IIA

103D CONGRESS

2D SESSION H. R. 967

IN THE SENATE OF THE UNITED STATES

OCTOBER 5 (legislative day, SEPTEMBER 12), 1994

Received; read twice and referred to the Committee on Agriculture, Nutrition,

and Forestry

AN ACT

To amend the Federal Insecticide, Fungicide, and

Rodenticide Act with respect to minor use pesticides.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CON4 TENTS.

5 (a) SHORT TITLE.—This Act may be cited as the

6 ‘‘Minor Crop Protection Act of 1994’’.
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1 (b) REFERENCE.—Whenever in this Act an amend2 ment or repeal is expressed in terms of an amendment

3 to, or repeal of, a section or other provision, the reference

4 shall be considered to be made to a section or other provi5 sion of the Federal Insecticide, Fungicide, and

6 Rodenticide Act.

7 (c) TABLE OF CONTENTS.—The table of contents for

8 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.
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1 TITLE I—MINOR CROP

2 PROTECTION

3 SEC. 101. MINOR CROP PROTECTION.

4 (a) DEFINITION.—Section 2 (7 U.S.C. 136) is

5 amended by adding at the end the following:

6 ‘‘(hh) MINOR USE.—The term ‘minor use’ means the

7 use of a pesticide on an animal, on a commercial agricul8 tural crop or site, or for the protection of public health

9 where—

10 ‘‘(1) the Administrator, in consultation with the

11 Secretary of Agriculture, determines that, based on

12 information provided by an applicant, the use does

13 not provide sufficient economic incentive to support

14 the initial registration or continuing registration of

15 a pesticide for such use; and

16 ‘‘(2) the Administrator has not determined

17 that, based on existing data, such use presents a

18 risk of an unreasonable adverse effect on the envi19 ronment.’’.

20 (b) EXCLUSIVE USE OF MINOR USE PESTICIDES.—

21 Section 3(c)(1)(F) (7 U.S.C. 136a(c)(1)(F)) is amended

22 by redesignating clauses (ii) and (iii) as clauses (iii) and

23 (iv), respectively, and by inserting after clause (i) the fol24 lowing:
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1 ‘‘(ii) The period of exclusive data use

2 for data submitted to support the applica3 tion for the original registration of a pes4 ticide under clause (i) shall be granted an

5 additional 3 years if, after the date of en6 actment of this clause, the Administrator

7 approves at least 3 minor uses of the pes8 ticide before the expiration of the period of

9 exclusive use under this clause. Any addi10 tional exclusive use period under this

11 clause shall terminate if the original data

12 submitter voluntarily cancels all registra13 tions of the pesticide containing such

14 minor uses.’’.

15 (c) TIME EXTENSIONS FOR DEVELOPMENT OF

16 MINOR USE DATA.—

17 (1) DATA CALL-IN.—Subparagraph (B) of sec18 tion 3(c)(2) (7 U.S.C. 136a(c)(2)(B)) is amended by

19 adding at the end the following:

20 ‘‘(vi) Upon the request of a registrant,

21 the Administrator shall, in the case of a

22 minor use, extend the deadline for the pro23 duction of residue chemistry data under

24 this subsection for data required solely to

25 support that minor use until the final
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1 deadline for submission of data under sec2 tion 4 for the other uses of the pesticide

3 if—

4 ‘‘(I) the data to support other

5 uses of the pesticide are being pro6 vided;

7 ‘‘(II) the registrant, in submit8 ting a request for such an extension,

9 provides a schedule, including dates to

10 measure progress, to assure that the

11 data production will be completed be12 fore the expiration of the extension

13 period;

14 ‘‘(III) the Administrator has de15 termined that such extension will not

16 significantly delay the Administrator’s

17 schedule for issuing a reregistration

18 eligibility determination required

19 under section 4; and

20 ‘‘(IV) the Administrator has de21 termined in writing that based on ex22 isting data, such extension would not

23 significantly increase the risk of any

24 unreasonable adverse effect on the en25 vironment.
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1 If the Administrator grants an extension

2 under this clause, the Administrator shall

3 monitor the development of the data and

4 shall ensure that the registrant is meeting

5 the schedule for the production of the

6 data. If the Administrator determines that

7 the registrant is not meeting the schedule

8 for the production of such data, the Ad9 ministrator may proceed in accordance

10 with clause (iv) regarding the continued

11 registration of the minor use and shall in12 form the public of such action. If, during

13 the extension period, the Administrator is

14 furnished data which are sufficient to de15 termine that an unreasonable adverse ef16 fect exists involving the minor use of the

