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<div class=Section1>
<p class=MsoPlainText><a
href="http://www.fda.gov/ora/fiars/ora_import_ia9929.html">http://www.fda.gov/ora/fiars/ora_import_ia9929.html</a><o:p></o:p></p>
<p class=MsoPlainText><o:p> </o:p></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>IA #99-29,
4/27/07, IMPORT ALERT #99-29, "DETENTION WITHOUT PHYSICAL<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>EXAMINATION OF
ALL VEGETABLE PROTEIN PRODUCTS FROM CHINA FOR ANIMAL OR HUMAN<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>FOOD USE DUE TO
THE PRESENCE OF MELAMINE AND/OR MELAMINE ANALOGS"<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>TYPE OF ALERT:
Detention Without Physical Examination (Countrywide)<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>(Note: This
import alert represents the Agency's current guidance to FDA field<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>personnel
regarding the manufacturer(s) and/or products(s) at issue. It does<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>not create or
confer any rights for or on any person, and does not operate to<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>bind FDA or the
public).<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>PRODUCTS: Wheat
Gluten<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Rice Gluten<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Rice Protein<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Rice Protein Concentrate<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Corn Gluten<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Corn Gluten Meal<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Corn By-Products<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Soy Protein<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Soy Gluten<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'> Proteins
(includes amino acids and protein hydrosylates)<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Mung Bean Protein<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>PRODUCT
02G[][]08 - Soy Bean Meal/Powder/Gluten/Protein Isolate<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>CODES:
18E[][]03 Soy Protein Powder<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
02F[][]08 Wheat Gluten<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
02E[][]06 - Wheat Flour Gluten<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
71M[][]01 Wheat Gluten<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
02D[][]12 Rice Protein<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
02D[][]13 Rice Gluten<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
71I[][]03 Rice Protein<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
71G[][]02 - Corn Gluten<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
02B[][][][] Milled Rice Products<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'> 54[][][][][]-
Amino acids and protein hydrosylates<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>PROBLEM:
Poisonous or Deleterious Substance<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Unfit For Food<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Unsafe Food Additive<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>PAF:
PES<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>COUNTRY:
China (CN)<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>MANUFACTURER/SHIPPER:
All<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>CHARGES:
"The article is subject to refusal of admission pursuant to<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
section 801(a)(3) in that it appears to bear or contain a<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
poisonous or deleterious substance, which may render it<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
injurious to health [Adulteration, section 402(a)(1)]"<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
and/or<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
"The article is subject to refusal of admission pursuant to<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
section 801(a)(3) in that it appears to bear or contain a<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
food additive that is unsafe within the meaning of section<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
409 [Adulteration, section 402(a)(2)(C)(i)]"<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
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and/or<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
"The article is subject to refusal of admission pursuant<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
to section 801(a)(3) in that it appears to be unfit for<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
food [Adulteration, 402(a)(3)]"<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>RECOMMENDING<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>OFFICE:
Division of Import Operations and Policy, HFC-170<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>REASON FOR<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>ALERT:
In recent weeks, there has been an outbreak of cat and dog deaths<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
and illness associated with pet food manufactured with vegetable<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
proteins contaminated with melamine and melamine related<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
compounds. In response to this outbreak, FDA has been conducting<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
an aggressive and intensive investigation. Pet food manufacturers<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
and others have recalled dog and cat food and other suspect<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
products and ingredients. This has been one of the largest pet<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
food recalls in history, a recall that continues to expand. Thus<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
far, 18 firms have recalled product, 17 Class I and 1 class II,<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
covering over 5,300 product lines. As of April 26, 2007, FDA had<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
received over 17,000 consumer complaints relating to this<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
outbreak, and those complaints included reports of approximately<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
1950 deaths of cats and 2200 deaths of dogs. The Agency is<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
working with federal, state, and local governments, academia, and<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
industry to assess the extent of the outbreak, better understand<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
how melamine and melamine related compounds contributed to the pet<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
deaths and illnesses, and to determine the underlying cause of the<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
contamination.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
As of April 26, 2007, FDA had collected approximately 750 samples<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
of wheat gluten and products made with wheat gluten and, of those<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
tested thus far, 330 were positive for melamine and/or melamine<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
related compounds. FDA had also collected approximately 85<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
samples of rice protein concentrate and products made with rice<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
protein concentrate and, of those tested thus far, 27
were<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
positive for melamine and/or melamine related compounds. FDA's<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
investigation has traced all of the positive samples as having<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
been imported from China.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
Although FDA's investigation is ongoing, the Agency has learned<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
the following about the outbreak and its association with<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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contaminated vegetable proteins from China:<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'> <o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
