104TH CONGRESS

2D SESSION H. R. 1627

AN ACT

To amend the Federal Insecticide, Fungicide, and

and Cosmetic Act, and for other purposes.Rodenticide Act and the Federal Food, Drug,
104TH CONGRESS

2D SESSION H. R. 1627

AN ACT

To amend the Federal Insecticide, Fungicide, and

Rodenticide Act and the Federal Food, Drug, and Cosmetic Act, 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,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Food Quality Protec3 tion Act of 1996’’.

4 TITLE I—SUSPENSION5 APPLICATORS

6 SEC. 101. REFERENCE.

7 Whenever in this title an amendment or repeal is ex8 pressed in terms of an amendment to, or repeal of, a sec9 tion or other provision, the reference shall be considered

10 to be made to a section or other provision of the Federal

11 Insecticide, Fungicide, and Rodenticide Act.

12 Subtitle A—Suspension

13 SEC. 102. SUSPENSION.

14 (a) SECTION 6(c)(1).—The second sentence of sec15 tion 6(c)(1) (7 U.S.C. 136d(c)(1)) is amended to read:

16 ‘‘Except as provided in paragraph (3), no order of suspen17 sion may be issued under this subsection unless the Ad18 ministrator has issued, or at the same time issues, a notice

19 of intention to cancel the registration or change the classi20 fication of the pesticide under subsection (b).’’.

21 (b) SECTION 6(c)(3).—Section 6(c)(3) (7 U.S.C.

22 136d(c)(3)) is amended—

23 (1) by inserting after the first sentence the fol24 lowing new sentence: ‘‘The Administrator may issue

25 an emergency order under this paragraph before is26 suing a notice of intention to cancel the registration
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1 or change the classification of the pesticide under

2 subsection (b) and the Administrator shall proceed

3 to issue the notice under subsection (b) within 90

4 days of issuing an emergency order. If the Adminis5 trator does not issue a notice under subsection (b)

6 within 90 days of issuing an emergency order, the

7 emergency order shall expire.’’; and

8 (2) by striking ‘‘In that case’’ and inserting ‘‘In

9 the case of an emergency order’’.

10 SEC. 103. TOLERANCE REEVALUATION AS PART OF REREG11 ISTRATION.

12 Section 4(g)(2) (7 U.S.C. 136a–1(g)(2)) is amended

13 by adding at the end the following:

14 ‘‘(E) As soon as the Administrator has

15 sufficient information with respect to the die16 tary risk of a particular active ingredient, but

17 in any event no later than the time the Admin18 istrator makes a determination under subpara19 graph (C) or (D) with respect to pesticides con20 taining a particular active ingredient, the Ad21 ministrator shall—

22 ‘‘(i) reassess each associated tolerance

23 and exemption from the requirement for a

24 tolerance issued under section 408 of the
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1 Federal Food, Drug, and Cosmetic Act (21

2 U.S.C. 346a);

3 ‘‘(ii) determine whether such tolerance

4 or exemption meets the requirements of

5 that Act;

6 ‘‘(iii) determine whether additional

7 tolerances or exemptions should be issued;

8 ‘‘(iv) publish in the Federal Register a

9 notice setting forth the determinations

10 made under this subparagraph; and

11 ‘‘(v) commence promptly such pro12 ceedings under this Act and section 408 of

13 the Federal Food, Drug, and Cosmetic Act

14 as are warranted by such determinations.’’.

15 SEC. 104. SCIENTIFIC ADVISORY PANEL.

16 Section 25(d) (7 U.S.C. 136w(d)) is amended—

17 (1) in the first sentence, by striking ‘‘The Ad18 ministrator shall’’ and inserting:

19 ‘‘(1) IN GENERAL.—The Administrator shall’’;

20 and

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

22 ‘‘(2) SCIENCE REVIEW BOARD.—There is estab23 lished a Science Review Board to consist of 60 sci24 entists who shall be available to the Scientific Advi25 sory Panel to assist in reviews conducted by the
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1 Panel. Members of the Board shall be selected in the

2 same manner as members of temporary subpanels

3 created under paragraph (1). Members of the Board

4 shall be compensated in the same manner as mem5 bers of the Panel.’’.

6 SEC. 105. NITROGEN STABILIZER.

7 (a) SECTION 2.—Section 2 (7 U.S.C. 136) is amend8 ed—

9 (1) in subsection (a)—

10 (A) in paragraph (1) by striking ‘‘or’’ after

11 ‘‘defoliant,’’ and inserting ‘‘, or nitrogen sta12 bilizer’’ after ‘‘desiccant’’;

13 (B) at the end of paragraph (3) by striking

14 ‘‘and’’;

15 (C) at the end of paragraph (4) by striking

16 the period and inserting ‘‘; and’’; and

17 (D) at the end by adding the following:

18 ‘‘(5) in the case of a nitrogen stabilizer, an in19 gredient which will prevent or hinder the process of

20 nitrification, denitrification, ammonia volatilization,

21 or urease production through action affecting soil

22 bacteria.’’;

23 (2) in subsection (u), by striking ‘‘and’’ before

24 ‘‘(2)’’ and by inserting ‘‘and (3) any nitrogen sta25 bilizer,’’ after ‘‘desiccant,’’; and
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1 (3) at the end by adding the following:

2 ‘‘(hh) NITROGEN STABILIZER.—The term ‘nitrogen

3 stabilizer’ means any substance or mixture of substances

4 intended for preventing or hindering the process of nitrifi5 cation, denitrification, ammonia volatilization, or urease

6 production through action upon soil bacteria. Such term

7 shall not include—

8 ‘‘(1) dicyandiamide;

9 ‘‘(2) ammonium thiosulfate; or

10 ‘‘(3) any substance or mixture of substances.—

11 ‘‘(A) that was not registered pursuant to

12 section 3 prior to January 1, 1992; and

13 ‘‘(B) that was in commercial agronomic

14 use prior to January 1, 1992, with respect to

15 which after January 1, 1992, the distributor or

16 seller of the substance or mixture has made no

17 specific claim of prevention or hindering of the

18 process of nitrification, denitrification, ammonia

19 volatilization urease production regardless of

20 the actual use or purpose for, or future use or

21 purpose for, the substance or mixture.

22 Statements made in materials required to be submitted

23 to any State legislative or regulatory authority, or required

24 by such authority to be included in the labeling or other

25 literature accompanying any such substance or mixture
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1 shall not be deemed a specific claim within the meaning

2 of this subsection.’’.

3 (b) SECTION 3(f).—Section 3(f) (7 U.S.C. 136a(f))

4 is amended by adding at the end the following:

5 ‘‘(4) MIXTURES OF NITROGEN STABILIZERS

6 AND FERTILIZER PRODUCTS.—Any mixture or other

7 combination of—

8 ‘‘(A) 1 or more nitrogen stabilizers reg9 istered under this Act; and

10 ‘‘(B) 1 or more fertilizer products,

11 shall not be subject to the provisions of this section

12 or sections 4, 5, 7, 15, and 17(a)(2) if the mixture

13 or other combination is accompanied by the labeling

14 required under this Act for the nitrogen stabilizer

15 contained in the mixture or other combination, the

16 mixture or combination is mixed or combined in ac17 cordance with such labeling, and the mixture or

18 combination does not contain any active ingredient

19 other than the nitrogen stabilizer.’’.

20 SEC. 106. PERIODIC REGISTRATION REVIEW.

21 (a) SECTION 6.—Section 6 (7 U.S.C. 136d) is

22 amended—

23 (1) in subsection (a), by striking the heading

24 and inserting the following:

25 ‘‘(a) EXISTING STOCKS AND INFORMATION.—’’; and
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1 (2) by amending paragraph (1) of subsection

2 (a) to read as follows:

3 ‘‘(1) EXISTING STOCKS.—The Administrator

4 may permit the continued sale and use of existing

5 stocks of a pesticide whose registration is suspended

6 or canceled under this section, or section 3 or 4, to

7 such extent, under such conditions, and for such

8 uses as the Administrator determines that such sale

9 or use is not inconsistent with the purposes of this

10 Act.’’.

11 (b) SECTION 3.—Section 3 (7 U.S.C. 136a) is

12 amended by adding at the end the following:

13 ‘‘(g) REGISTRATION REVIEW.—

14 ‘‘(1)(A) GENERAL RULE.—The registrations of

15 pesticides are to be periodically reviewed. The Ad16 ministrator shall by regulation establish a procedure

17 for accomplishing the periodic review of registra18 tions. The goal of these regulations shall be a review

19 of a pesticide’s registration every 15 years. No reg20 istration shall be canceled as a result of the registra21 tion review process unless the Administrator follows

22 the procedures and substantive requirements of sec23 tion 6.
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1 ‘‘(B) LIMITATION.—Nothing in this subsection

2 shall prohibit the Administrator from undertaking

3 any other review of a pesticide pursuant to this Act.

4 ‘‘(2)(A) DATA.—The Administrator shall use

5 the authority in subsection (c)(2)(B) to require the

6 submission of data when such data are necessary for

7 a registration review.

8 ‘‘(B) DATA SUBMISSION, COMPENSATION, AND

9 EXEMPTION.—For purposes of this subsection, the

10 provisions of subsections (c)(1), (c)(2)(B), and

11 (c)(2)(D) shall be utilized for and be applicable to

12 any data required for registration review.’’.

13 Subtitle B—Training for Mainte14 nance Applicators and Service

15 Technicians

16 SEC. 120. MAINTENANCE APPLICATORS AND SERVICE

17 TECHNICIANS DEFINITIONS.

18 Section 2 (7 U.S.C. 136), as amended by section 106,

19 is amended by adding at the end the following:

20 ‘‘(jj) MAINTENANCE APPLICATOR.—The term ‘main21 tenance applicator’ means any individual who, in the prin22 cipal course of such individual’s employment, uses, or su23 pervises the use of, a pesticide not classified for restricted

24 use (other than a ready to use consumer products pes25 ticides); for the purpose of providing structural pest con-
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1 trol or lawn pest control including janitors, general main2 tenance personnel, sanitation personnel, and grounds

3 maintenance personnel. The term ‘maintenance applicator’

4 does not include private applicators as defined in section

5 2(e)(2); individuals who use antimicrobial pesticides, sani6 tizers or disinfectants; individuals employed by Federal,

7 State, and local governments or any political subdivisions

8 thereof, or individuals who use pesticides not classified for

9 restricted use in or around their homes, boats, sod farms,

10 nurseries, greenhouses, or other noncommercial property.

11 ‘‘(kk) SERVICE TECHNICIAN.—The term ‘service

12 technician’ means any individual who uses or supervises

13 the use of pesticides (other than a ready to use consumer

14 products pesticide) for the purpose of providing structural

15 pest control or lawn pest control on the property of an16 other for a fee. The term ‘service technician’ does not in17 clude individuals who use antimicrobial pesticides, sani18 tizers or disinfectants; or who otherwise apply ready to

19 use consumer products pesticides.’’.

20 SEC. 121. MINIMUM REQUIREMENTS FOR TRAINING OF

21 MAINTENANCE APPLICATORS AND SERVICE

22 TECHNICIANS.

23 The Federal Insecticide, Fungicide, and Rodenticide

24 Act (7 U.S.C. 136 et seq.) is amended—
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1 (1) by redesignating sections 30 and 31 as sec2 tions 33 and 34, respectively; and

3 (2) by adding after section 29 the following:

4 ‘‘SEC. 30. MINIMUM REQUIREMENTS FOR TRAINING OF

5 MAINTENANCE APPLICATORS AND SERVICE

6 TECHNICIANS.

7 ‘‘Each State may establish minimum requirements

8 for training of maintenance applicators and service techni9 cians. Such training may include instruction in the safe

10 and effective handling and use of pesticides in accordance

11 with the Environmental Protection Agency approved label12 ing, and instruction in integrated pest management tech13 niques. The authority of the Administrator with respect

14 to minimum requirements for training of maintenance ap15 plicators and service technicians shall be limited to ensur16 ing that each State understands the provisions of this sec17 tion.’’.

18 TITLE II—MINOR USE CROP PRO19 TECTION, ANTIMICROBIAL

20 PESTICIDE REGISTRATION

21 REFORM, AND PUBLIC

22 HEALTH PESTICIDES

23 SEC. 201. REFERENCE.

24 Whenever in this title an amendment or repeal is ex25 pressed in terms of an amendment to, or repeal of, a sec-
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1 tion or other provision, the reference shall be considered

2 to be made to a section or other provision of the Federal

3 Insecticide, Fungicide, and Rodenticide Act.

4 Subtitle A—Minor Use Crop

5 Protection

6 SEC. 210. MINOR CROP PROTECTION.

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

8 amended by section 120, is further amended by adding

9 at the end the following:

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

11 use of a pesticide on an animal, on a commercial agricul12 tural crop or site, or for the protection of public health

13 where—

14 ‘‘(1) the total United States acreage for the

15 crop is less than 300,000 acres, as determined by

16 the Secretary of Agriculture; or

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

18 Secretary of Agriculture, determines that, based on

19 information provided by an applicant for registration

20 or a registrant, the use does not provide sufficient

21 economic incentive to support the initial registration

22 or continuing registration of a pesticide for such use

23 and—
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1 ‘‘(A) there are insufficient efficacious alter2 native registered pesticides available for the

3 use;

4 ‘‘(B) the alternatives to the pesticide use

5 pose greater risks to the environment or human

6 health;

7 ‘‘(C) the minor use pesticide plays or will

8 play a significant part in managing pest resist9 ance; or

10 ‘‘(D) the minor use pesticide plays or will

11 play a significant part in an integrated pest

12 management program.

13 The status as a minor use under this subsection shall con14 tinue as long as the Administrator has not determined

15 that, based on existing data, such use may cause an unrea16 sonable adverse effect on the environment and the use oth17 erwise qualifies for such status.’’.