17 pesticide, the Administrator shall provide,

18 in writing, to the registrant, a notice re19 voking the extension of time for submission

20 of data. Such data shall instead be due

21 within 30 days of receipt of such notice by

22 the registrant. Nothing in this clause shall

23 preclude the Administrator from proceed24 ing in accordance with the provisions of

25 section 6.’’.
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1 (2) REREGISTRATION.—Sections 4(d)(4)(B),

2 4(e)(2)(B), and 4(f)(2)(B) (7 U.S.C. 136a–

3 1(d)(4)(B), (e)(2)(B), and (f)(2)(B)) are each

4 amended by adding at the end the following: ‘‘Upon

5 the request of a registrant, the Administrator shall,

6 in the case of a minor use, extend the deadline for

7 the production of residue chemistry data under this

8 subsection for data required solely to support that

9 minor use until the final deadline for submission of

10 data under section 4 for the other uses of the pes11 ticide if—

12 ‘‘(i) the data to support other uses of

13 the pesticide are being provided;

14 ‘‘(ii) the registrant, in submitting a

15 request for such an extension provides a

16 schedule, including interim dates to meas17 ure progress, to assure that the data pro18 duction will be completed before the expi19 ration of the extension period;

20 ‘‘(iii) the Administrator has deter21 mined that such extension will not signifi22 cantly delay the Administrator’s schedule

23 for issuing a reregistration eligibility deter24 mination required under this section; and
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1 ‘‘(iv) the Administrator has deter2 mined in writing that based on existing

3 data, such extension would not signifi4 cantly increase the risk of any unreason5 able adverse effect on the environment.

6 If the Administrator determines that the reg7 istrant is not meeting the schedule for the pro8 duction of such data, the Administrator may

9 proceed in accordance with section

10 3(c)(2)(B)(iv) regarding the continued registra11 tion of the minor use and shall inform the pub12 lic of such action. If, during the extension pe13 riod, the Administrator is furnished data which

14 are sufficient to determine that an unreasonable

15 adverse effect exists involving the minor use of

16 the pesticide, the Administrator shall provide in

17 writing, to the registrant, a notice revoking the

18 extension of time for submission of data. Such

19 data shall instead be due within 30 days of re20 ceipt of such notice by the registrant. Nothing

21 in this subparagraph shall preclude the Admin22 istrator from proceeding in accordance with the

23 provisions of section 6.’’.

24 (d) MINOR USE WAIVER.—Section 3(c)(2) (7 U.S.C.

25 136a(c)(2)) is amended—
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1 (1) by inserting ‘‘IN GENERAL’’ after ‘‘(A)’’, by

2 inserting ‘‘ADDITIONAL DATA’’ after ‘‘(B)’’, and by

3 inserting ‘‘SIMPLIFIED PROCEDURES’’ after ‘‘(C)’’,

4 and

5 (2) by adding at the end the following:

6 ‘‘(E) MINOR USE WAIVER.—In handling

7 the registration of a pesticide for a minor use,

8 the Administrator may waive otherwise applica9 ble data requirements if the Administrator de10 termines that the absence of such data will not

11 prevent the Administrator from determining—

12 ‘‘(i) the incremental risk presented by

13 the minor use of the pesticide, and

14 ‘‘(ii) that such risk, if any, would not

15 be an unreasonable adverse effect on the

16 environment.’’.

17 (e) EXPEDITING MINOR USE REGISTRATIONS.—Sec18 tion 3(c)(3) (7 U.S.C. 136a(c)(3)) is amended—

19 (1) by inserting after ‘‘(A)’’ the following: ‘‘IN

20 GENERAL.—,

21 (2) by inserting after ‘‘(B)’’ the following:

22 ‘‘IDENTICAL OR SUBSTANTIALLY SIMILAR’’.—, and

23 (3) by adding at the end the following:

24 ‘‘(C) MINOR USE REGISTRATION.—
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1 ‘‘(i) The Administrator shall, as expe2 ditiously as possible, review and act on any

3 application (I) that proposes the initial

4 registration of a new pesticide active ingre5 dient if the active ingredient is proposed to

6 be registered solely for minor uses or for

7 non-minor uses and significant minor uses,

8 or (II) for a registration or a registration

9 amendment that proposes a new minor

10 use.

