Posted on 04/01/2007 4:49:58 PM PDT by Milwaukee_Guy
IA #99-26, IMPORT ALERT #99-26, "DETENTION WITHOUT PHYSICAL EXAMINATION AND INTENSIFIED COVERAGE OF WHEAT GLUTEN DUE TO THE PRESENCE OF MELAMINE"
TYPE OF ALERT: Detention Without Physical Examination
(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).
PRODUCT: Wheat Gluten
PRODUCT CODES: 02F[][]08 Wheat gluten 02E[][]06 - Wheat flour gluten 71M[][]01 wheat gluten
PROBLEMS: Poisonous or deleterious substance Unsafe food additive
PAF: PES FAD
PAC FOR COLLECTION: 71003A 09006A
COUNTRY: See Attachment
MANUFACTURER/ FEI#: See Attachment
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)]" (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 bear or contain a food additive that is unsafe within the meaning of section 409 [Adulteration, section 402(a)(2)(C)(i)]" (Oasis Charge Code: UNSAFE ADD)
RECOMMENDING OFFICE: Division of Compliance, CVM (HFV-230)
REASON FOR ALERT: In March 2007, FDA became aware of the illness and death of cats and dogs associated with certain pet food. Subsequently, samples of the implicated pet food were analyzed and found to contain melamine. The consumption of pet food containing melamine may be associated with acute renal failure in cats. Investigations have revealed that the sour ce of the melamine was wheat gluten which is an ingredient in the pet food. The attachment to this alert includes manufacturers whose wheat gluten products have been found to contain melamine. GUIDANCE: Districts may detain without physical examination, products offered for importation from manufacturers and shippers listed in the Attachment to this import alert. Report wheat gluten samples found positive for melamine to Cathie Marshall, CVM, Division of Compliance, HFV-232, at (240) 276-9217.
Appropriate screening criteria have been set for wheat gluten from China and the Netherlands, as a country through which transshipping of Chinese wheat gluten may occur. Sampling has been recommended. Recommendations for detention without physical examination of firms with violative product should be forwarded to DIOP, HFC- 170.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact Tom Savage, Division of Field Science, at 301-827-1026.
To enable the agency to assess whether the firm has identified the source of the problem, and has taken the appropriate steps to correct and prevent future occurrences, FDA recommends that a firm requesting removal from detention without physical examination provide the following information:
1. a. Results of the firm's investigation(s) into the problem of melamine contamination
b. Documentation showing corrective action(s)such as:
i. a description of the process(es) currently being used ii. verification that the process is adequate iii. measures that have been taken to prevent recontamination
c. Copies of three (3) production records showing the process, quantities processed, lot numbers and dates of processing.
AND
d. Documentation showing that a minimum of five (5) consecutive entries have been released by FDA based on third party laboratory analyses that show the shipments of wheat gluten do not contain melamine.
All requests for removal from DWPE should be forwarded to DIOP,(HFC-170) which in turn will forward the requests to CVM (HFV-230) for evaluation.
PRIORITIZATION GUIDANCE: I
FOI: No purging required
KEYWORDS: Feed, pet food, melamine, wheat gluten
PREPARED BY: Cathie Marshall, CVM, HFV-232, 240-276-9217 and Linda Wisniowski, DIOP, HFC-172, 301-443-6553
DATE LOADED INTO FIARS: March 30, 2007 ATTACHMENT 3/30/07
Firms and products currently under detention without physical examination
CHINA (CN)
Firm: Date DWPE Product /Code:
Xuzhou Anying Biologic Technology 3/30/07 Wheat gluten Development Company Ltd. 02F[][]08 Wangdian Industrial Zone, Peixian, CN-32, China 221623 FEI# 2000023594
My company did not use liquids in their product.
LOL! Sounds like you've been waiting awhile to use that one!
"Why the hell would the United States or Canada need to import any grain product from China?"