1. For the vegetable proteins and finished products that have been<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
found to be contaminated, it is unknown who the actual<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
manufacturers are, how many manufacturers there are, or where in<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
China they may be located.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
The samples of vegetable proteins that have tested positive for<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
the presence of melamine and melamine analogs have, thus far, been<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
traced to two Chinese firms, Xuzhou Anying Biologic Technology<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Development Co. Ltd. and Binzhou Futian Biology Technology Co.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Ltd. Records relating to the importation of these products<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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indicate that these two firms had manufactured the ingredients in<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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question. There is strong evidence, however, that these firms are<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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not the actual manufacturers. Moreover, despite
many weeks of<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
investigation, it is still unknown who the actual manufacturer or<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
manufacturers of the contaminated products imported from China<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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are.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
All of the contaminated wheat gluten has thus far been traced to<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Xuzhou Anying. According to the General Administration of Quality<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
Supervision, Inspection and Quarantine (AQSIQ) of the Chinese<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
government, Xuzhou Anying purchased its wheat gluten from 25<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
different manufacturers and Xuzhou Anying may just be a supplier.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Press statements by Xuzhou Anying state that it did not<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
manufacturer the wheat gluten it had shipped to United States that<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
has been associated with the outbreak, but that it received that<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
wheat gluten from other sources not named in the press statements.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Despite its investigation into the matter, FDA has been unable to<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
determine who, in fact, the actual manufacturer(s) are.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
2. The source of the contamination problem is currently unknown and<o:p></o:p></span></p>
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FDA has been unable to isolate the scope of the problem.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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Melamine is a molecule that has a number of commercial and<o:p></o:p></span></p>
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industrial uses. Other than a few limited authorizations for use<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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in food contact materials for human food, melamine has no approved<o:p></o:p></span></p>
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use as an ingredient in human or animal food in the United States.<o:p></o:p></span></p>
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FDA is continuing its investigation into how the melamine and<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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melamine related compounds may have gotten into the vegetable<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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protein, and has asked the Chinese government to help with this<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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investigation.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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In addition, FDA does not know how widespread the problem in China<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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might be. For example, FDA does not know which regions of the<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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country may or may not be impacted by the problem, which firms are<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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the major manufacturers and exporters of vegetable proteins to the<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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United States, where these vegetable proteins are grown in China,<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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and what controls are currently in place to prevent against<o:p></o:p></span></p>
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contamination.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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According to the Chinese government, Xuzhou Anying did not declare<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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the contaminated wheat gluten it shipped to the United States as a<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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raw material for feed or food. Rather, according to the Chinese<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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government, it was declared to them as non-food product, meaning<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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that it was not subject to mandatory inspection by the Chinese<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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government. In addition, in a communication to the U.S.<o:p></o:p></span></p>
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government, the Chinese government has requested that FDA either<o:p></o:p></span></p>
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request or require that U.S. importers of plant protein products<o:p></o:p></span></p>
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insist on AQSIQ certification, based on AQSIQ testing, as part of<o:p></o:p></span></p>
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the import contract. According to a media report, China's Foreign<o:p></o:p></span></p>
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Ministry issued a statement that the contaminated vegetable<o:p></o:p></span></p>
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protein managed to get past Chinese customs without inspection<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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because it had not been declared for use in pet food. The news<o:p></o:p></span></p>
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report said the contamination problem has prompted China to step<o:p></o:p></span></p>
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inspections of plant-based proteins and to list melamine as a<o:p></o:p></span></p>
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banned substance for food exports and domestic sales.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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This information indicates that there are manufacturing control<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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issues that cannot be linked to specific sources in China, but<o:p></o:p></span></p>