11 ‘‘(ii) For the purposes of clause (i)—

12 ‘‘(I) the term ‘as expeditiously as

13 possible’ means that the Adminis14 trator shall complete a review and

15 evaluation of all data submitted with

16 the application, to the greatest extent

17 practicable, no later than 6 months

18 after the submission of the applica19 tion, and

20 ‘‘(II) the term ‘significant minor

21 uses’ means 3 or more minor uses

22 proposed for every non-minor use, a

23 minor use that would, in the judgment

24 of the Administrator, serve as a re25 placement for any use which has been
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1 canceled in the 5 years preceding the

2 receipt of the application, or a minor

3 use that in the opinion of the Admin4 istrator would avoid the reissuance of

5 an emergency exemption under section

6 18 for that minor use.

7 ‘‘(D) ADEQUATE TIME FOR SUBMISSION

8 OF MINOR USE DATA.—If a registrant makes

9 a good faith request for a minor use waiver re10 garding data required by the Administrator

11 pursuant to paragraph (2)(B), and if the Ad12 ministrator denies in whole or in part such data

13 waiver request, the registrant shall have a full

14 time period for providing such data. Such full

15 time period extension shall not be available if

16 the Administrator determines that the data

17 waiver request was not made in good faith. Any

18 determination by the Administrator that a data

19 waiver request was not submitted in good faith

20 shall be made in writing to the registrant and

21 shall be subject to judicial review under the pro22 cedures prescribed by section 16(b).’’.

23 (f) TEMPORARY EXTENSION OF REGISTRATION FOR

24 UNSUPPORTED MINOR USES.—

25 (1) REREGISTRATION.—
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1 (A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C.

2 136a–1(d)(6) and (f)(3)) are each amended by

3 adding at the end the following: ‘‘If the reg4 istrant is not supporting a specific minor use of

5 the pesticide, but is supporting and providing

6 data in a timely fashion to support other food

7 uses the Administrator, at the written request

8 of the registrant, shall not take any action pur9 suant to this paragraph in regard to such un10 supported minor use until the final deadline for

11 the submission of data under section 4 for the

12 supported uses under this paragraph. Upon re13 ceipt of the request from the registrant, the Ad14 ministrator shall publish in the Federal Reg15 ister a notice of the receipt of the request and

16 the effective date upon which the uses not being

17 supported will be voluntarily deleted from the

18 registration. Notwithstanding the provisions of

19 this paragraph, the Administrator may take ac20 tion to cancel or suspend such minor use, pur21 suant to section 6, if the Administrator deter22 mines that the continuation of the minor use

23 may cause an unreasonable adverse effect on

24 the environment.’’.
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1 (B) Section 4(e)(3)(A) (7 U.S.C. 136a–

2 1(e)(3)(A)) is amended by adding at the end

3 the following: ‘‘If the registrant is not support4 ing a specific minor use of the pesticide, but is

5 supporting and providing data in a timely fash6 ion to support other food uses, the Adminis7 trator, at the written request of the registrant,

8 shall not take any action pursuant to this sub9 paragraph in regard to such unsupported minor

10 use until the final deadline for the submission

11 of data for the supported uses under this sub12 paragraph. Upon receipt of the request from

13 the registrant, the Administrator shall publish

14 in the Federal Register a notice of the receipt

15 of the request and the effective date upon which

16 the uses not being supported will be voluntarily

17 deleted from the registration. Notwithstanding

18 the provisions of this subparagraph, the Admin19 istrator may take action to cancel or suspend

20 such minor use, pursuant to section 6, if the

21 Administrator determines that the continuation

22 of the minor use may cause an unreasonable

23 adverse effect on the environment .’’.
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1 (2) DATA.—Section 3(c)(2)(B) (7 U.S.C.

2 136a(c)(2)(B)), as amended by subsection (c), is

3 further amended by adding at the end the following:

4 ‘‘(vii) If the registrant is not supporting a

5 specific minor use of the pesticide, but is sup6 porting and providing data in a timely fashion

7 to support other food uses, the Administrator,

8 at the written request of the registrant, shall

9 not take any action pursuant to this subpara10 graph in regard to such unsupported minor use

11 until the final deadline for the submission of

12 data under section 4 for the supported uses

13 under this paragraph. Upon receipt of the re14 quest from the registrant, the Administrator

15 shall publish in the Federal Register a notice of

16 the receipt of the request and the effective date

17 upon which the uses not being supported will be

18 voluntarily deleted from the registration. Not19 withstanding the provisions of this subpara20 graph, the Administrator may take action to

21 cancel or suspend such minor use, pursuant to

22 section 6, if the Administrator determines that

23 the continuation of the minor use would violate

24 the criteria contained in section 6.’’.
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1 (g) UTILIZATION OF DATA FOR VOLUNTARILY CAN2 CELED CHEMICALS.—Section 6(f) (7 U.S.C. 136d) is

