I

104TH CONGRESS

1ST SESSION H. R. 1352

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

respect to the minor use of a pesticide.

IN THE HOUSE OF REPRESENTATIVES

MARCH 29, 1995

Mr. DE LA GARZA (for himself, Mr. ROBERTS, Mr. EMERSON, Mr. CONDIT,

Mr. STENHOLM, Mr. BOEHNER, Mrs. THURMAN, Mr. CANADY of Florida,

Mr. ROSE, Mr. EWING, Mr. DOOLEY, and Mr. POMEROY) introduced the

following bill; which was referred to the Committee on Agriculture

A BILL

To amend the Federal Insecticide, Fungicide, and

Rodenticide Act with respect to the minor use of a pesticide.

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.

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

5 ‘‘Minor Use Crop Protection Act of 1995’’.

6 (b) REFERENCE.—Whenever in this Act an amend7 ment or repeal is expressed in terms of an amendment

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

9 shall be considered to be made to a section or other provi-
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1 sion of the Federal Insecticide, Fungicide, and

2 Rodenticide Act.

3 SEC. 2. 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 total United States acreage for the

11 crop is less than 300,000 acres; or

12 ‘‘(2) the Administrator, in consultation with the

13 Secretary of Agriculture, determines that, based on

14 information provided by an applicant for registration

15 or a registrant, the use does not provide sufficient

16 economic incentive to support the initial registration

17 or continuing registration of a pesticide for such use;

18 and—

19 ‘‘(A) there are insufficient efficacious alter20 native registered pesticides available for the

21 use; or

22 ‘‘(B) the alternatives to the pesticide pose

23 greater risks to the environment or human

24 health; or
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1 ‘‘(C) the pesticide plays or will play, a sig2 nificant part in managing pest resistance; or

3 ‘‘(D) the pesticide plays or will play a sig4 nificant part in an integrated pest management

5 program.

6 The status as a minor use under this subsection

7 shall continue as long as the Administrator has not

8 determined that, based on existing data, such use

9 may cause an unreasonable adverse effect on the en10 vironment and the use otherwise qualifies for such

11 status.’’.

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

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

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

15 (iv), respectively, and by inserting after clause (i) the fol16 lowing:

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

18 for data submitted to support the applica19 tion for the original registration of a pes20 ticide under clause (i) shall be extended

21 one additional year for each 3 minor uses

22 registered after the date of enactment of

23 this clause and, before the expiration of

24 the period of exclusive use under this

25 clause, up to a total of 3 additional years
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1 for all minor uses registered by the Admin2 istrator if the Administrator in consulta3 tion with the Secretary of Agriculture de4 termines that, based on information pro5 vided by an applicant for registration or a

6 registrant, that:

7 ‘‘(I) there are insufficient effica8 cious alternative registered pesticides

9 available for the use; or

10 ‘‘(II) the alternatives to the pes11 ticide pose greater risks to the envi12 ronment or human health; or

13 ‘‘(III) the pesticide plays or will

14 play a significant part in managing

15 pest resistance; or

16 ‘‘(IV) the pesticide plays or will

17 play a significant part in an inte18 grated pest management program.

19 The registration of a pesticide for a minor

20 use on a crop grouping established by the

21 Administrator shall be considered for pur22 poses of this clause one minor use for each

23 representative crop for which data are pro24 vided in the crop grouping. Any additional

25 exclusive use period under this clause shall
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1 be modified as appropriate or terminated if

2 the registrant voluntarily cancels the prod3 uct or deletes from the registration the

4 minor uses which formed the basis for the

5 extension of the additional exclusive use

6 period or if the Administrator determines

7 that the registrant is not actually market8 ing the product for such minor uses.’’.

9 (c) TIME EXTENSIONS FOR DEVELOPMENT OF

10 MINOR USE DATA.—

11 (1) DATA CALL-IN.—Subparagraph (B) of sec12 tion 3(c)(2) (7 U.S.C. 136a(c)(2)(B)) is amended by

13 adding at the end the following:

14 ‘‘(vi) Upon the request of a registrant

15 the Administrator shall, in the case of a

16 minor use, extend the deadline for the pro17 duction of residue chemistry data under

18 this subparagraph for data are required

19 solely to support that minor use until the

20 final deadline for submission of data under

21 section 4 for the other uses of the pesticide

22 established as of the date of enactment of

23 the Minor Use Crop Protection Amend24 ments of 1995, if—
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1 ‘‘(I) the data to support other

