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: 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
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
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)
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