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IA #99-29, 7/31/07, IMPORT ALERT #99-29, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF ALL VEGETABLE PROTEIN PRODUCTS FROM CHINA FOR ANIMAL OR HUMAN
FOOD USE DUE TO THE PRESENCE OF MELAMINE AND/OR MELAMINE ANALOGS"

          NOTE:     This alert has been revised to update the product Code.
                    Changes are bracketed by asterisks (***).

TYPE OF ALERT: Detention Without Physical Examination (Countrywide)

               (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).

PRODUCTS:      Wheat Gluten
               Rice Gluten
               Rice Protein
               Rice Protein Concentrate
               Corn Gluten
               Corn Gluten Meal
               Corn By-Products
               Soy Protein
               Soy Gluten
               Soy Meal
               Mung Bean Protein

PRODUCT        02G[][]08   Soy Bean Meal/Powder/Gluten/Protein Isolate
CODES:         18E[][]03   Soy Protein Powder
            *** 71L[][]07   Soybean Meal ***
               02F[][]08   Wheat Gluten
               02E[][]06   Wheat Flour Gluten
               71M[][]01   Wheat Gluten

               02D[][]12   Rice Protein
               02D[][]13   Rice Gluten
               71I[][]03   Rice Protein

               71G[][]02   Corn Gluten
               02B[][][][] Milled Rice Products

PROBLEM:       Poisonous or Deleterious Substance
               Unfit For Food
               Unsafe Food Additive

PAF:           PES

COUNTRY:       China (CN)

MANUFACTURER/
SHIPPER:       All

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 be unfit for food
               [Adulteration, 402(a)(3)]"

RECOMMENDING
OFFICE:        Division of Import Operations and Policy, HFC-170

REASON FOR
ALERT:         In recent weeks, there has been an outbreak of cat and dog
               deaths and illness associated with pet food manufactured
               with vegetable proteins contaminated with melamine and
               melamine related compounds.  In response to this outbreak,
               FDA has been conducting an aggressive and intensive
               investigation.  Pet food manufacturers and others have
               recalled dog and cat food and other suspect products and
               ingredients.  This has been one of the largest pet food
               recalls in history, a recall that continues to expand.  Thus
               far, 18 firms have recalled product, 17 Class I and 1 class
               II, covering over 5,300 product lines.  As of April 26,
               2007, FDA had received over 17,000 consumer complaints
               relating to this outbreak, and those complaints included
               reports of approximately 1950 deaths of cats and 2200 deaths
               of dogs.  The Agency is working with federal, state, and
               local governments, academia, and industry to assess the
               extent of the outbreak, better understand how melamine and
               melamine related compounds contributed to the pet deaths and
               illnesses, and to determine the underlying cause of the
               contamination.

               As of April 26, 2007, FDA had collected approximately 750
               samples of wheat gluten and products made with wheat gluten
               and, of those tested thus far, 330 were positive for
               melamine and/or melamine related compounds.  FDA had also
               collected approximately 85 samples of rice protein
               concentrate and products made with rice protein concentrate
               and, of those tested thus far, 27 were positive for melamine
               and/or melamine related compounds.  FDA's investigation has
               traced all of the positive samples as having been imported
               from China.

               Although FDA's investigation is ongoing, the Agency has
               learned the following about the outbreak and its association
               with contaminated vegetable proteins from China:

               1.   For the vegetable proteins and finished products that
                    have been found to be contaminated, it is unknown who
                    the actual manufacturers are, how many manufacturers
                    there are, or where in China they may be located.

                    The samples of vegetable proteins that have tested
                    positive for the presence of melamine and melamine
                    analogs have, thus far, been traced to two Chinese
                    firms, Xuzhou Anying Biologic Technology Development
                    Co. Ltd. and Binzhou Futian Biology Technology Co.
                    Ltd.  Records relating to the importation of these
                    products indicate that these two firms had
                    manufactured the ingredients in question.  There is
                    strong evidence, however, that these firms are not the
                    actual manufacturers.  Moreover, despite many weeks of
                    investigation, it is still unknown who the actual
                    manufacturer or manufacturers of the contaminated
                    products imported from China are.

                    All of the contaminated wheat gluten has thus far been
                    traced to Xuzhou Anying.  According to the General
                    Administration of Quality Supervision, Inspection and
                    Quarantine (AQSIQ) of the Chinese government, Xuzhou
                    Anying purchased its wheat gluten from 25 different
                    manufacturers and Xuzhou Anying may just be a
                    supplier.  Press statements by Xuzhou Anying state
                    that it did not manufacturer the wheat gluten it had
                    shipped to United States that has been associated with
                    the outbreak, but that it received that wheat gluten
                    from other sources not named in the press statements.

