Union Calendar No. 431

103D CONGRESS

2D SESSION H. R. 967

[Report No. 103–784]

A BILL

To amend the Federal Insecticide, Fungicide, and

ticides.Rodenticide Act with respect to minor use pesOCTOBER 3, 1994

Reported with an amendment, committed to the Commitordered to be printed tee of the Whole House on the State of the Union, and
IB

Union Calendar No. 431

103D CONGRESS

2D SESSION H. R. 967

[Report No. 103–784]

To amend the Federal Insecticide, Fungicide, and Rodenticide Act with

respect to minor use pesticides.

IN THE HOUSE OF REPRESENTATIVES

FEBRUARY 18, 1993

Mr. DE LA GARZA (for himself, Mr. ROBERTS, Mr. STENHOLM, Mr. SMITH

of Oregon, Mr. THOMAS of California, Mr. ROWLAND, Mr. INSLEE, Mr.

KOPETSKI, Mr. LEHMAN, Mr. FAZIO, Mr. DOOLEY, and Mr. CONDIT)

introduced the following bill; which was referred to the Committee on

Agriculture

JULY 9, 1993

Additional sponsors: Mr. LAROCCO, Mr. HENRY, Mr. RAVENEL, Mr. STUMP,

Mr. PAXON, Mr. SWIFT, Mr. BARRETT of Nebraska, Mr. CAMP, Mr. ALLARD, Mr. UPTON, Mr. GEKAS, Mr. MCHUGH, Mr. LEWIS of Flordia, Mr.

LEWIS of California, Mr. GALLEGLY, Mr. BOEHNER, Mr. EMERSON, Mr.

DOOLITTLE, Mr. KINGSTON, Mr. GILLMOR, Mr. KANJORSKI, Mr.

MCDADE, Mr. HOLDEN, Mr. QUILLEN, Mr. HUGHES, Mr. KYL, Mr.

JOHNSON of South Dakota, Mr. ROTH, Mr. SMITH of Michigan, Mr.

ORTON, Mr. PACKARD, Mr. EWING, Mr. PASTOR, Mr. SPRATT, Mr.

POMEROY, Mr. BARCIA of Michigan, Ms. SLAUGHTER, Mr. NUSSLE, Mr.

BACCUS of Florida, Mr. BONILLA, Mr. HOEKSTRA, Mr. BLILEY, Mr.

SHAW, Mr. CRAPO, Mr. KOLBE, Mr. HOUGHTON, Mr. ENGLISH of Oklahoma, Mr. CANADY, Mr. MCCANDLESS, Mr. DORNAN, Mr. BEREUTER,

Mr. SARPALIUS, Mr. MOORHEAD, Mr. SISISKY, Mr. POMBO, Mr. WALSH,

Mr. DICKEY, Mr. PETERSON of Minnesota, Mr. RIDGE, Mr. HANSEN, Mr.

WALKER, Mr. OLVER, Mr. DREIER, Mr. MATSUI, Mr. SANTORUM, Mr.

HERGER, Mr. BAKER of Louisiana, Mr. BISHOP, Mr. CLYBURN, Mr.

GUNDERSON, Mr. DARDEN, Mrs. THURMAN, Mr. TRAFICANT, Mrs.

FOWLER, Mr. BATEMAN, Mr. CALVERT, Mr. GILMAN, Mr. MCCOLLUM,

Ms. SNOWE, Mr. BEVILL, Mr. FIELDS of Texas, Mr. ANDREWS of New

Jersey, Mr. ZELIFF, Mr. JOHNSTON of Florida, Mr. BAKER of California,
2

•HR 967 RH

Mr. JOHNSON of Georgia, Mr. CASTLE, Mr. GOODLING, and Mr.

STEARNS

OCTOBER 3, 1994

Additional sponsors: Mr. BALLENGER, Mr. CARR of Michigan, Mr.

CUNNINGHAM, Mr. HOBSON, Mr. MURTHA, Mr. MACHTLEY, Mr. HANCOCK, Mr. PETERSON of Florida, Mr. YOUNG of Alaska, Mr. INGLIS of

South Carolina, Ms. DUNN, Mr. STUPAK, Mr. SOLOMON, Mr. JACOBS,

Mr. BLUTE, Mr. TALENT, Mr. HASTERT, Mr. LIGHTFOOT, Ms. KAPTUR,

Mr. COX, Mr. CLEMENT, Mr. CRAMER, Mr. LEVY, Ms. FURSE, Mr. MICA,

Mr. GOODLATTE, Mr. SMITH of New Jersey, Mr. GRANDY, Mr. FARR of

California, Mr. SMITH of Texas, Mrs. VUCANOVICH, Mr. ROYCE, Mr.

