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E-M:/ FDA Warning on China Food Imports



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Enviro-Mich message from "Alex J. Sagady & Associates" <ajs@sagady.com>
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Below from U.S. Food and Drug Administration  -- looks like contaminated
food products from China also might have gotten into the human food system.

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IA #99-29, 4/27/07,  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"

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)



==========================================Alex J. Sagady & Associates        http://www.sagady.com

Environmental Enforcement, Permit/Technical Review, Public Policy, 
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(517) 332-6971; (517) 332-8987 (fax); ajs@sagady.com
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