[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 967 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 967

 To amend the Federal Insecticide, Fungicide, and Rodenticide Act with 
                    respect to minor use pesticides.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 18, 1993

 Mr. de la Garza (for himself, Mr. Roberts, Mr. Stenholm, Mr. Smith of 
    Oregon, Mr. Thomas of California, Mr. Rowland, Mr. Inslee, Mr. 
Kopetski, Mr. Lehman, Mr. Fazio, Mr. Dooley, and Mr. Condit) introduced 
 the following bill; which was referred to the Committee on Agriculture

                              July 9, 1993

 Additional Sponsors: Mr. LaRocco, Mr. Henry, Mr. Ravenel, Mr. Stump, 
 Mr. Paxon, Mr. Swift, Mr. Barrett of Nebraska, Mr. Camp, Mr. Allard, 
 Mr. Upton, Mr. Gekas, Mr. McHugh, Mr. Lewis of Flordia, Mr. Lewis of 
California, Mr. Gallegly, Mr. Boehner, Mr. Emerson, Mr. Doolittle, Mr. 
   Kingston, Mr. Gillmor, Mr. Kanjorski, Mr. McDade, Mr. Holden, Mr. 
 Quillen, Mr. Hughes, Mr. Kyl, Mr. Johnson of South Dakota, Mr. Roth, 
 Mr. Smith of Michigan, Mr. Orton, Mr. Packard, Mr. Ewing, Mr. Pastor, 
  Mr. Spratt, Mr. Pomeroy, Mr. Barcia of Michigan, Ms. Slaughter, Mr. 
 Nussle, Mr. Baccus of Florida, Mr. Bonilla, Mr. Hoekstra, Mr. Bliley, 
Mr. Shaw, Mr. Crapo, Mr. Kolbe, Mr. Houghton, Mr. English of Oklahoma, 
 Mr. Canady, Mr. McCandless, Mr. Dornan, Mr. Bereuter, Mr. Sarpalius, 
   Mr. Moorhead, Mr. Sisisky, Mr. Pombo, Mr. Walsh, Mr. Dickey, Mr. 
 Peterson of Minnesota, Mr. Ridge, Mr. Hansen, Mr. Walker, Mr. Olver, 
    Mr. Dreier, Mr. Matsui, Mr. Santorum, Mr. Herger, Mr. Baker of 
  Louisiana, Mr. Bishop, Mr. Clyburn, Mr. Gunderson, Mr. Darden, Mrs. 
  Thurman, Mr. Traficant, Mrs. Fowler, Mr. Bateman, Mr. Calvert, Mr. 
 Gilman, Mr. McCollum, Ms. Snowe, Mr. Bevill, Mr. Fields of Texas, Mr. 
 Andrews of New Jersey, Mr. Zeliff, Mr. Johnston of Florida, Mr. Baker 
 of California, Mr. Johnson of Georgia, Mr. Castle, Mr. Goodling, and 
                              Mr. Stearns

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Insecticide, Fungicide, and Rodenticide Act with 
                    respect to minor use pesticides.

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

SECTION 1. SHORT TITLE AND REFERENCE.

    (A) Short Title.--This Act may be cited as the ``Minor Crop 
Pesticides Act of 1993 ''.
    (b) 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. 2. MINOR USE OF PESTICIDES.