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

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

20 (1) by redesignating clauses (ii) and (iii) as

21 clauses (iii) and (iv), respectively; and

22 (2) by inserting after clause (i) the following:

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

24 provided under clause (i) shall be extended

25 1 additional year for each 3 minor uses
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1 registered after the date of enactment of

2 this clause and within 7 years of the com3 mencement of the exclusive use period, up

4 to a total of 3 additional years for all

5 minor uses registered by the Administrator

6 if the Administrator, in consultation with

7 the Secretary of Agriculture, determines

8 that, based on information provided by an

9 applicant for registration or a registrant,

10 that—

11 ‘‘(I) there are insufficient effica12 cious alternative registered pesticides

13 available for the use;

14 ‘‘(II) the alternatives to the

15 minor use pesticide pose greater risks

16 to the environment or human health;

17 ‘‘(III) the minor use pesticide

18 plays or will play a significant part in

19 managing pest resistance; or

20 ‘‘(IV) the minor use pesticide

21 plays or will play a significant part in

22 an integrated pest management pro23 gram.

24 The registration of a pesticide for a minor

25 use on a crop grouping established by the
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1 Administrator shall be considered for pur2 poses of this clause 1 minor use for each

3 representative crop for which data are pro4 vided in the crop grouping. Any additional

5 exclusive use period under this clause shall

6 be modified as appropriate or terminated if

7 the registrant voluntarily cancels the prod8 uct or deletes from the registration the

9 minor uses which formed the basis for the

10 extension of the additional exclusive use

11 period or if the Administrator determines

12 that the registrant is not actually market13 ing the product for such minor uses.’’;

14 (3) in clause (iv), as amended by paragraph (1),

15 by striking ‘‘and (ii)’’ and inserting ‘‘, (ii), and

16 (iii)’’; and

17 (4) at the end of the section, as amended by

18 paragraph (1), by adding the following:

19 ‘‘(v) The period of exclusive use pro20 vided under clause (ii) shall not take into

21 effect until 1 year after enactment of this

22 clause, except where an applicant or reg23 istrant is applying for the registration of a

24 pesticide containing an active ingredient

25 not previously registered.
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1 ‘‘(vi) With respect to data submitted

2 after the date of enactment of this clause

3 by an applicant or registrant to support an

4 amendment adding a new use to an exist5 ing registration that does not retain any

6 period of exclusive use, if such data relates

7 solely to a minor use of a pesticide, such

8 data shall not, without the written permis9 sion of the original data submitter, be con10 sidered by the Administrator to support an

11 application for a minor use by another per12 son during the period of 10 years following

13 the date of submission of such data. The

14 applicant or registrant at the time the new

15 minor use is requested shall notify the Ad16 ministrator that to the best of their knowl17 edge the exclusive use period for the pes18 ticide has expired and that the data per19 taining solely to the minor use of a pes20 ticide is eligible for the provisions of this

21 paragraph. If the minor use registration

22 which is supported by data submitted pur23 suant to this subsection is voluntarily can24 celed or if such data are subsequently used

25 to support a nonminor use, the data shall
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1 no longer be subject to the exclusive use

2 provisions of this clause but shall instead

3 be considered by the Administrator in ac4 cordance with the provisions of clause (i),

5 as appropriate.’’.

6 (c) TIME EXTENSIONS FOR DEVELOPMENT OF

7 MINOR USE DATA.—

8 (1) DATA CALL-IN.—Section 3(c)(2)(B) (7

9 U.S.C. 136a(c)(2)(B)) is amended by adding at the

10 end the following:

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

12 Administrator shall, in the case of a minor use,

13 extend the deadline for the production of resi14 due chemistry data under this subparagraph for

15 data required solely to support that minor use

16 until the final deadline for submission of data

17 under section 4 for the other uses of the pes18 ticide established as of the date of enactment of

19 the Food Quality Protection Act of 1996, if—

20 ‘‘(I) the data to support other uses of

21 the pesticide on a food are being provided;

22 ‘‘(II) the registrant, in submitting a

23 request for such an extension, provides a

24 schedule, including interim dates to meas25 ure progress, to assure that the data pro-
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1 duction will be completed before the expi2 ration of the extension period;

3 ‘‘(III) the Administrator has deter4 mined that such extension will not signifi5 cantly delay the Administrator’s schedule

6 for issuing a reregistration eligibility deter7 mination required under section 4; and

8 ‘‘(IV) the Administrator has deter9 mined that based on existing data, such

10 extension would not significantly increase

11 the risk of any unreasonable adverse effect

12 on the environment. If the Administrator

13 grants an extension under this clause, the

14 Administrator shall monitor the develop15 ment of the data and shall ensure that the

16 registrant is meeting the schedule for the

17 production of the data. If the Adminis18 trator determines that the registrant is not

19 meeting or has not met the schedule for

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

22 clause (iv) regarding the continued reg23 istration of the affected products with the

24 minor use and shall inform the public of

25 such action. Notwithstanding the provi-
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1 sions of this clause, the Administrator may

2 take action to modify or revoke the exten3 sion under this clause if the Administrator

4 determines that the extension for the

5 minor use may cause an unreasonable ad6 verse effect on the environment. In such

7 circumstance, the Administrator shall pro8 vide, in writing to the registrant, a notice

9 revoking the extension of time for submis10 sion of data. Such data shall instead be

11 due in accordance with the date established

12 by the Administrator for the submission of

13 the data.’’.

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

15 4(e)(2)(B), and 4(f)(2)(B) (7 U.S.C. 136a–

16 1(d)(4)(B), (e)(2)(B), and (f)(2)(B)) are each

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

18 application of a registrant, the Administrator shall,

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

20 the production of residue chemistry data under this

21 subparagraph for data required solely to support

22 that minor use until the final deadline for submis23 sion of data under this section for the other uses of

24 the pesticide established as of the date of enactment

25 of the Food Quality Protection Act of 1996 if—
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1 ‘‘(i) the data to support other uses of

2 the pesticide on a food are being provided;

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

4 request for such an extension provides a

5 schedule, including interim dates to meas6 ure progress, to assure that the data pro7 duction will be completed before the expi8 ration of the extension period;

9 ‘‘(iii) the Administrator has deter10 mined that such extension will not signifi11 cantly delay the Administrator’s schedule

12 for issuing a reregistration eligibility deter13 mination required under this section; and

14 ‘‘(iv) the Administrator has deter15 mined that based on existing data, such

16 extension would not significantly increase

17 the risk of any unreasonable adverse effect

18 on the environment. If the Administrator

19 grants an extension under this subpara20 graph, the Administrator shall monitor the

21 development of the data and shall ensure

22 that the registrant is meeting the schedule

23 for the production of the data. If the Ad24 ministrator determines that the registrant

25 is not meeting or has not met the schedule
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1 for the production of such data, the Ad2 ministrator may proceed in accordance

3 with clause (iv) of section 3(c)(2)(B) or

4 other provisions of this section, as appro5 priate, regarding the continued registration

6 of the affected products with the minor use

7 and shall inform the public of such action.

8 Notwithstanding the provisions of this sub9 paragraph, the Administrator may take ac10 tion to modify or revoke the extension

11 under this subparagraph if the Adminis12 trator determines that the extension for

13 the minor use may cause an unreasonable

14 adverse affect on the environment. In such

15 circumstance, the Administrator shall pro16 vide written notice to the registrant revok17 ing the extension of time for submission of

18 data. Such data shall instead be due in ac19 cordance with the date then established by

20 the Administrator for submission of the

21 data.’’.

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

23 136a(c)(2)) is amended—

24 (1) by inserting ‘‘IN GENERAL.—’’ after ‘‘(A)’’;
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1 (2) by inserting ‘‘ADDITIONAL DATA.—’’ after

2 ‘‘(B)’’;

3 (3) by inserting ‘‘SIMPLIFIED PROCEDURES.—’’

4 after ‘‘(C)’’; and

5 (4) 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 complete application—

4 ‘‘(I) that proposes the initial reg5 istration of a new pesticide active in6 gredient if the active ingredient is

7 proposed to be registered solely for

8 minor uses, or proposes a registration

9 amendment solely for minor uses to

10 an existing registration; or

11 ‘‘(II) for a registration or a reg12 istration amendment that proposes

13 significant minor uses.

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

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

16 possible’ means that the Adminis17 trator shall, to the greatest extent

18 practicable, complete a review and

19 evaluation of all data, submitted with

20 a complete application, within 12

21 months after the submission of the

22 complete application, and the failure

23 of the Administrator to complete such

24 a review and evaluation under clause
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1 (i) shall not be subject to judicial re2 view; and

3 ‘‘(II) the term ‘significant minor

4 uses’ means 3 or more minor uses

5 proposed for every nonminor use, a

6 minor use that would, in the judgment

7 of the Administrator, serve as a re8 placement for any use which has been

9 canceled in the 5 years preceding the

10 receipt of the application, or a minor

11 use that in the opinion of the Admin12 istrator would avoid the reissuance of

13 an emergency exemption under section

14 18 for that minor use.

15 ‘‘(D) ADEQUATE TIME FOR SUBMISSION OF

16 MINOR USE DATA.—If a registrant makes a re17 quest for a minor use waiver, regarding data re18 quired by the Administrator, pursuant to para19 graph (2)(E), and if the Administrator denies

20 in whole or in part such data waiver request,

21 the registrant shall have a full-time period for

22 providing such data. For purposes of this sub23 paragraph, the term ‘full-time period’ means

24 the time period originally established by the Ad25 ministrator for submission of such data, begin-
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1 ning with the date of receipt by the registrant

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

3 (f) TEMPORARY EXTENSION OF REGISTRATION FOR

4 UNSUPPORTED MINOR USES.—

5 (1) REREGISTRATION.—

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

7 136a–1(d)(6) and (f)(3)) are each amended by

8 adding at the end the following: ‘‘If the reg9 istrant does not commit to support a specific

10 minor use of the pesticide, but is supporting

11 and providing data in a timely and adequate

12 fashion to support uses of the pesticide on a

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

14 uses and the registrant does not commit to sup15 port a specific minor use of the pesticide but is

16 supporting and providing data in a timely and

17 adequate fashion to support other nonfood uses

18 of the pesticide, the Administrator, at the writ19 ten request of the registrant, shall not take any

20 action pursuant to this paragraph in regard to

21 such unsupported minor use until the final

22 deadline established as of the date of enactment

23 of the Food Quality Protection Act of 1996, for

24 the submission of data under this section for

25 the supported uses identified pursuant to this
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1 paragraph unless the Administrator determines

2 that the absence of the data is significant

3 enough to cause human health or environmental

4 concerns. On such a determination the Admin5 istrator may refuse the request for extension by

6 the registrant. Upon receipt of the request from

7 the registrant, the Administrator shall publish

8 in the Federal Register a notice of the receipt

9 of the request and the effective date upon which

10 the uses not being supported will be voluntarily

11 deleted from the registration pursuant to sec12 tion 6(f)(1). If the Administrator grants an ex13 tension under this paragraph, the Adminis14 trator shall monitor the development of the

15 data for the uses being supported and shall en16 sure that the registrant is meeting the schedule

17 for the production of such data. If the Adminis18 trator determines that the registrant is not

19 meeting or has not met the schedule for the

20 production of such data, the Administrator may

21 proceed in accordance with section

22 3(c)(2)(B)(iv) regarding the continued registra23 tion of the affected products with the minor

24 and other uses and shall inform the public of

25 such action in accordance with section 6(f)(2).
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1 Notwithstanding this subparagraph, the Admin2 istrator may deny, modify, or revoke the tem3 porary extension under this paragraph if the

4 Administrator determines that the continuation

5 of the minor use may cause an unreasonable

6 adverse effect on the environment. In the event

7 of modification or revocation, the Administrator

8 shall provide, in writing, to the registrant a no9 tice revoking the temporary extension and es10 tablish a new effective date by which the minor

11 use shall be deleted from the registration.’’.

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

13 1(e)(3)(A)) is amended by adding at the end

14 the following: ‘‘If the registrant does not com15 mit to support a specific minor use of the pes16 ticide, but is supporting and providing data in

17 a timely and adequate fashion to support uses

18 of the pesticide on a food, or if all uses of the

19 pesticide are nonfood uses and the registrant

20 does not commit to support a specific minor use

21 of the pesticide but is supporting and providing

22 data in a timely and adequate fashion to sup23 port other nonfood uses of the pesticide, the

24 Administrator, at the written request of the

25 registrant, shall not take any action pursuant
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1 to this subparagraph in regard to such unsup2 ported minor use until the final deadline estab3 lished as of the date of enactment of the Food

4 Quality Protection Act of 1996, for the submis5 sion of data under this section for the sup6 ported uses identified pursuant to this subpara7 graph unless the Administrator determines that

8 the absence of the data is significant enough to

9 cause human health or environmental concerns.

10 On the basis of such determination, the Admin11 istrator may refuse the request for extension by

12 the registrant. 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 pursuant to sec18 tion 6(f)(1). If the Administrator grants an ex19 tension under this subparagraph, the Adminis20 trator shall monitor the development of the

21 data for the uses being supported and shall en22 sure that the registrant is meeting the schedule

23 for the production of such data. If the Adminis24 trator determines that the registrant is not

25 meeting or has not met the schedule for the
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•HR 1627 EH

1 production of such data, the Administrator may

2 proceed in accordance with section

3 3(c)(2)(B)(iv) regarding the continued registra4 tion of the affected products with the minor

5 and other uses and shall inform the public of

6 such action in accordance with section 6(f)(2).

