I 
114TH CONGRESS 
1ST SESSION H. R. 1424 
To amend the Federal Insecticide, Fungicide, and Rodenticide Act to allow 
the marketing, distribution, or sale of solid antimicrobial copper alloys 
with certain claims, to amend the Federal Food, Drug, and Cosmetic 
Act to exclude certain solid antimicrobial copper alloys from regulation 
as drugs or devices, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 18, 2015 
Mr. LATTA (for himself, Mr. MURPHY of Pennsylvania, and Mr. YARMUTH) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce, and in addition to the Committee on Agriculture, 
for a period to be subsequently determined by the Speaker, in each case 
for consideration of such provisions as fall within the jurisdiction of the 
committee concerned 
A BILL 
To 
amend 
the 
Federal 
Insecticide, 
Fungicide, 
and 
Rodenticide Act to allow the marketing, distribution, or 
sale of solid antimicrobial copper alloys with certain 
claims, to amend the Federal Food, Drug, and Cosmetic 
Act to exclude certain solid antimicrobial copper alloys 
from regulation as drugs or devices, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Infection Reduction 
Labeling Act’’. 
SEC. 2. TREATMENT OF SOLID ANTIMICROBIAL COPPER AL-
LOYS UNDER FEDERAL INSECTICIDE, FUN-
GICIDE, AND RODENTICIDE ACT. 
Section 3 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (7 U.S.C. 136a) is amended by adding 
at the end the following new subsection: 
‘‘(i) CLAIMS MADE FOR SOLID ANTIMICROBIAL COP-
PER ALLOYS.— 
‘‘(1) CERTAIN CLAIMS AUTHORIZED.—Notwith-
standing any other provision of this Act, solid anti-
microbial copper alloys, and products made from 
such alloys, may be marketed, distributed, 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— 
‘‘(A) federally funded clinical trials finding 
greater than 25 percent reductions in infection 
rate or 50 percent reductions in microbial bur-
den; or 
‘‘(B) federally funded clinical trials finding 
statistically significant reductions in infection 
rate or microbial burden. 
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‘‘(2) SUBMISSION
OR
REVIEW
OF
EFFICACY 
DATA
WAIVED.—The registration of solid anti-
microbial 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 (1). 
‘‘(3) CONSISTENCY OF CLAIMS WITH AGENCY- 
REGISTERED PRODUCT LABEL.— 
‘‘(A) IN
GENERAL.—Claims described in 
paragraph (1) shall be consistent with the prod-
uct label registered under this section. 
‘‘(B) PROCESS FOR MODIFICATION OF LA-
BELING.—In lieu of the notification process 
under subsection (c)(9), registration of a solid 
antimicrobial copper alloy may be modified to 
ensure the consistency of claims described in 
paragraph (1) with the product labeling pursu-
ant to the following process: 
‘‘(i) The registrant shall submit a no-
tification identifying the proposed claims 
that are consistent with the results of the 
clinical trials described in paragraph (1), 
and include a copy of the proposed amend-
ed product label. 
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‘‘(ii) Within 30 days after receipt of 
such a notification, the Administrator 
shall— 
‘‘(I) notify the registrant in writ-
ing if the Administrator objects to any 
of the proposed claims as not con-
sistent with the results of the clinical 
trials described in paragraph (1); and 
‘‘(II) state the reasons why. 
‘‘(iii) A registrant may file a response 
to any such objection not later than 30 
days after the registrant’s receipt of the 
objection. 
‘‘(iv) After receipt and consideration 
of any such response, the Administrator 
shall issue a decision within 30 days. 
‘‘(v) A decision under clause (iv) shall 
be considered to be a final agency action. 
‘‘(vi) A registrant may distribute or 
sell a solid antimicrobial copper alloy prod-
uct with the claims described in paragraph 
(1) after 60 days of submission of the noti-
fication described in this subparagraph, 
unless the Administrator issues an objec-
tion as described in this subparagraph. 
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‘‘(4) DEFINITION.—In this subsection, the term 
‘solid antimicrobial copper alloy’ means a solid cop-
per alloy that— 
‘‘(A) is registered under this section; 
‘‘(B) is listed under Environmental Protec-
tion Agency registration number 82012–1, 
82012–2, 82012–3, 82012–4, 82012–5, or 
82012–6, or is otherwise identified by a Unified 
Numbering System code in an Environmental 
Protection Agency registration; 
‘‘(C) has a copper content of not less than 
60 weight percent; and 
‘‘(D) has a content of not more than 0.1 
weight percent of each of the following: lead, 
chromium, and arsenic.’’. 
SEC. 3. TREATMENT OF SOLID ANTIMICROBIAL COPPER AL-
LOYS UNDER FEDERAL FOOD, DRUG, AND 
COSMETIC ACT. 
Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 569C of such Act (21 U.S.C. 360bbb–8c) the fol-
lowing: 
‘‘SEC. 569D. SOLID ANTIMICROBIAL COPPER ALLOYS. 
‘‘(a) EXCLUSION FROM TREATMENT AS DRUG OR 
DEVICE.—A product that is made from solid antimicrobial 
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copper alloy and has labeling making a claim regarding 
the microbial reduction or infection control efficacy of the 
alloy, consistent with the results of federally funded clin-
ical trials, shall not, by virtue of such claim— 
‘‘(1) be treated as a drug or device, or as a 
combination thereof, for purposes of this Act; or 
‘‘(2) otherwise be subject to regulation by the 
Food and Drug Administration. 
‘‘(b) DEFINITION.—In this section, the term ‘solid 
antimicrobial copper alloy’ means a solid copper alloy 
that— 
‘‘(1) is listed under Environmental Protection 
Agency registration number 82012–1, 82012–2, 
82012–3, 82012–4, 82012–5, or 82012–6, or is oth-
erwise identified by a Unified Numbering System 
code in an Environmental Protection Agency reg-
istration; 
‘‘(2) has a copper content of not less than 60 
weight percent; and 
‘‘(3) has a content of not more than 0.1 weight 
percent of each of the following: lead, chromium, 
and arsenic.’’. 
Æ 
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