[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1352 Introduced in House (IH)]







104th CONGRESS
  1st Session
                                H. R. 1352

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 29, 1995

Mr. de la Garza (for himself, Mr. Roberts, Mr. Emerson, Mr. Condit, Mr. 
 Stenholm, Mr. Boehner, Mrs. Thurman, Mr. Canady of Florida, Mr. Rose, 
Mr. Ewing, Mr. Dooley, and Mr. Pomeroy) introduced the following bill; 
           which was referred to the Committee on Agriculture

_______________________________________________________________________

                                 A BILL


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

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

SECTION 1. SHORT TITLE.

    (a) Short Title.--This Act may be cited as the ``Minor Use Crop 
Protection Act of 1995''.
    (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 CROP PROTECTION.

    (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 total United States acreage for the crop is less 
        than 300,000 acres; or
            ``(2) the Administrator, in consultation with the Secretary 
        of Agriculture, determines that, based on information provided 
        by an applicant for registration or a registrant, the use does 
        not provide sufficient economic incentive to support the 
        initial registration or continuing registration of a pesticide 
        for such use; and--
                    ``(A) there are insufficient efficacious 
                alternative registered pesticides available for the 
                use; or
                    ``(B) the alternatives to the pesticide pose 
                greater risks to the environment or human health; or
                    ``(C) the pesticide plays or will play, a 
                significant part in managing pest resistance; or
                    ``(D) the pesticide plays or will play a 
                significant part in an integrated pest management 
                program.
        The status as a minor use under this subsection shall continue 
        as long as the Administrator has not determined that, based on 
        existing data, such use may cause an unreasonable adverse 
        effect on the environment and the use otherwise qualifies for 
        such status.''.
    (b) Exclusive Use of Minor Use Pesticides.--Section 3(c)(1)(F) (7 
U.S.C. 136a(c)(1)(F)) is amended by redesignating clauses (ii) and 
(iii) as clauses (iii) and (iv), respectively, and by inserting after 
clause (i) the following:
                            ``(ii) The period of exclusive data use for 
                        data submitted to support the application for 
                        the original registration of a pesticide under 
                        clause (i) shall be extended one additional 
                        year for each 3 minor uses registered after the 
                        date of enactment of this clause and, before 
                        the expiration of the period of exclusive use 
                        under this clause, up to a total of 3 
                        additional years for all minor uses registered 
                        by the Administrator if the Administrator in 
                        consultation with the Secretary of Agriculture 
                        determines that, based on information provided 
                        by an applicant for registration or a 
                        registrant, that:
                                    ``(I) there are insufficient 
                                efficacious alternative registered 
                                pesticides available for the use; or
                                    ``(II) the alternatives to the 
                                pesticide pose greater risks to the 
                                environment or human health; or
                                    ``(III) the pesticide plays or will 
                                play a significant part in managing 
                                pest resistance; or
                                    ``(IV) the pesticide plays or will 
                                play a significant part in an 
                                integrated pest management program.
                        The registration of a pesticide for a minor use 
                        on a crop grouping established by the 
                        Administrator shall be considered for purposes 
                        of this clause one minor use for each 
                        representative crop for which data are provided 
                        in the crop grouping. Any additional exclusive 
                        use period under this clause shall be modified 
                        as appropriate or terminated if the registrant 
                        voluntarily cancels the product or deletes from 
                        the registration the minor uses which formed 
                        the basis for the extension of the additional 
                        exclusive use period or if the Administrator 
                        determines that the registrant is not actually 
                        marketing the product for such minor uses.''.
    (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 subparagraph 
                        for data are required solely to support that 
                        minor use until the final deadline for 
                        submission of data under section 4 for the 
                        other uses of the pesticide established as of 
                        the date of enactment of the Minor Use Crop 
                        Protection Amendments of 1995, if--
                                    ``(I) the data to support other 
                                uses of the pesticide on a food 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 or has not met the schedule for the 
                        production of such data, the Administrator may 
                        proceed in accordance with clause (iv) 
                        regarding the continued registration of the 
                        affected products with the minor use and shall 
                        inform the public of such action. 
                        Notwithstanding the provisions of this clause, 
                        the Administrator may take action to modify or 
                        revoke the extension under this clause if the 
                        Administrator determines that the extension for 
                        the minor use may cause an unreasonable adverse 
                        effect on the environment. In such 
                        circumstance, 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 in accordance 
                        with the date than established by the 
                        Administrator for the submission of the 
                        data.''.
            (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 subparagraph for data 
        required solely to support that minor use until the final 
        deadline for submission of data under this section for the 
        other uses of the pesticide established as of the date of 
        enactment of the Minor Use Crop Protection Amendments of 1995 
        if--
                            ``(i) the data to support other uses of the 
                        pesticide on a food 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 grants an extension under this 
                subparagraph, 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 or has not met the schedule 
                for the production of such data, the Administrator may 
                proceed in accordance with clause (iv) of section 
                3(c)(2)(B) or other provisions of this section, as 
                appropriate, regarding the continued registration of 
                the affected products with the minor use and shall 
                inform the public of such action. Notwithstanding the 
                provisions of this subparagraph, the Administrator may 
                take action to modify or revoke the extension under 
                this subparagraph if the Administrator determines that 
                the extension for the minor use may cause an 
                unreasonable adverse affect on the environment. In such 
                circumstance, 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 in accordance with the date then 
                established by the Administrator for submission of the 
                data.''.
    (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 complete 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 proposes a registration 
                                amendment solely for minor uses to an 
                                existing registration, or
                                    ``(II) for a registration or a 
                                registration amendment that proposes 
                                significant minor uses.
                            ``(ii) For the purposes of clause (i)--
                                    ``(I) the term `as expeditiously as 
                                possible' means that the Administrator 
                                shall to the greatest extent 
                                practicable complete a review and 
                                evaluation of all data, submitted with 
                                a complete application, within 12 
                                months after the submission of the 
                                complete application, and the failure 
                                of the Administrator to complete such a 
                                review and evaluation under clause (i) 
                                shall not be subject to judicial 
                                review, 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 request for a minor use 
                waiver, regarding data required by the Administrator, 
                pursuant to paragraph (2)(E), 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. For purposes of this subparagraph, 
                the term `full time period' means the time period 
