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

103d CONGRESS
  2d Session
                                H. R. 967

_______________________________________________________________________

                                 AN ACT


 
 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; REFERENCE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Minor Crop 
Protection Act of 1994''.
    (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.
    (c) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; reference; table of contents.
                     TITLE I--MINOR CROP PROTECTION

Sec. 101. Minor crop protection.
                   TITLE II--PUBLIC HEALTH PESTICIDES

Sec. 201. Definitions.
Sec. 202. Registration.
Sec. 203. Reregistration.
Sec. 204. Cancellation.
Sec. 205. Views of the Secretary of Health and Human Services.
Sec. 206. Authority of Administrator.
Sec. 207. Identification of pests.
Sec. 208. Authorization of appropriations.
                  TITLE III--ANTIMICROBIAL PESTICIDES

Sec. 301. Antimicrobial pesticides.
Sec. 302. Pesticide labeling.
     TITLE IV--EXPEDITED REVIEW OF CERTAIN PESTICIDE REGISTRATIONS

Sec. 401. Office of accelerated review.
Sec. 402. Expedited review of certain pesticide registrations.
Sec. 403. Conditional registration for certain pesticides.
Sec. 404. Integrated pest management.
Sec. 405. Resistance management.

                     TITLE I--MINOR CROP PROTECTION

SEC. 101. 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 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 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 granted an additional 3 
                        years if, after the date of enactment of this 
                        clause, the Administrator approves at least 3 
                        minor uses of the pesticide before the 
                        expiration of the period of exclusive use under 
                        this clause. Any additional exclusive use 
                        period under this clause shall terminate if the 
                        original data submitter voluntarily cancels all 
                        registrations of the pesticide containing 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 subsection 
                        for data 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 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 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 provisions 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 the final deadline for 
        submission of data under section 4 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 or a registration 
                        amendment that proposes a new minor use.
                            ``(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) 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 
                submission of data under section 4 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 food 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 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 
                food 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 submission of data 
                under section 4 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.''.
    (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 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 a risk 
        of an unreasonable adverse effect on the environment.''.
    (h) 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.''.
    (i) Department of Agriculture Minor Use Program.--The Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 121 et seq.), as 
amended by subsection (h), is amended by adding at the end 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 Research 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 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. Access to the 
        fund shall be given only 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. 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.''.

                   TITLE II--PUBLIC HEALTH PESTICIDES

SEC. 201. DEFINITIONS.

    (a) Adverse Effects.--Section 2(bb) (7 U.S.C. 136(bb)) is amended 
by adding at the end the following: ``The Administrator shall consider 
the risks and benefits of public health pesticides separate from the 
risks and benefits of other pesticides. In weighing any regulatory 
action concerning a public health pesticide under this Act, the 
Administrator shall weigh any risks of the pesticide against the health 
risks such as the diseases transmitted by the vector to be controlled 
by the pesticide.''.
    (b) New Definitions.--Section 2 (7 U.S.C. 136), as amended by 
section 101, is amended by adding at the end the following:
    ``(ii) Public Health Pesticide.--The term `public health pesticide' 
means any minor use pesticide product registered for use and used 
predominantly in public health programs for vector control or for other 
recognized health protection uses, including the prevention or 
mitigation of viruses, bacteria, or other microorganisms (other than 
viruses, bacteria, or other microorganisms on or in living man or other 
living animal) that pose a threat to public health.
    ``(jj) Vector.--The term `vector' means any organism capable of 
transmitting the causative agent of human disease or capable of 
producing human discomfort or injury, including mosquitoes, flies, 
fleas, cockroaches, or other insects and ticks, mites, or rats.''.

SEC. 202. REGISTRATION.

    Section 3(c)(2)(A) (7 U.S.C 136a(c)(2)(A)) is amended--
            (1) by inserting after ``pattern of use,'' the following: 
        ``the public health and agricultural need for such minor 
        use,'', and
            (2) by striking out ``potential exposure of man and the 
        environment to the pesticide'' and inserting in lieu thereof 
        ``potential beneficial or adverse effects on man and the 
        environment''.

SEC. 203. REREGISTRATION.