7 Notwithstanding this subparagraph, the Admin8 istrator may deny, modify, or revoke the tem9 porary extension under this subparagraph if the

10 Administrator determines that the continuation

11 of the minor use may cause an unreasonable

12 adverse effect on the environment. In the event

13 of modification or revocation, the Administrator

14 shall provide, in writing, to the registrant a no15 tice revoking the temporary extension and es16 tablish a new effective date by which the minor

17 use shall be deleted from the registration.’’.

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

19 136a(c)(2)(B)), as amended by subsection (c)(1), is

20 further amended by adding at the end the following:

21 ‘‘(vii) If the registrant does not commit to

22 support a specific minor use of the pesticide,

23 but is supporting and providing data in a timely

24 and adequate fashion to support uses of the

25 pesticide on a food, or if all uses of the pes-
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1 ticide are nonfood uses and the registrant does

2 not commit to support a specific minor use of

3 the pesticide but is supporting and providing

4 data in a timely and adequate fashion to sup5 port other nonfood uses of the pesticide, the

6 Administrator, at the written request of the

7 registrant, shall not take any action pursuant

8 to this clause in regard to such unsupported

9 minor use until the final deadline established as

10 of the date of enactment of the Food Quality

11 Protection Act of 1996, for the submission of

12 data under section 4 for the supported uses

13 identified pursuant to this clause unless the Ad14 ministrator determines that the absence of the

15 data is significant enough to cause human

16 health or environmental concerns. On the basis

17 of such determination, the Administrator may

18 refuse the request for extension by the reg19 istrant. Upon receipt of the request from the

20 registrant, the Administrator shall publish in

21 the Federal Register a notice of the receipt of

22 the request and the effective date upon which

23 the uses not being supported will be voluntarily

24 deleted from the registration pursuant to sec25 tion 6(f)(1). If the Administrator grants an ex-
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•HR 1627 EH

1 tension under this clause, the Administrator

2 shall monitor the development of the data for

3 the uses being supported and shall ensure that

4 the registrant is meeting the schedule for the

5 production of such data. If the Administrator

6 determines that the registrant is not meeting or

7 has not met the schedule for the production of

8 such data, the Administrator may proceed in

9 accordance with clause (iv) of this subpara10 graph regarding the continued registration of

11 the affected products with the minor and other

12 uses and shall inform the public of such action

13 in accordance with section 6(f)(2). Notwith14 standing the provisions of this clause, the Ad15 ministrator may deny, modify, or revoke the

16 temporary extension under this subparagraph if

17 the Administrator determines that the continu18 ation of the minor use may cause an unreason19 able adverse effect on the environment. In the

20 event of modification or revocation, the Admin21 istrator shall provide, in writing, to the reg22 istrant a notice revoking the temporary exten23 sion and establish a new effective date by which

24 the minor use shall be deleted from the reg25 istration.’’.
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1 (g) Section 6(f) (7 U.S.C. 136d(f)) is amended—

2 (1) in paragraph (1)(C)(ii) by striking ‘‘90-

3 day’’ each place it appears and inserting ‘‘180-day’’;

4 and

5 (2) in paragraph (3)(A) by striking ‘‘90-day’’

6 and inserting ‘‘180-day’’.

7 (h) UTILIZATION OF DATA FOR VOLUNTARILY CAN8 CELED CHEMICALS.—Section 6(f) (7 U.S.C. 136d(f)) is

9 amended by adding at the end the following:

10 ‘‘(4) UTILIZATION OF DATA FOR VOLUNTARILY

11 CANCELED PESTICIDE.—When an application is filed

12 with the Administrator for the registration of a pes13 ticide for a minor use and another registrant subse14 quently voluntarily cancels its registration for an

15 identical or substantially similar pesticide for an

16 identical or substantially similar use, the Adminis17 trator shall process, review, and evaluate the pend18 ing application as if the voluntary cancellation had

19 not yet taken place except that the Administrator

20 shall not take such action if the Administrator deter21 mines that such minor use may cause an unreason22 able adverse effect on the environment. In order to

23 rely on this subsection, the applicant must certify

24 that it agrees to satisfy any outstanding data re25 quirements necessary to support the reregistration of
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1 the pesticide in accordance with the data submission

2 schedule established by the Administrator.’’.

3 (i) ENVIRONMENTAL PROTECTION AGENCY MINOR

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

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

6 section 121, is amended by adding after section 30 the

7 following:

8 ‘‘SEC. 31. ENVIRONMENTAL PROTECTION AGENCY MINOR

9 USE PROGRAM.

10 ‘‘(a) The Administrator shall assure coordination of

11 minor use issues through the establishment of a minor use

12 program within the Office of Pesticide Programs. Such of13 fice shall be responsible for coordinating the development

14 of minor use programs and policies and consulting with

15 growers regarding minor use issues and registrations and

16 amendments which are submitted to the Environmental

17 Protection Agency.

18 ‘‘(b) The Office of Pesticide Programs shall prepare

19 a public report concerning the progress made on the reg20 istration of minor uses, including implementation of the

21 exclusive use as an incentive for registering new minor

22 uses, within 3 years of the passage of the Food Quality

23 Protection Act of 1996.’’.

24 (j) DEPARTMENT OF AGRICULTURE MINOR USE

25 PROGRAM.—The Federal Insecticide, Fungicide, and
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1 Rodenticide Act (7 U.S.C. 136 et seq.), as amended by

2 subsection (i), is amended by adding after section 31 the

3 following:

4 ‘‘SEC. 32. DEPARTMENT OF AGRICULTURE MINOR USE PRO5 GRAM.

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

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

8 shall assure the coordination of the responsibilities of the

9 Department of Agriculture related to minor uses of pes10 ticides, including—

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

12 Number 4 (IR–4) as described in section 2 of Public

13 Law 89–106 (7 U.S.C. 450i(e)) and the national

14 pesticide resistance monitoring program established

15 under section 1651 of the Food, Agriculture, Con16 servation, and Trade Act of 1990 (7 U.S.C. 5882);

17 ‘‘(2) supporting integrated pest management

18 research;

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

20 minor uses; and

21 ‘‘(4) providing assistance for minor use reg22 istrations, tolerances, and reregistrations with the

23 Environmental Protection Agency.

24 ‘‘(b)(1) MINOR USE PESTICIDE DATA.—
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1 ‘‘(A) GRANT AUTHORITY.—The Secretary, in

2 consultation with the Administrator, shall establish a

3 program to make grants for the development of data

4 to support minor use pesticide registrations and re5 registrations. The amount of any such grant shall

not exceed 1 6 ⁄2 of the cost of the project for which the

7 grant is made.

8 ‘‘(B) APPLICANTS.—Any person who wants to

9 develop data to support minor use pesticide registra10 tions and reregistrations may apply for a grant

11 under subparagraph (A). Priority shall be given to

12 an applicant for such a grant who does not directly

13 receive funds from the sale of pesticides registered

14 for minor uses.

15 ‘‘(C) DATA OWNERSHIP.—Any data that is de16 veloped under a grant under subparagraph (A) shall

17 be jointly owned by the Department of Agriculture

18 and the person who received the grant. Such a per19 son shall enter into an agreement with the Secretary

20 under which such person shall share any fee paid to

21 such person under section 3(c)(1)(F).

22 ‘‘(2) MINOR USE PESTICIDE DATA REVOLVING

23 FUND.—

24 ‘‘(A) ESTABLISHMENT.—There is established in

25 the Treasury of the United States a revolving fund
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•HR 1627 EH

1 to be known as the Minor Use Pesticide Data Re2 volving Fund. The Fund shall be available without

3 fiscal year limitation to carry out the authorized

4 purposes of this subsection.

5 ‘‘(B) CONTENTS OF THE FUND.—There shall

6 be deposited in the Fund—

7 ‘‘(i) such amounts as may be appropriated

8 to support the purposes of this subsection; and

9 ‘‘(ii) fees collected by the Secretary for any

10 data developed under a grant under paragraph

11 (1)(A).

12 ‘‘(C) AUTHORIZATIONS OF APPROPRIATIONS.—

13 There are authorized to be appropriated for each fis14 cal year to carry out the purposes of this subsection

15 $10,000,000 to remain available until expended.’’.

16 Subtitle B—Antimicrobial Pesticide

17 Registration Reform

18 SEC. 221. DEFINITIONS.

19 Section 2 (7 U.S.C. 136), as amended by section

20 210(a) is further amended—

21 (1) in subsection (u), by adding at the end the

22 following: ‘‘The term ‘pesticide’ does not include liq23 uid chemical sterilant products (including any

24 sterilant or subordinate disinfectant claims on such

25 products) for use on a critical or semi-critical device,
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1 as defined in section 201 of the Federal Food, Drug,

2 and Cosmetic Act (21 U.S.C. 321). For purposes of

3 the preceding sentence, the term ‘critical device’ in4 cludes any device which is introduced directly into

5 the human body, either into or in contact with the

6 bloodstream or normally sterile areas of the body

7 and the term ‘semi-critical device’ includes any de8 vice which contacts intact mucous membranes but

9 which does not ordinarily penetrate the blood barrier

10 or otherwise enter normally sterile areas of the

11 body.’’; and

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

13 ‘‘(mm) ANTIMICROBIAL PESTICIDE.—

14 ‘‘(1) IN GENERAL.—The term ‘antimicrobial

15 pesticide’ means a pesticide that—

16 ‘‘(A) is intended to—

17 ‘‘(i) disinfect, sanitize, reduce, or miti18 gate growth or development of micro19 biological organisms; or

20 ‘‘(ii) protect inanimate objects, indus21 trial processes or systems, surfaces, water,

22 or other chemical substances from con23 tamination, fouling, or deterioration caused

24 by bacteria, viruses, fungi, protozoa, algae,

25 or slime; and
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•HR 1627 EH

1 ‘‘(B) in the intended use is exempt from,

2 or otherwise not subject to, a tolerance under

3 section 408 of the Federal Food, Drug, and

4 Cosmetic Act (21 U.S.C. 346a and 348) or a

5 food additive regulation under section 409 of

6 such Act.

7 ‘‘(2) EXCLUDED PRODUCTS.—The term

8 ‘antimicrobial pesticide’ does not include —

9 ‘‘(A) a wood preservative or antifouling

10 paint product for which a claim of pesticidal ac11 tivity other than or in addition to an activity

12 described in paragraph (1) is made;

13 ‘‘(B) an agricultural fungicide product; or

14 ‘‘(C) an aquatic herbicide product.

15 ‘‘(3) INCLUDED PRODUCTS.—The term

16 ‘antimicrobial pesticide’ does include any other

17 chemical sterilant product (other than liquid chemi18 cal sterilant products exempt under subsection (u)),

19 any other disinfectant product, any other industrial

20 microbiocide product, and any other preservative

21 product that is not excluded by paragraph (2).’’.

22 SEC. 222. FEDERAL AND STATE DATA COORDINATION.

23 Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as

24 amended by section 210(f)(2), is amended by adding at

25 the end the following:
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•HR 1627 EH

1 ‘‘(viii)(I) If data required to support reg2 istration of a pesticide under subparagraph (A)

3 is requested by a Federal or State regulatory

4 authority, the Administrator shall, to the extent

5 practicable, coordinate data requirements, test

6 protocols, timetables, and standards of review

7 and reduce burdens and redundancy caused to

8 the registrant by multiple requirements on the

9 registrant.

10 ‘‘(II) The Administrator may enter into a

11 cooperative agreement with a State to carry out

12 subclause (I).

13 ‘‘(III) Not later than 1 year after the date

14 of enactment of this clause, the Administrator

15 shall develop a process to identify and assist in

16 alleviating future disparities between Federal

17 and State data requirements.’’.

18 SEC. 223. LABEL AND LABELING.

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

20 at the end the following:

21 ‘‘(9) LABELING.—

22 ‘‘(A) ADDITIONAL STATEMENTS.—Subject

23 to subparagraphs (B) and (C), it shall not be

24 a violation of this Act for a registrant to modify

25 the labeling of an antimicrobial pesticide prod-
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1 uct to include relevant information on product

2 efficacy, product composition, container com3 position or design, or other characteristics that

4 do not relate to any pesticidal claim or pes5 ticidal activity.

6 ‘‘(B) REQUIREMENTS.—Proposed labeling

7 information under subparagraph (A) shall not

8 be false or misleading, shall not conflict with or

9 detract from any statement required by law or

10 the Administrator as a condition of registration,

11 and shall be substantiated on the request of the

12 Administrator.

13 ‘‘(C) NOTIFICATION AND DISAPPROVAL.—

14 ‘‘(i) NOTIFICATION.—A registration

15 may be modified under subparagraph (A)

16 if —

17 ‘‘(I) the registrant notifies the

18 Administrator in writing not later

19 than 60 days prior to distribution or

20 sale of a product bearing the modified

21 labeling; and

22 ‘‘(II) the Administrator does not

23 disapprove of the modification under

24 clause (ii).
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•HR 1627 EH

1 ‘‘(ii) DISAPPROVAL.—Not later than

2 30 days after receipt of a notification

3 under clause (i), the Administrator may

4 disapprove the modification by sending the

5 registrant notification in writing stating

6 that the proposed language is not accept7 able and stating the reasons why the Ad8 ministrator finds the proposed modification

9 unacceptable.

10 ‘‘(iii) RESTRICTION ON SALE.—A reg11 istrant may not sell or distribute a product

12 bearing a disapproved modification.

13 ‘‘(iv) OBJECTION.—A registrant may

14 file an objection in writing to a disapproval

15 under clause (ii) not later than 30 days

16 after receipt of notification of the dis17 approval.

18 ‘‘(v) FINAL ACTION.—A decision by

19 the Administrator following receipt and

20 consideration of an objection filed under

21 clause (iv) shall be considered a final agen22 cy action.

