,i #aacth ,,congress #b;d ,session ,h4 ,r4 #ecej ,,in ,,the ,,house ,,of ,,representatives ,july #ca1 #bjad ,mr4 ,latta 7for himself and ,mr4 ,murphy of ,pennsylvania7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,agriculture1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to amend the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act to allow the marketing1 distribution1 or sale of solid antimicrobial copper alloys with certain claims1 to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to exclude certain solid antimicrobial copper alloys from regulation as drugs or devices1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,infection ,reduction ,labeling ,act of #bjad4 #b4 ,treatment of solid antimicrobial copper alloys under ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act ,section #c of the ,federal ,insecticide1 ,fungicide1 and ,rodenticide ,act 7#g ,u4,s4,c4 #acf;a7 is amended by adding at the end the following new subsection3 7i7 ,claims made for solid antimicrobial copper alloys 7#a7 ,certain claims authorized ,notwithstanding any other provision of this ,act1 solid antimicrobial copper alloys1 and products made from such alloys1 may be marketed1 distributed1 or sold with labeling making claims regarding the microbial reduction or infection control efficacy of the alloys if the claims are consistent with the results of-- 7,a7 federally-funded clinical trials finding greater than #be percent reductions in infection rate or #ej percent reductions in microbial burden2 or 7,b7 federally-funded clinical trials finding statistically significant reductions in infection rate or microbial burden4 7#b7 ,submission or review of efficacy data waived ,the registration of solid antimicrobial copper alloys under this section shall not require submission or review of efficacy data related to claims consistent with the results of the clinical trials described in paragraph 7#a74 7#c7 ,consistency of claims with agency-registered product label 7,a7 ,in general ,claims described in paragraph 7#a7 shall be consistent with the product label registered under this section4 7,b7 ,process for modification of labeling ,in lieu of the notification process under subsection 7c77#i71 registration of a solid antimicrobial copper alloy may be modified to ensure the consistency of claims described in paragraph 7#a7 with the product labeling pursuant to the following process3 7i7 ,the registrant shall submit a notification identifying the proposed claims that are consistent with the results of the clinical trials described in paragraph 7#a71 and include a copy of the proposed amended product label4 7ii7 ,within #cj days after receipt of such a notification1 the ,administrator shall-- 7,i7 notify the registrant in writing if the ,administrator objects to any of the proposed claims as not consistent with the results of the clinical trials described in paragraph 7#a72 and 7,,ii7 state the reasons why4 7iii7 ,a registrant may file a response to any such objection not later than #cj days after the registrant's receipt of the objection4 7iv7 ,after receipt and consideration of any such response1 the ,administrator shall issue a decision within #cj days4 7v7 ,a decision under clause 7iv7 shall be considered to be a final agency action4 7vi7 ,a registrant may distribute or sell a solid antimicrobial copper alloy product with the claims described in paragraph 7#a7 after #fj days of submission of the notification described in this subparagraph1 unless the ,administrator issues an objection as described in this subparagraph4 7#d7 ,definition ,in this subsection1 the term solid antimicrobial copper alloy means a solid copper alloy that-- 7,a7 is registered under this section2 7,b7 is listed under ,environmental ,protection ,agency registration number #hbjab-a1 #hbjab-b1 #hbjab-c1 #hbjab-d1 #hbjab-e1 or #hbjab-f1 or is otherwise identified by a ,unified ,numbering ,system code in an ,environmental ,protection ,agency registration2 7,c7 has a copper content of not less than #fj weight percent2 and 7,d7 has a content of not more than #j4a weight percent of each of the following3 lead1 chromium1 and arsenic4 4 #c4 ,treatment of solid antimicrobial copper alloys under ,federal ,food1 ,drug1 and ,cosmetic ,act ,subchapter ,e of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #efi;,c of such ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 the following3 #efi;,d4 ,solid antimicrobial copper alloys 7a7 ,exclusion from treatment as drug or device ,a product that is made from solid antimicrobial copper alloy and has labeling making a claim regarding the microbial reduction or infection control efficacy of the alloy1 consistent with the results of federally-funded clinical trials1 shall not1 by virtue of such claim-- 7#a7 be treated as a drug or device1 or as a combination thereof1 for purposes of this ,act2 or 7#b7 otherwise be subject to regulation by the ,food and ,drug ,administration4 7b7 ,definition ,in this section1 the term solid antimicrobial copper alloy means a solid copper alloy that-- 7#a7 is listed under ,environmental ,protection ,agency registration number #hbjab-a1 #hbjab-b1 #hbjab-c1 #hbjab-d1 #hbjab-e1 or #hbjab-f1 or is otherwise identified by a ,unified ,numbering ,system code in an ,environmental ,protection ,agency registration2 7#b7 has a copper content of not less than #fj weight percent2 and 7#c7 has a content of not more than #j4a weight percent of each of the following3 lead1 chromium1 and arsenic4 4