<html xmlns:v="urn:schemas-microsoft-com:vml" xmlns:o="urn:schemas-microsoft-com:office:office" xmlns:w="urn:schemas-microsoft-com:office:word" xmlns:m="http://schemas.microsoft.com/office/2004/12/omml" xmlns="http://www.w3.org/TR/REC-html40">
<head>
<meta http-equiv="Content-Type" content="text/html; charset=us-ascii">
<meta name="Generator" content="Microsoft Word 12 (filtered medium)">
<style><!--
/* Font Definitions */
@font-face
{font-family:Helvetica;
panose-1:2 11 6 4 2 2 2 2 2 4;}
@font-face
{font-family:Wingdings;
panose-1:5 0 0 0 0 0 0 0 0 0;}
@font-face
{font-family:"Cambria Math";
panose-1:2 4 5 3 5 4 6 3 2 4;}
@font-face
{font-family:Calibri;
panose-1:2 15 5 2 2 2 4 3 2 4;}
@font-face
{font-family:Georgia;
panose-1:2 4 5 2 5 4 5 2 3 3;}
/* Style Definitions */
p.MsoNormal, li.MsoNormal, div.MsoNormal
{margin:0in;
margin-bottom:.0001pt;
font-size:12.0pt;
font-family:"Times New Roman","serif";
color:#000099;}
a:link, span.MsoHyperlink
{mso-style-priority:99;
color:blue;
text-decoration:underline;}
a:visited, span.MsoHyperlinkFollowed
{mso-style-priority:99;
color:purple;
text-decoration:underline;}
span.EmailStyle17
{mso-style-type:personal-compose;
font-family:"Times New Roman","serif";
color:#000099;}
.MsoChpDefault
{mso-style-type:export-only;}
@page WordSection1
{size:8.5in 11.0in;
margin:1.0in 1.0in 1.0in 1.0in;}
div.WordSection1
{page:WordSection1;}
/* List Definitions */
@list l0
{mso-list-id:953441985;
mso-list-template-ids:-996929062;}
@list l0:level1
{mso-level-number-format:bullet;
mso-level-text:\F0B7;
mso-level-tab-stop:.5in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Symbol;}
ol
{margin-bottom:0in;}
ul
{margin-bottom:0in;}
--></style><!--[if gte mso 9]><xml>
<o:shapedefaults v:ext="edit" spidmax="1026" />
</xml><![endif]--><!--[if gte mso 9]><xml>
<o:shapelayout v:ext="edit">
<o:idmap v:ext="edit" data="1" />
</o:shapelayout></xml><![endif]-->
</head>
<body lang="EN-US" link="blue" vlink="purple">
<div class="WordSection1">
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><span style="font-size:12.0pt"><a href="http://www.reuters.com/article/2013/12/11/us-fda-antibiotic-idUSBRE9BA0RJ20131211">http://www.reuters.com/article/2013/12/11/us-fda-antibiotic-idUSBRE9BA0RJ20131211</a></span><o:p></o:p></font></p>
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><o:p> </o:p></font></p>
<p class="MsoNormal" style="margin-bottom:6.0pt"><font size="6" color="black" face="Georgia"><span style="font-size:21.0pt;font-family:"Georgia","serif";color:windowtext">New U.S. FDA rules aim to cut antibiotic use in farm animals<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.8pt"><font size="1" color="#222222" face="Arial"><span style="font-size:7.0pt;font-family:"Arial","sans-serif";color:#222222;text-transform:uppercase">By Ransdell Pierson and Charles Abbott<o:p></o:p></span></font></p>
<p class="MsoNormal" style="line-height:13.8pt"><font size="1" color="#999999" face="Helvetica"><span style="font-size:6.5pt;font-family:"Helvetica","sans-serif";color:#999999">Wed Dec 11, 2013 3:35pm EST
<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">(Reuters) - In a bid to stem a surge in human resistance to certain
antibiotics, U.S. regulators announced new guidelines to phase out their use as a growth enhancer in livestock.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">The Food and Drug Administration said the antibiotics could still be
used to treat illnesses in animals raised for meat, but should otherwise be pared back over the next three years under a voluntary program to keep them out of the human food supply.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">Although voluntary, the agency said it expects drugmakers to fully
adhere to the new guidelines and on Wednesday announced that two of these biggest purveyors of those antibiotics had already agreed to narrow their use.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">Doctors and hospitals have become increasingly worried in recent years
by new strains of bacteria that cannot be controlled by a wide range of current antibiotics. Part of the suspected reason for the emergence of these "superbugs" is that people who have eaten meat that contained antibiotics develop resistance to the drugs as
bacteria mutate to thwart them.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">"Because antimicrobial drug use in both humans and animals can contribute
to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary," the FDA said in a release.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">In guidance issued on Wednesday, the FDA asked global drugmakers and
animal health companies including Eli Lilly & Co and Zoetis to revise labels of medically important antibiotics by removing references to use in animal production.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">Once companies remove farm production uses of their antibiotics from
drug labels, it would become illegal for those drugs to be used for those purposes, Deputy FDA Commissioner Michael Taylor said in a conference call with journalists. The agency said about 25 animal health companies could be affected by the guidelines, especially
Lilly and Zoetis.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">Although the program is meant to be voluntary, Taylor said the FDA
would be able to take regulatory action against companies that fail to comply.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">The FDA's "final guidance," also brings the drugs under oversight of
veterinarians by changing the over-the-counter status of the products.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">The FDA said it will require animal pharmaceutical companies to notify
