Infection Reduction Labeling Act of 2014

Summary: Infection Reduction Labeling Act of 2014 - Amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to authorize solid antimicrobial copper alloys, and products made from such alloys, to be marketed, distributed, or sold with labels about their infection reduction and control efficacy if the antimicrobial claims made on the label are consistent with the results of federally-funded clinical trials finding: (1) greater than 25% reductions in infection rate or 50% reductions in microbial burden, or (2) statistically significant reductions in infection rate or microbial burden. Waives alloys from requirements to submit or review efficacy data related to the antimicrobial claims if the claims are consistent with the results of the trials. Sets forth an alternative process to modify the labeling of an alloy. Amends the Federal Food, Drug, and Cosmetic Act to exclude a product that is made from the alloy and has the antimicrobial labeling from regulation and treatment as a drug or device . 

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.''.