Gluten for human and animal food tested positive for the melamine

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IA #99-29, 1/7/08, 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: This alert has been revised to update the language of the

alert. 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: 02G08 Soy Bean Meal/Powder/Gluten/Protein Isolate

18E03 Soy Protein Powder

71L07 Soybean Meal

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

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)©(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

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.

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 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

REVISED BY: Sammi L. Hadden, DIOP, HFC-170, 301-443-6553

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

DATE LOADED

INTO FIARS: January 7, 2008

ATTACHMENT 1/ /08

Firms and products exempt from detention without physical examination

(Currently there are no firms listed in the attachment)