II

104TH CONGRESS

1ST SESSION S. 794

To amend the Federal Insecticide, Fungicide, and Rodenticide Act to facilitate

the minor use of a pesticide, and for other purposes.

IN THE SENATE OF THE UNITED STATES

MAY 11 (legislative day, MAY 1), 1995

Mr. LUGAR (for himself, Mr. INOUYE, Mr. SANTORUM, Mr. CRAIG, Mr.

COHEN, Mr. MACK, Mr. PRESSLER, Mr. BURNS, Mr. KERREY, Mr. GRAHAM, Mr. COATS, Mr. GORTON, Mr. PACKWOOD, Mr. CAMPBELL, Mr.

DORGAN, Mr. MCCONNELL, Mr. THURMOND, Mr. DOLE, Mr. JEFFORDS,

Mr. HELMS, Mr. BOND, Mr. GRASSLEY, Mrs. KASSEBAUM, Mr. HOLLINGS, Mr. JOHNSTON, Mr. INHOFE, Mr. ABRAHAM, Mrs. MURRAY, Ms.

SNOWE, Mrs. FEINSTEIN, Mr. HATCH, Mr. NICKLES, Mr. HATFIELD,

Mr. KEMPTHORNE, Mr. SPECTER, Mr. COCHRAN, Mr. PRYOR, Mr.

DASCHLE, Mr. HEFLIN, Mr. COVERDELL, Mr. LOTT, and Mr. CONRAD)

introduced the following bill; which was read twice and referred to the

Committee on Agriculture, Nutrition, and Forestry

A BILL

To amend the Federal Insecticide, Fungicide, and

Rodenticide Act to facilitate the minor use of a pesticide,

and for other purposes.

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; REFERENCES.

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

5 ‘‘Minor Use Crop Protection Act of 1995’’.
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1 (b) REFERENCES TO FEDERAL INSECTICIDE, FUN2 GICIDE, AND RODENTICIDE ACT.—Whenever in this Act

3 an amendment or repeal is expressed in terms of an

4 amendment to, or repeal of, a section or other provision,

5 the reference shall be considered to be made to a section

6 or other provision of the Federal Insecticide, Fungicide,

7 and Rodenticide Act (7 U.S.C. 136 et seq.).

8 SEC. 2. DEFINITION OF MINOR USE.

9 Section 2 (7 U.S.C. 136) is amended by adding at

10 the end the following:

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

12 use of a pesticide on an animal, on a commercial agricul13 tural crop or site, or for the protection of public health

14 if—

15 ‘‘(1)(A) in the case of the use of the pesticide

16 on a commercial agricultural crop or site, the total

17 quantity of acreage devoted to the crop in the

18 United States is less than 300,000 acres; or

19 ‘‘(B) the Administrator, in consultation with

20 the Secretary of Agriculture, determines that, based

21 on information provided by an applicant for registra22 tion or a registrant—

23 ‘‘(i) the use does not provide a sufficient

24 economic incentive to support the initial reg-
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1 istration or continuing registration of a pes2 ticide for the use; and

3 ‘‘(ii)(I) there are not a sufficient number

4 of efficacious alternative registered pesticides

5 available for the use; or

6 ‘‘(II) any 1 of the alternatives to the pes7 ticide pose a greater risk to the environment or

8 human health than the pesticide; or

9 ‘‘(III) the pesticide plays, or will play, a

10 significant part in managing pest resistance; or

11 ‘‘(IV) the pesticide plays, or will play, a

12 significant part in an integrated pest manage13 ment program; and

14 ‘‘(2) the Administrator does not determine that,

15 based on data existing on the date of the determina16 tion, the use may cause unreasonable adverse effects

17 on the environment.’’.