23 ‘‘(D) USE DILUTION.—The label or label24 ing required under this Act for an antimicrobial

25 pesticide that is or may be diluted for use may
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•HR 1627 EH

1 have a different statement of caution or protec2 tive measures for use of the recommended di3 luted solution of the pesticide than for use of a

4 concentrate of the pesticide if the Administrator

5 determines that —

6 ‘‘(i) adequate data have been submit7 ted to support the statement proposed for

8 the diluted solution uses; and

9 ‘‘(ii) the label or labeling provides

10 adequate protection for exposure to the di11 luted solution of the pesticide.’’.

12 SEC. 224. REGISTRATION REQUIREMENTS FOR

13 ANTIMICROBIAL PESTICIDES.

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

15 106(b), is further amended by adding at the end the fol16 lowing:

17 ‘‘(h) REGISTRATION REQUIREMENTS FOR

18 ANTIMICROBIAL PESTICIDES.—

19 ‘‘(1) EVALUATION OF PROCESS.—To the maxi20 mum extent practicable consistent with the degrees

21 of risk presented by a antimicrobial pesticide and

22 the type of review appropriate to evaluate the risks,

23 the Administrator shall identify and evaluate re24 forms to the antimicrobial registration process that

25 would reduce review periods existing as of the date
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1 of enactment of this subsection for antimicrobial

2 pesticide product registration applications and appli3 cations for amended registration of antimicrobial

4 pesticide products, including—

5 ‘‘(A) new antimicrobial active ingredients;

6 ‘‘(B) new antimicrobial end-use products;

7 ‘‘(C) substantially similar or identical

8 antimicrobial pesticides; and

9 ‘‘(D) amendments to antimicrobial pes10 ticide registrations.

11 ‘‘(2) REVIEW TIME PERIOD REDUCTION

12 GOAL.—Each reform identified under paragraph (1)

13 shall be designed to achieve the goal of reducing the

14 review period following submission of a complete ap15 plication, consistent with the degree of risk, to a pe16 riod of not more than —

17 ‘‘(A) 540 days for a new antimicrobial ac18 tive ingredient pesticide registration;

19 ‘‘(B) 270 days for a new antimicrobial use

20 of a registered active ingredient;

21 ‘‘(C) 120 days for any other new

22 antimicrobial product;

23 ‘‘(D) 90 days for a substantially similar or

24 identical antimicrobial product;
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•HR 1627 EH

1 ‘‘(E) 90 days for an amendment to an

2 antimicrobial registration that does not require

3 scientific review of data; and

4 ‘‘(F) 90 to 180 days for an amendment to

5 an antimicrobial registration that requires sci6 entific review of data and that is not otherwise

7 described in this paragraph.

8 ‘‘(3) IMPLEMENTATION.—

9 ‘‘(A) PROPOSED RULEMAKING.—

10 ‘‘(i) ISSUANCE.—Not later than 270

11 days after the date of enactment of this

12 subsection, the Administrator shall publish

13 in the Federal Register proposed regula14 tions to accelerate and improve the review

15 of antimicrobial pesticide products de16 signed to implement, to the extent prac17 ticable, the goals set forth in paragraph

18 (2).

19 ‘‘(ii) REQUIREMENTS.—Proposed reg20 ulations issued under clause (i) shall —

21 ‘‘(I) define the various classes of

22 antimicrobial use patterns, including

23 household, industrial, and institutional

24 disinfectants and sanitizing pesticides,

25 preservatives, water treatment, and
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1 pulp and paper mill additives, and

2 other such products intended to dis3 infect, sanitize, reduce, or mitigate

4 growth or development of micro5 biological organisms, or protect inani6 mate objects, industrial processes or

7 systems, surfaces, water, or other

8 chemical substances from contamina9 tion, fouling, or deterioration caused

10 by bacteria, viruses, fungi, protozoa,

11 algae, or slime;

12 ‘‘(II) differentiate the types of re13 view undertaken for antimicrobial pes14 ticides;

15 ‘‘(III) conform the degree and

16 type of review to the risks and bene17 fits presented by antimicrobial pes18 ticides and the function of review

19 under this Act, considering the use

20 patterns of the product, toxicity, ex21 pected exposure, and product type;

22 ‘‘(IV) ensure that the registration

23 process is sufficient to maintain

24 antimicrobial pesticide efficacy and

25 that antimicrobial pesticide products
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1 continue to meet product performance

2 standards and effectiveness levels for

3 each type of label claim made; and

4 ‘‘(V) implement effective and reli5 able deadlines for process manage6 ment.

7 ‘‘(iii) COMMENTS.—In developing the

8 proposed regulations, the Administrator

9 shall solicit the views from registrants and

10 other affected parties to maximize the ef11 fectiveness of the rule development process.

12 ‘‘(B) FINAL REGULATIONS.—

13 ‘‘(i) ISSUANCE.—The Administrator

14 shall issue final regulations not later than

15 240 days after the close of the comment

16 period for the proposed regulations.

17 ‘‘(ii) FAILURE TO MEET GOAL.—If a

18 goal described in paragraph (2) is not met

19 by the final regulations, the Administrator

20 shall identify the goal, explain why the goal

21 was not attained, describe the element of

22 the regulations included instead, and iden23 tify future steps to attain the goal.

24 ‘‘(iii) REQUIREMENTS.—In issuing

25 final regulations, the Administrator shall—
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1 ‘‘(I) consider the establishment of

2 a certification process for regulatory

3 actions involving risks that can be re4 sponsibly managed, consistent with

5 the degree of risk, in the most cost-ef6 ficient manner;

7 ‘‘(II) consider the establishment

8 of a certification process by approved

9 laboratories as an adjunct to the re10 view process;

11 ‘‘(III) use all appropriate and

12 cost-effective review mechanisms, in13 cluding—

14 ‘‘(aa) expanded use of notifi15 cation and non-notification proce16 dures;

17 ‘‘(bb) revised procedures for

18 application review; and

19 ‘‘(cc) allocation of appro20 priate resources to ensure

21 streamlined management of

22 antimicrobial pesticide registra23 tions; and
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1 ‘‘(IV) clarify criteria for deter2 mination of the completeness of an

3 application.

4 ‘‘(C) EXPEDITED REVIEW.—This sub5 section does not affect the requirements or ex6 tend the deadlines or review periods contained

7 in subsection (c)(3).

8 ‘‘(D) ALTERNATIVE REVIEW PERIODS.—If

9 the final regulations to carry out this paragraph

10 are not effective 630 days after the date of en11 actment of this subsection, until the final regu12 lations become effective, the review period, be13 ginning on the date of receipt by the Agency of

14 a complete application, shall be —

15 ‘‘(i) 2 years for a new antimicrobial

16 active ingredient pesticide registration;

17 ‘‘(ii) 1 year for a new antimicrobial

18 use of a registered active ingredient;

19 ‘‘(iii) 180 days for any other new

20 antimicrobial product;

21 ‘‘(iv) 90 days for a substantially simi22 lar or identical antimicrobial product;

23 ‘‘(v) 90 days for an amendment to an

24 antimicrobial registration that does not re25 quire scientific review of data; and
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1 ‘‘(vi) 240 days for an amendment to

2 an antimicrobial registration that requires

3 scientific review of data and that is not

4 otherwise described in this subparagraph.

5 ‘‘(E) WOOD PRESERVATIVES.—An applica6 tion for the registration, or for an amendment

7 to the registration, of a wood preservative prod8 uct for which a claim of pesticidal activity listed

9 in section 2(mm) is made (regardless of any

10 other pesticidal claim that is made with respect

11 to the product) shall be reviewed by the Admin12 istrator within the same period as that estab13 lished under this paragraph for an

14 antimicrobial pesticide product application, con15 sistent with the degree of risk posed by the use

16 of the wood preservative product, if the applica17 tion requires the applicant to satisfy the same

18 data requirements as are required to support an

19 application for a wood preservative product that

20 is an antimicrobial pesticide.

21 ‘‘(F) NOTIFICATION.—

22 ‘‘(i) IN GENERAL.—Subject to clause

23 (iii), the Administrator shall notify an ap24 plicant whether an application has been

25 granted or denied not later than the final
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1 day of the appropriate review period under

2 this paragraph, unless the applicant and

3 the Administrator agree to a later date.

4 ‘‘(ii) FINAL DECISION.—If the Admin5 istrator fails to notify an applicant within

6 the period of time required under clause

7 (i), the failure shall be considered an agen8 cy action unlawfully withheld or unreason9 ably delayed for purposes of judicial review

10 under chapter 7 of title 5, United States

11 Code.

12 ‘‘(iii) EXEMPTION.—This subpara13 graph does not apply to an application for

14 an antimicrobial pesticide that is filed

15 under subsection (c)(3)(B) prior to 90

16 days after the date of enactment of this

17 subsection.

18 ‘‘(4) ANNUAL REPORT.—

19 ‘‘(A) SUBMISSION.—Beginning on the date

20 of enactment of this subsection and ending on

21 the date that the goals under paragraph (2) are

22 achieved, the Administrator shall, not later than

23 March 1 of each year, prepare and submit an

24 annual report to the Committee on Agriculture

25 of the House of Representatives and the Com-
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1 mittee on Agriculture, Nutrition, and Forestry

2 of the Senate.

3 ‘‘(B) REQUIREMENTS.—A report submit4 ted under subparagraph (A) shall include a de5 scription of—

6 ‘‘(i) measures taken to reduce the

7 backlog of pending registration applica8 tions;

9 ‘‘(ii) progress toward achieving re10 forms under this subsection; and

11 ‘‘(iii) recommendations to improve the

12 activities of the Agency pertaining to

13 antimicrobial registrations.’’.

14 SEC. 225. DISPOSAL OF HOUSEHOLD, INDUSTRIAL, OR IN15 STITUTIONAL ANTIMICROBIAL PRODUCTS.

16 Section 19(h) (7 U.S.C. 136q(h)) is amended—

17 (1) by striking ‘‘Nothing in’’ and inserting the

18 following:

19 ‘‘(1) IN GENERAL.—Nothing in’’; and

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

21 ‘‘(2) ANTIMICROBIAL PRODUCTS.—A household,

22 industrial, or institutional antimicrobial product that

23 is not subject to regulation under the Solid Waste

24 Disposal Act (42 U.S.C. 6901 et seq.) shall not be

25 subject to the provisions of subsections (a), (e), and
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1 (f), unless the Administrator determines that such

2 product must be subject to such provisions to pre3 vent an unreasonable adverse effect on the environ4 ment.’’.

5 Subtitle C—Public Health

6 Pesticides

7 SEC. 230. DEFINITIONS.

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

9 136(bb)) is amended by adding at the end the following:

10 ‘‘The Administrator shall consider the risks and benefits

11 of public health pesticides separate from the risks and

12 benefits of other pesticides. In weighing any regulatory ac13 tion concerning a public health pesticide under this Act,

14 the Administrator shall weigh any risks of the pesticide

15 against the health risks such as the diseases transmitted

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

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

18 as amended by section 221, is amended by adding at the

19 end the following:

20 ‘‘(nn) PUBLIC HEALTH PESTICIDE.—The term ‘pub21 lic health pesticide’ means any minor use pesticide product

22 registered for use and used predominantly in public health

23 programs for vector control or for other recognized health

24 protection uses, including the prevention or mitigation of

25 viruses, bacteria, or other microorganisms (other than vi-
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1 ruses, bacteria, or other microorganisms on or in living

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

3 health.

4 ‘‘(oo) VECTOR.—The term ‘vector’ means any orga5 nism capable of transmitting the causative agent of human

6 disease or capable of producing human discomfort or in7 jury, including mosquitoes, flies, fleas, cockroaches, or

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

9 SEC. 231. REGISTRATION.

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

11 amended—

12 (1) by inserting after ‘‘pattern of use,’’ the fol13 lowing: ‘‘the public health and agricultural need for

14 such minor use,’’; and

15 (2) by striking ‘‘potential exposure of man and

16 the environment to the pesticide’’ and inserting ‘‘po17 tential beneficial or adverse effects on man and the

18 environment’’.

19 SEC. 232. REREGISTRATION.

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

21 (1) in subsection (i)(4), by redesignating sub22 paragraphs (B) and (C) as subparagraphs (C) and

23 (D), respectively, and by adding after subparagraph

24 (A) the following:
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1 ‘‘(B) The Administrator shall exempt any

2 public health pesticide from the payment of the

3 fee prescribed under paragraph (3) if, in con4 sultation with the Secretary of Health and

5 Human Services, the Administrator determines,

6 based on information supplied by the registrant,

7 that the economic return to the registrant from

8 sales of the pesticide does not support the reg9 istration or reregistration of the pesticide.’’;

10 (2) in subsection (i)(5), by redesignating sub11 paragraphs (F) and (G) as subparagraphs (G) and

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

13 (E) the following:

14 ‘‘(F) The Administrator shall exempt any

15 public health pesticide from the payment of the

16 fee prescribed under paragraph (3) if, in con17 sultation with the Secretary of Health and Hu18 mans Services, the Administrator determines,

19 based on information supplied by the registrant,

20 that the economic return to the registrant from

21 sales of the pesticide does not support the reg22 istration or reregistration of the pesticide.’’;

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

24 determine’’ and inserting ‘‘, to determine’’ and by

25 inserting before the period the following: ‘‘, or to de-
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1 termine the volume usage for public health pes2 ticides’’; and

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

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

5 end of clause (ii) and inserting thereof ‘‘; or’’, and

6 by adding after clause (ii) the following:

7 ‘‘(iii) proposes the initial or amended

8 registration of an end use pesticide that, if

9 registered as proposed, would be used for

10 a public health pesticide.’’.