It's called "Free Trade" for the step-by-step dismantling of the United States economy. It is deliberate on both sides of the Pacific.
Here is the background, from my brain:
Between 6 months and one year ago, a food company in China was using "Human protein" as an ingredient in soy sauce. It included bloody bandages and human hair. They got caught. They may not have even made the final product, but rather an ingredient to go in the final product.
I will search for the story; I read about it here on FR.
OK. Thanks.
Monitor the grain trade... what did these ships haul in their bulk cargo before the wheat???? Was there bulk fertilizer in the ship before the grain?
Remember dilution is the 90% of "making grade" when it comes to inspection standards.
The USA is the past master at taking perfectly good grain and dumping tons of "grain dust" into the cargo hold as the clean US grain gets loaded.
This is tragic, but that's the grain trade.
Update
Son on the way to the vets right now, dog is falling down.
Costco dry and wasnt eating, so he bought the alpo the other day, now the recall on the alpo.
Friends dog now drinking more water than usual, said her bowl was dry this morning, never ever been dry.
I wonder how much of this gets into HUMAN food products too?
So much for "globalization".
Damm. Prayers.
Coming soon to a neighborhood near you!
yeah otherwise Morris the cat would be on a telethon saying that "George Bush doesnt care about cat people"
Here in Shanghai, China, from where I am writing this, pet food in the supermarkets and in the pet shops, processed in China(!) is at least as expensive as any produced and sold in the USA. Also, dogs and cats sold in pet shops are at least as expensive as they would be in the pet shops in malls in the USA. And Shanghai residents pay out the money happily as if they got a bargain!
In the malls here women pay 760 Yuan ($100.00 USD) for a pair of what looks like boys knickers from 1890 !!! My family (All-American, by the way) can not afford to shop in most of the malls in Shanghai! But the malls are packed with people and the money is flowing. And most Americans have never even seen malls as luxurious as dozens of them are in Shanghai.
Eulogy on Old Drum
"The best friend a man has in this world may turn against him and become his enemy. His son or daughter that he has reared with loving care may prove ungrateful. Those who are nearest and dearest to us, those whom we trust with our happiness and our good name, may become traitors to their faith. The money that a man has, he may lose. It flies away from him, perhaps when he needs it the most. A man’s reputation may be sacrificed in a moment of ill-considered action. The people who are prone to fall on their knees to do us honor when success is with us may be the first to throw the stone of malice when failure settles its cloud upon our heads.
The one absolutely unselfish friend that a man can have in this selfish world, the one that never deserts him and the one that never proves ungrateful or treacherous is his dog."
"Gentleman of the Jury, a man’s dog stands by him in prosperity and in poverty, in health and in sickness. He will sleep on the cold ground, where the wintry winds blow and the snow drives fiercely, if only he may be near his master’s side. He will kiss the hand that has no food to offer, he will lick the wounds and sores that encounters the roughness of the world. He guards the sleep of his pauper master as if he were a prince. When all other friends desert, he remains. When riches take wings and reputation falls to pieces, he is as constant in his love as the sun in its journey through the heavens."
"If fortune drives the master forth an outcast in the world, friendless and homeless, the faithful dog asks no higher privilege than that of accompanying him to guard against danger, to fight against his enemies. When the last scene of all comes, and death takes the master in its embrace and his body is laid away in the cold ground, no matter if all other friends pursue their way, there by his graveside will the noble dog be found, his head between his paws, his eyes sad but open in alert watchfulness, faithful and true even to death."
Did you see post 83?
Did you also see #83.
Lunch Crowd Bump
Tuna isn't good for cats. This is what I have heard, but read up on it to be sure: It contains mercury which cats can't process so it builds up to toxic levels in their body.
Once in awhile for a treat is ok, but not as a regular diet.
Please let us know how it turns out - and tell your son we are praying for his doggie...
Everyone owns pets. This strikes the bureaucrats at their home too.
No wonder my former cat went nuts.
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