3 amended by adding at the end the following:

4 ‘‘(4) UTILIZATION OF DATA FOR VOLUNTARILY

5 CANCELED CHEMICALS.—When an application is

6 filed with the Administrator for the registration of

7 a pesticide for a minor use not later than 2 years

8 after another registrant voluntarily cancels its reg9 istration for an identical or substantially similar pes10 ticide for an identical or substantially similar use,

11 the Administrator shall process, review, and evaluate

12 the pending application as if the voluntary cancella13 tion had not yet taken place for purposes of the use

14 of data from such registration, except that the Ad15 ministrator may not take such action if the Adminis16 trator has evidence that such minor use presents a

17 risk of an unreasonable adverse effect on the envi18 ronment.’’.

19 (h) ENVIRONMENTAL PROTECTION AGENCY MINOR

20 USE PROGRAM.—The Federal Insecticide, Fungicide, and

21 Rodenticide Act (7 U.S.C. 121 et seq.) is amended by re22 designating sections 30 and 31 as sections 32 and 33, re23 spectively and adding after section 29 the following:
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1 ‘‘SEC. 30. ENVIRONMENTAL PROTECTION AGENCY MINOR

2 USE PROGRAM.

3 ‘‘The Environmental Protection Agency shall assure

4 coordination of minor use issues through the establish5 ment of a minor use program within the Office of Pes6 ticide Programs. Such office shall be responsible for co7 ordinating the development of minor use programs and

8 policies, consulting with growers regarding minor use is9 sues and registrations, and tracking and expediting minor

10 use registrations and amendments which are submitted to

11 the Environmental Protection Agency.’’.

12 (i) DEPARTMENT OF AGRICULTURE MINOR USE

13 PROGRAM.—The Federal Insecticide, Fungicide, and

14 Rodenticide Act (7 U.S.C. 121 et seq.), as amended by

15 subsection (h), is amended by adding at the end the follow16 ing:

17 ‘‘SEC. 31. DEPARTMENT OF AGRICULTURE MINOR USE PRO18 GRAM.

19 ‘‘(a) IN GENERAL.—The Secretary of Agriculture

20 (hereinafter in this section referred to as the ‘Secretary’)

21 shall ensure the coordination of the responsibilities of the

22 Department of Agriculture related to minor uses of pes23 ticides, including—

24 ‘‘(1) carrying out the Inter-Regional Research

25 Project Number 4 (IR-4) as described in section

26 2(e) of the Act entitled ‘An Act to facilitate the
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1 work of the Department of Agriculture, and for

2 other purposes’ (7 U.S.C. 4501(e)) and the national

3 pesticide resistance monitoring program established

4 under section 1651 of the Food, Agriculture, Con5 servation, and Trade Act of 1990 (7 U.S.C. 5882);

6 ‘‘(2) supporting integrated pest management

7 research;

8 ‘‘(3) consulting with growers to develop data for

9 minor uses; and

10 ‘‘(4) providing assistance for minor use reg11 istrations, tolerances, and reregistrations with the

12 Environmental Protection Agency.

13 ‘‘(b) MATCHING FUND PROGRAM.—

14 ‘‘(1) ESTABLISHMENT.—The Secretary of Agri15 culture shall establish a minor use matching fund

16 program. The matching fund program shall be uti17 lized to ensure the continued availability of minor

18 use crop protection chemicals, including the develop19 ment of data to support minor use pesticide registra20 tions and reregistrations. Access to the matching

21 fund program shall be available to any entity which

22 desires to develop data to support minor use reg23 istrations. Access to the fund shall be given only

24 those entities that do not directly receive funds from

25 the sale of products registered on minor uses. Any
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1 entity that seeks such funding under this paragraph

2 shall be required to match such funds with an equal

3 amount of its own funds. Any data developed

4 through the matching fund program shall be jointly

5 owned by the Department of Agriculture and by the

6 entity that receives such funding. All fees received

7 by the Department of Agriculture in return for the

8 use of such data under the matching fund program

9 shall be returned to a revolving fund which will sup10 port the matching fund program.

11 ‘‘(2) AUTHORIZATION.— There is authorized to

12 be appropriated for the revolving fund for the

13 matching fund program an annual sum not to ex14 ceed $10,000,000.’’.

15 TITLE II—PUBLIC HEALTH

16 PESTICIDES

17 SEC. 201. DEFINITIONS.

18 (a) ADVERSE EFFECTS.—Section 2(bb) (7 U.S.C.