    (a) Definition.--Section 2 (7 U.S.C. 136) is amended by adding at 
the end the following:
            ``(hh) Minor use.--The term `minor use' means the use of a 
        pesticide on an animal, on a commercial agricultural crop or 
        site, or for the protection of public health where--
                    ``(1) the Administrator, in consultation with the 
                Secretary of Agriculture, determines that, based on 
                information provided by an applicant, the use does not 
                provide sufficient economic incentive to support the 
                initial registration or continuing registration of a 
                pesticide for such use; and
                    ``(2) the Administrator has not determined that, 
                based on existing data, such use presents a risk of an 
                unreasonable adverse effect on the environment.''.
    (b) Exclusive Data Use.--Section 3(c)(1)(F) (7 U.S.C. 
136a(c)(1)(F)) is amended by redesignating clause (iii) as clause (iv) 
and by inserting after clause (ii) the following:
                            ``(iii) With respect to data submitted 
                        after the date of the enactment of this clause 
                        by an applicant or registrant to support an 
                        amendment adding a new use to an existing 
                        registration, to support or maintain in effect 
                        an existing registration, to support a new 
                        application for registration, or to support a 
                        reregistration, if such data relates solely to 
                        a minor use of a pesticide, such data shall 
                        not, without the written permission of the 
                        original data submitter, be considered by the 
                        Administrator to support an application for a 
                        minor use by another person during a period of 
                        10 years following the date of submission of 
                        such data. If the minor use registration which 
                        is supported by data submitted pursuant to this 
                        subsection is voluntarily canceled or if such 
                        data are subsequently used to support a non-
                        minor use, the data shall no longer be subject 
                        to the exclusive use provisions of this clause 
                        but shall instead be considered by the 
                        Administrator in accordance with the provisions 
                        of clauses (i) or (ii), as appropriate.''.
    (c) Time Extensions for Development of Minor Use Data.--
            (1) Data Call-In.--Subparagraph (B) of section 3(c)(2) (7 
        U.S.C. 136a(c)(2)(B)) is amended by adding at the end the 
        following:
                    ``(vi) Upon the request of a registrant, the 
                Administrator shall, in the case of a minor use, extend 
                the deadline for the production of residue chemistry 
                data under this subsection for data required solely to 
                support that minor use until 2 years after the final 
                deadline for submission of data for the other uses of 
                the pesticide if--
                            ``(I) the data to support other uses of the 
                        pesticide are being provided;
                            ``(II) the registrant, in submitting a 
                        request for such an extension, provides a 
                        schedule, including interim dates to measure 
                        progress, to assure that the data production 
                        will be completed before the expiration of the 
                        extension period;
                            ``(III) the Administrator has determined 
                        that such extension will not significantly 
                        delay the Administrator's schedule for issuing 
                        a reregistration eligibility determination 
                        required under section 4; and
                            ``(IV) the Administrator has determined in 
                        writing that based on existing data, such 
                        extension would not significantly increase the 
                        risk of any unreasonable adverse effect on the 
                        environment.
                If the Administrator grants an extension under this 
                clause, the Administrator shall monitor the development 
                of the data and shall ensure that the registrant is 
                meeting the schedule for the production of the data. If 
                the Administrator determines that the registrant is not 
                meeting the schedule for the production of such data, 
                the Administrator may proceed in accordance with clause 
                (iv) regarding the continued registration of the minor 
                use and shall inform the public of such action. If, 
                during the extension period, the Administrator is 
                furnished data which are sufficient to determine that 
                an unreasonable adverse effect exists involving the 
                minor use of the pesticide, the Administrator shall 
                provide, in writing, to the registrant, a notice 
                revoking the extension of time for submission of data. 
                Such data shall instead be due within 30 days of 
                receipt of such notice by the registrant. Nothing in 
                this clause shall preclude the Administrator from 
                proceeding in accordance with the provision of section 
                6.''.
            (2) Reregistration.--Sections 4(d)(4)(B), 4(e)(2)(B), and 
        4(f)(2)(B) (7 U.S.C. 136a-1(d)(4)(B), (e)(2)(B), and (f)(2)(B)) 
        are each amended by adding at the end the following: ``Upon the 
        request of a registrant, the Administrator shall, in the case 
        of a minor use, extend the deadline for the production of 
        residue chemistry data under this subsection for data required 
        solely to support that minor use until 2 years after the final 
        deadline for submission of data for the other uses of the 
        pesticide if--
                            ``(i) the data to support other uses of the 
                        pesticide are being provided;