18 SEC. 3. EXCLUSIVE USE OF MINOR USE PESTICIDES.

19 Section 3(c)(1)(F)(i) (7 U.S.C. 136a(c)(1)(F)(i)) is

20 amended—

21 (1) by striking ‘‘(i) With respect’’ and inserting

22 ‘‘(i)(I) With respect’’;

23 (2) by striking ‘‘a period of ten years following

24 the date the Administrator first registers the pes-
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1 ticide’’ and inserting ‘‘the exclusive data use period

2 determined under subclause (II)’’; and

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

4 ‘‘(II) Except as provided in subclauses

5 (III) and (IV), the exclusive data use pe6 riod under subclause (I) shall be 10 years

7 beginning on the date the Administrator

8 first registers the pesticide.

9 ‘‘(III) Subject to subclauses (IV), (V),

10 and (VI), the exclusive data use period

11 under subclause (II) shall be extended 1

12 year for each 3 minor uses registered after

13 the date of enactment of this subclause

14 and before the date that is 10 years after

15 the date the Administrator first registers

16 the pesticide, if the Administrator in con17 sultation with the Secretary of Agriculture,

18 determines that, based on information pro19 vided by an applicant for registration or a

20 registrant—

21 ‘‘(aa) there are not a sufficient

22 number of efficacious alternative reg23 istered pesticides available for the use;

24 or
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1 ‘‘(bb) any 1 of the alternatives to

2 the pesticide pose a greater risk to the

3 environment or human health than

4 the pesticide; or

5 ‘‘(cc) the pesticide plays, or will

6 play, a significant part in managing

7 pest resistance; or

8 ‘‘(dd) the pesticide plays, or will

9 play, a significant part in an inte10 grated pest management program.

11 ‘‘(IV) Notwithstanding subclause

12 (III), the exclusive data use period estab13 lished under this clause may not exceed 13

14 years.

15 ‘‘(V) For purposes of subclause (III),

16 the registration of a pesticide for a minor

17 use on a crop grouping established by the

18 Administrator shall be considered 1 minor

19 use for each representative crop for which

20 data are provided in the crop grouping.

21 ‘‘(VI) An extension under subclause

22 (III) shall be reduced or terminated if the

23 applicant for registration or the registrant

24 voluntarily cancels the pesticide or deletes

25 from the registration a minor use that
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1 formed the basis for the extension, or if

2 the Administrator determines that the ap3 plicant or registrant is not actually mar4 keting the pesticide for a minor use that

5 formed the basis for the extension.’’.

6 SEC. 4. TIME EXTENSIONS FOR DEVELOPMENT OF MINOR

7 USE DATA.

8 (a) IN GENERAL.—Section 3 (7 U.S.C. 136a) is

9 amended by adding at the end the following:

10 ‘‘(g) TIME EXTENSION FOR DEVELOPMENT OF

11 MINOR USE DATA.—

12 ‘‘(1) SUPPORTED USE.—In the case of a minor

13 use, the Administrator shall, on the request of a reg14 istrant and subject to paragraph (3), extend the

15 time for the production of residue chemistry data

16 under subsection (c)(2)(B) and subsections (d)(4),

17 (e)(2), and (f)(2) of section 4 for data required sole18 ly to support the minor use until the final date

19 under section 4 for submitting data on any other use

20 established not later than the date of enactment of

21 this subsection.

22 ‘‘(2) NONSUPPORTED USE.—

23 ‘‘(A) If a registrant does not commit to

24 support a minor use of a pesticide, the Admin25 istrator shall, on the request of the registrant
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1 and subject to paragraph (3), extend the time

2 for taking any action under subsection

3 (c)(2)(B) or subsection (d)(6), (e)(3)(A), or

4 (f)(3) of section 4 regarding the minor use until

5 the final date under section 4 for submitting

6 data on any other use established not later than

7 the date of enactment of this subsection.

8 ‘‘(B) On receipt of the request from the

9 registrant, the Administrator shall publish in

10 the Federal Register a notice of the receipt of

11 the request and the effective date on which the

12 uses not being supported will be deleted from

13 the registration under section 6(f)(1).

