IA #99-29, REVISED 2/23/2009, 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"
NOTE: The revision of this Import Alert dated 2/23/2009 updates the FDA contact information, and includes
information regarding third-party laboratory testing of detained articles. Changes are bracketed by
asterisks
(***).
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
Soy Meal
Mung Bean Protein
PRODUCT
CODES: 02G[][]08 Soy Bean Meal/Powder/Gluten/Protein Isolate
18E[][]03 Soy Protein Powder
71L[][]07 Soybean Meal
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
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 food additive, namely melamine and/or a melamine analog,
that is unsafe within the meaning of section 409 [Adulteration, section 402(a)(2)(C)(i)]"
*** OASIS charge code: MELAMINE ***
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 poisonous or deleterious substance which may render it
injurious to health [Adulteration, section 402(a)(1)]"
*** OASIS charge code: POISONOUS ***
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)]"
*** OASIS charge code: UNFIT4FOOD ***
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 firm
s
have recalled product, 17 Class I and 1 class II, covering over 5,300 product lines. As o
f
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 countrywide 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.
***In order to secure release of an individual shipment detained pursuant to this Import
Alert, the importer should provide results of a third-party laboratory analysis, of a
representative sample of the lot, which verifies the product does not contain melamine or
cyanuric acid. Third-party laboratories may use any method that is found acceptable to
FDA and which meets the method performance of the LC-MS/MS methods available at
http://www.cfsan.fda.gov/~comm/labmeth.html#melamine ***
*** For questions or issues concerning science, science policy, analysis, preparation, or
analytical methodology, contact the Division of Field Science at (301) 827-7605. ***
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 20857
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
should provide the following information:
1. Documentation showing that a minimum of five (5) consecutive non-violative shipments
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 report and compliance status of the firm (statement as to whether
such inspection concluded that the firm has adequate controls in place to ensure that its
products are free of melamine or its analogs).
b. If products were sampled during the course of the inspection, test results indicating that
the products are free of melamine and/or melamine analogs.
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
***ORGINAL ISSUE
DATE***: April 27, 2007
***ORIGINAL
PREPARED
BY***: Cathie Marshall, CVM, HFV-232, 240-276-9217
Salvatore Evola, CFSAN, HFS-606, 301-436-2164
Linda Wisniowski, DIOP, HFC-170, 301-443-6553
***REVISED BY: Nawab Siddiqui, DIOP, 7/31/2007
Sammi L. Hadden, DIOP, 1/7/2008
John E. Verbeten, DIOP, 2/23/2009 ***
DATE LOADED
INTO FIARS: February 23, 2009
ATTACHMENT 1/ /08
Firms and products exempt from detention without physical examination
(Currently there are no firms listed in the attachment)
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