                            ``(ii) the registrant, in submitting a 
                        request for such an extension provides a 
                        schedule, including interim dates to measure 
                        progress, to assure that the data production 
                        will be completed before the expiration of the 
                        extension period;
                            ``(iii) the Administrator has determined 
                        that such extension will not significantly 
                        delay the Administrator's schedule for issuing 
                        a reregistration eligibility determination 
                        required under this section; and
                            ``(iv) the Administrator has determined in 
                        writing that based on existing data, such 
                        extension would not significantly increase the 
                        risk of any unreasonable adverse effect on the 
                        environment.
                If the Administrator determines that the registrant is 
                not meeting the schedule for the production of such 
                data, the Administrator may proceed in accordance with 
                section 3(c)(2)(B)(iv) regarding the continued 
                registration of the minor use and shall inform the 
                public of such action. If, during the extension period, 
                the Administrator is furnished data which are 
                sufficient to determine that an unreasonable adverse 
                effect exists involving the minor use of the pesticide, 
                the Administrator shall provide, in writing, to the 
                registrant, a notice revoking the extension of time for 
                submission of data. Such data shall instead be due 
                within 30 days of receipt of such notice by the 
                registrant. Nothing in this subparagraph shall preclude 
                the Administrator from proceeding in accordance with 
                the provisions of section 6.''.
    (d) Minor Use Waiver.--Section 3(c)(2) (7 U.S.C. 136a(c)(2)) is 
amended--
            (1) by inserting ``In general'' after ``(A)'', by inserting 
        ``Additional data'' after ``(B)'', and by inserting 
        ``Simplified procedures'' after ``(C)'', and
            (2) by adding at the end the following:
                    ``(E) Minor use waiver.--In handling the 
                registration of a pesticide for a minor use, the 
                Administrator may waive otherwise applicable data 
                requirements if the Administrator determines that the 
                absence of such data will not prevent the Administrator 
                from determining--
                            ``(i) the incremental risk presented by the 
                        minor use of the pesticide, and
                            ``(ii) that such risk, if any, would not be 
                        an unreasonable adverse effect on the 
                        environment.''.
    (e) Expediting Minor Use Registrations.--Section 3(c)(3) (7 U.S.C. 
136a(c)(3)) is amended--
            (1) by inserting after ``(A)'' the following: ``In 
        general.--,
            (2) by inserting after ``(B)'' the following: ``Identical 
        or substantially similar''.--, and
            (3) by adding at the end the following:
                    ``(C) Minor use registration.--
                            ``(i) The Administrator shall, as 
                        expeditiously as possible, review and act on 
                        any application (I) that proposes the initial 
                        registration of a new pesticide active 
                        ingredient if the active ingredient is proposed 
                        to be registered solely for minor uses or for 
                        non-minor uses and significant minor uses, or 
                        (II) for a registration amendment that proposes 
                        a new minor use for an existing pesticide.
                            ``(ii) For the purposes of clause (i)--
                                    ``(I) the term `as expeditiously as 
                                possible' means that the Administrator 
                                shall complete a review and evaluation 
                                of all data submitted with the 
                                application, to the greatest extent 
                                practicable, no later than 6 months 
                                after the submission of the 
                                application, and
                                    ``(II) the term `significant minor 
                                uses' means 3 or more minor uses 
                                proposed for every non-minor use, a 
                                minor use that would, in the judgment 
                                of the Administrator, serve as a 
                                replacement for any use which has been 
                                canceled in the 5 years preceding the 
                                receipt of the application, or a minor 
                                use that in the opinion of the 
                                Administrator would avoid the 
                                reissuance of an emergency exemption 
                                under section 18 for that minor use.
                    ``(D) Adequate Time for Submission of Minor Use 
                Data.--If a registrant makes a good faith request for a 
                minor use waiver regarding data required by the 
                Administrator pursuant to paragraph (2)(B), and if the 
                Administrator denies in whole or in part such data 
                waiver request, the registrant shall have a full time 
                period for providing such data. Such full time period 
                extension shall not be available if the Administrator 
                determines that the data waiver request was not made in 
                good faith. Any determination by the Administrator that 
                a data waiver request was not submitted in good faith 
                shall be made in writing to the registrant and shall be 
                subject to judicial review under the procedures 
                prescribed by section 16(b).''.
    (f) Conditional Registration for Minor Uses.--Section 3(c)(7) (7 
U.S.C. 136a(c)(7)) is amended by inserting ``In general'' after 
