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[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1680 Introduced in House (IH)]

104th CONGRESS
  1st Session
                                H. R. 1680

 To amend the Federal Insecticide, Fungicide, and Rodenticide Act, and 
                          for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 18, 1995

Mr. Roberts (for himself, Mr. de la Garza, Mr. Emerson, and Mr. Condit) 
 introduced the following bill; which was referred to the Committee on 
                              Agriculture

_______________________________________________________________________

                                 A BILL

 
 To amend the Federal Insecticide, Fungicide, and Rodenticide Act, 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 ``Antimicrobial Pesticide Registration 
Reform Act of 1995''.

SEC. 2. REFERENCE.

    Whenever in this Act an amendment or repeal is expressed in terms 
of an amendment to, or repeal of, a section or other provision, the 
reference shall be considered to be made to a section or other 
provision of the Federal Insecticide, Fungicide, and Rodenticide Act.

SEC. 3. ANTIMICROBIAL PRODUCTS.

    (a) Definitions.--Amendments to the Act.--Section 2 (7 U.S.C. 136) 
is amended by adding at the end the following new subsection:
    ``(hh) Antimicrobial Pesticide.--The term `antimicrobial pesticide' 
means a pesticide, including but not limited to an antimicrobial active 
ingredient or an antimicrobial end-use product (including composition, 
packaging, and labeling), that--
            ``(1) is intended to--
                    ``(A) disinfect, sanitize, reduce, or mitigate 
                growth or development of microbiological organisms; or
                    ``(B) protect inanimate objects, industrial 
                processes or systems, surfaces, water or other chemical 
                substances from contamination, degradation, fouling, 
                inefficiency, or deterioration caused by 
                microbiological organisms (including, but not limited 
                to bacteria, viruses, fungi, algae or composite slime); 
                and
            ``(2) in the intended use is exempt from, or otherwise not 
        subject to, a tolerance under section 408 or section 409 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a or 
        348).''.
    (b) Requirements for Registration.--Section 3 (7 U.S.C. 136a) is 
amended by adding at the end the following new subsection:
    ``(g) Registration Requirements for Antimicrobial Pesticides.--
            ``(1) Evaluation of process.--The Administrator shall 
        identify and evaluate reforms to the antimicrobial registration 
        process that will reduce current review periods for--
                    ``(A) new antimicrobial active ingredients;
                    ``(B) new antimicrobial end-use products;
                    ``(C) substantially similar or identical 
                antimicrobial pesticides; and
                    ``(D) amendments to existing antimicrobial 
                pesticide registrations; by the maximum extent 
                practicable consistent with the degree and type of 
                review appropriate to the risks presented by the 
                antimicrobial pesticide.
            ``(2) Review time period reduction goal.--The reforms 
        identified under paragraph (1) shall be designed to achieve the 
        goal of reducing the review periods for each of the 
        antimicrobial pesticide registration actions described below to 
        the shorter of either a 75 percent reduction from the current 
        review time period or the following specific review periods:
                    ``(A) 12 months for a new antimicrobial active 
                ingredient pesticide registration.
                    ``(B) 6 months for a new antimicrobial use of a 
                registered active ingredient.
                    ``(C) 3 months for a new antimicrobial use of a 
                registered end-use product.
                    ``(D) 3 months for a new antimicrobial end-use 
                product registration.
                    ``(E) 3 months for a substantially similar or 
                identical antimicrobial product.
                    ``(F) 3 months for an amendment to a current 
                antimicrobial registration that requires scientific 
                review of data.
                    ``(G) 1 month for an application for an amendment 
                to a current antimicrobial registration that does not 
                require scientific review of data.
            ``(3) Advance notice of proposed rulemaking.--Not later 
        than 90 days after the date of enactment of this subsection, 
        the Administrator shall publish in the Federal Register an 
        advance notice of proposed rulemaking to solicit input for 
        rulemaking to--
                    ``(A) define the different classes of antimicrobial 
                use patterns, including but not limited to household 
                and similarly-formulated industrial and institutional 
                disinfectants and sanitizing pesticides, preservatives, 
                water treatment, and pulp and paper mill additives;
                    ``(B) differentiate the types of review (such as 
                those described in paragraphs (1) and (2)) undertaken 