11 SEC. 233. CANCELLATION.

12 Section 6(b) (7 U.S.C. 136d(b)) is amended by add13 ing after the eighth sentence the following: ‘‘When a public

14 health use is affected, the Secretary of Health and Human

15 Services should provide available benefits and use informa16 tion, or an analysis thereof, in accordance with the proce17 dures followed and subject to the same conditions as the

18 Secretary of Agriculture in the case of agricultural pes19 ticides.’’.

20 SEC. 234. VIEWS OF THE SECRETARY OF HEALTH AND

21 HUMAN SERVICES.

22 Section 21 (7 U.S.C. 136s) is amended by redesignat23 ing subsections (b) and (c) as subsections (c) and (d), re24 spectively, and by adding after subsection (a) the follow25 ing:
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1 ‘‘(b) SECRETARY OF HEALTH AND HUMAN SERV2 ICES.—The Administrator, before publishing regulations

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

4 the views of the Secretary of Health and Human Services

5 in the same manner as the views of the Secretary of Agri6 culture are solicited under section 25(a)(2).’’.

7 SEC. 235. AUTHORITY OF ADMINISTRATOR.

8 Section 25(a)(1) (7 U.S.C. 136w(a)(1)) is amend9 ed—

10 (1) by inserting after ‘‘various classes of pes11 ticides’’ the following: ‘‘, including public health pes12 ticides,’’; and

13 (2) by striking ‘‘and nonagricultural pesticides’’

14 and inserting ‘‘, nonagricultural, and public health

15 pesticides’’.

16 SEC. 236. IDENTIFICATION OF PESTS.

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

18 at the end the following:

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

20 in coordination with the Secretary of Agriculture and the

21 Secretary of Health and Human Services, shall identify

22 pests of significant public health importance and, in co23 ordination with the Public Health Service, develop and im24 plement programs to improve and facilitate the safe and

25 necessary use of chemical, biological, and other methods
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1 to combat and control such pests of public health impor2 tance.’’.

3 SEC. 237. PUBLIC HEALTH DATA.

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

5 at the end the following:

6 ‘‘(m) AUTHORIZATION OF FUNDS TO DEVELOP PUB7 LIC HEALTH DATA.—

8 ‘‘(1) DEFINITION.—For the purposes of this

9 section, ‘Secretary’ means the Secretary of Health

10 and Human Services, acting through the Public

11 Health Service.

12 ‘‘(2) CONSULTATION.—In the case of a pes13 ticide registered for use in public health programs

14 for vector control or for other uses the Adminis15 trator determines to be human health protection

16 uses, the Administrator shall, upon timely request by

17 the registrant or any other interested person, or on

18 the Administrator’s own initiative may, consult with

19 the Secretary prior to taking final action to suspend

20 registration under section 3(c)(2)(B)(iv), or cancel a

21 registration under section 4, 6(e), or 6(f). In con22 sultation with the Secretary, the Administrator shall

23 prescribe the form and content of requests under

24 this section.
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1 ‘‘(3) BENEFITS TO SUPPORT FAMILY.—The Ad2 ministrator, after consulting with the Secretary,

3 shall make a determination whether the potential

4 benefits of continued use of the pesticide for public

5 health or health protection purposes are of such sig6 nificance as to warrant a commitment by the Sec7 retary to conduct or to arrange for the conduct of

8 the studies required by the Administrator to support

9 continued registration under section 3 or reregistra10 tion under section 4.

11 ‘‘(4) ADDITIONAL TIME.—If the Administrator

12 determines that such a commitment is warranted

13 and in the public interest, the Administrator shall

14 notify the Secretary and shall, to the extent nec15 essary, amend a notice issued under section

16 3(c)(2)(B) to specify additional reasonable time peri17 ods for submission of the data.

18 ‘‘(5) ARRANGEMENTS.—The Secretary shall

19 make such arrangements for the conduct of required

20 studies as the Secretary finds necessary and appro21 priate to permit submission of data in accordance

22 with the time periods prescribed by the Adminis23 trator. Such arrangements may include Public

24 Health Service intramural research activities, grants,

25 contracts, or cooperative agreements with academic,
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1 public health, or other organizations qualified by ex2 perience and training to conduct such studies.

3 ‘‘(6) SUPPORT.—The Secretary may provide for

4 support of the required studies using funds author5 ized to be appropriated under this section, the Pub6 lic Health Service Act, or other appropriate authori7 ties. After a determination is made under subsection

8 (d), the Secretary shall notify the Committees on

9 Appropriations of the House Representatives and

10 the Senate of the sums required to conduct the nec11 essary studies.

12 ‘‘(7) AUTHORIZATION OF APPROPRIATIONS.—

13 There is authorized to be appropriated to carry out

14 the purposes of this section $12,000,000 for fiscal

15 year 1997, and such sums as may be necessary for

16 succeeding fiscal years.’’.

17 Subtitle D—Expedited Registration

18 of Reduced Risk Pesticides

19 SEC. 250. EXPEDITED REGISTRATION OF PESTICIDES .

20 Section 3(c) (7 U.S.C. 136a(c)), as amended by sec21 tion 223, is amended—

22 (1) by adding at the end of paragraph (1) the

23 following:

24 ‘‘(G) If the applicant is requesting that the

25 registration or amendment to the registration of
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1 a pesticide be expedited, an explanation of the

2 basis for the request must be submitted, in ac3 cordance with paragraph (10) of this sub4 section.’’; and

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

6 ‘‘(10) EXPEDITED REGISTRATION OF PES7 TICIDES.—

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

9 of enactment of this paragraph, the Adminis10 trator shall, utilizing public comment, develop

11 procedures and guidelines, and expedite the re12 view of an application for registration of a pes13 ticide or an amendment to a registration that

14 satisfies such guidelines.

15 ‘‘(B) Any application for registration or an

16 amendment, including biological and conven17 tional pesticides, will be considered for expe18 dited review under this paragraph. An applica19 tion for registration or an amendment shall

20 qualify for expedited review if use of the pes21 ticide proposed by the application may reason22 ably be expected to accomplish 1 or more of the

23 following:

24 ‘‘(i) Reduce the risks of pesticides to

25 human health.
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1 ‘‘(ii) Reduce the risks of pesticides to

2 nontarget organisms.

3 ‘‘(iii) Reduce the potential for con4 tamination of groundwater, surface water,

5 or other valued environmental resources.

6 ‘‘(iv) Broaden the adoption of inte7 grated pest management strategies, or

8 make such strategies more available or

9 more effective.

10 ‘‘(C) The Administrator, not later than 30

11 days after receipt of an application for expe12 dited review, shall notify the applicant whether

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

14 incomplete, the Administrator may either reject

15 the request for expedited review or ask the ap16 plicant for additional information to satisfy the

17 guidelines developed under subparagraph (A).’’.
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1 TITLE III—DATA COLLECTION

2 ACTIVITIES TO ASSURE THE

3 HEALTH OF INFANTS AND

4 CHILDREN AND OTHER MEAS5 URES

6 SEC. 301. DATA COLLECTION ACTIVITIES TO ASSURE THE

7 HEALTH OF INFANTS AND CHILDREN.

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

9 consultation with the Administrator of the Environmental

10 Protection Agency and the Secretary of Health and

11 Human Services, shall coordinate the development and im12 plementation of survey procedures to ensure that adequate

13 data on food consumption patterns of infants and children

14 are collected.

15 (b) PROCEDURES.—To the extent practicable, the

16 procedures referred to in subsection (a) shall include the

17 collection of data on food consumption patterns of a statis18 tically valid sample of infants and children.

19 (c) RESIDUE DATA COLLECTION.—The Secretary of

20 Agriculture shall ensure that the residue data collection

21 activities conducted by the Department of Agriculture in

22 cooperation with the Environmental Protection Agency

23 and the Department of Health and Human Services, pro24 vide for the improved data collection of pesticide residues,

25 including guidelines for the use of comparable analytical
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1 and standardized reporting methods, and the increased

2 sampling of foods most likely consumed by infants and

3 children.

4 SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION.

5 (a) IN GENERAL.—The Secretary of Agriculture shall

6 collect data of statewide or regional significance on the

7 use of pesticides to control pests and diseases of major

8 crops and crops of dietary significance, including fruits

9 and vegetables.

10 (b) COLLECTION.—The data shall be collected by sur11 veys of farmers or from other sources offering statistically

12 reliable data.

13 (c) COORDINATION.—The Secretary of Agriculture

14 shall, as appropriate, coordinate with the Administrator

15 of the Environmental Protection Agency in the design of

16 the surveys and make available to the Administrator the

17 aggregate results of the surveys to assist the Adminis18 trator.

19 SEC. 303. INTEGRATED PEST MANAGEMENT.

20 The Secretary of Agriculture, in cooperation with the

21 Administrator, shall implement research, demonstration,

22 and education programs to support adoption of Integrated

23 Pest Management. Integrated Pest Management is a sus24 tainable approach to managing pests by combining biologi25 cal, cultural, physical, and chemical tools in a way that
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1 minimizes economic, health, and environmental risks. The

2 Secretary of Agriculture and the Administrator shall make

3 information on Integrated Pest Management widely avail4 able to pesticide users, including Federal agencies. Federal

5 agencies shall use Integrated Pest Management techniques

6 in carrying out pest management activities and shall pro7 mote Integrated Pest Management through procurement

8 and regulatory policies, and other activities.

9 SEC. 304. COORDINATION OF CANCELLATION.

10 Section 2(bb) (7 U.S.C. 136(bb)) is amended—

11 (1) by inserting ‘‘(1)’’ after ‘‘means’’; and

12 (2) by striking the period at the end of the first

13 sentence and inserting ‘‘, or (2) a human dietary

14 risk from residues that result from a use of a pes15 ticide in or on any food inconsistent with the stand16 ard under section 408 of the Federal Food, Drug,

17 and Cosmetic Act (21 U.S.C. 346a).’’.

18 SEC. 305. PESTICIDE USE INFORMATION STUDY.

19 (a) The Secretary of Agriculture shall, in consultation

20 with the Administrator of the Environmental Protection

21 Agency, prepare a report to Congress evaluating the cur22 rent status and potential improvements in Federal pes23 ticide use information gathering activities. This report

24 shall at least include—
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1 (1) an analysis of the quality and reliability of

2 the information collected by the Department of Agri3 culture, the Environmental Protection Agency, and

4 other Federal agencies regarding the agricultural

5 use of pesticides; and

6 (2) an analysis of options to increase the effec7 tiveness of national pesticide use information collec8 tion, including an analysis of costs, burdens placed

9 on agricultural producers and other pesticide users,

10 and effectiveness in tracking risk reduction by those

11 options.

12 (b) The Secretary shall submit this report to Con13 gress not later than 1 year following the date of enactment

14 of this section.

15 TITLE IV—AMENDMENTS TO THE

16 FEDERAL FOOD, DRUG, AND

17 COSMETIC ACT

18 SEC 401. SHORT TITLE AND REFERENCE.

19 (a) SHORT TITLE.—This title may be cited as the

20 ‘‘Food Quality Protection Act of 1996 ’’.

21 (b) REFERENCE.—Whenever in this title an amend22 ment or repeal is expressed in terms of an amendment

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

24 shall be considered to be made to a section or other provi25 sion of the Federal Food, Drug, and Cosmetic Act.
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1 SEC. 402. DEFINITIONS.

2 (a) SECTION 201(q).—Section 201(q) (21 U.S.C.

3 321(q)) is amended to read as follows:

4 ‘‘(q)(1) The term ‘pesticide chemical’ means any sub5 stance that is a pesticide within the meaning of the Fed6 eral Insecticide, Fungicide, and Rodenticide Act, including

7 all active and inert ingredients of such pesticide.

8 ‘‘(2) The term ‘pesticide chemical residue’ means a

9 residue in or on raw agricultural commodity or processed

10 food of—

11 ‘‘(A) a pesticide chemical; or

12 ‘‘(B) any other added substance that is present

13 on or in the commodity or food primarily as a result

14 of the metabolism or other degradation of a pesticide

15 chemical.

16 ‘‘(3) Notwithstanding paragraphs (1) and (2), the

17 Administrator may by regulation except a substance from

18 the definition of ‘pesticide chemical’ or ‘pesticide chemical

19 residue’ if—

20 ‘‘(A) its occurrence as a residue on or in a raw

21 agricultural commodity or processed food is attrib22 utable primarily to natural causes or to human ac23 tivities not involving the use of any substances for

24 a pesticidal purpose in the production, storage, proc25 essing, or transportation of any raw agricultural

26 commodity or processed food; and
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1 ‘‘(B) the Administrator, after consultation with

2 the Secretary, determines that the substance more

3 appropriately should be regulated under one or more

4 provisions of this Act other than sections

5 402(a)(2)(B) and 408.’’.

6 (b) SECTION 201(s).—Paragraphs (1) and (2) of sec7 tion 201(s) (21 U.S.C. 321(s)) are amended to read as

8 follows:

9 ‘‘(1) a pesticide chemical residue in or on a raw

10 agricultural commodity or processed food; or

11 ‘‘(2) a pesticide chemical; or’’.

12 (c) SECTION 201.—Section 201 (21 U.S.C. 321) is

13 amended by adding at the end the following:

14 ‘‘(gg) The term ‘processed food’ means any food

15 other than a raw agricultural commodity and includes any

16 raw agricultural commodity that has been subject to proc17 essing, such as canning, cooking, freezing, dehydration, or

18 milling.

19 ‘‘(hh) The term ‘Administrator’ means the Adminis20 trator of the United States Environmental Protection

21 Agency.’’.

22 SEC. 403. PROHIBITED ACTS.

23 Section 301(j) (21 U.S.C. 331(j)) is amended in the

24 first sentence by inserting before the period the following:
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1 ‘‘; or the violating of section 408(i)(2) or any regulation

2 issued under that section.’’.