14 ‘‘(3) CONDITIONS.—Paragraphs (1) and (2)

15 shall apply only if—

16 ‘‘(A) the registrant commits to support

17 and provide data for—

18 ‘‘(i) any use of the pesticide on a food;

19 or

20 ‘‘(ii) any other use, if all uses of the

21 pesticide are for uses other than food;

22 ‘‘(B)(i) the registrant provides a schedule

23 for producing the data referred to in subpara24 graph (A) with the request for an extension;
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1 ‘‘(ii) the schedule includes interim dates

2 for measuring progress; and

3 ‘‘(iii) the Administrator determines that

4 the registrant is able to produce the data re5 ferred to in subparagraph (A) before a final

6 date established by the Administrator;

7 ‘‘(C) the Administrator determines that

8 the extension would not significantly delay issu9 ance of a determination of eligibility for rereg10 istration under section 4; and

11 ‘‘(D) the Administrator determines that,

12 based on data existing on the date of the deter13 mination, the extension would not significantly

14 increase the risk of unreasonable adverse effects

15 on the environment.

16 ‘‘(4) MONITORING.—If the Administrator

17 grants an extension under paragraph (1) or (2), the

18 Administrator shall—

19 ‘‘(A) monitor the development of any data

20 the registrant committed to under paragraph

21 (3)(A); and

22 ‘‘(B) ensure that the registrant is meeting

23 the schedule provided under paragraph (3)(B)

24 for producing the data.
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1 ‘‘(5) NONCOMPLIANCE.—If the Administrator

2 determines that a registrant is not meeting a sched3 ule provided by the registrant under paragraph

4 (3)(B), the Administrator may—

5 ‘‘(A) revoke any extension to which the

6 schedule applies; and

7 ‘‘(B) proceed in accordance with subsection

8 (c)(2)(B)(iv).

9 ‘‘(6) MODIFICATION OR REVOCATION.—The Ad10 ministrator may modify or revoke an extension

11 under this subsection if the Administrator deter12 mines that the extension could cause unreasonable

13 adverse effects on the environment. If the Adminis14 trator modifies or revokes an extension under this

15 paragraph, the Administrator shall provide written

16 notice to the registrant of the modification or rev17 ocation.’’.

18 (b) CONFORMING AMENDMENTS.—

19 (1) Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B))

20 is amended by adding at the end the following:

21 ‘‘(vi) Subsection (g) shall apply to this sub22 paragraph.’’.

23 (2) Subsections (d)(4), (e)(2), and (f)(2) of sec24 tion 4 (7 U.S.C. 136a–1) are each amended by add25 ing at the end the following:
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1 ‘‘(C) Section 3(g) shall apply to this para2 graph.’’.

3 (3) Subsections (d)(6) and (f)(3) of section 4 (7

4 U.S.C. 136a–1) are each amended by striking ‘‘The

5 Administrator shall’’ and inserting ‘‘Subject to sec6 tion 3(g), the Administrator shall’’.

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

8 1(e)(3)(A)) is amended by striking ‘‘If the reg9 istrant’’ and inserting ‘‘Subject to section 3(g), if

10 the registrant’’.

11 SEC. 5. MINOR USE WAIVER.

12 Section 3(c)(2) (7 U.S.C. 136a(c)(2)) is amended by

13 adding at the end the following:

14 ‘‘(E) In the case of the registration of a

15 pesticide for a minor use, the Administrator

16 may waive otherwise applicable data require17 ments if the Administrator determines that the

18 absence of the data will not prevent the Admin19 istrator from determining—

20 ‘‘(i) the incremental risk presented by

21 the minor use of the pesticide; and

22 ‘‘(ii) whether the minor use of the

23 pesticide would have unreasonable adverse

24 effects on the environment.’’.
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1 SEC. 6. EXPEDITING MINOR USE REGISTRATIONS.

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

3 adding at the end the following:

4 ‘‘(C)(i) As expeditiously as practicable

5 after receipt, the Administrator shall review and

6 act on a complete application that—

7 ‘‘(I) proposes the initial registration

8 of a new pesticide active ingredient, if the

9 active ingredient is proposed to be reg10 istered solely for a minor use, or proposes

11 a registration amendment to an existing

12 registration solely for a minor use; or

13 ‘‘(II) for a registration or a registra14 tion amendment, proposes a significant

15 minor use.

