"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"

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 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.

Districts may detain without physical examination, all vegetable protein products identified in the attachment for this alert.

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.fda.gov/AnimalVeterinary/ScienceResearch/ToolsResources/ucm135002.htm***

*** For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600. ***

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
12420 Parklawn Drive
Elem - 3109
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.

Wheat Gluten, Rice Gluten, Rice Protein, Rice Protein Concentrate, Corn Gluten, Corn Gluten Meal, ***Corn Milled Protein***, Soy Protein, Soy Gluten, Soy Meal, Mung Bean Protein

"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 ***