3 SEC. 404. ADULTERATED FOOD.

4 Section 402(a) (21 U.S.C. 342(a)) is amended by

5 striking ‘‘(2)(A) if it bears’’ and all that follows through

6 ‘‘(3) if it consists’’ and inserting the following: ‘‘(2)(A)

7 if it bears or contains any added poisonous or added dele8 terious substance (other than a substance that is a pes9 ticide chemical residue in or on a raw agricultural com10 modity or processed food, a food additive, a color additive,

11 or a new animal drug) that is unsafe within the meaning

12 of section 406; or (B) if it bears or contains a pesticide

13 chemical residue that is unsafe within the meaning of sec14 tion 408(a); or (C) if it is or if it bears or contains (i)

15 any food additive that is unsafe within the meaning of sec16 tion 409; or (ii) a new animal drug (or conversion product

17 thereof) that is unsafe within the meaning of section 512;

18 or (3) if it consists’’.

19 SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE

20 CHEMICAL RESIDUES.

21 Section 408 (21 U.S.C. 346a) is amended to read as

22 follows:

23 ‘‘TOLERANCES AND EXEMPTIONS FOR PESTICIDE

24 CHEMICAL RESIDUES

25 ‘‘SEC. 408. (a) REQUIREMENT FOR TOLERANCE OR

26 EXEMPTION.—
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1 ‘‘(1) GENERAL RULE.—Except as provided in

2 paragraph (2) or (3), any pesticide chemical residue

3 in or on a food shall be deemed unsafe for the pur4 pose of section 402(a)(2)(B) unless—

5 ‘‘(A) a tolerance for such pesticide chemi6 cal residue in or on such food is in effect under

7 this section and the quantity of the residue is

8 within the limits of the tolerance; or

9 ‘‘(B) an exemption from the requirement

10 of a tolerance is in effect under this section for

11 the pesticide chemical residue.

12 For the purposes of this section, the term ‘food’,

13 when used as a noun without modification, shall

14 mean a raw agricultural commodity or processed

15 food.

16 ‘‘(2) PROCESSED FOOD.—Notwithstanding

17 paragraph (1)—

18 ‘‘(A) if a tolerance is in effect under this

19 section for a pesticide chemical residue in or on

20 a raw agricultural commodity, a pesticide chem21 ical residue that is present in or on a processed

22 food because the food is made from that raw

23 agricultural commodity shall not be considered

24 unsafe within the meaning of section

25 402(a)(2)(B) despite the lack of a tolerance for
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1 the pesticide chemical residue in or on the proc2 essed food if the pesticide chemical has been

3 used in or on the raw agricultural commodity in

4 conformity with a tolerance under this section,

5 such residue in or on the raw agricultural com6 modity has been removed to the extent possible

7 in good manufacturing practice, and the con8 centration of the pesticide chemical residue in

9 the processed food is not greater than the toler10 ance prescribed for the pesticide chemical resi11 due in the raw agricultural commodity; or

12 ‘‘(B) if an exemption for the requirement

13 for a tolerance is in effect under this section for

14 a pesticide chemical residue in or on a raw agri15 cultural commodity, a pesticide chemical residue

16 that is present in or on a processed food be17 cause the food is made from that raw agricul18 tural commodity shall not be considered unsafe

19 within the meaning of section 402(a)(2)(B).

20 ‘‘(3) RESIDUES OF DEGRADATION PRODUCTS.—

21 If a pesticide chemical residue is present in or on a

22 food because it is a metabolite or other degradation

23 product of a precursor substance that itself is a pes24 ticide chemical or pesticide chemical residue, such a

25 residue shall not be considered to be unsafe within
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1 the meaning of section 402(a)(2)(B) despite the lack

2 of a tolerance or exemption from the need for a tol3 erance for such residue in or on such food if—

4 ‘‘(A) the Administrator has not determined

5 that the degradation product is likely to pose

6 any potential health risk from dietary exposure

7 that is of a different type than, or of a greater

8 significance than, any risk posed by dietary ex9 posure to the precursor substance;

10 ‘‘(B) either—

11 ‘‘(i) a tolerance is in effect under this

12 section for residues of the precursor sub13 stance in or on the food, and the combined

14 level of residues of the degradation product

15 and the precursor substance in or on the

16 food is at or below the stoichiometrically

17 equivalent level that would be permitted by

18 the tolerance if the residue consisted only

19 of the precursor substance rather than the

20 degradation product; or

21 ‘‘(ii) an exemption from the need for

22 a tolerance is in effect under this section

23 for residues of the precursor substance in

24 or on the food; and
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1 ‘‘(C) the tolerance or exemption for resi2 dues of the precursor substance does not state

3 that it applies only to particular named sub4 stances and does not state that it does not

5 apply to residues of the degradation product.

6 ‘‘(4) EFFECT OF TOLERANCE OR EXEMP7 TION.—While a tolerance or exemption from the re8 quirement for a tolerance is in effect under this sec9 tion for a pesticide chemical residue with respect to

10 any food, the food shall not by reason of bearing or

11 containing any amount of such a residue be consid12 ered to be adulterated within the meaning of section

13 402(a)(1).

14 ‘‘(b) AUTHORITY AND STANDARD FOR TOLER15 ANCE.—

16 ‘‘(1) AUTHORITY.—The Administrator may

17 issue regulations establishing, modifying, or revoking

18 a tolerance for a pesticide chemical residue in or on

19 a food—

20 ‘‘(A) in response to a petition filed under

21 subsection (d); or

22 ‘‘(B) on the Administrator’s own initiative

23 under subsection (e).
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1 As used in this section, the term ‘modify’ shall not

2 mean expanding the tolerance to cover additional

3 foods.

4 ‘‘(2) STANDARD.—

5 ‘‘(A) GENERAL RULE.—

6 ‘‘(i) STANDARD.—The Administrator

7 may establish or leave in effect a tolerance

8 for a pesticide chemical residue in or on a

9 food only if the Administrator determines

10 that the tolerance is safe. The Adminis11 trator shall modify or revoke a tolerance if

12 the Administrator determines it is not safe.

13 ‘‘(ii) DETERMINATION OF SAFETY.—

14 As used in this section, the term ‘safe’,

15 with respect to a tolerance for a pesticide

16 chemical residue’, means that the Adminis17 trator has determined that there is a rea18 sonable certainty that no harm will result

19 from aggregate exposure to the pesticide

20 chemical residue, including all anticipated

21 dietary exposures and all other exposures

22 for which there is reliable information.

23 ‘‘(iii) RULE OF CONSTRUCTION.—

24 With respect to a tolerance, a pesticide

25 chemical residue meeting the standard
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1 under clause (i) is not an eligible pesticide

2 chemical residue for purposes of subpara3 graph (B).

4 ‘‘(B) TOLERANCES FOR ELIGIBLE PES5 TICIDE CHEMICAL RESIDUES.—

6 ‘‘(i) DEFINITION.—As used in this

7 subparagraph, the term ‘eligible pesticide

8 chemical residue’ means a pesticide chemi9 cal residue as to which—

10 ‘‘(I) the Administrator is not able

11 to identify a level of exposure to the

12 residue at which the residue will not

13 cause or contribute to a known or an14 ticipated harm to human health (re15 ferred to in this section as a ‘non16 threshold effect’);

17 ‘‘(II) the lifetime risk of experi18 encing the nonthreshold effect is ap19 propriately assessed by quantitative

20 risk assessment; and

21 ‘‘(III) with regard to any known

22 or anticipated harm to human health

23 for which the Administrator is able to

24 identify a level at which the residue

25 will not cause such harm (referred to
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1 in this section as a ‘threshold effect’),

2 the Administrator determines that the

3 level of aggregate exposure is safe.

4 ‘‘(ii) DETERMINATION OF TOLER5 ANCE.—Notwithstanding subparagraph

6 (A)(i), a tolerance for an eligible pesticide

7 chemical residue may be left in effect or

8 modified under this subparagraph if—

9 ‘‘(I) at least one of the conditions

10 described in clause (iii) is met; and

11 ‘‘(II) both of the conditions de12 scribed in clause (iv) are met.

13 ‘‘(iii) CONDITIONS REGARDING USE.—

14 For purposes of clause (ii), the conditions

15 described in this clause with respect to a

16 tolerance for an eligible pesticide chemical

17 residue are the following:

18 ‘‘(I) Use of the pesticide chemical

19 that produces the residue protects

20 consumers from adverse effects on

21 health that would pose a greater risk

22 than the dietary risk from the residue.

23 ‘‘(II) Use of the pesticide chemi24 cal that produces the residue is nec25 essary to avoid a significant disrup-
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1 tion in domestic production of an ade2 quate, wholesome, and economical

3 food supply.

4 ‘‘(iv) CONDITIONS REGARDING

5 RISK.—For purposes of clause (ii), the

6 conditions described in this clause with re7 spect to a tolerance for an eligible pesticide

8 chemical residue are the following:

9 ‘‘(I) The yearly risk associated

10 with the nonthreshold effect from ag11 gregate exposure to the residue does

12 not exceed 10 times the yearly risk

13 that would be allowed under subpara14 graph (A) for such effect.

15 ‘‘(II) The tolerance is limited so

16 as to ensure that the risk over a life17 time associated with the nonthreshold

18 effect from aggregate exposure to the

19 residue is not greater than twice the

20 lifetime risk that would be allowed

21 under subparagraph (A) for such ef22 fect.

23 ‘‘(v) REVIEW.—Five years after the

24 date on which the Administrator makes a

25 determination to leave in effect or modify
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1 a tolerance under this subparagraph, and

2 thereafter as the Administrator deems ap3 propriate, the Administrator shall deter4 mine, after notice and opportunity for com5 ment, whether it has been demonstrated to

6 the Administrator that a condition de7 scribed in clause (iii)(I) or clause (iii)(II)

8 continues to exist with respect to the toler9 ance and that the yearly and lifetime risks

10 from aggregate exposure to such residue

11 continue to comply with the limits specified

12 in clause (iv). If the Administrator deter13 mines by such date that such demonstra14 tion has not been made, the Administrator

15 shall, not later than 180 days after the

16 date of such determination, issue a regula17 tion under subsection (e)(1) to modify or

18 revoke the tolerance.

19 ‘‘(vi) INFANTS AND CHILDREN.—Any

20 tolerance under this subparagraph shall

21 meet the requirements of subparagraph

22 (C).

23 ‘‘(C) EXPOSURE OF INFANTS AND CHIL24 DREN.—In establishing, modifying, leaving in

25 effect, or revoking a tolerance or exemption for
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1 a pesticide chemical residue, the Adminis2 trator—

3 ‘‘(i) shall assess the risk of the pes4 ticide chemical residue based on—

5 ‘‘(I) available information about

6 consumption patterns among infants

7 and children that are likely to result

8 in disproportionately high consump9 tion of foods containing or bearing

10 such residue among infants and chil11 dren in comparison to the general

12 population;

13 ‘‘(II) available information con14 cerning the special susceptibility of in15 fants and children to the pesticide

16 chemical residues, including neuro17 logical differences between infants and

18 children and adults, and effects of in

19 utero exposure to pesticide chemicals;

20 and

21 ‘‘(III) available information con22 cerning the cumulative effects on in23 fants and children of such residues

24 and other substances that have a com25 mon mechanism of toxicity; and
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1 ‘‘(ii) shall—

2 ‘‘(I) ensure that there is a rea3 sonable certainty that no harm will re4 sult to infants and children from ag5 gregate exposure to the pesticide

6 chemical residue; and

7 ‘‘(II) publish a specific deter8 mination regarding the safety of the

9 pesticide chemical residue for infants

10 and children.

11 The Secretary of Health and Human Services

12 and the Secretary of Agriculture, in consulta13 tion with the Administrator, shall conduct sur14 veys to document dietary exposure to pesticides

15 among infants and children. In the case of

16 threshold effects, for purposes of clause (ii)(I)

17 an additional tenfold margin of safety for the

18 pesticide chemical residue and other sources of

19 exposure shall be applied for infants and chil20 dren to take into account potential pre- and

21 post-natal toxicity and completeness of the data

22 with respect to exposure and toxicity to infants

23 and children. Notwithstanding such require24 ment for an additional margin of safety, the

25 Administrator may use a different margin of
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1 safety for the pesticide chemical residue only if,

2 on the basis of reliable data, such margin will

3 be safe for infants and children.

4 ‘‘(D) FACTORS.—In establishing, modify5 ing, leaving in effect, or revoking a tolerance or

6 exemption for a pesticide chemical residue, the

7 Administrator shall consider, among other rel8 evant factors—

9 ‘‘(i) the validity, completeness, and re10 liability of the available data from studies

11 of the pesticide chemical and pesticide

12 chemical residue;

13 ‘‘(ii) the nature of any toxic effect

14 shown to be caused by the pesticide chemi15 cal or pesticide chemical residue in such

16 studies;

17 ‘‘(iii) available information concerning

18 the relationship of the results of such stud19 ies to human risk;

20 ‘‘(iv) available information concerning

21 the dietary consumption patterns of con22 sumers (and major identifiable subgroups

23 of consumers);

24 ‘‘(v) available information concerning

25 the cumulative effects of such residues and
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1 other substances that have a common

2 mechanism of toxicity;

3 ‘‘(vi) available information concerning

4 the aggregate exposure levels of consumers

5 (and major identifiable subgroups of con6 sumers) to the pesticide chemical residue

7 and to other related substances, including

8 dietary exposure under the tolerance and

9 all other tolerances in effect for the pes10 ticide chemical residue, and exposure from

11 other non-occupational sources;

12 ‘‘(vii) available information concerning

13 the variability of the sensitivities of major

14 identifiable subgroups of consumers;

15 ‘‘(viii) such information as the Admin16 istrator may require on whether the pes17 ticide chemical may have an effect in hu18 mans that is similar to an effect produced

19 by a naturally occurring estrogen or other

20 endocrine effects; and

21 ‘‘(ix) safety factors which in the opin22 ion of experts qualified by scientific train23 ing and experience to evaluate the safety of

24 food additives are generally recognized as
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1 appropriate for the use of animal experi2 mentation data.