WOLF, Mr. DEUTSCH, Mr. BARCA of Wisconsin, and Mr. EHLERS

OCTOBER 3, 1994

Reported with an amendment, committed to the Committee of the Whole

House on the State of the Union, and ordered to be printed

[Strike out all after the enacting clause and insert the part printed in italic]

[For text of introduced bill, see copy of bill as introduced on February 18, 1993]

A BILL

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’’.

7 (b) REFERENCE.—Whenever in this Act an amend8 ment or repeal is expressed in terms of an amendment to,

9 or repeal of, a section or other provision, the reference shall
3

•HR 967 RH

1 be considered to be made to a section or other provision

2 of the Federal Insecticide, Fungicide, and Rodenticide Act.

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

4 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.

5 TITLE I—MINOR CROP

6 PROTECTION

7 SEC. 101. MINOR CROP PROTECTION.

8 (a) DEFINITION.—Section 2 (7 U.S.C. 136) is amend9 ed by adding at the end the following:

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

11 use of a pesticide on an animal, on a commercial agricul-
4

•HR 967 RH

1 tural crop or site, or for the protection of public health

2 where—

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

4 Secretary of Agriculture, determines that, based on

5 information provided by an applicant, the use does

6 not provide sufficient economic incentive to support

7 the initial registration or continuing registration of a

8 pesticide for such use; and

9 ‘‘(2) the Administrator has not determined that,

10 based on existing data, such use presents a risk of an

11 unreasonable adverse effect on the environment.’’.

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

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

14 redesignating clauses (ii) and (iii) as clauses (iii) and (iv),

15 respectively, and by inserting after clause (i) the following:

16 ‘‘(ii) The period of exclusive data use

17 for data submitted to support the applica18 tion for the original registration of a pes19 ticide under clause (i) shall be granted an

20 additional 3 years if, after the date of en21 actment of this clause, the Administrator

22 approves at least 3 minor uses of the pes23 ticide before the expiration of the period of

24 exclusive use under this clause. Any addi25 tional exclusive use period under this clause
5

•HR 967 RH

1 shall terminate if the original data submit2 ter voluntarily cancels all registrations of

3 the pesticide containing such minor uses.’’.

4 (c) TIME EXTENSIONS FOR DEVELOPMENT OF MINOR

5 USE DATA.—

6 (1) DATA CALL-IN.—Subparagraph (B) of section

7 3(c)(2) (7 U.S.C. 136a(c)(2)(B)) is amended by add8 ing at the end the following:

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

10 the Administrator shall, in the case of a

11 minor use, extend the deadline for the pro12 duction of residue chemistry data under this

13 subsection for data required solely to sup14 port that minor use until the final deadline

15 for submission of data under section 4 for

16 the other uses of the pesticide if—

17 ‘‘(I) the data to support other uses

18 of the pesticide are being provided;

19 ‘‘(II) the registrant, in submitting

20 a request for such an extension, pro21 vides a schedule, including dates to

22 measure progress, to assure that the

23 data production will be completed be24 fore the expiration of the extension pe25 riod;
6

•HR 967 RH

1 ‘‘(III) the Administrator has de2 termined that such extension will not

3 significantly delay the Administrator’s

4 schedule for issuing a reregistration

5 eligibility determination required

6 under section 4; and

7 ‘‘(IV) the Administrator has de8 termined in writing that based on ex9 isting data, such extension would not

10 significantly increase the risk of any

11 unreasonable adverse effect on the envi12 ronment.

13 If the Administrator grants an extension

14 under this clause, the Administrator shall

15 monitor the development of the data and

16 shall ensure that the registrant is meeting

17 the schedule for the production of the data.

18 If the Administrator determines that the

19 registrant is not meeting the schedule for

20 the production of such data, the Adminis21 trator may proceed in accordance with

22 clause (iv) regarding the continued registra23 tion of the minor use and shall inform the

24 public of such action. If, during the exten25 sion period, the Administrator is furnished
7

•HR 967 RH

1 data which are sufficient to determine that

2 an unreasonable adverse effect exists involv3 ing the minor use of the pesticide, the Ad4 ministrator shall provide, in writing, to the

5 registrant, a notice revoking the extension of

6 time for submission of data. Such data shall

7 instead be due within 30 days of receipt of

8 such notice by the registrant. Nothing in

9 this clause shall preclude the Administrator

10 from proceeding in accordance with the pro11 visions of section 6.’’.

