[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3338 Introduced in House (IH)]







104th CONGRESS
  2d Session
                                H. R. 3338

To reform antimicrobial pesticide registration, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 25, 1996

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

_______________________________________________________________________

                                 A BILL


 
To reform antimicrobial pesticide registration, 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. DEFINITIONS.

    Section 2 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (7 U.S.C. 136) is amended--
            (1) in subsection (k), by striking ``yeast, and bacteria'' 
        and inserting ``and yeast'';
            (2) in subsection (u), by adding at the end the following: 
        ``The term `pesticide' does not include liquid chemical 
        sterilant products for use on a critical or semi-critical 
        medical or dental device, as defined in section 201 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).''; and
            (3) by adding at the end the following:
    ``(hh) Antimicrobial Pesticide.--
            ``(1) In general.--The term `antimicrobial pesticide' means 
        a pesticide that--
                    ``(A) is intended to--
                            ``(i) disinfect, sanitize, reduce, or 
                        mitigate growth or development of 
                        microbiological organisms; or
                            ``(ii) protect inanimate objects, 
                        industrial processes or systems, surfaces, 
                        water, or other chemical substances from 
                        contamination, fouling, or deterioration caused 
                        by bacteria, viruses, fungi, protozoa, algae, 
                        or slime; and
                    ``(B) in the intended use is exempt from, or 
                otherwise not subject to, a tolerance under section 408 
                or 409 of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 346a and 348).
            ``(2) Excluded products.--The term `antimicrobial 
        pesticide' does not include--
                    ``(A) a wood preservative or antifouling paint 
                product for which a claim of pesticidal activity other 
                than or in addition to an activity described in 
                paragraph (1) is made;
                    ``(B) an agricultural fungicide product; or
                    ``(C) an aquatic herbicide product.
            ``(3) Included products.--The term `antimicrobial 
        pesticide' does include any other chemical sterilant product 
        (other than liquid chemical sterilant products exempt under 
        subsection (u)), any other disinfectant product, any other 
        industrial microbiocide product, and any other preservative 
        product that is not excluded by paragraph (2).''.

SEC. 3. FEDERAL AND STATE DATA COORDINATION.

    Section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (7 U.S.C. 136a(c)(2)(B)) is amended by adding at the 
end the following:
                            ``(vi) Coordination of data requirements.--
                                    ``(I) In general.--If data required 
                                to support registration of a pesticide 
                                under subparagraph (A) is requested by 
                                a Federal or State regulatory 
                                authority, the Administrator shall, to 
                                the extent practicable, coordinate data 
                                requirements, test protocols, 
                                timetables, and standards of review and 
                                reduce burdens and redundancy caused to 
                                the registrant by multiple requirements 
                                on the registrant.
                                    ``(II) Cooperative agreement.--The 
                                Administrator may enter into a 
                                cooperative agreement with a State to 
                                carry out subclause (I).
                                    ``(III) Disparities.--Not later 
                                than 1 year after the date of enactment 
                                of this clause, the Administrator shall 
                                develop a process to identify and 
                                assist in alleviating future 
                                disparities between Federal and State 
                                data requirements.''.

SEC. 4. LABEL AND LABELING.

    Section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide 
Act (7 U.S.C. 136a(c)) is amended by adding at the end the following:
            ``(9) Labeling.--
                    ``(A) Additional statements.--Subject to 
                subparagraphs (B) and (C), it shall not be a violation 
                of this Act for a registrant to modify the labeling of 
                an antimicrobial pesticide product to include relevant 
                information on product efficacy, product composition, 
                container composition or design, or other 
                characteristics that do not relate to any pesticidal 
                claim or pesticidal activity.
                    ``(B) Requirements.--Proposed labeling information 
                under subparagraph (A) shall not be false or 
                misleading, shall not conflict with or detract from any 
                statement required by law or the Administrator as a 
                condition of registration, and shall be substantiated 
                on the request of the Administrator.
                    ``(C) Notification and disapproval.--
                            ``(i) Notification.--A registration may be 
                        modified under subparagraph (A) if--
                                    ``(I) the registrant notifies the 
                                Administrator in writing not later than 
                                60 days prior to distribution or sale 
                                of a product bearing the modified 
                                labeling; and
                                    ``(II) the Administrator does not 
                                disapprove of the modification under 
                                clause (ii).
                            ``(ii) Disapproval.--Not later than 30 days 
                        after receipt of a notification under clause 
                        (i), the Administrator may disapprove the 
                        modification by sending the registrant 
                        notification in writing stating that the 
                        proposed language is not acceptable and stating 
                        the reasons why the Administrator finds the 
                        proposed modification unacceptable.
                            ``(iii) Restriction on sale.--A registrant 
                        may not sell or distribute a product bearing a 
                        disapproved modification.
                            ``(iv) Objection.--A registrant may file an 
                        objection in writing to a disapproval under 
                        clause (ii) not later than 30 days after 
                        receipt of notification of the disapproval.
                            ``(v) Final action.--A decision by the 
                        Administrator following receipt and 
                        consideration of an objection filed under 
                        clause (iv) shall be considered a final agency 
                        action.
                    ``(D) Use dilution.--The label or labeling required 
                under this Act for an antimicrobial pesticide that is 
                or may be diluted for use may have a different 
                statement of caution or protective measures for use of 
                the recommended diluted solution of the pesticide than 
                for use of a concentrate of the pesticide if the 
                Administrator determines that--
                            ``(i) adequate data have been submitted to 
                        support the statement proposed for the diluted 
                        solution uses; and
                            ``(ii) the label or labeling provides 
                        adequate protection for exposure to the diluted 
                        solution of the pesticide.''.