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instead require country-wide monitoring.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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3. On April 17, 2007, pet food manufacturers in South Africa
recalled<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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dry cat and dog food due to formulation with a contaminated corn<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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gluten, a vegetable protein. FDA has learned that the corn gluten<o:p></o:p></span></p>
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was contaminated with melamine and that the corn gluten had been<o:p></o:p></span></p>
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imported from a third-party supplier in China. According to news<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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reports, the contaminated pet food has been linked to the deaths<o:p></o:p></span></p>
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of approximately 30 dogs in South Africa.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>GUIDANCE:
Districts may detain without physical examination, all Vegetable<o:p></o:p></span></p>
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protein products from China.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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Appropriate screening criteria have been set.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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For questions or issues concerning science, science policy,
sample<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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collection, analysis, preparation, or analytical methodology,<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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contact Mr. Thomas Savage, Division of Field Science, at 301-827-<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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1026.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
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If a firm, shipper or importer believes that their product should<o:p></o:p></span></p>
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not be subject to detention under this import alert they should<o:p></o:p></span></p>
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forward information supporting their position to FDA at the<o:p></o:p></span></p>
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following address:<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
Food and Drug Administration<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
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Division of Import Operations and Policy (HFC-170)<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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5600 Fishers Lane, Room 12-36<o:p></o:p></span></p>
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
Rockville, MD 20587<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
In order to adequately assess whether a manufacturer has the<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
appropriate controls and processes in place to ensure the quality<o:p></o:p></span></p>
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
of the product being produced, the firm or shipper must provide<o:p></o:p></span></p>
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the following information:<o:p></o:p></span></p>
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1. Documentation showing that a minimum of five (5)<o:p></o:p></span></p>
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consecutive entries have been released by FDA based on<o:p></o:p></span></p>
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third party laboratory analyses using FDA recommended<o:p></o:p></span></p>
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
methods and that all shipments did not contain the<o:p></o:p></span></p>
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presence of melamine and/or melamine analogs.<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'> AND<o:p></o:p></span></p>
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2. Certificate, such as from AQSIQ, indicating that an<o:p></o:p></span></p>
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inspection of the manufacturer was conducted and<o:p></o:p></span></p>
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adequate controls are in place. Information should<o:p></o:p></span></p>
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also include:<o:p></o:p></span></p>
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a. Copy of the inspectional reports and compliance<o:p></o:p></span></p>
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status of the manufacturer.<o:p></o:p></span></p>
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b. If products were sampled during the course of the<o:p></o:p></span></p>
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inspection, test results indicating that the<o:p></o:p></span></p>
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
products are free of melamine and/or melamine<o:p></o:p></span></p>
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analog.<o:p></o:p></span></p>
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margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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All requests for removal (exemption) from DWPE will be forwarded<o:p></o:p></span></p>
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
by DIOP to CVM (HFV-230) or CFSAN (HFS-606) for<o:p></o:p></span></p>
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evaluation depending on the intended final use in animal<o:p></o:p></span></p>
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or human food.<o:p></o:p></span></p>
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margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>PRIORITIZATION<o:p></o:p></span></p>
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style='font-size:10.0pt;font-family:"Courier New";color:black'>GUIDANCE:
I<o:p></o:p></span></p>
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margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>FOI:
No purging required<o:p></o:p></span></p>
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margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>KEYWORDS:
Feed, pet food, human food, melamine, gluten, protein,<o:p></o:p></span></p>
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concentrate, rice, wheat, corn, soy, mung bean<o:p></o:p></span></p>
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margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>PREPARED
BY: Cathie Marshall, CVM, HFV-232, 240-276-9217<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
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style='font-size:10.0pt;font-family:"Courier New";color:black'>
Salvatore Evola, CFSAN, HFS-606- 302-436-2164<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>
Linda Wisniowski, DIOP, HFC-172, 301-443-6553<o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:12.0pt;margin-right:0in;
margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>DATE LOADED<o:p></o:p></span></p>
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margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'>INTO
FIARS: April 27, 2007<o:p></o:p></span></p>
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margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
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ATTACHMENT<o:p></o:p></span></p>
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style='font-size:10.0pt;font-family:"Courier New";color:black'>Firms and
products exempt from detention without physical examination<o:p></o:p></span></p>
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margin-bottom:12.0pt;margin-left:0in;background:#EEEEEE'><span
style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
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(Currently there are no firms listed in the attachment)<o:p></o:p></span></p>
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style='font-size:10.0pt;font-family:"Courier New";color:black'><o:p> </o:p></span></p>
<p class=MsoPlainText><o:p> </o:p></p>
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