<div dir="ltr">On September 29, 2014, the U.S. Food and Drug Administration will open a 75-day comment period to accept public comments on revisions to proposed rules on produce safety that are designed to implement the Food Safety Modernization Act (FSMA). The proposed revisions are intended to be "more flexible and less burdensome in key areas," and are already available for public inspection with this link from the FDA website (1) (Click the "Federal Register Notice" link below):<div><div><div><br></div></div><blockquote style="margin:0px 0px 0px 40px;border:none;padding:0px"><blockquote style="margin:0px 0px 0px 40px;border:none;padding:0px"><h4 style="font-family:'Helvetica Neue',Helvetica,Arial,sans-serif;line-height:1.1;margin-top:0px;margin-bottom:11px;font-size:14px;color:rgb(51,51,51)">Proposed Rule Supplement</h4></blockquote></blockquote><div><ul style="margin:1em 0px 0px;padding-left:0px;font-size:0.875em;color:rgb(51,51,51);font-family:'Helvetica Neue',Helvetica,Arial,sans-serif"><ul><li style="margin:0px 0px 0px 1.25em"><a target="_blank" href="https://www.federalregister.gov/articles/2014/09/29/2014-22447/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption" style="color:rgb(30,95,137);text-decoration:none;word-break:break-word">Federal Register Notice</a></li><li style="margin:0px 0px 0px 1.25em"><a target="" href="http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm#produce" style="color:rgb(30,95,137);font-size:10pt;text-decoration:none">Questions & Answers</a></li><li style="margin:0px 0px 0px 1.25em"><a target="" href="http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM412921.pdf" style="color:rgb(30,95,137);font-size:10pt;text-decoration:none">Print-Friendly Fact Sheet (PDF: 1.9MB)</a></li></ul></ul></div></div><div><br></div><div><div><div>FSMA was signed into law by President Obama in January 2011 to enable the FDA to prevent safety problems in the U.S. food supply "rather than primarily reacting to problems after they occur." (2) It's being called "the most sweeping reform of our food safety laws in more than 70 years." (3) In 2013, the FDA proposed regulations to implement FSMA, called the <span style="color:rgb(51,51,51);font-family:'Helvetica Neue',Helvetica,Arial,sans-serif;line-height:1.1">Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption</span>. </div><div><br></div><div>Amid outbreaks of listeria, <i>E. coli</i>, salmonella and other food-borne illnesses, food safety advocacy groups have been pressuring the FDA to complete these regulations. (4) At the same time, the botanicals industry, extension specialists , and small farmers/growers have been weighing in on aspects of the regulations that will impact them. (5)<br></div><div><br></div><div>The new regulations will impact medicinal plant products that are intended for human consumption because they fall mainly into the category of "dietary supplements" in the United States, which are regulated by the Food and Drug Administration as "foods." (6) <br></div><div><br></div><div>The FDA's proposed revisions seek to make the FSMA regulations more flexible, practical and targeted. (7) The FDA must complete these regulations by August 30, 2015 and publish the final regulations by October 31, 2015. (8)<br></div><div><br></div><div><div>You can view all 943 of the comments that were posted in the 2013 comment period by going to the Federal Register website (9) and clicking on "View all documents and comments in this Docket": <a href="http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0921">http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0921</a><br></div></div></div><div><br></div><div>Comments on the proposed revisions to the proposed regulations to implement FSMA will be accepted electronically and in writing between September 29, 2014 and December 15, 2014. (10) </div><div><div><br></div><div>More information on FSMA and botanicals:</div><div><span style="color:rgb(51,51,51);font-family:'Helvetica Neue',Helvetica,Arial,sans-serif;line-height:1">(1) FSMA Proposed Rule for Produce Safety (includes fact sheet and summary of revisions)</span></div><div><a href="http://www.fda.gov/Food/guidanceRegulation/FSMA/ucm334114.htm">http://www.fda.gov/Food/guidanceRegulation/FSMA/ucm334114.htm</a></div><div><span