FYI about grains from China.. Inclusing SOY!
- 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."
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.
IA #99-29, 4/27/07, IMPORT ALERT #99-29, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF ALL VEGETABLE PROTEIN PRODUCTS FROM CHINA FOR ANIMAL
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
personnel regarding the manufacturer(s) and/or products(s) at issue.
not create or confer any rights for or on any person, and does not
bind FDA or the public).
PRODUCTS: Wheat Gluten
Rice Protein Concentrate
Corn Gluten Meal
Proteins (includes amino acids and protein hydrosylates)
Mung Bean Protein
PRODUCT 02G08 - Soy Bean Meal/Powder/Gluten/Protein Isolate
CODES: 18E03 Soy Protein Powder
02F08 Wheat Gluten
02E06 - Wheat Flour Gluten
71M01 Wheat Gluten
02D12 Rice Protein
02D13 Rice Gluten
71I03 Rice Protein
71G02 - Corn Gluten
02B Milled Rice Products
54- Amino acids and protein hydrosylates
PROBLEM: Poisonous or Deleterious Substance
Unfit For Food
Unsafe Food Additive
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
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)