``(A)'', by inserting ``Conditional amendment'' after ``(B)'', by 
inserting ``Conditional registration'' after ``(C)'', and by adding at 
the end the following:
                    ``(D) Additional minor uses.--
                            ``(i) The Administrator shall conditionally 
                        amend the registration of a pesticide to permit 
                        additional minor uses of such pesticide 
                        notwithstanding that data concerning the 
                        pesticide may be insufficient to support an 
                        unconditional registration amendment, if the 
                        Administrator determines that--
                                    ``(I) the applicant has submitted 
                                satisfactory data pertaining to the 
                                proposed additional minor use, and
                                    ``(II) amending the registration in 
                                the manner proposed by the applicant 
                                would not significantly increase the 
                                risk of any unreasonable adverse effect 
                                on the environment.
                            ``(ii) Notwithstanding clause (i), no 
                        registration of a pesticide may be amended to 
                        permit an additional minor use of such 
                        pesticide if the Administrator has issued a 
                        notice stating that such pesticide, or any 
                        ingredient thereof, meets or exceeds risk 
                        criteria associated in whole or in part with 
                        human dietary exposure enumerated in 
                        regulations issued under this Act, and during 
                        the pendency of any risk-benefit evaluation 
                        initiated by such notice, if--
                                    ``(I) the additional minor use of 
                                such pesticide involves a major food or 
                                feed crop, or
                                    ``(II) the additional minor use of 
                                such pesticide involves a minor food or 
                                feed crop and the Administrator 
                                determines, with the concurrence of the 
                                Secretary of Agriculture, there is 
                                available an effective alternative 
                                pesticide that does not meet or exceed 
                                such risk criteria.
                            ``(iii) An applicant seeking amended 
                        registration under this subparagraph shall 
                        submit such data as would be required to obtain 
                        registration of a similar pesticide under 
                        paragraph (5). If the applicant is unable to 
                        submit an item of data (other than data 
                        pertaining to the proposed additional minor 
                        use) because it has not yet been generated, the 
                        Administrator shall amend the registration 
                        under such conditions as will require the 
                        submission of such data not later than the time 
                        such data are required to be submitted with 
                        respect to similar pesticides already 
                        registered under this Act. The determinations 
                        required under this clause shall be made by the 
                        Administrator in writing to the registrant and 
                        shall be subject to judicial review under the 
                        procedures prescribed by section 16(b).''.
    (g) Expedited Conditional Registration to Replace Previously 
Canceled Registrations or Deleted Uses on a One-time Basis.--Section 
3(c)(7) (7 U.S.C. 136a(c)(7)), as amended by subsection (f), is amended 
by adding at the end the following:
                    ``(E) Conditional minor use registration.--The 
                Administrator may conditionally register or amend the 
                registration of a pesticide for a minor use if the 
                registrant establishes that--
                            ``(i) the active ingredient is being 
                        supported for reregistration as required by 
                        section 4 of this Act;
                            ``(ii) the minor use proposed for 
                        registration was a registered use of a product 
                        that has been canceled, proposed for 
                        cancellation, or deleted as a use under section 
                        4 or section 6 of this Act after December 24, 
                        1988; and
                            ``(iii) the use directly requires only 
                        residue chemistry data for reregistration.
                Before granting the conditional registration, the 
                Administrator must determine that approval of the 
                registration or amendment in the manner proposed by the 
                applicant would not significantly increase the risk of 
                an unreasonable adverse effect on the environment, and 
                that there is an existing tolerance for the use. The 
                applicant shall either commit to the submission of data 
                required for reregistration of the pesticide or use by 
                the final deadline, established as of the date of the 
                approval of the application, for the submission of the 
                last data needed to support registration of the 
                pesticide active ingredient, or agree to cease 
                distribution and sale of the pesticide by this date. In 
                cases where the registrant has committed to the 
                submission of data, the Administrator may extend the 
                expiration date for the conditional registration to a 
                date 6 months past the scheduled data submission date 
                to allow time for Agency review of the application. 
                Distribution and sale by the registrant of pesticides 
                registered for the use must cease on the expiration 
                date. The Administrator shall provide expedited review 
