FDA import alert

Food recall info:
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" 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
          Proteins (includes amino acids and protein hydrosylates)
          Mung Bean Protein
PRODUCT   02G[][]08 - Soy Bean Meal/Powder/Gluten/Protein Isolate
CODES:    18E[][]03   Soy Protein Powder
          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

          54[][][][][]- Amino acids and protein hydrosylates

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

PREPARED BY:  Cathie Marshall, CVM, HFV-232, 240-276-9217
              Salvatore Evola, CFSAN, HFS-606- 302-436-2164
              Linda Wisniowski, DIOP, HFC-172, 301-443-6553

DATE LOADED
INTO FIARS:   April 27, 2007

                           ATTACHMENT
Firms and products exempt from detention without physical examination

       (Currently there are no firms listed in the attachment)<