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Re: E-M:/ FDA Warning on China Food Imports



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Enviro-Mich message from Larry Nooden <ldnum@umich.edu>
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Figuring out where these contaminants have gone (been buried) in the human food chain is going to be difficult. You can bet these products were not just used in animal foods. This revelation has been slow in coming, and given what the Bush administration has been doing with the FDA, we can not expect quick (or any) answers on which of our foods are contaminated. Quick action would make a huge difference. It is like the PBB problem in Michigan many years ago; attempts to deny/conceal it greatly magnified the problem.

Any postings with this information would be a great service.

--On Tuesday, May 01, 2007 4:35 AM -0400 "Alex J. Sagady & Associates" <ajs@sagady.com> wrote:

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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,
Expert Witness Review and Litigation Investigation on Air, Water and
Waste/Community Environmental and Resource Protection
Prospectus at:  http://www.sagady.com/sagady.pdf

657 Spartan Ave,  East Lansing, MI  48823
(517) 332-6971; (517) 332-8987 (fax); ajs@sagady.com
==========================================



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Larry D. Noodén, Professor Emeritus Ph. 734-764-4436 1270 Natural Sci. Bldg. FAX 734-647-0884 Biology Dept. 734-763-0544 University of Michigan Ann Arbor, MI 48109-1048 http://www.biology.lsa.umich.edu/~ldnum/


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