19 136(bb)) is amended by adding at the end the following:

20 ‘‘The Administrator shall consider the risks and benefits

21 of public health pesticides separate from the risks and

22 benefits of other pesticides. In weighing any regulatory ac23 tion concerning a public health pesticide under this Act,

24 the Administrator shall weigh any risks of the pesticide
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1 against the health risks such as the diseases transmitted

2 by the vector to be controlled by the pesticide.’’.

3 (b) NEW DEFINITIONS.—Section 2 (7 U.S.C. 136),

4 as amended by section 101, is amended by adding at the

5 end the following:

6 ‘‘(ii) PUBLIC HEALTH PESTICIDE.—The term ‘public

7 health pesticide’ means any minor use pesticide product

8 registered for use and used predominantly in public health

9 programs for vector control or for other recognized health

10 protection uses, including the prevention or mitigation of

11 viruses, bacteria, or other microorganisms (other than vi12 ruses, bacteria, or other microorganisms on or in living

13 man or other living animal) that pose a threat to public

14 health.

15 ‘‘(jj) VECTOR.—The term ‘vector’ means any orga16 nism capable of transmitting the causative agent of human

17 disease or capable of producing human discomfort or in18 jury, including mosquitoes, flies, fleas, cockroaches, or

19 other insects and ticks, mites, or rats.’’.

20 SEC. 202. REGISTRATION.

21 Section 3(c)(2)(A) (7 U.S.C 136a(c)(2)(A)) is

22 amended—

23 (1) by inserting after ‘‘pattern of use,’’ the fol24 lowing: ‘‘the public health and agricultural need for

25 such minor use,’’, and
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1 (2) by striking out ‘‘potential exposure of man

2 and the environment to the pesticide’’ and inserting

3 in lieu thereof ‘‘potential beneficial or adverse effects

4 on man and the environment’’.

5 SEC. 203. REREGISTRATION.

6 Section 4 (7 U.S.C. 136a–1) is amended—

7 (1) in subsection (i)(4), by redesignating sub8 paragraphs (B) and (C) as subparagraphs (C) and

9 (D), respectively and by adding after subparagraph

10 (A) the following:

11 ‘‘(B) The Administrator shall exempt any

12 public health pesticide from the payment of the

13 fee prescribed under paragraph (3) if, in con14 sultation with the Secretary of Health and

15 Human Services, the Administrator determines,

16 based on information supplied by the registrant,

17 that the economic return to the registrant from

18 sales of the pesticide does not support the reg19 istration or reregistration of the pesticide.’’;

20 (2) in subsection (i)(5), by redesignating sub21 paragraphs (F) and (G) as subparagraphs (G) and

22 (H), respectively, and by adding after subparagraph

23 (E) the following:

24 ‘‘(F) The Administrator shall exempt any

25 public health pesticide from the payment of the
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1 fee prescribed under paragraph (3) if, in con2 sultation with the Secretary of Health and

3 Human Services, the Administrator determines,

4 based on information supplied by the registrant,

5 that the economic return to the registrant from

6 sales of the pesticide does not support the reg7 istration or reregistration of the pesticide.’’;

8 (3) in subsection (i)(7)(B), by striking out ‘‘or

9 to determine’’ and inserting in lieu thereof ‘‘, to de10 termine’’ and by inserting before the period the fol11 lowing: ‘‘, or to determine the volume usage for pub12 lic health pesticides’’; and

13 (4) in subsection (k)(3)(A), by striking out ‘‘or’’

14 at the end of clause (i), by striking the period at the

15 end of clause (ii) and inserting in lieu thereof ‘‘; or’’,

16 and by inserting after clause (ii) the following:

17 ‘‘(iii) proposes the initial or amended

18 registration of an end use pesticide that, if

19 registered as proposed, would be used for

20 a public health pesticide.’’.

21 SEC. 204. CANCELLATION.

22 Section 6(b) is amended by striking out ‘‘or’’ at the

23 end of paragraph (1), by striking out the period at the

24 end of paragraph (2) and inserting in lieu thereof ‘‘; or’’,

25 and by adding after paragraph (2) the following:
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1 ‘‘(3) if a pesticide is registered or proposed for

2 registration for public health uses, to send the notice

3 specified in this subsection to the Secretary of

4 Health and Human Services for review.

5 The Secretary of Health and Human Services shall com6 ment under this subsection in accordance with the proce7 dures followed and subject to the same conditions as com8 ments by the Secretary of Agriculture in the case of agri9 cultural pesticides.’’.