SEC. 5. REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES.

    Section 3 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (7 U.S.C. 136a) is amended by adding at the end the following:
    ``(g) Registration Requirements for Antimicrobial Pesticides.--
            ``(1) Evaluation of process.--To the maximum extent 
        practicable consistent with the degrees of risk presented by a 
        antimicrobial pesticide and the type of review appropriate to 
        evaluate the risks, the Administrator shall identify and 
        evaluate reforms to the antimicrobial registration process that 
        would reduce review periods existing as of the date of 
        enactment of this subsection for antimicrobial pesticide 
        product registration applications and applications for amended 
        registration of antimicrobial pesticide products, including--
                    ``(A) new antimicrobial active ingredients;
                    ``(B) new antimicrobial end-use products;
                    ``(C) substantially similar or identical 
                antimicrobial pesticides; and
                    ``(D) amendments to antimicrobial pesticide 
                registrations.
            ``(2) Review time period reduction goal.--Each reform 
        identified under paragraph (1) shall be designed to achieve the 
        goal of reducing the review period following submission of a 
        complete application, consistent with the degree of risk, to a 
        period of not more than--
                    ``(A) 540 days for a new antimicrobial active 
                ingredient pesticide registration;
                    ``(B) 270 days for a new antimicrobial use of a 
                registered active ingredient;
                    ``(C) 120 days for any other new antimicrobial 
                product;
                    ``(D) 90 days for a substantially similar or 
                identical antimicrobial product;
                    ``(E) 90 days for an amendment to an antimicrobial 
                registration that does not require scientific review of 
                data; and
                    ``(F) 90 to 180 days for an amendment to an 
                antimicrobial registration that requires scientific 
                review of data and that is not otherwise described in 
                this paragraph.
            ``(3) Implementation.--
                    ``(A) Proposed rulemaking.--
                            ``(i) Issuance.--Not later than 270 days 
                        after the date of enactment of this subsection, 
                        the Administrator shall publish in the Federal 
                        Register proposed regulations to accelerate and 
                        improve the review of antimicrobial pesticide 
                        products designed to implement, to the extent 
                        practicable, the goals set forth in paragraph 
                        (2).
                            ``(ii) Requirements.--Proposed regulations 
                        issued under clause (i) shall--
                                    ``(I) define the various classes of 
                                antimicrobial use patterns, including 
                                household, industrial, and 
                                institutional disinfectants and 
                                sanitizing pesticides, preservatives, 
                                water treatment, and pulp and paper 
                                mill additives, and other such products 
                                intended to disinfect, sanitize, 
                                reduce, or mitigate growth or 
                                development of microbiological 
                                organisms, or protect inanimate 
                                objects, industrial processes or 
                                systems, surfaces, water, or other 
                                chemical substances from contamination, 
                                fouling, or deterioration caused by 
                                bacteria, viruses, fungi, protozoa, 
                                algae, or slime;
                                    ``(II) differentiate the types of 
                                review undertaken for antimicrobial 
                                pesticides;
                                    ``(III) conform the 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, expected 
                                exposure, and product type;
                                    ``(IV) ensure that the registration 
                                process is sufficient to maintain 
                                antimicrobial pesticide efficacy and 
                                that antimicrobial pesticide products 
                                continue to meet product performance 
                                standards and effectiveness levels for 
                                each type of label claim made; and
                                    ``(V) implement effective and 
                                reliable deadlines for process 
                                management.
                            ``(iii) Comments.--In developing the 
                        proposed regulations, the Administrator shall 
                        solicit the views from registrants and other 
                        affected parties to maximize the effectiveness 
                        of the rule development process.
                    ``(B) Final regulations.--
                            ``(i) Issuance.--The Administrator shall 
                        issue final regulations not later than 240 days 
                        after the close of the comment period for the 
                        proposed regulations.
                            ``(ii) Failure to meet goal.--If a goal 
                        described in paragraph (2) is not met by the 
                        final regulations, the Administrator shall 
                        identify the goal, explain why the goal was not 
                        attained, describe the element of the 
                        regulations included instead, and identify 
                        future steps to attain the goal.
                            ``(iii) Requirements.--In issuing final 
                        regulations, the Administrator shall--
                                    ``(I) consider the establishment of 
                                a certification process for regulatory 
                                actions involving risks that can be 
                                responsibly managed, consistent with 
                                the degree of risk, in the most cost-
                                efficient manner;
                                    ``(II) consider the establishment 