12 (2) REREGISTRATION.—Sections 4(d)(4)(B),

13 4(e)(2)(B), and 4(f)(2)(B) (7 U.S.C. 136a–1(d)(4)(B),

14 (e)(2)(B), and (f)(2)(B)) are each amended by adding

15 at the end the following: ‘‘Upon the request of a reg16 istrant, the Administrator shall, in the case of a

17 minor use, extend the deadline for the production of

18 residue chemistry data under this subsection for data

19 required solely to support that minor use until the

20 final deadline for submission of data under section 4

21 for the other uses of the pesticide if—

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

23 the pesticide are being provided;

24 ‘‘(ii) the registrant, in submitting a re25 quest for such an extension provides a
8

•HR 967 RH

1 schedule, including interim dates to meas2 ure progress, to assure that the data produc3 tion will be completed before the expiration

4 of the extension period;

5 ‘‘(iii) the Administrator has deter6 mined that such extension will not signifi7 cantly delay the Administrator’s schedule

8 for issuing a reregistration eligibility deter9 mination required under this section; and

10 ‘‘(iv) the Administrator has determined

11 in writing that based on existing data, such

12 extension would not significantly increase

13 the risk of any unreasonable adverse effect

14 on the environment.

15 If the Administrator determines that the reg16 istrant is not meeting the schedule for the pro17 duction of such data, the Administrator may

18 proceed in accordance with section 3(c)(2)(B)(iv)

19 regarding the continued registration of the minor

20 use and shall inform the public of such action.

21 If, during the extension period, the Adminis22 trator is furnished data which are sufficient to

23 determine that an unreasonable adverse effect ex24 ists involving the minor use of the pesticide, the

25 Administrator shall provide in writing, to the
9

•HR 967 RH

1 registrant, a notice revoking the extension of

2 time for submission of data. Such data shall in3 stead be due within 30 days of receipt of such

4 notice by the registrant. Nothing in this sub5 paragraph shall preclude the Administrator from

6 proceeding in accordance with the provisions of

7 section 6.’’.

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

9 136a(c)(2)) is amended—

10 (1) by inserting ‘‘IN GENERAL’’ after ‘‘(A)’’, by

11 inserting ‘‘ADDITIONAL DATA’’ after ‘‘(B)’’, and by in12 serting ‘‘SIMPLIFIED PROCEDURES’’ after ‘‘(C)’’, and

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

14 ‘‘(E) MINOR USE WAIVER.—In handling the

15 registration of a pesticide for a minor use, the

16 Administrator may waive otherwise applicable

17 data requirements if the Administrator deter18 mines that the absence of such data will not pre19 vent the Administrator from determining—

20 ‘‘(i) the incremental risk presented by

21 the minor use of the pesticide, and

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

23 be an unreasonable adverse effect on the en24 vironment.’’.
10

•HR 967 RH

1 (e) EXPEDITING MINOR USE REGISTRATIONS.—Sec2 tion 3(c)(3) (7 U.S.C. 136a(c)(3)) is amended—

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

4 GENERAL.—,

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

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

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

8 ‘‘(C) MINOR USE REGISTRATION.—

9 ‘‘(i) The Administrator shall, as expe10 ditiously as possible, review and act on any

11 application (I) that proposes the initial reg12 istration of a new pesticide active ingredi13 ent if the active ingredient is proposed to be

14 registered solely for minor uses or for non15 minor uses and significant minor uses, or

16 (II) for a registration or a registration

17 amendment that proposes a new minor use.

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

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

20 possible’ means that the Administrator

21 shall complete a review and evaluation

22 of all data submitted with the applica23 tion, to the greatest extent practicable,

24 no later than 6 months after the sub25 mission of the application, and
11

•HR 967 RH

1 ‘‘(II) the term ‘significant minor

2 uses’ means 3 or more minor uses pro3 posed for every non-minor use, a minor

4 use that would, in the judgment of the

5 Administrator, serve as a replacement

6 for any use which has been canceled in

7 the 5 years preceding the receipt of the

8 application, or a minor use that in the

9 opinion of the Administrator would

10 avoid the reissuance of an emergency

11 exemption under section 18 for that

12 minor use.

13 ‘‘(D) ADEQUATE TIME FOR SUBMISSION OF

14 MINOR USE DATA.—If a registrant makes a

15 good faith request for a minor use waiver regard16 ing data required by the Administrator pursuant

17 to paragraph (2)(B), and if the Administrator

18 denies in whole or in part such data waiver re19 quest, the registrant shall have a full time period

20 for providing such data. Such full time period

21 extension shall not be available if the Adminis22 trator determines that the data waiver request

23 was not made in good faith. Any determination

24 by the Administrator that a data waiver request

25 was not submitted in good faith shall be made in
12

•HR 967 RH

1 writing to the registrant and shall be subject to

2 judicial review under the procedures prescribed

3 by section 16(b).’’.

4 (f) TEMPORARY EXTENSION OF REGISTRATION FOR

5 UNSUPPORTED MINOR USES.—

6 (1) REREGISTRATION.—

7 (A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C.