2 uses of the pesticide on a food are

3 being provided;

4 ‘‘(II) the registrant, in submit5 ting a request for such an extension,

6 provides a schedule, including interim

7 dates to measure progress, to assure

8 that the data production will be com9 pleted before the expiration of the ex10 tension period;

11 ‘‘(III) the Administrator has de12 termined that such extension will not

13 significantly delay the Administrator’s

14 schedule for issuing a reregistration

15 eligibility determination required

16 under section 4; and

17 ‘‘(IV) the Administrator has de18 termined in writing that based on ex19 isting data, such extension would not

20 significantly increase the risk of any

21 unreasonable adverse effect on the en22 vironment.

23 If the Administrator grants an extension

24 under this clause, the Administrator shall

25 monitor the development of the data and
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1 shall ensure that the registrant is meeting

2 the schedule for the production of the

3 data. If the Administrator determines that

4 the registrant is not meeting or has not

5 met the schedule for the production of

6 such data, the Administrator may proceed

7 in accordance with clause (iv) regarding

8 the continued registration of the affected

9 products with the minor use and shall in10 form the public of such action. Notwith11 standing the provisions of this clause, the

12 Administrator may take action to modify

13 or revoke the extension under this clause if

14 the Administrator determines that the ex15 tension for the minor use may cause an

16 unreasonable adverse effect on the environ17 ment. In such circumstance, the Adminis18 trator shall provide, in writing to the reg19 istrant, a notice revoking the extension of

20 time for submission of data. Such data

21 shall instead be due in accordance with the

22 date than established by the Administrator

23 for the submission of the data.’’.

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

25 4(e)(2)(B), and 4(f)(2)(B) (7 U.S.C. 136a–
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1 1(d)(4)(B), (e)(2)(B), and (f)(2)(B)) are each

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

3 the request of a registrant, the Administrator shall,

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

5 the production of residue chemistry data under this

6 subparagraph for data required solely to support

7 that minor use until the final deadline for submis8 sion of data under this section for the other uses of

9 the pesticide established as of the date of enactment

10 of the Minor Use Crop Protection Amendments of

11 1995 if—

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

13 the pesticide on a food 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 grants an extension under

7 this subparagraph, the Administrator shall

8 monitor the development of the data and shall

9 ensure that the registrant is meeting the sched10 ule for the production of the data. If the Ad11 ministrator determines that the registrant is

12 not meeting or has not met the schedule for the

13 production of such data, the Administrator may

14 proceed in accordance with clause (iv) of section

15 3(c)(2)(B) or other provisions of this section, as

16 appropriate, regarding the continued registra17 tion of the affected products with the minor use

18 and shall inform the public of such action. Not19 withstanding the provisions of this subpara20 graph, the Administrator may take action to

21 modify or revoke the extension under this sub22 paragraph if the Administrator determines that

23 the extension for the minor use may cause an

24 unreasonable adverse affect on the environment.

25 In such circumstance, the Administrator shall
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1 provide, in writing to the registrant, a notice re2 voking the extension of time for submission of

3 data. Such data shall instead be due in accord4 ance with the date then established by the Ad5 ministrator for submission of the data.’’.

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

7 136a(c)(2)) is amended—

8 (1) by inserting ‘‘IN GENERAL.—’’ after ‘‘(A)’’,

9 by inserting ‘‘ADDITIONAL DATA.—’’ after ‘‘(B)’’,

10 and by inserting ‘‘SIMPLIFIED PROCEDURES.—’’

11 after ‘‘(C)’’, and

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

13 ‘‘(E) MINOR USE WAIVER.—In handling

14 the registration of a pesticide for a minor use,

15 the Administrator may waive otherwise applica16 ble data requirements if the Administrator de17 termines that the absence of such data will not

18 prevent the Administrator from determining—

19 ‘‘(i) the incremental risk presented by

20 the minor use of the pesticide, and

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

22 be an unreasonable adverse effect on the

23 environment.’’.

