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
Getting a federal agency to move at ALL is something of a miracle.
______________________________________________________
Could it be because it is in more than just pet food?
Nah, that couldn't happen, right?
Melamine is also a fertilizer, very popular in countries where the government doesn't want people to have access to ammonium nitrate.
You win "Best Post Award."
:-)
R-i-i-i-i-i-ight.
Sorry about your fur baby. Knowing they knew must be even more awful.
You guys keep me going!
Great Catch...
"Xuzhou" is possibly selling wheat under a "grade 1" classification according to this web site...
http://www.ec21.com/manufacturers/wheat_grade_1.html
A possible ?? Netherland connection could be a holding company advertising on the same page, as "Condor Holding B.V. "...
Transhipped from China through Holland? Transhipped?
That's seems suspicious.
Sounds like a blow to their ISO 9001/9002 certification?
Ooops! :-O
>>"Some pet food company is going to get sued flat for that saving."
>Man can you see the laywers around the US just drooling to get one of these cases and maybe make it a class-action.
Good. I hope the scumbags cutting corners by outsourcing food to cheap, unsafe foreign vendors and their abettors in the govt. letting such things slide have to pay and pay and pay.
There's no excuse for allowing food that kills to enter our homes. This is sickening.
You can just noticed a previously unobserved elephant in the living room.
God knows what else this stuff is in.
I've been asking that very question since the story broke.
I have no sympathy for the company in this at all, especially the decision makers.
I didn't know they had the authority to issue such an order on their own.
Where is US Customs, CDC and Homeland Insecurity?
Thank you.
Oh-but-it-hurts-me-more-than-it-hurts-theeeem.
:-D
Wonder how much I have eaten of this stuff....any stats on human kidney failure....
Likely you have consumed more if you are a vegetarian. The wheat gluten is in fake turkey products, tofu-like products, etc.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.