10 SEC. 205. VIEWS OF THE SECRETARY OF HEALTH AND

11 HUMAN SERVICES.

12 Section 21 (7 U.S.C. 136s) is amended by redesig13 nating subsections (b) and (c) as subsections (c) and (d),

14 respectively, and by adding after subsection (a) the follow15 ing:

16 ‘‘(b) SECRETARY OF HEALTH AND HUMAN SERV17 ICES.—The Administrator, before publishing regulations

18 under this Act for any public health pesticide, shall solicit

19 the views of the Secretary of Health and Human Services

20 in the same manner as the views of the Secretary of Agri21 culture are solicited under section 25(a).’’.

22 SEC. 206. AUTHORITY OF ADMINISTRATOR.

23 Section 25(a)(1) (7 U.S.C 136w(a)(1)) is amended—
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1 (1) by inserting after ‘‘various classes of pes2 ticides’’ the following: ‘‘, including public health pes3 ticides,’’, and

4 (2) by striking out ‘‘and nonagricultural pes5 ticides’’ and inserting in lieu thereof ‘‘, non6 agricultural, and public health pesticides’’.

7 SEC. 207. IDENTIFICATION OF PESTS.

8 Section 28 (7 U.S.C. 136w–3) is amended by adding

9 at the end the following:

10 ‘‘(d) PUBLIC HEALTH PESTS.—The Administrator,

11 in coordination with the Secretary of Health and Human

12 Services, shall identify pests of significant public health

13 importance and, in coordination with the Public Health

14 Service, develop and implement programs to improve and

15 facilitate the safe and necessary use of chemical, biologi16 cal, and other methods to combat and control such pests

17 of public health importance.’’.

18 SEC. 208. AUTHORIZATION OF APPROPRIATIONS.

19 There is authorized to be appropriated to carry out

20 the purposes of this title $12,000,000 for fiscal year 1995

21 and such sums as may be necessary for succeeding fiscal

22 years.
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1 TITLE III—ANTIMICROBIAL

2 PESTICIDES

3 SEC. 301. ANTIMICROBIAL PESTICIDES.

4 (a) DEFINITIONS.—Section 2 (7 U.S.C. 136), as

5 amended by sections 101 and 201, is amended by adding

6 at the end the following:

7 ‘‘(kk) ANTIMICROBIAL PESTICIDE.—The term

8 ‘antimicrobial pesticide’ means a pesticide which—

9 ‘‘(1) is intended to sterilize, disinfect, sanitize,

10 mitigate growth and development, or protect inani11 mate objects, industrial processes or systems, sur12 faces, or chemical substances from contamination,

13 degradation, fouling, inefficiency, or deterioration

14 caused by microbiological organisms (including bac15 teria, viruses, fungi, algae, or composite slime); and

16 ‘‘(2) in the intended use is exempt from, or oth17 erwise not subject to, a tolerance under sections 408

18 or 409 of the Federal Food, Drug, and Cosmetic

19 Act.’’.

20 (b) REQUIREMENTS FOR REGISTRATION.—Section 3

21 (7 U.S.C. 136a) is amended by adding at the end the fol22 lowing:

23 ‘‘(g) REGISTRATION REQUIREMENTS FOR

24 ANTIMICROBIAL PESTICIDES.—Within 1 year of the date

25 of the enactment of the Minor Crop Protection Act of
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1 1994, the Administrator shall propose regulations estab2 lishing requirements for the registration of antimicrobial

3 pesticides, including guidelines specifying the information

4 and data required for registration. Such guidelines shall

5 provide applicants for registration with information suffi6 cient to determine each scientific study that must be sub7 mitted as part of a registration application, specify re8 quired methods for data developed or submitted in support

9 of a registration, and describe registration application for10 mat requirements and any objective criteria for evaluating

11 the completeness of the application.

12 ‘‘(h) STUDY OF ANTIMICROBIAL REGISTRATION PRO13 CEDURES.—Not later than 2 years after the date of the

14 enactment of this subsection, the Administrator shall pre15 pare a report for Congress that evaluates the process for

16 registering antimicrobial pesticides. The Administrator

17 shall submit the report to the Committee on Agriculture

18 of the House of Representatives and the Committee on

19 Agriculture, Nutrition, and Forestry of the Senate. The

20 report shall include the following:

21 ‘‘(1) An evaluation of different ways to acceler22 ate the review of pesticides which meet the criteria

23 of paragraph (3)(B)(i) and an estimate of the re24 sources the Administrator would need to implement

25 such changes.
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1 ‘‘(2) An estimate of the resources needed to

2 make a decision—

3 ‘‘(A) within 90 days of receipt of an appli4 cation to register a pesticide that meets the cri5 teria of paragraph (3)(B)(i), whether to ap6 prove the application;

7 ‘‘(B) within 300 days of receipt of an ap8 plication to register an antimicrobial pesticide

9 that contains a new active ingredient, whether

10 to approve the application; or

11 ‘‘(C) within 200 days of receipt of an ap12 plication to add a new use to the registration of

13 an antimicrobial pesticide, whether to approve

14 the application.