8 136a–1(d)(6) and (f)(3)) are each amended by

9 adding at the end the following: ‘‘If the reg10 istrant is not supporting a specific minor use of

11 the pesticide, but is supporting and providing

12 data in a timely fashion to support other food

13 uses the Administrator, at the written request of

14 the registrant, shall not take any action pursu15 ant to this paragraph in regard to such unsup16 ported minor use until the final deadline for the

17 submission of data under section 4 for the sup18 ported uses under this paragraph. Upon receipt

19 of the request from the registrant, the Adminis20 trator shall publish in the Federal Register a no21 tice of the receipt of the request and the effective

22 date upon which the uses not being supported

23 will be voluntarily deleted from the registration.

24 Notwithstanding the provisions of this para25 graph, the Administrator may take action to
13

•HR 967 RH

1 cancel or suspend such minor use, pursuant to

2 section 6, if the Administrator determines that

3 the continuation of the minor use may cause an

4 unreasonable adverse effect on the environment.’’.

5 (B) Section 4(e)(3)(A) (7 U.S.C. 136a–

6 1(e)(3)(A)) is amended by adding at the end the

7 following: ‘‘If the registrant is not supporting a

8 specific minor use of the pesticide, but is sup9 porting and providing data in a timely fashion

10 to support other food uses, the Administrator, at

11 the written request of the registrant, shall not

12 take any action pursuant to this subparagraph

13 in regard to such unsupported minor use until

14 the final deadline for the submission of data for

15 the supported uses under this subparagraph.

16 Upon receipt of the request from the registrant,

17 the Administrator shall publish in the Federal

18 Register a notice of the receipt of the request and

19 the effective date upon which the uses not being

20 supported will be voluntarily deleted from the

21 registration. Notwithstanding the provisions of

22 this subparagraph, the Administrator may take

23 action to cancel or suspend such minor use, pur24 suant to section 6, if the Administrator deter25 mines that the continuation of the minor use
14

•HR 967 RH

1 may cause an unreasonable adverse effect on the

2 environment .’’.

3 (2) DATA.—Section 3(c)(2)(B) (7 U.S.C.

4 136a(c)(2)(B)), as amended by subsection (c), is fur5 ther amended by adding at the end the following:

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

7 specific minor use of the pesticide, but is sup8 porting and providing data in a timely fashion

9 to support other food uses, the Administrator, at

10 the written request of the registrant, shall not

11 take any action pursuant to this subparagraph

12 in regard to such unsupported minor use until

13 the final deadline for the submission of data

14 under section 4 for the supported uses under this

15 paragraph. Upon receipt of the request from the

16 registrant, the Administrator shall publish in the

17 Federal Register a notice of the receipt of the re18 quest and the effective date upon which the uses

19 not being supported will be voluntarily deleted

20 from the registration. Notwithstanding the provi21 sions of this subparagraph, the Administrator

22 may take action to cancel or suspend such minor

23 use, pursuant to section 6, if the Administrator

24 determines that the continuation of the minor
15

•HR 967 RH

1 use would violate the criteria contained in sec2 tion 6.’’.

3 (g) UTILIZATION OF DATA FOR VOLUNTARILY CAN4 CELED CHEMICALS.—Section 6(f) (7 U.S.C. 136d) is

5 amended by adding at the end the following:

6 ‘‘(4) UTILIZATION OF DATA FOR VOLUNTARILY

7 CANCELED CHEMICALS.—When an application is filed

8 with the Administrator for the registration of a pes9 ticide for a minor use not later than 2 years after an10 other registrant voluntarily cancels its registration for

11 an identical or substantially similar pesticide for an

12 identical or substantially similar use, the Adminis13 trator shall process, review, and evaluate the pending

14 application as if the voluntary cancellation had not

15 yet taken place for purposes of the use of data from

16 such registration, except that the Administrator may

17 not take such action if the Administrator has evidence

18 that such minor use presents a risk of an unreason19 able adverse effect on the environment.’’.

20 (h) ENVIRONMENTAL PROTECTION AGENCY MINOR

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

22 Rodenticide Act (7 U.S.C. 121 et seq.) is amended by redes23 ignating sections 30 and 31 as sections 32 and 33, respec24 tively and adding after section 29 the following:
16

•HR 967 RH

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 establishment

5 of a minor use program within the Office of Pesticide Pro6 grams. Such office shall be responsible for coordinating the

7 development of minor use programs and policies, consulting

8 with growers regarding minor use issues and registrations,

9 and tracking and expediting minor use registrations and

10 amendments which are submitted to the Environmental

11 Protection Agency.’’.

12 (i) DEPARTMENT OF AGRICULTURE MINOR USE PRO13 GRAM.—The Federal Insecticide, Fungicide, and

14 Rodenticide Act (7 U.S.C. 121 et seq.), as amended by sub15 section (h), is amended by adding at the end the following:

16 ‘‘SEC. 31. DEPARTMENT OF AGRICULTURE MINOR USE PRO17 GRAM.