    Section 4 (7 U.S.C. 136a-1) is amended--
            (1) in subsection (i)(4), by redesignating subparagraphs 
        (B) and (C) as subparagraphs (C) and (D), respectively and by 
        adding after subparagraph (A) the following:
                    ``(B) The Administrator shall exempt any public 
                health pesticide from the payment of the fee prescribed 
                under paragraph (3) if, in consultation with the 
                Secretary of Health and Human Services, the 
                Administrator determines, based on information supplied 
                by the registrant, that the economic return to the 
                registrant from sales of the pesticide does not support 
                the registration or reregistration of the pesticide.'';
            (2) in subsection (i)(5), by redesignating subparagraphs 
        (F) and (G) as subparagraphs (G) and (H), respectively, and by 
        adding after subparagraph (E) the following:
                    ``(F) The Administrator shall exempt any public 
                health pesticide from the payment of the fee prescribed 
                under paragraph (3) if, in consultation with the 
                Secretary of Health and Human Services, the 
                Administrator determines, based on information supplied 
                by the registrant, that the economic return to the 
                registrant from sales of the pesticide does not support 
                the registration or reregistration of the pesticide.'';
            (3) in subsection (i)(7)(B), by striking out ``or to 
        determine'' and inserting in lieu thereof ``, to determine'' 
        and by inserting before the period the following: ``, or to 
        determine the volume usage for public health pesticides''; and
            (4) in subsection (k)(3)(A), by striking out ``or'' at the 
        end of clause (i), by striking the period at the end of clause 
        (ii) and inserting in lieu thereof ``; or'', and by inserting 
        after clause (ii) the following:
                            ``(iii) proposes the initial or amended 
                        registration of an end use pesticide that, if 
                        registered as proposed, would be used for a 
                        public health pesticide.''.

SEC. 204. CANCELLATION.

    Section 6(b) is amended by striking out ``or'' at the end of 
paragraph (1), by striking out the period at the end of paragraph (2) 
and inserting in lieu thereof ``; or'', and by adding after paragraph 
(2) the following:
            ``(3) if a pesticide is registered or proposed for 
        registration for public health uses, to send the notice 
        specified in this subsection to the Secretary of Health and 
        Human Services for review.
 The Secretary of Health and Human Services shall comment under this 
subsection in accordance with the procedures followed and subject to 
the same conditions as comments by the Secretary of Agriculture in the 
case of agricultural pesticides.''.

SEC. 205. VIEWS OF THE SECRETARY OF HEALTH AND HUMAN SERVICES.

    Section 21 (7 U.S.C. 136s) is amended by redesignating subsections 
(b) and (c) as subsections (c) and (d), respectively, and by adding 
after subsection (a) the following:
    ``(b) Secretary of Health and Human Services.--The Administrator, 
before publishing regulations under this Act for any public health 
pesticide, shall solicit the views of the Secretary of Health and Human 
Services in the same manner as the views of the Secretary of 
Agriculture are solicited under section 25(a).''.

SEC. 206. AUTHORITY OF ADMINISTRATOR.

    Section 25(a)(1) (7 U.S.C 136w(a)(1)) is amended--
            (1) by inserting after ``various classes of pesticides'' 
        the following: ``, including public health pesticides,'', and
            (2) by striking out ``and nonagricultural pesticides'' and 
        inserting in lieu thereof ``, nonagricultural, and public 
        health pesticides''.

SEC. 207. IDENTIFICATION OF PESTS.

    Section 28 (7 U.S.C. 136w-3) is amended by adding at the end the 
following:
    ``(d) Public Health Pests.--The Administrator, in coordination with 
the Secretary of Health and Human Services, shall identify pests of 
significant public health importance and, in coordination with the 
Public Health Service, develop and implement programs to improve and 
facilitate the safe and necessary use of chemical, biological, and 
other methods to combat and control such pests of public health 
importance.''.

SEC. 208. AUTHORIZATION OF APPROPRIATIONS.

    There is authorized to be appropriated to carry out the purposes of 
this title $12,000,000 for fiscal year 1995 and such sums as may be 
necessary for succeeding fiscal years.

                  TITLE III--ANTIMICROBIAL PESTICIDES

SEC. 301. ANTIMICROBIAL PESTICIDES.