24 (e) EXPEDITING MINOR USE REGISTRATIONS.—Sec25 tion 3(c)(3) (7 U.S.C. 136a(c)(3)) is amended—
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1 (1) by inserting after ‘‘(A)’’ the following: ‘‘IN

2 GENERAL.—’’;

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

4 ‘‘IDENTICAL OR SUBSTANTIALLY SIMILAR.—’’; and

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

6 ‘‘(C) MINOR USE REGISTRATION.—

7 ‘‘(i) The Administrator shall, as expe8 ditiously as possible, review and act on any

9 complete application—

10 ‘‘(I) that proposes the initial reg11 istration of a new pesticide active in12 gredient if the active ingredient is

13 proposed to be registered solely for

14 minor uses, or proposes a registration

15 amendment solely for minor uses to

16 an existing registration, or

17 ‘‘(II) for a registration or a reg18 istration amendment that proposes

19 significant minor uses.

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

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

22 possible’ means that the Adminis23 trator shall to the greatest extent

24 practicable complete a review and

25 evaluation of all data, submitted with
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1 a complete application, within 12

2 months after the submission of the

3 complete application, and the failure

4 of the Administrator to complete such

5 a review and evaluation under clause

6 (i) shall not be subject to judicial re7 view, and

8 ‘‘(II) the term ‘significant minor

9 uses’ means 3 or more minor uses

10 proposed for every non-minor use, a

11 minor use that would, in the judgment

12 of the Administrator, serve as a re13 placement for any use which has been

14 canceled in the 5 years preceding the

15 receipt of the application, or a minor

16 use that in the opinion of the Admin17 istrator would avoid the reissuance of

18 an emergency exemption under section

19 18 for that minor use.

20 ‘‘(D) ADEQUATE TIME FOR SUBMISSION OF

21 MINOR USE DATA.—If a registrant makes a re22 quest for a minor use waiver, regarding data re23 quired by the Administrator, pursuant to para24 graph (2)(E), and if the Administrator denies

25 in whole or in part such data waiver request,
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1 the registrant shall have a full time period for

2 providing such data. For purposes of this sub3 paragraph, the term ‘full time period’ means

4 the time period originally established by the Ad5 ministrator for submission of such data, begin6 ning with the date of receipt by the registrant

7 of the Administrator’s notice of denial.’’.

8 (f) TEMPORARY EXTENSION OF REGISTRATION FOR

9 UNSUPPORTED MINOR USES.—

10 (1) REREGISTRATION.—

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

12 136a–1(d)(6) and (f)(3)) are each amended by

13 adding at the end the following: ‘‘If the reg14 istrant does not commit to support a specific

15 minor use of the pesticide, but is supporting

16 and providing data in a timely and adequate

17 fashion to support uses of the pesticide on a

18 food, or if all uses of the pesticide are nonfood

19 uses and the registrant does not commit to sup20 port a specific minor use of the pesticide but is

21 supporting and providing data in a timely and

22 adequate fashion to support other nonfood uses

23 of the pesticide, the Administrator, at the writ24 ten request of the registrant, shall not take any

25 action pursuant to this paragraph in regard to
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1 such unsupported minor use until the final

2 deadline established as of the date of enactment

3 of the Minor Use Crop Protection Amendments

4 of 1995, for the submission of data under this

5 section for the supported uses identified pursu6 ant to this paragraph unless the Administrator

7 determines that the absence of the data is sig8 nificant enough to cause human health or envi9 ronmental concerns. On such a determination

10 the Administrator may refuse the request for

11 extension by the registrant. Upon receipt of the

12 request from the registrant, the Administrator

13 shall publish in the Federal Register a notice of

14 the receipt of the request and the effective date

15 upon which the uses not being supported will be

16 voluntarily deleted from the registration pursu17 ant to section 6(f)(1). If the Administrator

18 grants an extension under this paragraph, the

19 Administrator shall monitor the development of

20 the data for the uses being supported and shall

21 ensure that the registrant is meeting the sched22 ule for the production of such data. If the Ad23 ministrator determines that the registrant is

24 not meeting or has not met the schedule for the

25 production of such data, the Administrator may
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1 proceed in accordance with clause (iv) of section

2 3(c)(2)(B) regarding the continued registration

3 of the affected products with the minor and

4 other uses and shall inform the public of such

5 action in accordance with section 6(f)(2). Not6 withstanding the provision of this subpara7 graph, the Administrator may deny, modify, or

8 revoke the temporary extension under this para9 graph if the Administrator determines that the

10 continuation of the minor use may cause an un11 reasonable adverse effect on the environment.

12 In the event of modification or revocation the

13 Administrator shall provide, in writing, to the

14 registrant, a notice revoking the temporary ex15 tension and establish a new effective date by

16 which the minor use shall be deleted from the

17 registration.

