection to the shipment of peanuts over the 25 ppb level for
aflatoxin to processors if facilities are available to remove moldy or otherwise
defective nuts from the lot before incorporation into the finished product.
Lots of raw peanuts which have been shipped to processors containing aflatoxin
above 25 ppb level may be subject to appropriate action in cases where there is a
lack of assurance that the finished product will comply with the current action level.
Raw peanuts, returned to the U.S. after export, should not be detained because of
aflatoxin contamination. However, districts that learn of U.S. raw peanuts being
returned should so inform Mr. J.S. Miller, Assistant Chief, Specialty Crops Branch,
USDA/AMS, Independence Avenue, Washington, D.C. (202-447-5697) to make
certain that USDA is aware of the return.
REGULATORY ACTION GUIDANCE:
The following represents the criteria for recommending legal action to CFSAN/Office
of *Compliance*/Division of Enforcement (HFS-605):
Analyze nuts in accordance with applicable methods outlined in the current edition of
the Official Methods of Analysis of the Association of the Official Analytical Chemists
and supplements (at the time of this transmittal, Twelfth Edition sections 26.014-26.019 and 26.A17).
Recommend legal action where the following conditions are met:
REMARKS:
Raw peanuts which have been sampled by USDA should not be sampled routinely on
an objective basis. However, sampling and appropriate follow-up is indicated when
lots of raw peanuts are reported by USDA certificate of analysis as exceeding 25
micrograms of aflatoxin per kilogram, and when such peanuts are destined for
processors that do not have facilities and procedures to remove defective nuts, and
there is no assurance that the finished products will be below the 20 mcgs/kg
guideline.
The above guideline criteria do not preclude recommending action at lower than 20
mcgs/kg levels of aflatoxin in the finished product where there are inadequate
control and sorting procedures, or deliberate attempts to dilute aflatoxin containing
lots.
NOTE: The reserve sample must be of sufficient size to provide for the chick embryo test should it become necessary.
*Material between asterisks is new or revised*
Issued: 10/1/80
Revised: 3/95, 5/2005