16 ‘‘(ii) As used in clause (i):

17 ‘‘(I) The term ‘as expeditiously as

18 practicable’ means the Administrator shall,

19 to the greatest extent practicable, complete

20 a review and evaluation of all data submit21 ted with the application not later than 1

22 year after submission of the application.

23 ‘‘(II) The term ‘significant minor use’

24 means—
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1 ‘‘(aa) 3 or more proposed minor

2 uses for each proposed use that is not

3 minor;

4 ‘‘(bb) a minor use that the Ad5 ministrator determines could replace a

6 use that was canceled not earlier than

7 5 years preceding the receipt of the

8 application; or

9 ‘‘(cc) a minor use that the Ad10 ministrator determines would avoid

11 the reissuance of an emergency ex12 emption under section 18 for the

13 minor use.

14 ‘‘(iii) Review and action on an application

15 under clause (i) shall not be subject to judicial

16 review.

17 ‘‘(D) On receipt by the registrant of a de18 nial of a request to waive a data requirement

19 under paragraph (2)(E), the registrant shall

20 have the full time period originally established

21 by the Administrator for submission of the

22 data, beginning on the date of receipt by the

23 registrant of the denial.’’.
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1 SEC. 7. UTILIZATION OF DATA FOR VOLUNTARILY CAN2 CELED CHEMICALS.

3 Section 6(f) (7 U.S.C. 136d) is amended by adding

4 the following:

5 ‘‘(4) UTILIZATION OF DATA FOR VOLUNTARILY

6 CANCELED CHEMICALS.—The Administrator shall

7 process, review, and evaluate the application for a

8 voluntarily canceled pesticide as if the registrant had

9 not canceled the registration, if—

10 ‘‘(A) another application is pending on the

11 effective date of the voluntary cancellation for

12 the registration of a pesticide that is—

13 ‘‘(i) for a minor use;

14 ‘‘(ii) identical or substantially similar

15 to the canceled pesticide; and

16 ‘‘(iii) for an identical or substantially

17 similar use as the canceled pesticide;

18 ‘‘(B) the Administrator determines that

19 the minor use will not cause unreasonable ad20 verse effects on the environment; and

21 ‘‘(C) the applicant certifies that the appli22 cant will satisfy any outstanding data require23 ment necessary to support the reregistration of

24 the pesticide, in accordance with any data sub25 mission schedule established by the Adminis26 trator.’’.
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1 SEC. 8. MINOR USE PROGRAMS.

2 The Act is amended—

3 (1) by redesignating sections 30 and 31 (7

4 U.S.C. 136x and 136y) as sections 33 and 34, re5 spectively; and

6 (2) by inserting after section 29 (7 U.S.C.

7 136w–4) the following:

8 ‘‘SEC. 30. ENVIRONMENTAL PROTECTION AGENCY MINOR

9 USE PROGRAM.

10 ‘‘(a) ESTABLISHMENT.—The Administrator shall es11 tablish a minor use program in the Office of Pesticide Pro12 grams.

13 ‘‘(b) RESPONSIBILITIES.—In carrying out the pro14 gram established under subsection (a), the Administrator

15 shall—

16 ‘‘(1) coordinate the development of minor use

17 programs and policies; and

18 ‘‘(2) consult with growers regarding a minor

19 use issue, registration, or amendment that is submit20 ted to the Environmental Protection Agency.

21 ‘‘SEC. 31. DEPARTMENT OF AGRICULTURE MINOR USE PRO22 GRAM.

23 ‘‘(a) ESTABLISHMENT.—The Secretary of Agri24 culture shall establish a minor use program.

