IA#26-03 --- 8/17/88
TYPE OF ALERT: Surveillance
PRODUCT : Olive Oil, Virgin Grades or Cold Pressed Grades
PROBLEM : Perchloroethylene (PCE) and Trichloroethylene (TCE)
PAC : 09006A
COUNTRY : All Countries
MANUFACTURER/
SHIPPER : All
CHARGE : "The article is subject to refusal of admission pursuant to
Section 801 (a)(3) because it appears to be adulterated under
Section 402 (a)(2)(C) in that it contains the food additive,
perchloroethylene (and/or trichloroethylene), which is unsafe
within the meaning of section 409".
RECOMMENDING
OFFICE : HFC-131
REASON FOR
ALERT : On April 28, 1988, Import Operations Branch issued an Import
Bulletin (26B-01) advising districts of reported findings of
PCE or TCE in olive oil by the U.S.D.O.D. and the Government
of the Federal Republic of Germany.
On May 2, 1988, ORA issued an assignment to sample shipments
of all grades of olive oil. Approximately 160 samples of
olive oil were sampled and examined. Levels reported ranged
from none (<50 ppb) to 956 ppb with 37 samples containing
detectable levels. Trichloroethylene (TCE) was also reported
in 7 samples at levels up to 891 ppb. No PCE or TCE was found
in three domestically produced olive oil samples tested.
Subsequent review of the findings by CFSAN toxicologists
concluded that the levels found should not pose a hazard to
the public health. However, in July, 1988, FDA received
information from Italy, Spain, France, and Germany which
suggests that the industrial solvents, PCE and TCE, are being
used in a food additive context in one or more of those
countries and that these uses are the source of these
substances in the olive oil from those countries. Reported
possible uses include putting PCE contaminated olives into the
regular production, following extraction of those olives with
PCE to test for oil content in the Foss-Let test and use as a
solvent for degreasing and cleaning tanks, harvesting nets or
other equipment in the plant. In view of this information,
the agency is now viewing the PCE and TCE residues in olive
oil as unsafe food additives.
Residues were found in the product from many countries. Much
of the olive oil from other countries is reportedly produced
in Spain, and the bulk of reported residues are in product
manufactured in Spain. However, since these products are
frequently transshipped, we have no basis for excluding
product from any country from the alert. The substances are
reportedly found in virgin or cold pressed grades of olive
oil. Refining apparently removes the substances.
INSTRUCTIONS : Detain olive oil in import status found to contain over 50 ppb
PCE or TCE.
FOI : No purging required.
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