                of any application under this section in accordance 
                with the provisions in paragraph (3). The Administrator 
                may take action at any time prior to the established 
                date to order deletion of uses approved under this 
                subsection, if no registrant is fulfilling commitments 
                for other uses, or if the Administrator becomes aware 
                that the delay may result in a risk of an unreasonable 
                adverse effect on the environment. If the registrant 
                does not voluntarily comply with the order by 
                requesting deletion of use, the Administrator may 
                cancel registrations with the use by order without a 
                hearing. All applications for such conditional 
                registration or amendment must be submitted to the 
                Administrator within 1 year after the date of enactment 
                of this provision.''.
    (h) Temporary Extension of Registration for Unsupported Minor 
Uses.--
            (1) Reregistration.--
                    (A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C. 136a-
                1(d)(6) and (f)(3)) are each amended by adding at the 
                end the following: ``If the registrant is not 
                supporting a specific minor use of the pesticide, but 
                is supporting and providing data in a timely fashion to 
                support other food uses the Administrator, at the 
                written request of the registrant, shall not take any 
                action pursuant to this paragraph in regard to such 
                unsupported minor use until the final deadline for the 
                submission of data for the supported uses under this 
                paragraph. Upon receipt of the request from the 
                registrant, the Administrator shall publish in the 
                Federal Register a notice of the receipt of the request 
                and the effective date upon which the uses not being 
                supported will be voluntarily deleted from the 
                registration. Notwithstanding the provisions of this 
                paragraph, the Administrator may take action to cancel 
                or suspend such minor use, pursuant to section 6, if 
                the Administrator determines that the continuation of 
                the minor use may cause an unreasonable adverse effect 
                on the environment.''.
                    (B) Section 4(e)(3)(A) (7 U.S.C. 136a-1(e)(3)(A)) 
                is amended by adding at the end the following: ``If the 
                registrant is not supporting a specific minor use of 
                the pesticide, but is supporting and providing data in 
                a timely fashion to support other uses, the 
                Administrator, at the written request of the 
                registrant, shall not take any action pursuant to this 
                subparagraph in regard to such unsupported minor use 
                until the final deadline for the submission of data for 
                the supported uses under this subparagraph. Upon 
                receipt of the request from the registrant, the 
                Administrator shall publish in the Federal Register a 
                notice of the receipt of the request and the effective 
                date upon which the uses not being supported will be 
                voluntarily deleted from the registration. 
                Notwithstanding the provisions of this subparagraph, 
                the Administrator may take action to cancel or suspend 
                such minor use, pursuant to section 6, if the 
                Administrator determines that the continuation of the 
                minor use may cause an unreasonable adverse effect on 
                the environment .''.
            (2) Data.--Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as 
        amended by subsection (c), is further amended by adding at the 
        end the following:
                    ``(vii) If the registrant is not supporting a 
                specific minor use of the pesticide, but is supporting 
                and providing data in a timely fashion to support other 
                uses, the Administrator, at the written request of the 
                registrant, shall not take any action pursuant to this 
                subparagraph in regard to such unsupported minor use 
                until the final deadline for the submission of data for 
                the supported uses under this paragraph. Upon receipt 
                of the request from the registrant, the Administrator 
                shall publish in the Federal Register a notice of the 
                receipt of the request and the effective date upon 
                which the uses not being supported will be voluntarily 
                deleted from the registration. Notwithstanding the 
                provisions of this subparagraph, the Administrator may 
                take action to cancel or suspend such minor use, 
                pursuant to section 6, if the Administrator determines 
                that the continuation of the minor use would violate 
                the criteria contained in section 6.''.
    (i) Utilization of Data for Voluntarily Canceled Chemicals.--
Section 6(f) (7 U.S.C. 136d) is amended by adding at the end the 
following:
            ``(4) Utilization of data for voluntarily canceled 
        chemicals.--When an application is filed with the Administrator 
        for the registration of a pesticide for a minor use not later 
        than 2 years after another registrant voluntarily cancels its 
        registration for an identical or substantially similar 
        pesticide for an identical or substantially similar use, the 
        Administrator shall process, review, and evaluate the pending 
        application as if the voluntary cancellation had not yet taken 
        place for purposes of the use of data from such registration, 
        except that the Administrator may not take such action if the 
        Administrator has evidence that such minor use presents the 
        risk of an unreasonable adverse effect on the environment.''.
    (j) Environmental Protection Agency Minor Use Program.--The Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 121 et seq.) is 
amended by redesignating sections 30 and 31 as sections 32 and 33, 
respectively and adding after section 29 the following:

