IA #20-05,  2/13/02, IMPORT ALERT #20-05, "DETENTION WITHOUT PHYSICAL EXAMINATION
AND SURVEILLANCE OF GRAPE JUICE DUE TO LEAD CONTAMINATION"

TYPE OF
ALERT:    Detention Without Physical Examination (DWPE)
          Surveillance

     (Note: This import alert represents the Agency's current guidance to FDA
     field personnel regarding the manufacturer(s) and/or products(s) at issue.
     It does not create or confer any rights for or on any person, and does not
     operate to bind FDA or the public).

PRODUCT:  Grape juice, grape juice concentrate

PRODUCT
CODE:          20D[][]09

PROBLEM:  Excessive levels of lead

PAC FOR
COLLECTION:    04019A

PAF:      MET (Metals in Products)

COUNTRY:  Argentina (AR)

MANUFACTURER
FEI#:          Buenaventura O. Rodriguez
          Dir Postal 9 De Julio 427
          Mendoza, Argentina
          FEI# 1000377025

IMPORTER'S
ID#:      N/A

CHARGE:   "The article is subject to refusal of admission to Section 801(a)(3)
          in that it appears to contain a poisonous or deleterious substance,
          lead, which may render it injurious to health [Adulteration, Section
          402(a)(1)]."

OASIS CHARGE
CODE:          POISONOUS

RECOMMENDING
OFFICE:   SAN-DO (HFR-PA140)
          FLA-DO (HFR-SE240)

REASON FOR
ALERT:    SAN-DO analyzed a shipment of grape juice concentrate and found
          elevated levels of lead.  The average level of lead found in the
          concentrate was of 0.076mg/l.  The calculated exposure to lead from
          a single 8 oz. serving prepared from this concentrate would be more
          than three times the Provisional Total Tolerable Intake of Lead for
          children.  As a result of these findings, CFSAN supported a seizure
          of the shipment based on the excessive levels of lead.

GUIDANCE: Districts may detain without physical examination shipments of grape
          juice concentrate from the manufacturer identified above.

          Surveillance of grape juice and grape juice concentrate from other
          Argentinean sources is warranted.

          For questions or issues concerning science, science policy, sample
          collection, analysis, preparation, or analytical methodology,
          contact the Division of Field Science at (301) 827-7605.

PRIORITIZATION
GUIDANCE: I

FOI:      No purging required

KEYWORDS: Lead, poisonous, metals, juice, grape juice

PREPARED
BY:       Ted Poplawski, DIOP, (301) 443-6553

DATE LOADED
INTO FIARS:    February 13, 2002