                originally established by the Administrator for 
                submission of such data, beginning with the date of 
                receipt by the registrant of the Administrator's notice 
                of denial.''.
    (f) 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 does not commit 
                to support a specific minor use of the pesticide, but 
                is supporting and providing data in a timely and 
                adequate fashion to support uses of the pesticide on a 
                food, or if all uses of the pesticide are nonfood uses 
                and the registrant does not commit to support a 
                specific minor use of the pesticide but is supporting 
                and providing data in a timely and adequate fashion to 
                support other nonfood uses of the pesticide, 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 established as of the date of 
                enactment of the Minor Use Crop Protection Amendments 
                of 1995, for the submission of data under this section 
                for the supported uses identified pursuant to this 
                paragraph unless the Administrator determines that the 
                absence of the data is significant enough to cause 
                human health or environmental concerns. On such a 
                determination the Administrator may refuse the request 
                for extension by the registrant. 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 pursuant to section 6(f)(1). If 
                the Administrator grants an extension under this 
                paragraph, the Administrator shall monitor the 
                development of the data for the uses being supported 
                and shall ensure that the registrant is meeting the 
                schedule for the production of such data. If the 
                Administrator determines that the registrant is not 
                meeting or has not met the schedule for the production 
                of such data, the Administrator may proceed in 
                accordance with clause (iv) of section 3(c)(2)(B) 
                regarding the continued registration of the affected 
                products with the minor and other uses and shall inform 
                the public of such action in accordance with section 
                6(f)(2). Notwithstanding the provision of this 
                subparagraph, the Administrator may deny, modify, or 
                revoke the temporary extension under this paragraph if 
                the Administrator determines that the continuation of 
                the minor use may cause an unreasonable adverse effect 
                on the environment. In the event of modification or 
                revocation the Administrator shall provide, in writing, 
                to the registrant, a notice revoking the temporary 
                extension and establish a new effective date by which 
                the minor use shall be deleted from the registration.
                    (B) Section 4(e)(3)(A) (7 U.S.C. 136a-(e)(3)(A)) is 
                amended by adding at the end the following: ``If the 
                registrant does not commit to support a specific minor 
                use of the pesticide, but is supporting and providing 
                data in a timely and adequate fashion to support uses 
                of the pesticide on a food, or if all uses of the 
                pesticide are nonfood uses and the registrant does not 
commit to support a specific minor use of the pesticide but is 
supporting and providing data in a timely and adequate fashion to 
support other nonfood uses of the pesticide, 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 established as of the date of enactment of the Minor Use 
Crop Protection Amendments of 1995, for the submission of data under 
this section for the supported uses identified pursuant to this 
subparagraph unless the Administrator determines that the absence of 
the data is significant enough to cause human health or environmental 
concerns. On the basis of such determination the Administrator may 
refuse the request for extension by the registrant. 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 pursuant to section 6(f)(1). 
If the Administrator grants an extension under this subparagraph, the 
Administrator shall monitor the development of the data for the uses 
being supported and shall ensure that the registrant is meeting the 
schedule for the production of such data. If the Administrator 
determines that the registrant is not meeting or has not met the 
schedule for the production of such data, the Administrator may proceed 
in accordance with clause (iv) of section 3(c)(2)(B) regarding the 
continued registration of the affected products with the minor and 
other uses and shall inform the public of such action in accordance 
with section 6(f)(2). Notwithstanding the provisions of this 
subparagraph, the Administrator may deny, modify, or revoke the 
temporary extension under this subparagraph if the Administrator 
determines that the continuation of the minor use may cause an 
unreasonable adverse effect on the environment. In the event of 
modification or revocation, the Administrator shall provide, in 
writing, to the registrant, a notice revoking the temporary extension 
and establish a new effective date by which the minor use shall be 
deleted from the registration.
            (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 does not commit 
                        to support a specific minor use of the 
                        pesticide, but is supporting and providing data 
                        in a timely and adequate fashion to support 
                        uses of the pesticide on a food, or if all uses 
                        of the pesticide are nonfood uses and the 
                        registrant does not commit to support a 
                        specific minor use of the pesticide but is 
                        supporting and providing data in a timely and 
                        adequate fashion to support other nonfood uses 
                        of the pesticide, the Administrator, at the 
                        written request of the registrant, shall not 
                        take any action pursuant to this clause in 
                        regard to such unsupported minor use until the 
                        final deadline established as of the date of 
                        enactment of the Minor Use Crop Protection 
                        Amendments of 1995, for the submission of data 
                        under section 4 for the supported uses 
                        identified pursuant to this clause unless the 
                        Administrator determines that the absence of 
                        the data is significant enough to cause human 
                        health or environmental concerns. On the basis 
                        of such determination, the Administrator may 
                        refuse the request for extension by the 
                        registrant. 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 
                        pursuant to section 6(f)(1). If the 
                        Administrator grants an extension under this 
                        clause, the Administrator shall monitor the 
                        development of the data for the uses being 
                        supported and shall ensure that the registrant 
                        is meeting the schedule for the production of 
                        such data. If the Administrator determines that 
                        the registrant is not meeting or has not met 
                        the schedule for the production of such data, 
                        the Administrator may proceed in accordance 
                        with clause (iv) of this subparagraph regarding 
                        the continued registration of the affected 
                        products with the minor and other uses and 
                        shall inform the public of such action in 
                        accordance with section 6(f)(2). 
                        Notwithstanding the provisions of this clause, 
                        the Administrator may deny, modify, or revoke 
                        the temporary extension under this subparagraph 
                        if the Administrator determines that the 
                        continuation of the minor use may cause an 
                        unreasonable adverse effect on the environment. 
                        In the event of modification or revocation, the 
                        Administrator shall provide, in writing, to the 
                        registrant, a notice revoking the temporary 
                        extension and establish a new effective date by 
                        which the minor use shall be deleted from the 
                        registration.
    (g) 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 and another 
        registrant subsequently 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, except that the 
Administrator shall not take such action if the Administrator 
determines that such minor use may cause an unreasonable adverse effect 
on the environment. In order to rely on this paragraph, the applicant 
must certify that it agrees to satisfy any outstanding data 
requirements necessary to support the reregistration of the pesticide 
in accordance with the data submission schedule established by the 
Administrator.''.
    (h) Environmental Protection Agency Minor Use Program.--The Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 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 Administrator 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 and consulting with 
growers regarding minor use issues and registrations and amendments 
which are submitted to the Environmental Protection Agency.''.
    (i) Department of Agriculture Minor Use Program.--The Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), as 
amended by subsection (h), is amended by adding after section 30 the 
following:

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

    ``(a) In General.--The Secretary of Agriculture (hereinafter in 
this section referred to as the `Secretary') shall ensure the 
coordination of the responsibilities of the Department of Agriculture 
related to minor uses of pesticides, including--
            ``(1) carrying out the Inter-Regional Project Number 4 (IR-
        4) as described in section 2(e) of the Act entitled `An Act to 
        facilitate the work of the Department of Agriculture, and for 
        other purposes' (7 U.S.C. 4501(e)) and the national pesticide 
        resistance monitoring program established under section 1651 of 
        the Food, Agriculture, Conservation, and Trade Act of 1990 (7 
        U.S.C. 5882);
            ``(2) supporting integrated pest management research;
            ``(3) consulting with growers to develop data for minor 
        uses; and
            ``(4) providing assistance for minor use registrations, 
        tolerances, and reregistrations with the Environmental 
        Protection Agency.
    ``(b) Matching Fund Program.--
            ``(1) Establishment.--The Secretary of Agriculture, in 
        consultation with the Administrator, shall establish and 
        administer a minor use matching fund program. The matching fund 
        program shall be utilized to ensure the continued availability 
        of minor use crop protection chemical, 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 funding under this 
        paragraph shall be required to match such 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. 
        Any data developed under this subsection shall be subject to 
        the provisions of section 3(c)(1)(F). All compensation 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>