15 ‘‘(3) A calculation of the amount of fees paid

16 under section 4(i)(5) that are paid for antimicrobial

17 pesticides.

18 ‘‘(4) A calculation of the amount of appro19 priated funds involving the registration and rereg20 istration of antimicrobial pesticides.’’.

21 SEC. 302. PESTICIDE LABELING.

22 For pesticides that are or may be diluted for use, the

23 label or labeling required under the Federal Insecticide,

24 Fungicide, and Rodenticide Act may have a different

25 statement of caution or protective measures for use of rec-
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1 ommended diluted solutions of the pesticide than for use

2 of concentrates of the pesticide. Such a precautionary

3 statement shall provide adequate protection for exposure

4 to the dilute solution of the pesticide.

5 TITLE IV—EXPEDITED REVIEW

6 OF CERTAIN PESTICIDE REG7 ISTRATIONS

8 SEC. 401. OFFICE OF ACCELERATED REVIEW.

9 The Administrator shall establish within the Office

10 of Pesticide Programs an office to oversee and expedite

11 the evaluation of applications for the registration of pes12 ticides that meet the criteria of paragraph (9) of section

13 3(c) of the Federal Insecticide, Fungicide, and

14 Rodenticide Act.

15 SEC. 402. EXPEDITED REVIEW OF CERTAIN PESTICIDE REG16 ISTRATIONS.

17 Section 3(c) (7 U.S.C. 136a(c)) is amended—

18 (1) in paragraph (1) by adding at the end the

19 following:

20 ‘‘(G) If the applicant is requesting the ex21 pedited registration, or amendment to the reg22 istration, of a pesticide, an explanation of the

23 basis for the request, in accordance with para24 graph (9) of this subsection.’’; and

25 (2) by adding at the end the following:
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1 ‘‘(9) EXPEDITED REGISTRATION OF CERTAIN

2 PESTICIDES.—

3 ‘‘(A)(i) Not later than 1 year after the

4 date of the enactment of this paragraph and

5 after opportunity for public comment, the Ad6 ministrator shall develop regulations and guide7 lines for the expedited review of applications for

8 the registration of pesticides that meet the cri9 teria of this subparagraph.

10 ‘‘(ii) The Administrator shall expedite the

11 review of an application for registration of a

12 pesticide or an amendment to a registration

13 that satisfies the guidelines developed under

14 this subparagraph. Biological pesticides will be

15 presumed to qualify for expedited review under

16 this paragraph. In developing guidelines for the

17 expedited review of a pesticide under this para18 graph, the Administrator shall consider the ex19 tent to which a pesticide may reasonably be ex20 pected to—

21 ‘‘(I) reduce the risks of pesticides to

22 human health;

23 ‘‘(II) exhibit a high degree of specific24 ity for the target pest and pose a low risk

25 for nontarget organisms;
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1 ‘‘(III) facilitate the management of

2 pests while conserving existing natural con3 trols; or

4 ‘‘(IV) minimize the potential for

5 ground water or surface water contamina6 tion, or other valued environmental re7 sources.

8 ‘‘(B)(i) The Administrator, not later than

9 30 days after receipt of an application for expe10 dited review, shall notify the applicant whether

11 the application is complete. If it is found to be

12 incomplete, the Administrator shall reject the

13 request for an expedited review.

14 ‘‘(ii) If the application is complete, the Ad15 ministrator shall notify the applicant whether

16 the application qualifies for expedited review

17 within 60 days.

18 ‘‘(iii) If an application for registration or

19 an amendment qualifies for expedited review

20 under this paragraph, the Administrator shall,

21 not later than 6 months after accepting such

22 application, notify the registrant if the applica23 tion has been granted or denied. If the applica24 tion is denied, the Administrator shall comply

25 with the procedure under section 3(c)(6).
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1 ‘‘(C) If at any time after the expedited

2 registration of a pesticide, the registrant has

3 additional information bearing on the pes4 ticide’s ability to meet the guidelines established

5 under subparagraph (A), the registrant shall

6 immediately submit a report containing such in7 formation to the Administrator.’’.

