Binzhou Futian Biology Technology Co., Ltd. web site

RECALLED PRODUCT:

Melamine tainted rice protein.

PRESS RELEASES:

4/19/07:

FDA Import Alert IA9928

IA  #99-28, 4/19/07,   IMPORT ALERT #99-28, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF RICE PROTEIN, RICE PROTEIN CONCENTRATE AND RICE GLUTEN DUE TO
THE PRESENCE OF MELAMINE"

TYPE OF ALERT: Detention Without Physical Examination

(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:       Rice Protein
               Rice Protein Concentrate
               Rice Gluten

PRODUCT
CODES:         02D[][]12   Rice protein/rice protein concentrate
                         (human food use)
               02D[][]13   Rice gluten (human food use)
               71I[][]03   Rice protein/rice protein concentrate
                              (animal food use)

PROBLEM:       Poisonous or deleterious substance

PAF:           PES

PAC FOR
COLLECTION:  04R853 (human food use)
               71R853 (animal food use)

COUNTRY:       See Attachment

MANUFACTURER/
FEI#:          See Attachment

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

                    and/or

               "The article is subject to refusal of admission pursuant to
               section 801(a)(3)in that it appears to bear or contain a
               food additive that is unsafe within the meaning of section
               409 [Adulteration, section 402(a)(2)(C)(i)]"
                    and/or

                    "The article is subject to refusal of admission pursuant to
                    section 801(a)(3) in that it appears to unfit for food
                    [Adulteration, 402(a)(3)]"

RECOMMENDING
OFFICE:        Division of Import Operations and Policy (HFC-170)
REASON FOR
ALERT:         On April 15, 2007, a Californian importer/marketer of
               ingredients for pet food notified FDA of a bag labeled as
               containing melamine that was included with a shipment of
               rice protein concentrate.  The importer reported that during
               the week of April 2, they received and unloaded a shipment
               of rice protein concentrate purchased from Binzhou Futian
               Biology Technology Co., Ltd., Shandong, China.

               During the unloading of the white tote bags of rice protein
               concentrate, the firm's employees observed a pink bag with
               the word "melamine"  stenciled on the side of the bag.  The
               firm isolated  the pink bag outside of the warehouse and
               segregated  the remainder of the shipment within the
               warehouse.

               Analysis by the firm detected the presence of  melamine in
               the rice protein concentrate in the pink bag, although it
               was apparently not detected in the accompanying white bags
               of rice protein concentrate.  Subsequent analysis by FDA,
               however, did reveal the presence of melamine in white bags
               of rice protein  concentrate.

               On April 16, 2007, an own-label distributor of pet food
               notified FDA that the firm had recently received  complaints
               of vomiting and renal injury in pets.  The
               distributor attributed the complaints to a formulation
               change three weeks earlier that included the incorporation
               of rice protein concentrate received from the Californian
               importer.  Analysis by the firm and FDA revealed the
               presence of melamine in the finished pet food product.

               On April 17, 2007, the distributor initiated a voluntary
               nationwide recall of Venison dog products (dog food and  dog
               treats) and dry Venison cat food.

GUIDANCE:      Districts may detain without physical examination,  products
               offered for importation from manufacturers and  shippers
               listed in the Attachment to this import alert.
               Report rice protein, rice protein concentrate and rice
               gluten samples found positive for melamine for animal food
               use to Cathie Marshall, CVM, Division of Compliance,
               HFV-232, at (240) 276-9217 and positive samples for
               melamine for human food use to Salvatore Evola, CFSAN,
               Division of Enforcement, HFS-606, at (301)436-2164.

               Appropriate screening criteria have been set for rice
               protein, rice protein concentrate and rice gluten from
               China.

               Recommendations for detention without physical examination
               of firms with violative product should be forwarded to DIOP,
               HFC-170.

               For questions or issues concerning science, science  policy,
               sample collection, analysis, preparation, or  analytical
               methodology, contact Tom Savage, Division of
               Field Science, at (301) 827-1026.

               To enable the agency to assess whether the firm has
               identified the source of the problem, and has taken the
               appropriate steps to correct and prevent future
                    occurrences, FDA recommends that a firm requesting removal
                    from detention without physical examination provide the
                    following information:

             1.     a. Results of the firm's investigation(s) into the  problem
                    of melamine contamination

                 b. Documentation showing corrective action(s)such as:

                    i.   a description of the process(es) currently
                         being used
                    ii.  verification that the process is adequate
                    iii. measures that have been taken to prevent
                         recontamination

                 c.  Copies of three (3) production records showing the
                     process, quantities processed, lot numbers and
                     dates of processing.

                     AND
               d.   Documentation showing that a minimum of five (5)
                    consecutive entries have been released by FDA
                    based on third party laboratory analyses that show the
                    shipments of rice protein and rice protein
                    concentrate do not contain melamine.

All requests for removal from DWPE should be forwarded to  DIOP,(HFC-170)
which in turn will forward the requests to   CVM (HFV-230) for evaluation.

PRIORITIZATION
GUIDANCE:      I

FOI:           No purging required

KEYWORDS:      Feed, pet food, melamine, rice, protein, concentrate

PREPARED BY:   Cathie Marshall, CVM, HFV-232, 240-276-9217 and
               Linda Wisniowski, DIOP, HFC-172, 301-443-6553

DATE LOADED
INTO FIARS:    April 19, 2007

                                             ATTACHMENT 4/19/07

Firms and products currently under detention without physical examination

                     CHINA (CN)

Firm:                                   Date DWPE   Product /Code:

Binzhou Futian Biology Technology        04/19/07   Rice Protein/gluten
Co., Ltd.                                              71I[][]03
No. 11 Yuanqian Street,
Jinsanjiao Development District,
Shandong, China
FEI No. 2000022765
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