``SEC. 30. ENVIRONMENTAL PROTECTION AGENCY MINOR USE PROGRAM.

    ``The Environmental Protection Agency shall assure coordination of 
minor use issues through the establishment of a minor use program 
within the Office of Pesticide Programs. Such office shall be 
responsible for coordinating the development of minor use programs and 
policies, consulting with growers regarding minor use issues and 
registrations, and tracking and expediting minor use registrations and 
amendments which are submitted to the Environmental Protection 
Agency.''.
    (k) Department of Agriculture Minor Use Program.--The Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 121 et seq.), as 
amended by subsection (j), is amended by adding at the end the 
following:

``SEC. 31. DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM.

    ``(a) Program.--The Department of Agriculture shall assure 
coordination through establishment of a minor use program, of its 
responsibilities, including administering the IR-4 Program and the 
National Agricultural Pesticide Impact Assessment Program, supporting 
IPM research, consulting with growers to develop data for minor uses, 
and assisting minor use registrations, tolerances, and reregistrations 
with the Environmental Protection Agency.
    ``(b) Matching Fund Program.--
            ``(1) Establishment.--The Secretary of Agriculture shall 
        establish a minor use matching fund program. The matching fund 
        program shall be utilized to ensure the continued availability 
        of minor use crop protection chemicals, including the 
        development of data to support minor use pesticide 
        registrations and reregistrations. Access to the matching fund 
        program shall be available to any entity which desires to 
        develop data to support minor use registrations. Priority for 
        access to the fund shall be given those entities that do not 
        directly receive funds from the sale of products registered on 
        minor uses. Any entity that seeks such matching funds shall be 
        required to match such matching funds with an equal amount of 
        its own funds. Any data developed through the matching fund 
        program shall be jointly owned by the Department of Agriculture 
        and by the entity that receives such funding. Such data may be 
        utilized by other entities for the purpose of seeking 
        registrations and tolerances, if such entities receive written 
        permission from the Department of Agriculture and the entity 
        that produced the data. All fees received by the Department of 
        Agriculture in return for the use of such data under the 
        matching fund program shall be returned to a revolving fund 
        which will support the matching fund program.
            ``(2) Authorization.-- There is authorized to be 
        appropriated for the revolving fund for the matching fund 
        program an annual sum not to exceed $10,000,000.''.

                                 <all>

HR 967 SC----2