style="color:rgb(51,51,51);font-family:'Helvetica Neue',Helvetica,Arial,sans-serif;line-height:1"><br></span></div><div><div><span style="color:rgb(51,51,51);font-family:'Helvetica Neue',Helvetica,Arial,sans-serif;line-height:1">(2) Background on the FDA Food Safety Modernization Act (FSMA)</span><br></div></div><div><div><div><font><a href="http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm239907.htm">http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm239907.htm</a><br></font></div><div><br></div></div></div><div><div><span style="color:rgb(51,51,51);font-family:'Helvetica Neue',Helvetica,Arial,sans-serif;line-height:1">(3) FDA Food Safety Modernization Act (FSMA)</span><br></div><div><font color="#333333" face="Helvetica Neue, Helvetica, Arial, sans-serif"><span style="line-height:10.399999618530273px"><a href="http://www.fda.gov/Food/GuidanceRegulation/FSMA/">http://www.fda.gov/Food/GuidanceRegulation/FSMA/</a></span></font></div></div><div><font color="#333333" face="Helvetica Neue, Helvetica, Arial, sans-serif"><span style="line-height:10.399999618530273px"><br></span></font></div><div><div>(4) Obama Administration Sued for Delay of FSMA<br></div><div><a href="http://www.foodsafetynews.com/2012/08/obama-administration-sued-for-delay-on-fsma-implementation/#.VCLKM_ldUaY">http://www.foodsafetynews.com/2012/08/obama-administration-sued-for-delay-on-fsma-implementation/#.VCLKM_ldUaY</a></div></div><div><br></div><div>(5) FSMA's Role in Supplement Regulation<br></div><div><div><a href="http://www.naturalproductsinsider.com/articles/2014/05/fsma-s-role-in-supplement-regulation.aspx">http://www.naturalproductsinsider.com/articles/2014/05/fsma-s-role-in-supplement-regulation.aspx</a></div></div><div><br></div><div>(6) Using Dietary Supplements Wisely (with more information on how they are regulated)<br></div><div><div><a href="http://nccam.nih.gov/health/supplements/wiseuse.htm">http://nccam.nih.gov/health/supplements/wiseuse.htm</a><br></div><div><br></div><div>(7) Constituent update: FDA Seeks to Make FSMA Proposals More Flexible, Targeted <br></div><div><div><div><a href="http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm415132.htm">http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm415132.htm</a></div></div><div><br></div><div>(8) FDA agrees to new deadlines on FSMA final rules</div><div><a href="http://www.foodnavigator-usa.com/Regulation/FDA-agrees-to-new-deadlines-on-FSMA-final-rules">http://www.foodnavigator-usa.com/Regulation/FDA-agrees-to-new-deadlines-on-FSMA-final-rules</a><br></div><div><br></div><div>(9) <a href="http://regulations.gov">regulations.gov</a></div><div><a href="http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0921">http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0921</a><br></div><div><br></div><div>(10) DHS-FDA Proposed Rule on Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption</div><div><a href="https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-22447.pdf">https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-22447.pdf</a><br></div><div><br clear="all"><div><div dir="ltr"><div>Patricia S. De Angelis, Ph.D.</div><div>Botanist/US Fish & Wildlife Service</div><div>Chair/Medicinal Plant Working Group</div><div><br></div></div></div><div class="gmail_quote"><div><div><div align="center" style="background-color:rgb(255,255,255)"><table style="background-color:rgb(255,255,255)" border="0" width="100%" cellpadding="0" cellspacing="0"><tbody><tr><td rowspan="1" colspan="1" align="center"><table style="background-color:rgb(255,255,255)" border="0" width="100%" cellspacing="0" cellpadding="0"><tbody><tr><td valign="top" rowspan="1" colspan="1" align="left"><div style="max-width:620px;margin-left:auto;margin-right:auto" align="center"><table style="margin-left:auto;margin-right:auto" border="0" width="100%" cellspacing="0" cellpadding="0"><tbody><tr><td rowspan="1" colspan="1"><br></td><td valign="top" width="620" rowspan="1" colspan="1" align="center"></td><td rowspan="1" colspan="1"><img height="5" vspace="0" border="0" hspace="0" width="1" alt="" src="https://imgssl.constantcontact.com/letters/images/1101116784221/S.gif"></td></tr></tbody></table></div></td></tr></tbody></table>
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