                for antimicrobial pesticides;
                    ``(C) conform and degree and type of review to the 
                risks and benefits presented by antimicrobial 
                pesticides and the function of review under this Act 
                considering the use patterns of the product, toxicity, 
                and product type;
                    ``(D) ensure that the review process is sufficient 
                to maintain antimicrobial pesticide efficacy and that 
                household and similarly-formulated industrial and 
                institutional disinfectant and sanitizing pesticides 
                continue to meet product performance standards and 
                specific effectiveness levels reflected in subdivision 
                G of the Agency's Pesticide Assessment Guidelines for 
                each type of label claim made; and
                    ``(E) implement effective deadlines for process 
                management, that can be relied upon by both the 
                registrant and the Agency.
            ``(4) Implementation.--
                    ``(A) Regulations.--Within 1 year of the date of 
                enactment of this subsection, the Administrator shall 
                propose regulations, to be effective within 180 days of 
                their publication in the Federal Register, to carry out 
                and meet the goals set forth in paragraph (2). The 
                Administrator shall consider the establishment of a 
                certification process for regulatory actions involving 
                risks that can be responsibly managed consistent with 
                their degree in the most cost efficient manner. The 
                Administrator shall also consider, as an adjunct to the 
                review process, the establishment of a certification 
                process by approved laboratories. In addition to 
                considering certification processes, the Administrator 
                shall also utilize all appropriate and cost effective 
                review mechanisms, including--
                            ``(i) expanded use of notification and non-
                        notification procedures;
                            ``(ii) revised procedures for application 
                        review; and
                            ``(iii) allocation of appropriate and 
                        sufficient resources to ensure streamlined 
                        management of antimicrobial pesticide 
                        registrations.
                    ``(B) Transition period.--In the case of an 
                antimicrobial pesticide application filed after 90 days 
                after the date of enactment of this subsection, the 
                following shall apply:
                            ``(i) The review period for the 
                        registration of an antimicrobial end-use 
                        pesticide that, if registered as proposed, 
                        would be substantially similar or identical in 
                        composition and labeling to a currently-
                        registered antimicrobial pesticide identified 
                        in the application, or that would differ in 
                        composition and labeling from such currently-
                        registered antimicrobial pesticide only in ways 
                        that would not significantly increase the risk 
                        of unreasonable adverse effects on the 
                        environment, shall be not more than 135 days.
                            ``(ii) The review period for an amendment 
                        to a current registration that does not require 
                        scientific review of data shall be no more than 
                        135 days.
                            ``(iii) No rule promulgated under 
                        subparagraph (A) may extend, absent consent of 
                        the registrant, the time periods established 
                        under this subparagraph.
                    ``(C) Alternative review periods.--In the case of 
                antimicrobial pesticide applications other than those 
                described in subparagraph (B), if the final rules to 
                carry out this paragraph are not effective 545 days 
                after the date of enactment of this subsection, the 
                following review periods, beginning on the date of 
                receipt by the Agency of a complete application, shall 
                apply:
                            ``(i) 18 months for a new active ingredient 
                        pesticide registration.
                            ``(ii) 12 months for a new use of a 
                        registered active ingredient.
                            ``(iii) 6 months for a new use of a 
                        registered end-use product.
                            ``(iv) 6 months for a new end-use product 
                        registration.
                            ``(v) 135 days for a substantially similar 
                        or identical product.
                            ``(vi) 6 months for an amendment to a 
                        current registration that requires scientific 
                        review of data.
                            ``(vii) 135 days for an application for an 