    (a) Definitions.--Section 2 (7 U.S.C. 136), as amended by sections 
101 and 201, is amended by adding at the end the following:
    ``(kk) Antimicrobial Pesticide.--The term `antimicrobial pesticide' 
means a pesticide which--
            ``(1) is intended to sterilize, disinfect, sanitize, 
        mitigate growth and development, or protect inanimate objects, 
        industrial processes or systems, surfaces, or chemical 
        substances from contamination, degradation, fouling, 
        inefficiency, or deterioration caused by microbiological 
        organisms (including bacteria, viruses, fungi, algae, or 
        composite slime); and
            ``(2) in the intended use is exempt from, or otherwise not 
        subject to, a tolerance under sections 408 or 409 of the 
        Federal Food, Drug, and Cosmetic Act.''.
    (b) Requirements for Registration.--Section 3 (7 U.S.C. 136a) is 
amended by adding at the end the following:
    ``(g) Registration Requirements for Antimicrobial Pesticides.--
Within 1 year of the date of the enactment of the Minor Crop Protection 
Act of 1994, the Administrator shall propose regulations establishing 
requirements for the registration of antimicrobial pesticides, 
including guidelines specifying the information and data required for 
registration. Such guidelines shall provide applicants for registration 
with information sufficient to determine each scientific study that 
must be submitted as part of a registration application, specify 
required methods for data developed or submitted in support of a 
registration, and describe registration application format requirements 
and any objective criteria for evaluating the completeness of the 
application.
    ``(h) Study of Antimicrobial Registration Procedures.--Not later 
than 2 years after the date of the enactment of this subsection, the 
Administrator shall prepare a report for Congress that evaluates the 
process for registering antimicrobial pesticides. The Administrator 
shall submit the report to the Committee on Agriculture of the House of 
Representatives and the Committee on Agriculture, Nutrition, and 
Forestry of the Senate. The report shall include the following:
            ``(1) An evaluation of different ways to accelerate the 
        review of pesticides which meet the criteria of paragraph 
        (3)(B)(i) and an estimate of the resources the Administrator 
        would need to implement such changes.
            ``(2) An estimate of the resources needed to make a 
        decision--
                    ``(A) within 90 days of receipt of an application 
                to register a pesticide that meets the criteria of 
                paragraph (3)(B)(i), whether to approve the 
                application;
                    ``(B) within 300 days of receipt of an application 
                to register an antimicrobial pesticide that contains a 
                new active ingredient, whether to approve the 
                application;
                    ``(C) within 200 days of receipt of an application 
                to add a new use to the registration of an 
                antimicrobial pesticide, whether to approve the 
                application.
            ``(3) A calculation of the amount of fees paid under 
        section 4(i)(5) that are paid for antimicrobial pesticides.
            ``(4) A calculation of the amount of appropriated funds 
        involving the registration and reregistration of antimicrobial 
        pesticides.''.

SEC. 302. PESTICIDE LABELING.

    For pesticides that are or may be diluted for use, the label or 
labeling required under the Federal Insecticide, Fungicide, and 
Rodenticide Act may have a different statement of caution or protective 
measures for use of recommended diluted solutions of the pesticide than 
for use of concentrates of the pesticide. Such a precautionary 
statement shall provide adequate protection for exposure to the dilute 
solution of the pesticide.

     TITLE IV--EXPEDITED REVIEW OF CERTAIN PESTICIDE REGISTRATIONS

SEC. 401. OFFICE OF ACCELERATED REVIEW.

    The Administrator shall establish within the Office of Pesticide 
Programs an office to oversee and expedite the evaluation of 
applications for the registration of pesticides that meet the criteria 
of paragraph (9) of section 3(c) of the Federal Insecticide, Fungicide, 
and Rodenticide Act.

SEC. 402. EXPEDITED REVIEW OF CERTAIN PESTICIDE REGISTRATIONS.

    Section 3(c) (7 U.S.C. 136a(c)) is amended--
            (1) in paragraph (1) by adding at the end the following:
                    ``(G) If the applicant is requesting the expedited 
                registration, or amendment to the registration, of a 
                pesticide, an explanation of the basis for the request, 
                in accordance with paragraph (9) of this subsection.''; 
                and
            (2) by adding at the end the following:
            ``(9) Expedited registration of certain pesticides.--
                    ``(A)(i) Not later than 1 year after the date of 
                the enactment of this paragraph and after opportunity 
                for public comment, the Administrator shall develop 
                regulations and guidelines for the expedited review of 
                applications for the registration of pesticides that 
                meet the criteria of this subparagraph.
                    ``(ii) The Administrator shall expedite the review 
                of an application for registration of a pesticide or an 
                amendment to a registration that satisfies the 
                guidelines developed under this subparagraph. 
                Biological pesticides will be presumed to qualify for 
                expedited review under this paragraph. In developing 
                guidelines for the expedited review of a pesticide 
                under this paragraph, the Administrator shall consider 
                the extent to which a pesticide may reasonably be 
                expected to--
                            ``(I) reduce the risks of pesticides to 
                        human health;
                            ``(II) exhibit a high degree of specificity 
                        for the target pest and pose a low risk for 
                        nontarget organisms;
                            ``(III) facilitate the management of pests 
                        while conserving existing natural controls; or
                            ``(IV) minimize the potential for ground 
                        water or surface water contamination, or other 
                        valued environmental resources.
                    ``(B)(i) The Administrator, not later than 30 days 
                after receipt of an application for expedited review, 
                shall notify the applicant whether the application is 
                complete. If it is found to be incomplete, the 
                Administrator shall reject the request for an expedited 
                review.
                    ``(ii) If the application is complete, the 
                Administrator shall notify the applicant whether the 
                application qualifies for expedited review within 60 
                days.
                    ``(iii) If an application for registration or an 
                amendment qualifies for expedited review under this 
                paragraph, the Administrator shall, not later than 6 
                months after accepting such application, notify the 
                registrant if the application has been granted or 
                denied. If the application is denied, the Administrator 
                shall comply with the procedure under section 3(c)(6).
                    ``(C) If at any time after the expedited 
                registration of a pesticide, the registrant has 
                additional information bearing on the pesticide's 
                ability to meet the guidelines established under 
                subparagraph (A), the registrant shall immediately 
                submit a report containing such information to the 
                Administrator.''.