3 ‘‘(E) DATA AND INFORMATION REGARDING

4 ANTICIPATED AND ACTUAL RESIDUE LEVELS.—

5 ‘‘(i) AUTHORITY.—In establishing, modify6 ing, leaving in effect, or revoking a tolerance for

7 a pesticide chemical residue, the Administrator

8 may consider available data and information on

9 the anticipated residue levels of the pesticide

10 chemical in or on food and the actual residue

11 levels of the pesticide chemical that have been

12 measured in food, including residue data col13 lected by the Food and Drug Administration.

14 ‘‘(ii) REQUIREMENT.—If the Administrator

15 relies on anticipated or actual residue levels in

16 establishing, modifying, or leaving in effect a

17 tolerance, the Administrator shall pursuant to

18 subsection (f)(1) require that data be provided

19 five years after the date on which the tolerance

20 is established, modified, or left in effect, and

21 thereafter as the Administrator deems appro22 priate, demonstrating that such residue levels

23 are not above the levels so relied on. If such

24 data are not so provided, or if the data do not

25 demonstrate that the residue levels are not
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1 above the levels so relied on, the Administrator

2 shall, not later than 180 days after the date on

3 which the data were required to be provided,

4 issue a regulation under subsection (e)(1), or

5 an order under subsection (f)(2), as appro6 priate, to modify or revoke the tolerance.

7 ‘‘(F) PERCENT OF FOOD ACTUALLY

8 TREATED.—In establishing, modifying, leaving

9 in effect, or revoking a tolerance for a pesticide

10 chemical residue, the Administrator may, when

11 assessing chronic dietary risk, consider available

12 data and information on the percent of food ac13 tually treated with the pesticide chemical (in14 cluding aggregate pesticide use data collected

15 by the Department of Agriculture) only if the

16 Administrator—

17 ‘‘(i) finds that the data are reliable

18 and provide a valid basis to show what per19 centage of the food derived from such crop

20 is likely to contain such pesticide chemical

21 residue;

22 ‘‘(ii) finds that the exposure estimate

23 does not understate exposure for any sig24 nificant subpopulation group;
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1 ‘‘(iii) finds that, if data are available

2 on pesticide use and consumption of food

3 in a particular area, the population in such

4 area is not dietarily exposed to residues

5 above those estimated by the Adminis6 trator; and

7 ‘‘(iv) provides for the periodic reevalu8 ation of the estimate of anticipated dietary

9 exposure.

10 ‘‘(3) DETECTION METHODS.—

11 ‘‘(A) GENERAL RULE.—A tolerance for a

12 pesticide chemical residue in or on a food shall

13 not be established or modified by the Adminis14 trator unless the Administrator determines,

15 after consultation with the Secretary, that there

16 is a practical method for detecting and measur17 ing the levels of the pesticide chemical residue

18 in or on the food.

19 ‘‘(B) DETECTION LIMIT.—A tolerance for

20 a pesticide chemical residue in or on a food

21 shall not be established at or modified to a level

22 lower than the limit of detection of the method

23 for detecting and measuring the pesticide chem24 ical residue specified by the Administrator

25 under subparagraph (A).
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1 ‘‘(4) INTERNATIONAL STANDARDS.—In estab2 lishing a tolerance for a pesticide chemical residue in

3 or on a food, the Administrator shall determine

4 whether a maximum residue level for the pesticide

5 chemical has been established by the Codex

6 Alimentarius Commission. If a Codex maximum resi7 due level has been established for the pesticide

8 chemical and the Administrator does not propose to

9 adopt the Codex level, the Administrator shall pub10 lish for public comment a notice explaining the rea11 sons for departing from the Codex level.

12 ‘‘(c) AUTHORITY AND STANDARD FOR EXEMP13 TIONS.—

14 ‘‘(1) AUTHORITY.—The Administrator may

15 issue a regulation establishing, modifying, or revok16 ing an exemption from the requirement for a toler17 ance for a pesticide chemical residue in or on food—

18 ‘‘(A) in response to a petition filed under

19 subsection (d); or

20 ‘‘(B) on the Administrator’s initiative

21 under subsection (e).

22 ‘‘(2) STANDARD.—

23 ‘‘(A) GENERAL RULE.—

24 ‘‘(i) STANDARD.—The Administrator

25 may establish or leave in effect an exemp-
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1 tion from the requirement for a tolerance

2 for a pesticide chemical residue in or on

3 food only if the Administrator determines

4 that the exemption is safe. The Adminis5 trator shall modify or revoke an exemption

6 if the Administrator determines it is not

7 safe.

8 ‘‘(ii) DETERMINATION OF SAFETY.—

9 The term ‘safe’, with respect to an exemp10 tion for a pesticide chemical residue,

11 means that the Administrator has deter12 mined that there is a reasonable certainty

13 that no harm will result from aggregate ex14 posure to the pesticide chemical residue,

15 including all anticipated dietary exposures

16 and all other exposures for which there is

17 reliable information.

18 ‘‘(B) FACTORS.—In making a determina19 tion under this paragraph, the Administrator

20 shall take into account, among other relevant

21 considerations, the considerations set forth in

22 subparagraphs (C) and (D) of subsection

23 (b)(2).

24 ‘‘(3) LIMITATION.—An exemption from the re25 quirement for a tolerance for a pesticide chemical
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1 residue in or on food shall not be established or

2 modified by the Administrator unless the Adminis3 trator determines, after consultation with the Sec4 retary—

5 ‘‘(A) that there is a practical method for

6 detecting and measuring the levels of such pes7 ticide chemical residue in or on food; or

8 ‘‘(B) that there is no need for such a

9 method, and states the reasons for such deter10 mination in issuing the regulation establishing

11 or modifying the exemption.

12 ‘‘(d) PETITION FOR TOLERANCE OR EXEMPTION.—

13 ‘‘(1) PETITIONS AND PETITIONERS.—Any per14 son may file with the Administrator a petition pro15 posing the issuance of a regulation—

16 ‘‘(A) establishing, modifying, or revoking a

17 tolerance for a pesticide chemical residue in or

18 on a food; or

19 ‘‘(B) establishing, modifying, or revoking

20 an exemption from the requirement of a toler21 ance for such a residue.

22 ‘‘(2) PETITION CONTENTS.—

23 ‘‘(A) ESTABLISHMENT.—A petition under

24 paragraph (1) to establish a tolerance or ex25 emption for a pesticide chemical residue shall
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1 be supported by such data and information as

2 are specified in regulations issued by the Ad3 ministrator, including—

4 ‘‘(i)(I) an informative summary of the

5 petition and of the data, information, and

6 arguments submitted or cited in support of

7 the petition; and

8 ‘‘(II) a statement that the petitioner

9 agrees that such summary or any informa10 tion it contains may be published as a part

11 of the notice of filing of the petition to be

12 published under this subsection and as

13 part of a proposed or final regulation is14 sued under this section;

15 ‘‘(ii) the name, chemical identity, and

16 composition of the pesticide chemical resi17 due and of the pesticide chemical that pro18 duces the residue;

19 ‘‘(iii) data showing the recommended

20 amount, frequency, method, and time of

21 application of that pesticide chemical;

22 ‘‘(iv) full reports of tests and inves23 tigations made with respect to the safety of

24 the pesticide chemical, including full infor25 mation as to the methods and controls
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1 used in conducting those tests and inves2 tigations;

3 ‘‘(v) full reports of tests and inves4 tigations made with respect to the nature

5 and amount of the pesticide chemical resi6 due that is likely to remain in or on the

7 food, including a description of the analyt8 ical methods used;

9 ‘‘(vi) a practical method for detecting

10 and measuring the levels of the pesticide

11 chemical residue in or on the food, or for

12 exemptions, a statement why such a meth13 od is not needed;

14 ‘‘(vii) a proposed tolerance for the

15 pesticide chemical residue, if a tolerance is

16 proposed;

17 ‘‘(viii) if the petition relates to a toler18 ance for a processed food, reports of inves19 tigations conducted using the processing

20 method(s) used to produce that food;

21 ‘‘(ix) such information as the Admin22 istrator may require to make the deter23 mination under subsection (b)(2)(C);

24 ‘‘(x) such information as the Adminis25 trator may require on whether the pes-
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1 ticide chemical may have an effect in hu2 mans that is similar to an effect produced

3 by a naturally occurring estrogen or other

4 endocrine effects;

5 ‘‘(xi) information regarding exposure

6 to the pesticide chemical residue due to

7 any tolerance or exemption already granted

8 for such residue;

9 ‘‘(xii) practical methods for removing

10 any amount of the residue that would ex11 ceed any proposed tolerance; and

12 ‘‘(xiii) such other data and informa13 tion as the Administrator requires by regu14 lation to support the petition.

15 If information or data required by this subpara16 graph is available to the Administrator, the per17 son submitting the petition may cite the avail18 ability of the information or data in lieu of sub19 mitting it. The Administrator may require a pe20 tition to be accompanied by samples of the pes21 ticide chemical with respect to which the peti22 tion is filed.

23 ‘‘(B) MODIFICATION OR REVOCATION.—

24 The Administrator may by regulation establish

25 the requirements for information and data to
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1 support a petition to modify or revoke a toler2 ance or to modify or revoke an exemption from

3 the requirement for a tolerance.

4 ‘‘(3) NOTICE.—A notice of the filing of a peti5 tion that the Administrator determines has met the

6 requirements of paragraph (2) shall be published by

7 the Administrator within 30 days after such deter8 mination. The notice shall announce the availability

9 of a description of the analytical methods available

10 to the Administrator for the detection and measure11 ment of the pesticide chemical residue with respect

12 to which the petition is filed or shall set forth the

13 petitioner’s statement of why such a method is not

14 needed. The notice shall include the summary re15 quired by paragraph (2)(A)(i)(I).

16 ‘‘(4) ACTIONS BY THE ADMINISTRATOR.—

17 ‘‘(A) IN GENERAL.—The Administrator

18 shall, after giving due consideration to a peti19 tion filed under paragraph (1) and any other

20 information available to the Administrator—

21 ‘‘(i) issue a final regulation (which

22 may vary from that sought by the petition)

23 establishing, modifying, or revoking a tol24 erance for the pesticide chemical residue or

25 an exemption of the pesticide chemical res-
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1 idue from the requirement of a tolerance

2 (which final regulation shall be issued

3 without further notice and without further

4 period for public comment);

5 ‘‘(ii) issue a proposed regulation

6 under subsection (e), and thereafter issue

7 a final regulation under such subsection; or

8 ‘‘(iii) issue an order denying the peti9 tion.

10 ‘‘(B) PRIORITIES.—The Administrator

11 shall give priority to petitions for the establish12 ment or modification of a tolerance or exemp13 tion for a pesticide chemical residue that ap14 pears to pose a significantly lower risk to

15 human health from dietary exposure than pes16 ticide chemical residues that have tolerances in

17 effect for the same or similar uses.

18 ‘‘(C) EXPEDITED REVIEW OF CERTAIN PE19 TITIONS.—

20 ‘‘(i) DATE CERTAIN FOR REVIEW.—If

21 a person files a complete petition with the

22 Administrator proposing the issuance of a

23 regulation establishing a tolerance or ex24 emption for a pesticide chemical residue

25 that presents a lower risk to human health
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1 than a pesticide chemical residue for which

2 a tolerance has been left in effect or modi3 fied under subsection (b)(2)(B), the Ad4 ministrator shall complete action on such

5 petition under this paragraph within 1

6 year.

7 ‘‘(ii) REQUIRED DETERMINATIONS.—

8 If the Administrator issues a final regula9 tion establishing a tolerance or exemption

10 for a safer pesticide chemical residue under

11 clause (i), the Administrator shall, not

12 later than 180 days after the date on

13 which the regulation is issued, determine

14 whether a condition described in subclause

15 (I) or (II) of subsection (b)(2)(B)(iii) con16 tinues to exist with respect to a tolerance

17 that has been left in effect or modified

18 under subsection (b)(2)(B). If such condi19 tion does not continue to exist, the Admin20 istrator shall, not later than 180 days after

21 the date on which the determination under

22 the preceding sentence is made, issue a

23 regulation under subsection (e)(1) to mod24 ify or revoke the tolerance.
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1 ‘‘(e) ACTION ON ADMINISTRATOR’S OWN INITIA2 TIVE.—

3 ‘‘(1) GENERAL RULE.—The Administrator may

4 issue a regulation—

5 ‘‘(A) establishing, modifying, suspending

6 under subsection (l)(3), or revoking a tolerance

7 for a pesticide chemical or a pesticide chemical

8 residue;

9 ‘‘(B) establishing, modifying, suspending

10 under subsection (l)(3), or revoking an exemp11 tion of a pesticide chemical residue from the re12 quirement of a tolerance; or

13 ‘‘(C) establishing general procedures and

14 requirements to implement this section.

15 ‘‘(2) NOTICE.—Before issuing a final regulation

16 under paragraph (1), the Administrator shall issue

17 a notice of proposed rulemaking and provide a pe18 riod of not less than 60 days for public comment on

19 the proposed regulation, except that a shorter period

20 for comment may be provided if the Administrator

21 for good cause finds that it would be in the public

22 interest to do so and states the reasons for the find23 ing in the notice of proposed rulemaking.

