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
I worked in an industry that had occasional problems with rail cars and trucks that weren't cleaned properly. It wasn't life threatening but it messed up our product.
"I didn't do it, noboby saw me, no one can prove anything."
A load of grain can be re-sold while enroute and go to a second buyer. With the ethanol crazed higher grain prices in the US the grain just seeks the best price. Then again maybe an inspector in Holland rejected the load as unfit for human consumption.
Ships that can't find business have been used as grain for storage while awaiting a good price. Petroleum tankers were used for that purpose when there was a glut of tankers on the market. Also at the end of the vessels useful life as a tanker they would downgrade them to carry grain.
"Paranoia? Wha.. what makes you say that?"
Indeed it does. Imported Asian ginseng products are one of the worst. They use human feces for fertilizer and spray many U.S. banned chemicals on their plants.
If you take ginseng, it is best to use true American "wild harvested" or "wild simulated" roots (Panax quinquefolium) or U.S. certified organic. Asian ginseng (Panax ginseng) is imported by the ton to the U.S. and sold in health food stores. Buyer beware!
Heart breaking!!!
Ummmmmm, your question in the previous post...
I am genuinely sorry to read that. One loss is tough, but four is unimaginable.
It's only been recent history where the government prohibited carrying foodstuffs in carriers that contained chemicals.
Take 2:
Ummmmmmmm, post #41...
They probably buy grain from us and then make the gluten and sell it back to us.
If you saw great meat sales last few weeks it could be the PetMenu co. dumping their supplies in the suppermarkets that would take it!
I know one of the markets in my area had great sales on Beef going next to nothing!
Remember that stuff is for the dogs!:)
We're finding a lot of Jelly Beans made in China and Mexico on the shelves! No thanks.
Check out frozen fish sources at your supermarket. Many are now imported from China. Being forced to read every label for 'Country of Origin' has made shopping quite a chore these days. With the exception of bananas, if it ain't from America (U.S.), I ain't eating it!
It was a real puzzle we could not figure out what was going on!
Just heart wrenching...
Making one wonder for years what happen!
Because American does not make the poison kind.
You would know better than the rest of us,,,
for that amount of product to have been tainted,,,
must be the bulk-carrier...
shipping records must have led them back-track...
this stuff will turn up in other places,IMHO,this week.
Ruh roh. Dog meat being dumped on the market for human consumption!!
Why do I say volume versus surface area? Because you use surface tension properties to determine the thickness of the "skin" of fluid present on the interior surface of the vessel once it is drained.
In reality the quantity left over is much less since the interior is hosed down and let dry.
Stop going to Chinese Restaurants....I'm tellin' ya. Heck, stop buying anything from China that touches food, just like the post said previously. I won't buy ANY glassware unless it's USA made.
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