                        amendment to a current registration that does 
                        not require scientific review of data.
                    ``(D) Notification.--
                            ``(i) In general.--The Administrator shall 
                        notify the registrant prior to the end of the 
                        appropriate review period specified in 
                        subparagraph (B) or (C) whether an application 
                        has been granted or denied.
                            ``(ii) Final decision.--If the 
                        Administrator fails to timely notify the 
                        registrant under clause (i) whether an 
                        application has been granted or denied, the 
                        application shall be deemed to be denied and 
                        such denial shall be considered a final agency 
                        action subject to judicial review under section 
                        551 of title 5, United States Code, et seq.
                    ``(E) Oversight.--The Committee on Agriculture of 
                the House of Representatives and the Committee on 
                Agriculture, Nutrition, and Forestry of the Senate 
                shall thereafter conduct such oversight as is necessary 
                to ensure that the reform goal for the antimicrobial 
                registration process are met.
            ``(5) Annual report.--Not later than March 1 of each year 
        after date of enactment of this subsection until the reform 
        goals specified in this subsection have been achieved, the 
        Administrator shall prepare and submit an annual report to the 
        Committee on Agriculture of the House of Representatives and 
        the Committee on Agriculture, Nutrition, and Forestry of the 
        Senate. This report shall include those measures taken to 
        reduce the backlog of pending registration applications, 
        progress toward achieving the reforms, and recommendations to 
        improve the activities of the Agency pertaining to 
        antimicrobial registrations.''.
    ``(c) Label and Labeling Statements.--Section 3(c) (7 U.S.C. 
136a(c)) is amended by adding at the end the following new paragraph:
            ``(9) Label and labeling statements.--
                    ``(A) Additional statements.--A registrant of an 
                antimicrobial pesticide may not change the label or 
                labeling statements required under this Act or by 
                regulation including the pesticidal claims, ingredient 
                statement, directions for use, warning and caution 
                statements and Agency registration numbers, without the 
                approval of the Administrator. A registrant of an 
                antimicrobial pesticide may make or alter other label 
                or labeling statements or amendments that are truthful 
                and not misleading and that do not relate to or affect 
                such required label or labeling statements.
                    ``(B) Use dilution.--For antimicrobial pesticides 
                that are or may be diluted for use, the label or 
                labeling required under this Act may have a different 
                statement of caution or protective measures for use of 
                recommended diluted solutions of the pesticide than for 
                the use of concentrates of the pesticide. Such a 
                precautionary statement shall provide adequate 
                protection for exposure to the diluted solution of the 
                pesticide.''.
    (d) Disposal and Household and Similarly Formulated Industrial and 
Institutional Disinfectant and Sanitizer Products.--Section 19(h) (7 
U.S.C. 136q(h)) is amended by adding at the end the following new 
sentence: ``Household and similarly-formulated industrial and 
institutional disinfectant and sanitizer products which are not 
otherwise subject to regulation under the Solid Waste Disposal Act (42 
U.S.C. 6901 et. seq.) shall not be subject to regulation under this 
section.''.
    (e) Data Coordination and Synchronization.--Section 3(c)(2)(B) (7 
U.S.C. 136a(c)(2)(B)) is amended by adding at the end the following new 
clause:
            ``(vi) Whenever data of a type specified in the guidelines 
        published under subparagraph (A) is requested by one or more 
        State or Federal agencies, the Administrator shall, to the 
        extent practicable, share data and information and shall 
        coordinate and synchronize such data requests including, but 
        not limited to, test protocols, timetables, and standards of 
        review among the agencies so as to reduce burdens and to avoid 
        unnecessary repetition and redundancy. In addition, within one 
        year after the date of enactment of this clause, the 
        Administrator shall, by rule, develop and implement procedures 
        for such coordination and synchronization by the Administrator 
        so as to result in identical and concurrent data requirements 
        by all the agencies. Nothing in this clause shall be 
        interpreted as affecting the authority of States to regulate 
        pesticides as provided in section 24(a).''.
                                 <all>
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