I 

113TH CONGRESS 

2D SESSION H. R. 5350 

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 

JULY 31, 2014 

Mr. LATTA (for himself and Mr. MURPHY of Pennsylvania) introduced the following bill; which was referred to the Committee on Energy 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 purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Infection Reduction 

3 Labeling Act of 2014’’. 

4 SEC. 2. TREATMENT OF SOLID ANTIMICROBIAL COPPER AL5 LOYS UNDER FEDERAL INSECTICIDE, FUN6 GICIDE, AND RODENTICIDE ACT. 

7 Section 3 of the Federal Insecticide, Fungicide, and 

8 Rodenticide Act (7 U.S.C. 136a) is amended by adding 

9 at the end the following new subsection: 

10 ‘‘(i) CLAIMS MADE FOR SOLID ANTIMICROBIAL COP11 PER ALLOYS.— 

12 ‘‘(1) CERTAIN CLAIMS AUTHORIZED.—Notwith13 standing any other provision of this Act, solid anti14 microbial copper alloys, and products made from 

15 such alloys, may be marketed, distributed, or sold 

16 with labeling making claims regarding the microbial 

17 reduction or infection control efficacy of the alloys if 

18 the claims are consistent with the results of— 

19 ‘‘(A) federally-funded clinical trials finding 

20 greater than 25 percent reductions in infection 

21 rate or 50 percent reductions in microbial bur22 den; or 

23 ‘‘(B) federally-funded clinical trials finding 

24 statistically significant reductions in infection 

25 rate or microbial burden. 


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•HR 5350 IH

1 ‘‘(2) SUBMISSION OR REVIEW OF EFFICACY

2 DATA WAIVED.—The registration of solid anti3 microbial copper alloys under this section shall not 

4 require submission or review of efficacy data related 

5 to claims consistent with the results of the clinical 

6 trials described in paragraph (1). 

7 ‘‘(3) CONSISTENCY OF CLAIMS WITH AGENCY8 REGISTERED PRODUCT LABEL.— 

9 ‘‘(A) IN GENERAL.—Claims described in 

10 paragraph (1) shall be consistent with the prod11 uct label registered under this section. 

12 ‘‘(B) PROCESS FOR MODIFICATION OF LA13 BELING.—In lieu of the notification process 

14 under subsection (c)(9), registration of a solid 

15 antimicrobial copper alloy may be modified to 

16 ensure the consistency of claims described in 

17 paragraph (1) with the product labeling pursu18 ant to the following process: 

19 ‘‘(i) The registrant shall submit a no20 tification identifying the proposed claims 

21 that are consistent with the results of the 

22 clinical trials described in paragraph (1), 

23 and include a copy of the proposed amend24 ed product label. 


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•HR 5350 IH

1 ‘‘(ii) Within 30 days after receipt of 

2 such a notification, the Administrator 

3 shall— 

4 ‘‘(I) notify the registrant in writ5 ing if the Administrator objects to any 

6 of the proposed claims as not con7 sistent with the results of the clinical 

8 trials described in paragraph (1); and 

9 ‘‘(II) state the reasons why. 

10 ‘‘(iii) A registrant may file a response 

11 to any such objection not later than 30 

12 days after the registrant’s receipt of the 

13 objection. 

14 ‘‘(iv) After receipt and consideration 

15 of any such response, the Administrator 

16 shall issue a decision within 30 days. 

17 ‘‘(v) A decision under clause (iv) shall 

18 be considered to be a final agency action. 

19 ‘‘(vi) A registrant may distribute or 

20 sell a solid antimicrobial copper alloy prod21 uct with the claims described in paragraph 

22 (1) after 60 days of submission of the noti23 fication described in this subparagraph, 

24 unless the Administrator issues an objec25 tion as described in this subparagraph. 


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1 ‘‘(4) DEFINITION.—In this subsection, the term 

2 ‘solid antimicrobial copper alloy’ means a solid cop3 per alloy that— 

4 ‘‘(A) is registered under this section; 

5 ‘‘(B) is listed under Environmental Protec6 tion Agency registration number 82012–1, 

7 82012–2, 82012–3, 82012–4, 82012–5, or 

8 82012–6, or is otherwise identified by a Unified 

9 Numbering System code in an Environmental 

10 Protection Agency registration; 

11 ‘‘(C) has a copper content of not less than 

12 60 weight percent; and 

13 ‘‘(D) has a content of not more than 0.1 

14 weight percent of each of the following: lead, 

15 chromium, and arsenic.’’. 

16 SEC. 3. TREATMENT OF SOLID ANTIMICROBIAL COPPER AL17 LOYS UNDER FEDERAL FOOD, DRUG, AND 

18 COSMETIC ACT. 

19 Subchapter E of chapter V of the Federal Food, 

20 Drug, and Cosmetic Act is amended by inserting after sec21 tion 569C of such Act (21 U.S.C. 360bbb–8c) the fol22 lowing: 

23 ‘‘SEC. 569D. SOLID ANTIMICROBIAL COPPER ALLOYS. 

24 ‘‘(a) EXCLUSION FROM TREATMENT AS DRUG OR

25 DEVICE.—A product that is made from solid antimicrobial 


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1 copper alloy and has labeling making a claim regarding 

2 the microbial reduction or infection control efficacy of the 

3 alloy, consistent with the results of federally-funded clin4 ical trials, shall not, by virtue of such claim— 

5 ‘‘(1) be treated as a drug or device, or as a 

6 combination thereof, for purposes of this Act; or 

7 ‘‘(2) otherwise be subject to regulation by the 

8 Food and Drug Administration. 

9 ‘‘(b) DEFINITION.—In this section, the term ‘solid 

10 antimicrobial copper alloy’ means a solid copper alloy 

11 that— 

12 ‘‘(1) is listed under Environmental Protection 

13 Agency registration number 82012–1, 82012–2, 

14 82012–3, 82012–4, 82012–5, or 82012–6, or is oth15 erwise identified by a Unified Numbering System 

16 code in an Environmental Protection Agency reg17 istration; 

18 ‘‘(2) has a copper content of not less than 60 

19 weight percent; and 

20 ‘‘(3) has a content of not more than 0.1 weight 

21 percent of each of the following: lead, chromium, 

22 and arsenic.’’. 

Æ 


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