                    Despite its investigation into the matter, FDA has
                    been unable to determine who, in fact, the actual
                    manufacturer(s) are.

               2.   The source of the contamination problem is currently
                    unknown and FDA has been unable to isolate the scope
                    of the problem.  Melamine is a molecule that has a
                    number of commercial and industrial uses.  Other than
                    a few limited authorizations for use in food contact
                    materials for human food, melamine has no approved use
                    as an ingredient in human or animal food in the United
                    States.  FDA is continuing its investigation into how
                    the melamine and melamine related compounds may have
                    gotten into the vegetable protein, and has asked the
                    Chinese government to help with this investigation.

                    In addition, FDA does not know how widespread the
                    problem in China might be.  For example, FDA does not
                    know which regions of the country may or may not be
                    impacted by the problem, which firms are the major
                    manufacturers and exporters of vegetable proteins to
                    the United States, where these vegetable proteins are
                    grown in China, and what controls are currently in
                    place to prevent against contamination.

                    According to the Chinese government, Xuzhou Anying did
                    not declare the contaminated wheat gluten it shipped
                    to the United States as a raw material for feed or
                    food.  Rather, according to the Chinese government, it
                    was declared to them as non-food product, meaning that
                    it was not subject to mandatory inspection by the
                    Chinese government.  In addition, in a communication
                    to the U.S. government, the Chinese government has
                    requested that FDA either request or require that U.S.
                    importers of plant protein products insist on AQSIQ
                    certification, based on AQSIQ testing, as part of the
                    import contract.  According to a media report, China's
                    Foreign Ministry issued a statement that the
                    contaminated vegetable protein managed to get past
                    Chinese customs without inspection because it had not
                    been declared for use in pet food.  The news report
                    said the contamination problem has prompted China to
                    step up inspections of plant-based proteins and to
                    list melamine as a banned substance for food exports
                    and domestic sales.

                    This information indicates that there are
                    manufacturing control issues that cannot be linked to
                    specific sources in China, but instead require
                    country-wide monitoring.

               3.   On April 17, 2007, pet food manufacturers in South
                    Africa recalled dry cat and dog food due to
                    formulation with a contaminated corn gluten, a
                    vegetable protein.  FDA has learned that the corn
                    gluten was contaminated with melamine and that the
                    corn gluten had been imported from a third-party
                    supplier in China.  According to news reports, the
                    contaminated pet food has been linked to the deaths of
                    approximately 30 dogs in South Africa.

GUIDANCE:      Districts may detain without physical examination, all
               Vegetable protein products from China.

               Appropriate screening criteria have been set.

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

               If a firm, shipper or importer believes that their product
               should not be subject to detention under this import alert
               they should forward information supporting their  position
               to FDA at the following address:

                    Food and Drug Administration
                    Division of Import Operations and Policy (HFC-170)
                    5600 Fishers Lane, Room 12-36
                    Rockville, MD 20587

               In order to adequately assess whether a manufacturer has the
               appropriate controls and processes in place to ensure the
               quality of the product being produced, the firm or shipper
               must provide the following information:

               1.   Documentation showing that a minimum of five (5)
                    consecutive entries have been released by FDA based on
                    third party laboratory analyses using FDA recommended
                    methods and that all shipments did not contain the
                    presence of melamine and/or melamine analogs.

                               AND

               2.   Certificate, such as from AQSIQ, indicating that an
                    inspection of the manufacturer was conducted and
                    adequate controls are in place.  Information should
                    also include:

                    a.   Copy of the inspectional reports and compliance
                         status of the manufacturer.

                    b.   If products were sampled during the course of
                         the inspection, test results indicating that the
                         products are free of melamine and/or melamine
                         analog.

               All requests for removal (exemption) from DWPE will be
               forwarded by DIOP to CVM (HFV-230) or CFSAN (HFS-606) for
               evaluation depending on the intended final use in animal or
               human food.

PRIORITIZATION
GUIDANCE:      I

FOI:           No purging required

KEYWORDS:      Feed, pet food, human food, melamine, gluten, protein,
               concentrate, rice, wheat, corn, soy, mung bean

REVISED BY:         Nawab Siddiqui, DIOP, 301-594-3871

PREPARED BY:   Cathie Marshall, CVM, HFV-232, 240-276-9217
               Salvatore Evola, CFSAN, HFS-606- 301-436-2164
               Linda Wisniowski, DIOP, HFC-172, 301-443-6553

DATE LOADED
INTO FIARS:         July 31, 2007

                            ATTACHMENT

Firms and products exempt from detention without physical examination

     (Currently there are no firms listed in the attachment)