the agency within three months of their intent to adopt its strategy. The companies would then have three years to complete the transition process.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">CRITICS QUESTION ENFORCEMENT<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">Critics on Wednesday said the guidelines give drugmakers too much discretion
in policing their own use of antibiotics.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">Democratic lawmaker Louise Slaughter called the FDA move an inadequate
response to the overuse of antibiotics "with no mechanism for enforcement and no metric for success."<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">Her view was echoed by consumer and environmental advocacy groups.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">"Our fear ... is that there will be no reduction in antibiotic use
as companies will either ignore the plan altogether or simply switch from using antibiotics for routine growth promotion to using the same antibiotics for routine disease prevention," said Steven Roach, senior analyst with advocacy group Keep Antibiotics Working.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">Morningstar analyst David Krempa said the FDA issued similar voluntary
guidelines in April 2012, meant to limit use of important antibiotics in food-producing animals, but they appear to have been largely ignored by farmers.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">He said compliance with the FDA's latest set of voluntary guidelines
could be equally spotty.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">"Compliance will be tough because all the farmers and meat producers
know these products increase the size of their animals," Krempa said. "They can continue to use them, and just say there's a disease going through their herds."<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">But even if antibiotics use in livestock indeed comes down, Krempa
said it would be only a "small negative" for Zoetis because it, like other animal health companies, sells such a wide range of products for both livestock and pets.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">The FDA said it had already received support for the new measures from
Zoetis and Elanco, a unit of Eli Lilly, which sell a large percentage of the products that will eventually be phased out.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">Elanco said in a statement that it would voluntarily narrow use of
antibiotics used to treat both humans and animals "only to therapeutic purposes of treating, controlling and preventing diseases in animals under the supervision of a veterinarian."<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">Other companies with animal health businesses include Merck & Co, Novartis
AG, Sanofi and Bayer AG.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">Bayer and Sanofi said the FDA strategy would not affect the types of
products they sell, but both companies said they support the FDA's position.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">"It is important that these medically important antibiotics are used
responsibly and with veterinary oversight," a Bayer spokeswoman said.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="margin-bottom:12.0pt;line-height:13.8pt"><font size="1" color="black" face="Georgia"><span style="font-size:9.0pt;font-family:"Georgia","serif";color:windowtext">(Additional reporting by Esha Dey in Bangalore; Editing by Michele
Gershberg, Matthew Lewis, Andrew Hay and Bob Burgdorfer)<o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><o:p> </o:p></font></p>
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><o:p> </o:p></font></p>
<p class="MsoNormal"><font size="2" color="navy" face="Times New Roman"><span style="font-size:10.0pt;color:navy">Deborah L. DeBiasi</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><b><font size="2" color="navy"><span style="font-size:10.0pt;color:navy;font-weight:bold">Email: Deborah.DeBiasi@deq.virginia.gov</span></font></b><b><i><font size="2" color="red"><span style="font-size:10.0pt;color:red;font-weight:bold;font-style:italic"><br>
</span></font></i></b><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">WEB site address:
<a href="http://www.deq.virginia.gov/">www.deq.virginia.gov</a></span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">Virginia Department of Environmental Quality</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">Office of Water Permits
</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">Industrial Pretreatment/Whole Effluent Toxicity (WET) Program</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">PPCPs, EDCs, and Microconstituents<o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="2" color="navy" face="Times New Roman"><span style="font-size:11.0pt;color:navy"><a href="http://www.deq.virginia.gov/Programs/Water/PermittingCompliance/PollutionDischargeElimination/Microconstituents.aspx">http://www.deq.virginia.gov/Programs/Water/PermittingCompliance/PollutionDischargeElimination/Microconstituents.aspx</a></span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy"><o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="2" color="navy" face="Times New Roman"><span style="font-size:10.0pt;color:navy">Mail: P.O. Box 1105, Richmond, VA 23218</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">Location: 629 E. Main Street, Richmond, VA 23219</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">PH: 804-698-4028 FAX: 804-698-4032<o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><o:p> </o:p></font></p>
</div>
</body>
</html>