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
Carolyn
My bad.....
*chuckle* It happens to me too. No problem.
My guess? The human food supply is riddled with this stuff.
Mustn't panic the peons.
Mark my words, if people die, it's the end of the Bush administration.
This may not be popular to say on FR, but if I die, I'm calling for his impeachment!
So you are one of the "only 16 confirmed cases"? That continuous statement makes my blood boil as well.
Won't you be too busy arranging your funeral? < /Red Dwarf>
Uh huh, it's the Jooooooooooos! (It's always the Jooooooooos!)
> Mark my words, if people die, it's the end of the Bush administration.
He's already demonstrated he cares about his donors' profits from cheap labor more than the security and economic well-being of the country (illegal immigration, Dubai port scandal).
If the Dims are crafty enough, they'll use this to political advantage... even while they take huge wads of money from the people that do this. But at this point, if they introduce legislation (with teeth) to regulate food imports to this country I would say good on 'em and W better not veto... Another missed opportunity for the GOP.
The woman at the FDA who called said they have thousands to investigate.
got to www.petconnection.com check out their database count on people who have listed their anima.
http://www.huffingtonpost.com/david-goldstein/tainted-wheat-gluten-sold_b_44743.html
Pray for W.
Pray for all of us.
Is this the same company that got caught making soy sauce from used maxi pads?
Everything that comes from China is cheap crap, including food products. No company in the USA should be allowed to import food from this toxic wasteland.
When have they ever failed to stand on the bones of the just?
(The fact that I want a source rather than calling BS speaks volumes all by itself)
That certainly sounds like a reasonable theory, albeit disturbing that food grade cargo would share the same container as fertilizer or other chemicals.
"Why the hell would the United States or Canada need to import any grain product from China?"
Because they can buy stuff from China that's not fit for human consumption (or apparently pets, either) for dirt-cheap prices? One imagines this is the case, anyway.
A lot of people who think this global economy is the best thing since sliced bread need to be told that. You cannot control the safety of the food supply when you don't grow it!
Ding, ding, ding - we have a winner folks!
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