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

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

20 shall ensure the coordination of the responsibilities of the

21 Department of Agriculture related to minor uses of pes22 ticides, including—

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

24 Project Number 4 (IR-4) as described in section 2(e)

25 of the Act entitled ‘An Act to facilitate the work of the

26 Department of Agriculture, and for other purposes’ (7
17

•HR 967 RH

1 U.S.C. 4501(e)) and the national pesticide resistance

2 monitoring program established under section 1651 of

3 the Food, Agriculture, Conservation, and Trade Act of

4 1990 (7 U.S.C. 5882);

5 ‘‘(2) supporting integrated pest management re6 search;

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

8 minor uses; and

9 ‘‘(4) providing assistance for minor use registra10 tions, tolerances, and reregistrations with the Envi11 ronmental Protection Agency.

12 ‘‘(b) MATCHING FUND PROGRAM.—

13 ‘‘(1) ESTABLISHMENT.—The Secretary of Agri14 culture shall establish a minor use matching fund

15 program. The matching fund program shall be uti16 lized to ensure the continued availability of minor use

17 crop protection chemicals, including the development

18 of data to support minor use pesticide registrations

19 and reregistrations. Access to the matching fund pro20 gram shall be available to any entity which desires to

21 develop data to support minor use registrations. Ac22 cess to the fund shall be given only those entities that

23 do not directly receive funds from the sale of products

24 registered on minor uses. Any entity that seeks such

25 funding under this paragraph shall be required to
18

•HR 967 RH

1 match such funds with an equal amount of its own

2 funds. Any data developed through the matching fund

3 program shall be jointly owned by the Department of

4 Agriculture and by the entity that receives such fund5 ing. All fees received by the Department of Agri6 culture in return for the use of such data under the

7 matching fund program shall be returned to a revolv8 ing fund which will support the matching fund pro9 gram.

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

11 be appropriated for the revolving fund for the match12 ing fund program an annual sum not to exceed

13 $10,000,000.’’.

14 TITLE II—PUBLIC HEALTH

15 PESTICIDES

16 SEC. 201. DEFINITIONS.

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

18 136(bb)) is amended by adding at the end the following:

19 ‘‘The Administrator shall consider the risks and benefits of

20 public health pesticides separate from the risks and benefits

21 of other pesticides. In weighing any regulatory action con22 cerning a public health pesticide under this Act, the Admin23 istrator shall weigh any risks of the pesticide against the

24 health risks such as the diseases transmitted by the vector

25 to be controlled by the pesticide.’’.
19

•HR 967 RH

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

2 amended by section 101, is amended by adding at the end

3 the following:

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

5 health pesticide’ means any minor use pesticide product

6 registered for use and used predominantly in public health

7 programs for vector control or for other recognized health

8 protection uses, including the prevention or mitigation of

9 viruses, bacteria, or other microorganisms (other than vi10 ruses, bacteria, or other microorganisms on or in living

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

12 health.

13 ‘‘(jj) VECTOR.—The term ‘vector’ means any organism

14 capable of transmitting the causative agent of human dis15 ease or capable of producing human discomfort or injury,

16 including mosquitoes, flies, fleas, cockroaches, or other in17 sects and ticks, mites, or rats.’’.

18 SEC. 202. REGISTRATION.

19 Section 3(c)(2)(A) (7 U.S.C 136a(c)(2)(A)) is amend20 ed—

21 (1) by inserting after ‘‘pattern of use,’’ the fol22 lowing: ‘‘the public health and agricultural need for

23 such minor use,’’, and

24 (2) by striking out ‘‘potential exposure of man

25 and the environment to the pesticide’’ and inserting
20

•HR 967 RH

1 in lieu thereof ‘‘potential beneficial or adverse effects

2 on man and the environment’’.