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

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

20 following: ‘‘If the registrant does not commit to

21 support a specific minor use of the pesticide,

22 but is supporting and providing data in a timely

23 and adequate fashion to support uses of the

24 pesticide on a food, or if all uses of the pes25 ticide are nonfood uses and the registrant does
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1 not commit to support a specific minor use of

2 the pesticide but is supporting and providing

3 data in a timely and adequate fashion to sup4 port other nonfood uses of the pesticide, the

5 Administrator, at the written request of the

6 registrant, shall not take any action pursuant

7 to this subparagraph in regard to such unsup8 ported minor use until the final deadline estab9 lished as of the date of enactment of the Minor

10 Use Crop Protection Amendments of 1995, for

11 the submission of data under this section for

12 the supported uses identified pursuant to this

13 subparagraph unless the Administrator deter14 mines that the absence of the data is significant

15 enough to cause human health or environmental

16 concerns. On the basis of such determination

17 the Administrator may refuse the request for

18 extension by the registrant. Upon receipt of the

19 request from the registrant, the Administrator

20 shall publish in the Federal Register a notice

21 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 pursuant to section 6(f)(1). If the Adminis25 trator grants an extension under this subpara-
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1 graph, the Administrator shall monitor the de2 velopment of the data for the uses being sup3 ported and shall ensure that the registrant is

4 meeting the schedule for the production of such

5 data. If the Administrator determines that the

6 registrant is not meeting or has not met the

7 schedule for the production of such data, the

8 Administrator may proceed in accordance with

9 clause (iv) of section 3(c)(2)(B) regarding the

10 continued registration of the affected products

11 with the minor and other uses and shall inform

12 the public of such action in accordance with

13 section 6(f)(2). Notwithstanding the provisions

14 of this subparagraph, the Administrator may

15 deny, modify, or revoke the temporary extension

16 under this subparagraph if the Administrator

17 determines that the continuation of the minor

18 use may cause an unreasonable adverse effect

19 on the environment. In the event of modifica20 tion or revocation, the Administrator shall pro21 vide, in writing, to the registrant, a notice re22 voking the temporary extension and establish a

23 new effective date by which the minor use shall

24 be deleted from the registration.
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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 does not com5 mit to support a specific minor use of the

6 pesticide, but is supporting and providing

7 data in a timely and adequate fashion to

8 support uses of the pesticide on a food, or

9 if all uses of the pesticide are nonfood uses

10 and the registrant does not commit to sup11 port a specific minor use of the pesticide

12 but is supporting and providing data in a

13 timely and adequate fashion to support

14 other nonfood uses of the pesticide, the

15 Administrator, at the written request of

16 the registrant, shall not take any action

17 pursuant to this clause in regard to such

18 unsupported minor use until the final

19 deadline established as of the date of en20 actment of the Minor Use Crop Protection

21 Amendments of 1995, for the submission

22 of data under section 4 for the supported

23 uses identified pursuant to this clause un24 less the Administrator determines that the

25 absence of the data is significant enough to
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1 cause human health or environmental con2 cerns. On the basis of such determination,

3 the Administrator may refuse the request

4 for extension by the registrant. Upon re5 ceipt of the request from the registrant,

6 the Administrator shall publish in the Fed7 eral Register a notice of the receipt of the

8 request and the effective date upon which

9 the uses not being supported will be volun10 tarily deleted from the registration pursu11 ant to section 6(f)(1). If the Administrator

12 grants an extension under this clause, the

13 Administrator shall monitor the develop14 ment of the data for the uses being sup15 ported and shall ensure that the registrant

16 is meeting the schedule for the production

17 of such data. If the Administrator deter18 mines that the registrant is not meeting or

19 has not met the schedule for the produc20 tion of such data, the Administrator may

21 proceed in accordance with clause (iv) of

22 this subparagraph regarding the continued

23 registration of the affected products with

24 the minor and other uses and shall inform

25 the public of such action in accordance
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1 with section 6(f)(2). Notwithstanding the

2 provisions of this clause, the Administrator

3 may deny, modify, or revoke the temporary

4 extension under this subparagraph if the

5 Administrator determines that the continu6 ation of the minor use may cause an un7 reasonable adverse effect on the environ8 ment. In the event of modification or rev9 ocation, the Administrator shall provide, in

10 writing, to the registrant, a notice revoking

11 the temporary extension and establish a

12 new effective date by which the minor use

13 shall be deleted from the registration.

