[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5350 Introduced in House (IH)]
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Infection Reduction Labeling Act of
2014''.
SEC. 2. TREATMENT OF SOLID ANTIMICROBIAL COPPER ALLOYS UNDER FEDERAL
INSECTICIDE, FUNGICIDE, 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 Copper Alloys.--
``(1) Certain claims authorized.--Notwithstanding any other
provision of this Act, solid antimicrobial 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 burden; or
``(B) federally-funded clinical trials finding
statistically significant reductions in infection rate
or microbial burden.
``(2) 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 (1).
``(3) Consistency of claims with agency-registered product
label.--
``(A) In general.--Claims described in paragraph
(1) shall be consistent with the product label
registered under this section.
``(B) Process for modification of labeling.--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 pursuant to the following process:
``(i) The registrant shall submit a
notification 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 amended product
label.
``(ii) Within 30 days after receipt of such
a notification, the Administrator shall--
``(I) 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
(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 product with
the claims described in paragraph (1) after 60
days of submission of the notification
described in this subparagraph, unless the
Administrator issues an objection as described
in this subparagraph.
``(4) Definition.--In this subsection, the term `solid
antimicrobial copper alloy' means a solid copper alloy that--
``(A) is registered under this section;
``(B) is listed under Environmental Protection
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 ALLOYS 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 section 569C of such Act (21 U.S.C.
360bbb-8c) the following:
``SEC. 569D. SOLID ANTIMICROBIAL COPPER ALLOYS.
``(a) 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 alloy, consistent with the results of federally-funded clinical
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 otherwise identified by a Unified
Numbering System code in an Environmental Protection Agency
registration;
``(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.''.
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