25 ‘‘(b) RESPONSIBILITIES.—In carrying out the pro26 gram established under subsection (a), the Secretary shall
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1 coordinate the responsibilities of the Department of Agri2 culture related to the minor use of a pesticide, including—

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

4 Project Number 4 established under section 2(e) of

5 Public Law 89–106 (7 U.S.C. 450i(e));

6 ‘‘(2) carrying out the national pesticide resist7 ance monitoring program established under section

8 1651(d) of the Food, Agriculture, Conservation, and

9 Trade Act of 1990 (7 U.S.C. 5882(d));

10 ‘‘(3) supporting integrated pest management

11 research;

12 ‘‘(4) consulting with growers to develop data for

13 minor uses; and

14 ‘‘(5) providing assistance for minor use reg15 istrations, tolerances, and reregistrations with the

16 Environmental Protection Agency.

17 ‘‘SEC. 32. MINOR USE MATCHING FUND PROGRAM.

18 ‘‘(a) ESTABLISHMENT.—The Secretary of Agri19 culture, in consultation with the Administrator, shall es20 tablish and administer a minor use matching fund pro21 gram.

22 ‘‘(b) RESPONSIBILITIES.—In carrying out the pro23 gram, the Secretary shall—

24 ‘‘(1) ensure the continued availability of minor

25 use pesticides; and
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1 ‘‘(2) develop data to support minor use pes2 ticide registrations and reregistrations.

3 ‘‘(c) ELIGIBILITY.—Any person that desires to de4 velop data to support a minor use registration shall be

5 eligible to participate in the program.

6 ‘‘(d) PRIORITY.—In carrying out the program, the

7 Secretary shall provide a priority for funding to a person

8 that does not directly receive funds from the sale of a

9 product registered for a minor use.

10 ‘‘(e) MATCHING FUNDS.—To be eligible for funds

11 under the program, a person shall match the amount of

12 funds provided under the program with an equal amount

13 of non-Federal funds.

14 ‘‘(f) OWNERSHIP OF DATA.—Any data developed

15 through the program shall be jointly owned by the Depart16 ment of Agriculture and the person that receives funds

17 under this section.

18 ‘‘(g) STATEMENT.—Any data developed under this

19 subsection shall be submitted in a statement that complies

20 with section 3(c)(1)(F).

21 ‘‘(h) COMPENSATION.—Any compensation received

22 by the Department of Agriculture for the use of data de23 veloped under this section shall be placed in a revolving

24 fund. The fund shall be used, subject to appropriations,

25 to carry out the program.
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1 ‘‘(i) AUTHORIZATION FOR APPROPRIATIONS.—There

2 are authorized to be appropriated to carry out this section

3 $10,000,000 for each fiscal year.’’.

4 SEC. 9. CONFORMING AMENDMENTS TO FIFRA TABLE OF

5 CONTENTS.

6 The table of contents in section 1(b) (7 U.S.C. prec.

7 121) is amended—

8 (1) by adding at the end of the items relating

9 to section 2 the following new item:

‘‘(hh) Minor use.’’;

10 (2) by adding at the end of the items relating

11 to section 3 the following new items:

‘‘(g) Time extension for development of minor use data.

‘‘(1) Supported data.

‘‘(2) Nonsupported data.

‘‘(3) Conditions.

‘‘(4) Monitoring.

‘‘(5) Noncompliance.

‘‘(6) Modification or revocation.’’;

12 (3) by adding at the end of the items relating

13 to section 6(f) the following new item:

‘‘(4) Utilization of data for voluntarily canceled chemicals.’’;

14 and

15 (4) by striking the items relating to sections 30

16 and 31 and inserting the following new items:

‘‘Sec. 30. Environmental Protection Agency minor use program.

‘‘(a) Establishment.

‘‘(b) Responsibilities.

‘‘Sec. 31. Department of Agriculture minor use program.

‘‘(a) Establishment.

‘‘(b) Responsibilities.

‘‘Sec. 32. Minor use matching fund program.

‘‘(a) Establishment.

‘‘(b) Responsibilities.
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‘‘(c) Eligibility.

‘‘(d) Priority.

‘‘(e) Matching funds.

‘‘(f) Ownership of data.

‘‘(g) Statement.

‘‘(h) Compensation.

‘‘(i) Authorization for appropriations.

‘‘Sec. 33. Severability.

‘‘Sec. 34. Authorization for appropriations.’’.

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