14 (g) UTILIZATION OF DATA FOR VOLUNTARILY CAN15 CELED CHEMICALS.—Section 6(f) (7 U.S.C. 136d) is

16 amended by adding at the end the following:

17 ‘‘(4) UTILIZATION OF DATA FOR VOLUNTARILY

18 CANCELED CHEMICALS.—When an application is

19 filed with the Administrator for the registration of

20 a pesticide for a minor use and another registrant

21 subsequently voluntarily cancels its registration for

22 an identical or substantially similar pesticide for an

23 identical or substantially similar use, the Adminis24 trator shall process, review, and evaluate the pend25 ing application as if the voluntary cancellation had
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1 not yet taken place, except that the Administrator

2 shall not take such action if the Administrator deter3 mines that such minor use may cause an unreason4 able adverse effect on the environment. In order to

5 rely on this paragraph, the applicant must certify

6 that it agrees to satisfy any outstanding data re7 quirements necessary to support the reregistration of

8 the pesticide in accordance with the data submission

9 schedule established by the Administrator.’’.

10 (h) ENVIRONMENTAL PROTECTION AGENCY MINOR

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

12 Rodenticide Act (7 U.S.C. 136 et seq.) is amended by re13 designating sections 30 and 31 as sections 32 and 33, re14 spectively and adding after section 29 the following:

15 ‘‘SEC. 30. ENVIRONMENTAL PROTECTION AGENCY MINOR

16 USE PROGRAM.

17 ‘‘The Administrator shall assure coordination of

18 minor use issues through the establishment of a minor use

19 program within the Office of Pesticide Programs. Such of20 fice shall be responsible for coordinating the development

21 of minor use programs and policies and consulting with

22 growers regarding minor use issues and registrations and

23 amendments which are submitted to the Environmental

24 Protection Agency.’’.
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1 (i) DEPARTMENT OF AGRICULTURE MINOR USE

2 PROGRAM.—The Federal Insecticide, Fungicide, and

3 Rodenticide Act (7 U.S.C. 136 et seq.), as amended by

4 subsection (h), is amended by adding after section 30 the

5 following:

6 ‘‘SEC. 31. DEPARTMENT OF AGRICULTURE MINOR USE PRO7 GRAM.

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

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

10 shall ensure the coordination of the responsibilities of the

11 Department of Agriculture related to minor uses of pes12 ticides, including—

13 ‘‘(1) carrying out the Inter-Regional Project

14 Number 4 (IR–4) as described in section 2(e) of the

15 Act entitled ‘An Act to facilitate the work of the De16 partment of Agriculture, and for other purposes’ (7

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

18 monitoring program established under section 1651

19 of the Food, Agriculture, Conservation, and Trade

20 Act of 1990 (7 U.S.C. 5882);

21 ‘‘(2) supporting integrated pest management

22 research;

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

24 minor uses; and
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1 ‘‘(4) providing assistance for minor use reg2 istrations, tolerances, and reregistrations with the

3 Environmental Protection Agency.

4 ‘‘(b) MATCHING FUND PROGRAM.—

5 ‘‘(1) ESTABLISHMENT.—The Secretary of Agri6 culture, in consultation with the Administrator, shall

7 establish and administer a minor use matching fund

8 program. The matching fund program shall be uti9 lized to ensure the continued availability of minor

10 use crop protection chemical, including the develop11 ment of data to support minor use pesticide registra12 tions and reregistrations. Access to the matching

13 fund program shall be available to any entity which

14 desires to develop data to support minor use reg15 istrations. Priority for access to the fund shall be

16 given those entities that do not directly receive funds

17 from the sale of products registered on minor uses.

18 Any entity that seeks such funding under this para19 graph shall be required to match such funds with an

20 equal amount of its own funds. Any data developed

21 through the matching fund program shall be jointly

22 owned by the Department of Agriculture and by the

23 entity that receives such funding. Any data devel24 oped under this subsection shall be subject to the

25 provisions of section 3(c)(1)(F). All compensation
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1 received by the Department of Agriculture in return

2 for the use of such data under the matching fund

3 program shall be returned to a revolving fund which

4 will support the matching fund program.

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

6 be appropriated for the revolving fund for the

7 matching fund program an annual sum not to ex8 ceed $10,000,000.’’.

Æ