3 SEC. 203. REREGISTRATION.

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

5 (1) in subsection (i)(4), by redesignating sub6 paragraphs (B) and (C) as subparagraphs (C) and

7 (D), respectively and by adding after subparagraph

8 (A) the following:

9 ‘‘(B) The Administrator shall exempt any

10 public health pesticide from the payment of the

11 fee prescribed under paragraph (3) if, in con12 sultation with the Secretary of Health and

13 Human Services, the Administrator determines,

14 based on information supplied by the registrant,

15 that the economic return to the registrant from

16 sales of the pesticide does not support the reg17 istration or reregistration of the pesticide.’’;

18 (2) in subsection (i)(5), by redesignating sub19 paragraphs (F) and (G) as subparagraphs (G) and

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

21 (E) the following:

22 ‘‘(F) The Administrator shall exempt any

23 public health pesticide from the payment of the

24 fee prescribed under paragraph (3) if, in con25 sultation with the Secretary of Health and
21

•HR 967 RH

1 Human Services, the Administrator determines,

2 based on information supplied by the registrant,

3 that the economic return to the registrant from

4 sales of the pesticide does not support the reg5 istration or reregistration of the pesticide.’’;

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

7 determine’’ and inserting in lieu thereof ‘‘, to deter8 mine’’ and by inserting before the period the follow9 ing: ‘‘, or to determine the volume usage for public

10 health pesticides’’; and

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

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

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

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

15 ‘‘(iii) proposes the initial or amended

16 registration of an end use pesticide that, if

17 registered as proposed, would be used for a

18 public health pesticide.’’.

19 SEC. 204. CANCELLATION.

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

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

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

23 by adding after paragraph (2) the following:

24 ‘‘(3) if a pesticide is registered or proposed for

25 registration for public health uses, to send the notice
22

•HR 967 RH

1 specified in this subsection to the Secretary of Health

2 and Human Services for review.

3 The Secretary of Health and Human Services shall com4 ment under this subsection in accordance with the proce5 dures followed and subject to the same conditions as com6 ments by the Secretary of Agriculture in the case of agricul7 tural pesticides.’’.

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

9 HUMAN SERVICES.

10 Section 21 (7 U.S.C. 136s) is amended by redesig11 nating subsections (b) and (c) as subsections (c) and (d),

12 respectively, and by adding after subsection (a) the follow13 ing:

14 ‘‘(b) SECRETARY OF HEALTH AND HUMAN SERV15 ICES.—The Administrator, before publishing regulations

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

17 the views of the Secretary of Health and Human Services

18 in the same manner as the views of the Secretary of Agri19 culture are solicited under section 25(a).’’.

20 SEC. 206. AUTHORITY OF ADMINISTRATOR.

21 Section 25(a)(1) (7 U.S.C 136w(a)(1)) is amended—

22 (1) by inserting after ‘‘various classes of pes23 ticides’’ the following: ‘‘, including public health pes24 ticides,’’, and
23

•HR 967 RH

1 (2) by striking out ‘‘and nonagricultural pes2 ticides’’ and inserting in lieu thereof ‘‘, non3 agricultural, and public health pesticides’’.

4 SEC. 207. IDENTIFICATION OF PESTS.

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

6 at the end the following:

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

8 coordination with the Secretary of Health and Human

9 Services, shall identify pests of significant public health im10 portance and, in coordination with the Public Health Serv11 ice, develop and implement programs to improve and facili12 tate the safe and necessary use of chemical, biological, and

13 other methods to combat and control such pests of public

14 health importance.’’.

15 SEC. 208. AUTHORIZATION OF APPROPRIATIONS.

16 There is authorized to be appropriated to carry out

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

18 and such sums as may be necessary for succeeding fiscal

19 years.

20 TITLE III—ANTIMICROBIAL

21 PESTICIDES

22 SEC. 301. ANTIMICROBIAL PESTICIDES.

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

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

25 at the end the following:
24

•HR 967 RH

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

2 ‘antimicrobial pesticide’ means a pesticide which—

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

4 mitigate growth and development, or protect inani5 mate objects, industrial processes or systems, surfaces,

6 or chemical substances from contamination, degrada7 tion, fouling, inefficiency, or deterioration caused by

8 microbiological organisms (including bacteria, vi9 ruses, fungi, algae, or composite slime); and

10 ‘‘(2) in the intended use is exempt from, or oth11 erwise not subject to, a tolerance under section 408 or

12 409 of the Federal Food, Drug, and Cosmetic Act.’’.

13 (b) REQUIREMENTS FOR REGISTRATION.—Section 3 (7

14 U.S.C. 136a) is amended by adding at the end the follow15 ing:

16 ‘‘(g) REGISTRATION REQUIREMENTS FOR

17 ANTIMICROBIAL PESTICIDES.—Within 1 year of the date of

18 the enactment of the Minor Crop Protection Act of 1994,

19 the Administrator shall propose regulations establishing re20 quirements for the registration of antimicrobial pesticides,

21 including guidelines specifying the information and data

22 required for registration. Such guidelines shall provide ap23 plicants for registration with information sufficient to de24 termine each scientific study that must be submitted as part

25 of a registration application, specify required methods for
25

•HR 967 RH

1 data developed or submitted in support of a registration,

2 and describe registration application format requirements

3 and any objective criteria for evaluating the completeness

4 of the application.