                                of a certification process by approved 
                                laboratories as an adjunct to the 
                                review process;
                                    ``(III) use all appropriate and 
                                cost-effective review mechanisms, 
                                including--
                                            ``(aa) expanded use of 
                                        notification and non-
                                        notification procedures;
                                            ``(bb) revised procedures 
                                        for application review; and
                                            ``(cc) allocation of 
                                        appropriate resources to ensure 
                                        streamlined management of 
                                        antimicrobial pesticide 
                                        registrations; and
                                    ``(IV) clarify criteria for 
                                determination of the completeness of an 
                                application.
                    ``(C) Expedited review.--This subsection does not 
                affect the requirements or extend the deadlines or 
                review periods contained in subsection (c)(3).
                    ``(D) Alternative review periods.--If the final 
                regulations to carry out this paragraph are not 
                effective 630 days after the date of enactment of this 
                subsection, until the final regulations become 
                effective, the review period, beginning on the date of 
                receipt by the Agency of a complete application, shall 
                be--
                            ``(i) 2 years for a new antimicrobial 
                        active ingredient pesticide registration;
                            ``(ii) 1 year for a new antimicrobial use 
                        of a registered active ingredient;
                            ``(iii) 180 days for any other new 
                        antimicrobial product;
                            ``(iv) 90 days for a substantially similar 
                        or identical antimicrobial product;
                            ``(v) 90 days for an amendment to an 
                        antimicrobial registration that does not 
                        require scientific review of data; and
                            ``(vi) 240 days for an amendment to an 
                        antimicrobial registration that requires 
                        scientific review of data and that is not 
                        otherwise described in this subparagraph.
                    ``(E) Wood preservatives.--An application for the 
                registration, or for an amendment to the registration, 
                of a wood preservative product for which a claim of 
                pesticidal activity listed in section 2(hh)(1) is made 
                (regardless of any other pesticidal claim that is made 
                with respect to the product) shall be reviewed by the 
                Administrator within the same period as that 
                established under this paragraph for an antimicrobial 
                pesticide product application, consistent with the 
                degree of risk posed by the use of the wood 
                preservative product, if the application requires the 
                applicant to satisfy the same data requirements as are 
                required to support an application for a wood 
                preservative product that is an antimicrobial 
                pesticide.
                    ``(F) Notification.--
                            ``(i) In general.--Subject to clause (iii), 
                        the Administrator shall notify an applicant 
                        whether an application has been granted or 
                        denied not later than the final day of the 
                        appropriate review period under this paragraph, 
                        unless the applicant and the Administrator 
                        agree to a later date.
                            ``(ii) Final decision.--If the 
                        Administrator fails to notify an applicant 
                        within the period of time required under clause 
                        (i), the failure shall be considered an agency 
                        action unlawfully withheld or unreasonably 
                        delayed for purposes of judicial review under 
                        section 706(1) of title 5, United States Code.
                            ``(iii) Exemption.--This subparagraph does 
                        not apply to an application for an 
                        antimicrobial pesticide that is filed under 
                        subsection (c)(3)(B) prior to 90 days after the 
                        date of enactment of this subsection.
            ``(4) Annual report.--
                    ``(A) Submission.--Beginning on the date of 
                enactment of this subsection and ending on the date 
                that the goals under paragraph (2) are achieved, the 
                Administrator shall, not later than March 1 of each 
                year, 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.
                    ``(B) Requirements.--A report submitted under 
                subparagraph (A) shall include a description of--
                            ``(i) measures taken to reduce the backlog 
                        of pending registration applications;
                            ``(ii) progress toward achieving reforms 
                        under this subsection; and
                            ``(iii) recommendations to improve the 
                        activities of the Agency pertaining to 
                        antimicrobial registrations.''.

SEC. 6. DISPOSAL OF HOUSEHOLD, INDUSTRIAL, OR INSTITUTIONAL 
              ANTIMICROBIAL PRODUCTS.

    Section 19(h) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (7 U.S.C. 136q(h)) is amended--
            (1) by striking ``Nothing in'' and inserting the following:
            ``(1) In general.--Nothing in''; and
            (2) by adding at the end the following:
            ``(2) Antimicrobial products.--A household, industrial, or 
        institutional antimicrobial product that is not subject to 
        regulation under the Solid Waste Disposal Act (42 U.S.C. 6901 
        et seq.) shall not be subject to the provisions of subsections 
        (a), (e), and (f), unless the Administrator determines that 
        such product must be subject to such provisions to prevent an 
        unreasonable adverse effect on the environment.''.
                                 <all>