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FYI about grains from China.. Inclusing SOY!

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  • froggymeowmeow
    FDA Says 4,150 Pet Deaths Reported Lots of tidbits from this FDA release. And finally, an acknowledgment from the FDA that more than 16 pets may be dead. All
    Message 1 of 1 , May 1, 2007
      FDA Says 4,150 Pet Deaths Reported
      Lots of tidbits from this FDA release. And finally, an acknowledgment
      from the FDA that more than 16 pets may be dead.

      All vegetable protein from China is being detained. It includes the
      following: 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.

      USA Today also reports on this news. Says "an import alert of this
      breadth is rare."

      Highlights below:

      1,950 cats and 2,200 dogs reported dead.
      FDA does not know the scope of the problem.
      Original source of toxins still not known.
      Firms got around Chinese inspection by saying it wasn't food.
      New standards for import use established.
      Full release after the jump.

      (Thanks mike)

      IA #99-29, 4/27/07, IMPORT ALERT #99-29, "DETENTION WITHOUT PHYSICAL
      OR HUMAN

      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)


      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)]"


      "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)]"


      "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)]"

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

      ALERT: In recent weeks, there has been an outbreak of cat and dog
      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

      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

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

      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

      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
      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.


      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

      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.


      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

      INTO FIARS: April 27, 2007

      Firms and products exempt from detention without physical examination

      (Currently there are no firms listed in the attachment)

      Cities: All
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