5 ‘‘(h) STUDY OF ANTIMICROBIAL REGISTRATION PRO6 CEDURES.—Not later than 2 years after the date of the en7 actment of this subsection, the Administrator shall prepare

8 a report for Congress that evaluates the process for register9 ing antimicrobial pesticides. The Administrator shall sub10 mit the report to the Committee on Agriculture of the House

11 of Representatives and the Committee on Agriculture, Nu12 trition, and Forestry of the Senate. The report shall include

13 the following:

14 ‘‘(1) An evaluation of different ways to accelerate

15 the review of pesticides which meet the criteria of

16 paragraph (3)(B)(i) and an estimate of the resources

17 the Administrator would need to implement such

18 changes.

19 ‘‘(2) An estimate of the resources needed to make

20 a decision—

21 ‘‘(A) within 90 days of receipt of an appli22 cation to register a pesticide that meets the cri23 teria of paragraph (3)(B)(i), whether to approve

24 the application;
26

•HR 967 RH

1 ‘‘(B) within 300 days of receipt of an appli2 cation to register an antimicrobial pesticide that

3 contains a new active ingredient, whether to ap4 prove the application;

5 ‘‘(C) within 200 days of receipt of an appli6 cation to add a new use to the registration of an

7 antimicrobial pesticide, whether to approve the

8 application.

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

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

11 pesticides.

12 ‘‘(4) A calculation of the amount of appropriated

13 funds involving the registration and reregistration of

14 antimicrobial pesticides.’’.

15 SEC. 302. PESTICIDE LABELING.

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

17 label or labeling required under the Federal Insecticide,

18 Fungicide, and Rodenticide Act may have a different state19 ment of caution or protective measures for use of rec20 ommended diluted solutions of the pesticide than for use of

21 concentrates of the pesticide. Such a precautionary state22 ment shall provide adequate protection for exposure to the

23 dilute solution of the pesticide.
27

•HR 967 RH

1 TITLE IV—EXPEDITED REVIEW

2 OF CERTAIN PESTICIDE REG3 ISTRATIONS

4 SEC. 401. OFFICE OF ACCELERATED REVIEW.

5 The Administrator shall establish within the Office of

6 Pesticide Programs an office to oversee and expedite the

7 evaluation of applications for the registration of pesticides

8 that meet the criteria of paragraph (9) of section 3(c) of

9 the Federal Insecticide, Fungicide, and Rodenticide Act.

10 SEC. 402. EXPEDITED REVIEW OF CERTAIN PESTICIDE REG11 ISTRATIONS.

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

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

14 following:

15 ‘‘(G) If the applicant is requesting the expe16 dited registration, or amendment to the registra17 tion, of a pesticide, an explanation of the basis

18 for the request, in accordance with paragraph

19 (9) of this subsection.’’; and

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

21 ‘‘(9) EXPEDITED REGISTRATION OF CERTAIN

22 PESTICIDES.—

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

24 of the enactment of this paragraph and after op25 portunity for public comment, the Administrator
28

•HR 967 RH

1 shall develop regulations and guidelines for the

2 expedited review of applications for the registra3 tion of pesticides that meet the criteria of this

4 subparagraph.

5 ‘‘(ii) The Administrator shall expedite the

6 review of an application for registration of a

7 pesticide or an amendment to a registration that

8 satisfies the guidelines developed under this sub9 paragraph. Biological pesticides will be pre10 sumed to qualify for expedited review under this

11 paragraph. In developing guidelines for the expe12 dited review of a pesticide under this paragraph,

13 the Administrator shall consider the extent to

14 which a pesticide may reasonably be expected

15 to—

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

17 human health;

18 ‘‘(II) exhibit a high degree of specific19 ity for the target pest and pose a low risk

20 for nontarget organisms;

21 ‘‘(III) facilitate the management of

22 pests while conserving existing natural con23 trols; or

24 ‘‘(IV) minimize the potential for

25 ground water or surface water contamina-
29

•HR 967 RH

1 tion, or other valued environmental re2 sources.

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

4 30 days after receipt of an application for expe5 dited review, shall notify the applicant whether

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

7 incomplete, the Administrator shall reject the re8 quest for an expedited review.

9 ‘‘(ii) If the application is complete, the Ad10 ministrator shall notify the applicant whether

11 the application qualifies for expedited review

12 within 60 days.

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

14 an amendment qualifies for expedited review

15 under this paragraph, the Administrator shall,

16 not later than 6 months after accepting such ap17 plication, notify the registrant if the application

18 has been granted or denied. If the application is

19 denied, the Administrator shall comply with the

20 procedure under section 3(c)(6).