SEC. 403. CONDITIONAL REGISTRATION FOR CERTAIN PESTICIDES.

    Section 3(c)(7) (7 U.S.C. 136a(c)(7)) is amended by adding at the 
end the following:
                    ``(D)(i) The Administrator may conditionally 
                register or amend the registration of a pesticide that 
                meets the criteria of paragraph (9) if--
                            ``(I) the applicant agrees to generate any 
                        additional data that the Administrator deems 
                        appropriate to evaluate the pesticide; and
                            ``(II) the applicant agrees to submit 
                        periodic reports as the Administrator may 
                        require.
                A conditional registration under this subparagraph 
                shall be granted only if the Administrator determines, 
                based on available information, that use of the 
                pesticide during such period will not cause any 
                unreasonable adverse effect on the environment and that 
                use of the pesticide is in the public interest.
                    ``(ii) If at any time after a conditional 
                registration is approved under this subparagraph, and 
                before a complete set of data has been submitted in 
                support of the registration, the Administrator 
                determines that a pesticide does not meet the criteria 
                specified in clause (i), the Administrator may by order 
                suspend the registration until such time as the 
                registrant demonstrates that the criteria for 
                conditional registration are met. Such order shall be 
                sent to the registrant and published in the Federal 
                Register. The order shall include the bases for 
                suspension together with a description of the types of 
                information the Administrator believes must be 
                submitted to determine whether the pesticide meets the 
                criteria for conditional registration.
                    ``(iii) A registrant, or any other interested 
                person with the concurrence of the registrant, may, 
                within 30 days of publication of the suspension order 
                in the Federal Register, petition the Administrator to 
                reconsider the issuance of the suspension order. A 
                petitioner must include in the petition specific bases 
                supporting the petition. The Administrator shall, 
                within 90 days of receipt of the last of such 
                petitions, issue an order granting or denying petitions 
                timely received. Such order shall be sent to the 
                petitioner and published in the Federal Register, and 
                shall include the factual and legal bases for the 
                Administrator's determination of the petition.
                    ``(iv) If the Administrator receives information or 
                a petition with respect to any adverse effects of a 
                pesticide for which a conditional registration has been 
                granted under this subparagraph, the Administrator may 
                refer the matter to a Scientific Advisory Panel for 
                review.''.

SEC. 404. INTEGRATED PEST MANAGEMENT.

    (a) Integrated Pest Management Projects.--The Secretary of 
Agriculture, in consultation with the Administrator of the 
Environmental Protection Agency, shall encourage integrated pest 
management projects to be organized around specific pests and specific 
environmental problems faced by growers and others in partnership with 
scientists from local research organizations, including land-grant or 
other universities and the Department, or growers, and funded by a 
competitive, peer review grants program.
    (b) Goals and Objectives.--The goals and objectives of integrated 
pest management projects shall be area-specific and commodity or crop-
specific in manner that allows the projects to be qualitatively and 
quantitatively evaluated. The Environmental Protection Agency and the 
Department of Agriculture shall evaluate the implementation and 
effectiveness of integrated pest management projects based on the 
following criteria:
            (1) Risks to growers from crop losses and drastic yield 
        variations.
            (2) Effectiveness of the utilization of alternative 
        pesticides, including resistant hosts, biological control 
        agents, and cultural controls.
            (3) Use of practices that avoid or minimize the development 
        of genetic resistance in pests to chemicals or other tactics 
        used to control them.

SEC. 405. RESISTANCE MANAGEMENT.

    Section 3(c) (7 U.S.C. 136a(c)), as amended by section 402, is 
amended by adding at the end the following:
            ``(10) Evidence of pest resistance.--If the Secretary of 
        Agriculture, in consultation with the Administrator, determines 
        that pest resistance to a pesticide is detected and is likely 
        to diminish the efficacy of the product or threatens to 
        accelerate the evolution of resistance to other registrations 
        of the same or similar products, the Administrator shall 
        provide technical assistance to the applicant or registrant 
        to--
                    ``(A) develop a plan to minimize the potential for 
                development of resistance that includes amended 
                labeling directions for resistance strategies; and
                    ``(B) conduct monitoring and submit reports as the 
                Administrator may deem necessary to evaluate the 
                effectiveness of the resistance plan.
        The plan developed under subparagraph (A) should also address 
        the potential for resistance development in other geographical 
        areas of the United States.''.

            Passed the House of Representatives October 4, 1994.

            Attest:






                                                                 Clerk.






103d CONGRESS

  2d Session

                               H. R. 967

_______________________________________________________________________

                                 AN ACT

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