8 SEC. 403. CONDITIONAL REGISTRATION FOR CERTAIN PES9 TICIDES.

10 Section 3(c)(7) (7 U.S.C. 136a(c)(7)) is amended by

11 adding at the end the following:

12 ‘‘(D)(i) The Administrator may condi13 tionally register or amend the registration of a

14 pesticide that meets the criteria of paragraph

15 (9) if—

16 ‘‘(I) the applicant agrees to generate

17 any additional data that the Administrator

18 deems appropriate to evaluate the pes19 ticide; and

20 ‘‘(II) the applicant agrees to submit

21 periodic reports as the Administrator may

22 require.

23 A conditional registration under this subpara24 graph shall be granted only if the Administrator

25 determines, based on available information, that
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1 use of the pesticide during such period will not

2 cause any unreasonable adverse effect on the

3 environment and that use of the pesticide is in

4 the public interest.

5 ‘‘(ii) If at any time after a conditional reg6 istration is approved under this subparagraph,

7 and before a complete set of data has been sub8 mitted in support of the registration, the Ad9 ministrator determines that a pesticide does not

10 meet the criteria specified in clause (i), the Ad11 ministrator may by order suspend the registra12 tion until such time as the registrant dem13 onstrates that the criteria for conditional reg14 istration are met. Such order shall be sent to

15 the registrant and published in the Federal

16 Register. The order shall include the bases for

17 suspension together with a description of the

18 types of information the Administrator believes

19 must be submitted to determine whether the

20 pesticide meets the criteria for conditional reg21 istration.

22 ‘‘(iii) A registrant, or any other interested

23 person with the concurrence of the registrant,

24 may, within 30 days of publication of the sus25 pension order in the Federal Register, petition
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1 the Administrator to reconsider the issuance of

2 the suspension order. A petitioner must include

3 in the petition specific bases supporting the pe4 tition. The Administrator shall, within 90 days

5 of receipt of the last of such petitions, issue an

6 order granting or denying petitions timely re7 ceived. Such order shall be sent to the peti8 tioner and published in the Federal Register,

9 and shall include the factual and legal bases for

10 the Administrator’s determination of the peti11 tion.

12 ‘‘(iv) If the Administrator receives infor13 mation or a petition with respect to any adverse

14 effects of a pesticide for which a conditional

15 registration has been granted under this sub16 paragraph, the Administrator may refer the

17 matter to a Scientific Advisory Panel for re18 view.’’.

19 SEC. 404. INTEGRATED PEST MANAGEMENT.

20 (a) INTEGRATED PEST MANAGEMENT PROJECTS.—

21 The Secretary of Agriculture, in consultation with the Ad22 ministrator of the Environmental Protection Agency, shall

23 encourage integrated pest management projects to be or24 ganized around specific pests and specific environmental

25 problems faced by growers and others in partnership with
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1 scientists from local research organizations, including

2 land-grant or other universities and the Department, or

3 growers, and funded by a competitive, peer review grants

4 program.

5 (b) GOALS AND OBJECTIVES.—The goals and objec6 tives of integrated pest management projects shall be

7 area-specific and commodity or crop-specific in manner

8 that allows the projects to be qualitatively and quan9 titatively evaluated. The Environmental Protection Agency

10 and the Department of Agriculture shall evaluate the im11 plementation and effectiveness of integrated pest manage12 ment projects based on the following criteria:

13 (1) Risks to growers from crop losses and dras14 tic yield variations.

15 (2) Effectiveness of the utilization of alternative

16 pesticides, including resistant hosts, biological con17 trol agents, and cultural controls.

18 (3) Use of practices that avoid or minimize the

19 development of genetic resistance in pests to chemi20 cals or other tactics used to control them.

21 SEC. 405. RESISTANCE MANAGEMENT.

22 Section 3(c) (7 U.S.C. 136a(c)), as amended by sec23 tion 402, is amended by adding at the end the following:

24 ‘‘(10) EVIDENCE OF PEST RESISTANCE.—If the

25 Secretary of Agriculture, in consultation with the
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1 Administrator, determines that pest resistance to a

2 pesticide is detected and is likely to diminish the ef3 ficacy of the product or threatens to accelerate the

4 evolution of resistance to other registrations of the

5 same or similar products, the Administrator shall

6 provide technical assistance to the applicant or reg7 istrant to—

8 ‘‘(A) develop a plan to minimize the poten9 tial for development of resistance that includes

10 amended labeling directions for resistance strat11 egies; and

12 ‘‘(B) conduct monitoring and submit re13 ports as the Administrator may deem necessary

14 to evaluate the effectiveness of the resistance

15 plan.

16 The plan developed under subparagraph (A) should

17 also address the potential for resistance development

18 in other geographical areas of the United States.’’.

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