ReginaW
Wed, May-02-07, 20:26
IMPORT ALERT #99-29 (http://www.fda.gov/ora/fiars/ora_import_ia9929.html)
IA #99-29, 4/27/07, 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"
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
Proteins (includes amino acids and protein hydrosylates)
Mung Bean Protein
PRODUCT 02G[][]08 - Soy Bean Meal/Powder/Gluten/Protein Isolate
CODES: 18E[][]03 Soy Protein Powder
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
54[][][][][]- Amino acids and protein hydrosylates
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 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 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 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.
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 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
analog.
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
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
IA #99-29, 4/27/07, 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"
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
Proteins (includes amino acids and protein hydrosylates)
Mung Bean Protein
PRODUCT 02G[][]08 - Soy Bean Meal/Powder/Gluten/Protein Isolate
CODES: 18E[][]03 Soy Protein Powder
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
54[][][][][]- Amino acids and protein hydrosylates
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 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 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 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.
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 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
analog.
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
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