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<p class=MsoNormal><b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'>From:</span></b><span
style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'> Press releases
about FDA Recalls [mailto:FDA-RECALLS-L@LIST.NIH.GOV] <b>On Behalf Of </b>FDA
Recalls<br>
<b>Sent:</b> Wednesday, May 30, 2007 1:56 PM<br>
<b>To:</b> FDA-RECALLS-L@LIST.NIH.GOV<br>
<b>Subject:</b> Tembec and Uniscope Voluntary Recall Feed Ingredients<o:p></o:p></span></p>
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<p class=MsoNormal><strong><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>FDA
Press Release</span></strong><span style='font-size:10.0pt'><o:p></o:p></span></p>
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<p class=MsoNormal><span style='font-size:10.0pt'> <o:p></o:p></span></p>
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<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>This
listserv covers mainly Class I (life-threatening) recalls. A complete listing
of recalls can be found in the FDA Enforcement Report at: <a
href="http://www.fda.gov/opacom/Enforce.html"
title="http://www.fda.gov/opacom/Enforce.html">http://www.fda.gov/opacom/Enforce.html</a></span><o:p></o:p></p>
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<p><strong><span style='font-size:10.0pt'>FOR IMMEDIATE RELEASE</span></strong><span
style='font-size:10.0pt'><br>
P07-94 <br>
May 30, 2007 </span><o:p></o:p></p>
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<td width="33%" style='width:33.0%;padding:0in 0in 0in 0in'>
<p class=contacts><strong><span style='font-size:10.0pt'>Media Inquiries:</span></strong><span
style='font-size:10.0pt'> <br>
301-827-6242<br>
<strong>Consumer Inquiries:</strong> <br>
888-INFO-FDA </span><o:p></o:p></p>
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<h2><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>Tembec and
Uniscope Voluntary Recall Feed Ingredients <br>
FDA Asks Feed Manufacturers to Avoid Ingredients Containing Melamine </span><span
style='font-family:"Arial","sans-serif"'><o:p></o:p></span></h2>
<p><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>The U.S.
Food and Drug Administration (FDA) is alerting livestock and fish/shrimp feed
manufacturers about a voluntary recall of products used in feed production
because several have been found to contain melamine and related compounds.<o:p></o:p></span></p>
<p><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>The feed
ingredients were made by Tembec BTLSR Inc. of Toledo, Ohio and Uniscope, Inc.
of Johnstown, Colo.<o:p></o:p></span></p>
<p><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>Tembec, a
contract manufacturer for Uniscope, makes AquaBond and Aqua-Tec II, which it
distributes for Uniscope. Uniscope makes Xtra-Bond using ingredients supplied
by Tembec. All of the products are binding agents that are used to make
pelleted feed for cattle, sheep, and goats, or fish and shrimp.<o:p></o:p></span></p>
<p><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>The
companies have confirmed that Tembec added melamine as part of the formulation
of the products to improve the binding properties of pelleted feed. Melamine is
not approved as an additive for animal or fish/shrimp feed. <o:p></o:p></span></p>
<p><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>The
companies have stopped adding melamine to the feed products.<o:p></o:p></span></p>
<p><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>Based on the
levels of melamine and related compounds in the initial ingredients, FDA
estimated the probable level of melamine and related compounds in livestock
feed as less than 50 parts per million (ppm) based on the recommended mix rate
of two to four pounds of binding agent per ton of livestock feed. The estimated
levels in fish and shrimp feed are less than 233 ppm and 465 ppm, respectively,
of melamine and related compounds. The estimated levels of melamine and related
compounds vary in the livestock feed and the fish and shrimp feed because of
differing levels of melamine in the binding agents used for each type of feed.<o:p></o:p></span></p>
<p><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>FDA advises
feed manufacturers and others who mix their own feed not to use these products,
and to contact the manufacturers. FDA advises feed manufacturers to recall
finished feed that is made from AquaBond or Aqua-Tec II due to the estimated
levels of melamine and related compounds in the finished products. FDA believes
that no recall is warranted of the finished feed made from Xtra-Bond based on
the estimated levels of melamine and related compounds in the finished product
and based on currently available data and information. <o:p></o:p></span></p>
<p><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>The
estimated melamine levels in feed made with these binding agents are similar to
the levels discussed in the interim safety/risk assessment of melamine and
related compounds made available by FDA earlier this month. In that assessment,
federal scientists determined that, based on currently available data and
information, the consumption of pork, chicken, domestic fish, and eggs from
animals inadvertently fed animal feed contaminated with melamine and its
analogues is very unlikely to pose a human health risk.<o:p></o:p></span></p>
<p><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>The interim
safety/risk assessment concludes that in the most extreme risk assessment
scenario, when scientists assumed that all the solid food a person consumes in
an entire day contained melamine and the melamine compound cyanuric acid in
equal amounts, the potential exposure is about 250 times lower than the dose
considered safe. This is a large safety margin. Translated to consumption
levels, this means that a person weighing 132 pounds would have to eat more
than 800 pounds per day of food containing melamine and its compounds to
approach a level of consumption that would cause a health concern. <o:p></o:p></span></p>
<p><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>FDA is
encouraging domestic feed suppliers to be vigilant in quality control in their
supply chain and to monitor for any improper additives, including melamine and
its analogs. <o:p></o:p></span></p>
<p><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>The Tembec
and Uniscope products also reportedly contain a urea formaldehyde resin-type
ingredient, a raw ingredient used to make the binding agent in these products.
FDA is investigating this use of the urea formaldehyde resin-type ingredient in
the Tembec and Uniscope products, and will take appropriate regulatory action
if warranted.<o:p></o:p></span></p>
<p align=center style='text-align:center'><span style='font-size:10.0pt;
font-family:"Arial","sans-serif"'>#### <o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>FDA's
Recalls, Market Withdrawals and Safety Alerts Page: <a
href="http://www.fda.gov/opacom/7alerts.html"
title="http://www.fda.gov/opacom/7alerts.html">http://www.fda.gov/opacom/7alerts.html</a>
<o:p></o:p></span></p>
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