21 ‘‘(C) If at any time after the expedited reg22 istration of a pesticide, the registrant has addi23 tional information bearing on the pesticide’s

24 ability to meet the guidelines established under

25 subparagraph (A), the registrant shall imme-
30

•HR 967 RH

1 diately submit a report containing such informa2 tion to the Administrator.’’.

3 SEC. 403. CONDITIONAL REGISTRATION FOR CERTAIN PES4 TICIDES.

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

6 adding at the end the following:

7 ‘‘(D)(i) The Administrator may condi8 tionally register or amend the registration of a

9 pesticide that meets the criteria of paragraph (9)

10 if—

11 ‘‘(I) the applicant agrees to generate

12 any additional data that the Administrator

13 deems appropriate to evaluate the pesticide;

14 and

15 ‘‘(II) the applicant agrees to submit

16 periodic reports as the Administrator may

17 require.

18 A conditional registration under this subpara19 graph shall be granted only if the Administrator

20 determines, based on available information, that

21 use of the pesticide during such period will not

22 cause any unreasonable adverse effect on the en23 vironment and that use of the pesticide is in the

24 public interest.
31

•HR 967 RH

1 ‘‘(ii) If at any time after a conditional reg2 istration is approved under this subparagraph,

3 and before a complete set of data has been sub4 mitted in support of the registration, the Admin5 istrator determines that a pesticide does not meet

6 the criteria specified in clause (i), the Adminis7 trator may by order suspend the registration

8 until such time as the registrant demonstrates

9 that the criteria for conditional registration are

10 met. Such order shall be sent to the registrant

11 and published in the Federal Register. The order

12 shall include the bases for suspension together

13 with a description of the types of information the

14 Administrator believes must be submitted to de15 termine whether the pesticide meets the criteria

16 for conditional registration.

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

18 person with the concurrence of the registrant,

19 may, within 30 days of publication of the sus20 pension order in the Federal Register, petition

21 the Administrator to reconsider the issuance of

22 the suspension order. A petitioner must include

23 in the petition specific bases supporting the peti24 tion. The Administrator shall, within 90 days of

25 receipt of the last of such petitions, issue an
32

•HR 967 RH

1 order granting or denying petitions timely re2 ceived. Such order shall be sent to the petitioner

3 and published in the Federal Register, and shall

4 include the factual and legal bases for the Ad5 ministrator’s determination of the petition.

6 ‘‘(iv) If the Administrator receives informa7 tion or a petition with respect to any adverse ef8 fects of a pesticide for which a conditional reg9 istration has been granted under this subpara10 graph, the Administrator may refer the matter to

11 a Scientific Advisory Panel for review.’’.

12 SEC. 404. INTEGRATED PEST MANAGEMENT.

13 (a) INTEGRATED PEST MANAGEMENT PROJECTS.—

14 The Secretary of Agriculture, in consultation with the Ad15 ministrator of the Environmental Protection Agency, shall

16 encourage integrated pest management projects to be orga17 nized around specific pests and specific environmental

18 problems faced by growers and others in partnership with

19 scientists from local research organizations, including land20 grant or other universities and the Department, or growers,

21 and funded by a competitive, peer review grants program.

22 (b) GOALS AND OBJECTIVES.—The goals and objectives

23 of integrated pest management projects shall be area-spe24 cific and commodity or crop-specific in manner that allows

25 the projects to be qualitatively and quantitatively evalu-
33

•HR 967 RH

1 ated. The Environmental Protection Agency and the De2 partment of Agriculture shall evaluate the implementation

3 and effectiveness of integrated pest management projects

4 based on the following criteria:

5 (1) Risks to growers from crop losses and drastic

6 yield variations.

7 (2) Effectiveness of the utilization of alternative

8 pesticides, including resistant hosts, biological control

9 agents, and cultural controls.

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

11 development of genetic resistance in pests to chemicals

12 or other tactics used to control them.

13 SEC. 405. RESISTANCE MANAGEMENT.

14 Section 3(c) (7 U.S.C. 136a(c)), as amended by section

15 402, is amended by adding at the end the following:

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

17 Secretary of Agriculture, in consultation with the Ad18 ministrator, determines that pest resistance to a pes19 ticide is detected and is likely to diminish the efficacy

20 of the product or threatens to accelerate the evolution

21 of resistance to other registrations of the same or

22 similar products, the Administrator shall require the

23 applicant or registrant to—

24 ‘‘(A) develop a plan to minimize the poten25 tial for development of resistance that includes
34

•HR 967 RH

1 amended labeling directions for resistance strate2 gies; and

3 ‘‘(B) conduct monitoring and submit re4 ports as the Administrator may deem necessary

5 to evaluate the effectiveness of the resistance

6 plan.

7 The plan developed under subparagraph (A) should

8 also address the potential for resistance development

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

HR 967 RH——2

HR 967 RH——3