24 ‘‘(f) SPECIAL DATA REQUIREMENTS.—
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1 ‘‘(1) REQUIRING SUBMISSION OF ADDITIONAL

2 DATA.—If the Administrator determines that addi3 tional data or information are reasonably required to

4 support the continuation of a tolerance or exemption

5 that is in effect under this section for a pesticide

6 chemical residue on a food, the Administrator

7 shall—

8 ‘‘(A) issue a notice requiring the person

9 holding the pesticide registrations associated

10 with such tolerance or exemption to submit the

11 data or information under section 3(c)(2)(B) of

12 the Federal Insecticide, Fungicide, and

13 Rodenticide Act;

14 ‘‘(B) issue a rule requiring that testing be

15 conducted on a substance or mixture under sec16 tion 4 of the Toxic Substances Control Act; or

17 ‘‘(C) publish in the Federal Register, after

18 first providing notice and an opportunity for

19 comment of not less than 60 days’ duration, an

20 order—

21 ‘‘(i) requiring the submission to the

22 Administrator by one or more interested

23 persons of a notice identifying the person

24 or persons who will submit the required

25 data and information;
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1 ‘‘(ii) describing the type of data and

2 information required to be submitted to

3 the Administrator and stating why the

4 data and information could not be obtained

5 under the authority of section 3(c)(2)(B)

6 of the Federal Insecticide, Fungicide, and

7 Rodenticide Act or section 4 of the Toxic

8 Substances Control Act;

9 ‘‘(iii) describing the reports of the Ad10 ministrator required to be prepared during

11 and after the collection of the data and in12 formation;

13 ‘‘(iv) requiring the submission to the

14 Administrator of the data, information,

15 and reports referred to in clauses (ii) and

16 (iii); and

17 ‘‘(v) establishing dates by which the

18 submissions described in clauses (i) and

19 (iv) must be made.

20 The Administrator may under subparagraph

21 (C) revise any such order to correct an error.

22 The Administrator may under this paragraph

23 require data or information pertaining to

24 whether the pesticide chemical may have an ef25 fect in humans that is similar to an effect pro-
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1 duced by a naturally occurring estrogen or

2 other endocrine effects.

3 ‘‘(2) NONCOMPLIANCE.—If a submission re4 quired by a notice issued in accordance with para5 graph (1)(A), a rule issued under paragraph (1)(B),

6 or an order issued under paragraph (1)(C) is not

7 made by the time specified in such notice, rule, or

8 order, the Administrator may by order published in

9 the Federal Register modify or revoke the tolerance

10 or exemption in question. In any review of such an

11 order under subsection (g)(2), the only material

12 issue shall be whether a submission required under

13 paragraph (1) was not made by the time specified.

14 ‘‘(g) EFFECTIVE DATE, OBJECTIONS, HEARINGS,

15 AND ADMINISTRATIVE REVIEW.—

16 ‘‘(1) EFFECTIVE DATE.—A regulation or order

17 issued under subsection (d)(4), (e)(1), or (f)(2) shall

18 take effect upon publication unless the regulation or

19 order specifies otherwise. The Administrator may

20 stay the effectiveness of the regulation or order if,

21 after issuance of such regulation or order, objections

22 are filed with respect to such regulation or order

23 pursuant to paragraph (2).

24 ‘‘(2) FURTHER PROCEEDINGS.—
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1 ‘‘(A) OBJECTIONS.—Within 60 days after

2 a regulation or order is issued under subsection

3 (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or

4 (n)(5)(C), any person may file objections there5 to with the Administrator, specifying with par6 ticularity the provisions of the regulation or

7 order deemed objectionable and stating reason8 able grounds therefor. If the regulation or order

9 was issued in response to a petition under sub10 section (d)(1), a copy of each objection filed by

11 a person other than the petitioner shall be

12 served by the Administrator on the petitioner.

13 ‘‘(B) HEARING.—An objection may include

14 a request for a public evidentiary hearing upon

15 the objection. The Administrator shall, upon

16 the initiative of the Administrator or upon the

17 request of an interested person and after due

18 notice, hold a public evidentiary hearing if and

19 to the extent the Administrator determines that

20 such a public hearing is necessary to receive

21 factual evidence relevant to material issues of

22 fact raised by the objections. The presiding offi23 cer in such a hearing may authorize a party to

24 obtain discovery from other persons and may

25 upon a showing of good cause made by a party
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1 issue a subpoena to compel testimony or pro2 duction of documents from any person. The

3 presiding officer shall be governed by the Fed4 eral Rules of Civil Procedure in making any

5 order for the protection of the witness or the

6 content of documents produced and shall order

7 the payment of a reasonable fees and expenses

8 as a condition to requiring testimony of the wit9 ness. On contest, such a subpoena may be en10 forced by a Federal district court.

11 ‘‘(C) FINAL DECISION.—As soon as prac12 ticable after receiving the arguments of the par13 ties, the Administrator shall issue an order

14 stating the action taken upon each such objec15 tion and setting forth any revision to the regu16 lation or prior order that the Administrator has

17 found to be warranted. If a hearing was held

18 under subparagraph (B), such order and any

19 revision to the regulation or prior order shall,

20 with respect to questions of fact at issue in the

21 hearing, be based only on substantial evidence

22 of record at such hearing, and shall set forth in

23 detail the findings of facts and the conclusions

24 of law or policy upon which the order or regula25 tion is based.
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1 ‘‘(h) JUDICIAL REVIEW.—

2 ‘‘(1) PETITION.—In a case of actual con3 troversy as to the validity of any regulation issued

4 under subsection (e)(1)(C), or any order issued

5 under subsection (f)(1)(C) or (g)(2)(C), or any regu6 lation that is the subject of such an order, any per7 son who will be adversely affected by such order or

8 regulation may obtain judicial review by filing in the

9 United States Court of Appeals for the circuit

10 wherein that person resides or has its principal place

11 of business, or in the United States Court of Ap12 peals for the District of Columbia Circuit, within 60

13 days after publication of such order or regulation, a

14 petition praying that the order or regulation be set

15 aside in whole or in part.

16 ‘‘(2) RECORD AND JURISDICTION.—A copy of

17 the petition under paragraph (1) shall be forthwith

18 transmitted by the clerk of the court to the Adminis19 trator, or any officer designated by the Adminis20 trator for that purpose, and thereupon the Adminis21 trator shall file in the court the record of the pro22 ceedings on which the Administrator based the order

23 or regulation, as provided in section 2112 of title 28,

24 United States Code. Upon the filing of such a peti25 tion, the court shall have exclusive jurisdiction to af-
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1 firm or set aside the order or regulation complained

2 of in whole or in part. As to orders issued following

3 a public evidentiary hearing, the findings of the Ad4 ministrator with respect to questions of fact shall be

5 sustained only if supported by substantial evidence

6 when considered on the record as a whole.

7 ‘‘(3) ADDITIONAL EVIDENCE.—If a party ap8 plies to the court for leave to adduce additional evi9 dence and shows to the satisfaction of the court that

10 the additional evidence is material and that there

11 were reasonable grounds for the failure to adduce

12 the evidence in the proceeding before the Adminis13 trator, the court may order that the additional evi14 dence (and evidence in rebuttal thereof) shall be

15 taken before the Administrator in the manner and

16 upon the terms and conditions the court deems

17 proper. The Administrator may modify prior find18 ings as to the facts by reason of the additional evi19 dence so taken and may modify the order or regula20 tion accordingly. The Administrator shall file with

21 the court any such modified finding, order, or regu22 lation.

23 ‘‘(4) FINAL JUDGMENT; SUPREME COURT RE24 VIEW.—The judgment of the court affirming or set25 ting aside, in whole or in part, any regulation or any
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1 order and any regulation which is the subject of

2 such an order shall be final, subject to review by the

3 Supreme Court of the United States as provided in

4 section 1254 of title 28 of the United States Code.

5 The commencement of proceedings under this sub6 section shall not, unless specifically ordered by the

7 court to the contrary, operate as a stay of a regula8 tion or order.

9 ‘‘(5) APPLICATION.—Any issue as to which re10 view is or was obtainable under this subsection shall

11 not be the subject of judicial review under any other

12 provision of law.

13 ‘‘(i) CONFIDENTIALITY AND USE OF DATA.—

14 ‘‘(1) GENERAL RULE.—Data and information

15 that are or have been submitted to the Adminis16 trator under this section or section 409 in support

17 of a tolerance or an exemption from a tolerance shall

18 be entitled to confidential treatment for reasons of

19 business confidentiality and to exclusive use and

20 data compensation to the same extent provided by

21 sections 3 and 10 of the Federal Insecticide, Fun22 gicide, and Rodenticide Act.

23 ‘‘(2) EXCEPTIONS.—

24 ‘‘(A) IN GENERAL.—Data and information

25 that are entitled to confidential treatment
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1 under paragraph (1) may be disclosed, under

2 such security requirements as the Adminis3 trator may provide by regulation, to—

4 ‘‘(i) employees of the United States

5 authorized by the Administrator to exam6 ine such data and information in the carry7 ing out of their official duties under this

8 Act or other Federal statutes intended to

9 protect the public health; or

10 ‘‘(ii) contractors with the United

11 States authorized by the Administrator to

12 examine such data and information in the

13 carrying out of contracts under this Act or

14 such statutes.

15 ‘‘(B) CONGRESS.—This subsection does

16 not authorize the withholding of data or infor17 mation from either House of Congress or from,

18 to the extent of matter within its jurisdiction,

19 any committee or subcommittee of such com20 mittee or any joint committee of Congress or

21 any subcommittee of such joint committee.

22 ‘‘(3) SUMMARIES.—Notwithstanding any provi23 sion of this subsection or other law, the Adminis24 trator may publish the informative summary re25 quired by subsection (d)(2)(A)(i) and may, in issu-
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1 ing a proposed or final regulation or order under

2 this section, publish an informative summary of the

3 data relating to the regulation or order.

4 ‘‘(j) STATUS OF PREVIOUSLY ISSUED REGULA5 TIONS.—

6 ‘‘(1) REGULATIONS UNDER SECTION 406.—Reg7 ulations affecting pesticide chemical residues in or

8 on raw agricultural commodities promulgated, in ac9 cordance with section 701(e), under the authority of

10 section 406(a) upon the basis of public hearings in11 stituted before January 1, 1953, shall be deemed to

12 be regulations issued under this section and shall be

13 subject to modification or revocation under sub14 sections (d) and (e), and shall be subject to review

15 under subsection (q).

16 ‘‘(2) REGULATIONS UNDER SECTION 409.—Reg17 ulations that established tolerances for substances

18 that are pesticide chemical residues in or on proc19 essed food, or that otherwise stated the conditions

20 under which such pesticide chemicals could be safely

21 used, and that were issued under section 409 on or

22 before the date of the enactment of this paragraph,

23 shall be deemed to be regulations issued under this

24 section and shall be subject to modification or rev-
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1 ocation under subsection (d) or (e), and shall be

2 subject to review under subsection (q).

3 ‘‘(3) REGULATIONS UNDER SECTION 408.—Reg4 ulations that established tolerances or exemptions

5 under this section that were issued on or before the

6 date of the enactment of this paragraph shall remain

7 in effect unless modified or revoked under subsection

8 (d) or (e), and shall be subject to review under sub9 section (q).

10 ‘‘(k) TRANSITIONAL PROVISION.—If, on the day be11 fore the date of the enactment of this subsection, a sub12 stance that is a pesticide chemical was, with respect to

13 a particular pesticidal use of the substance and any result14 ing pesticide chemical residue in or on a particular food—

15 ‘‘(1) regarded by the Administrator or the Sec16 retary as generally recognized as safe for use within

17 the meaning of the provisions of subsection (a) or

18 section 201(s) as then in effect; or

19 ‘‘(2) regarded by the Secretary as a substance

20 described by section 201(s)(4);

21 such a pesticide chemical residue shall be regarded as ex22 empt from the requirement for a tolerance, as of the date

23 of enactment of this subsection. The Administrator shall

24 by regulation indicate which substances are described by

25 this subsection. Any exemption under this subsection may
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1 be modified or revoked as if it had been issued under sub2 section (c).

3 ‘‘(l) HARMONIZATION WITH ACTION UNDER OTHER

4 LAWS.—

5 ‘‘(1) COORDINATION WITH FIFRA.—To the ex6 tent practicable and consistent with the review dead7 lines in subsection (q), in issuing a final rule under

8 this subsection that suspends or revokes a tolerance

9 or exemption for a pesticide chemical residue in or

10 on food, the Administrator shall coordinate such ac11 tion with any related necessary action under the

12 Federal Insecticide, Fungicide, and Rodenticide Act.

13 ‘‘(2) REVOCATION OF TOLERANCE OR EXEMP14 TION FOLLOWING CANCELLATION OF ASSOCIATED

15 REGISTRATIONS.—If the Administrator, acting under

16 the Federal Insecticide, Fungicide, and Rodenticide

17 Act, cancels the registration of each pesticide that

18 contains a particular pesticide chemical and that is

19 labeled for use on a particular food, or requires that

20 the registration of each such pesticide be modified to

21 prohibit its use in connection with the production,

22 storage, or transportation of such food, due in whole

23 or in part to dietary risks to humans posed by resi24 dues of that pesticide chemical on that food, the Ad25 ministrator shall revoke any tolerance or exemption
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1 that allows the presence of the pesticide chemical, or

2 any pesticide chemical residue that results from its

3 use, in or on that food. Subsection (e) shall apply to

4 actions taken under this paragraph. A revocation

5 under this paragraph shall become effective not later

6 than 180 days after—

7 ‘‘(A) the date by which each such cancella8 tion of a registration has become effective; or

9 ‘‘(B) the date on which the use of the can10 celed pesticide becomes unlawful under the

11 terms of the cancellation, whichever is later.

12 ‘‘(3) SUSPENSION OF TOLERANCE OR EXEMP13 TION FOLLOWING SUSPENSION OF ASSOCIATED REG14 ISTRATIONS.—

15 ‘‘(A) SUSPENSION.—If the Administrator,

16 acting under the Federal Insecticide, Fungicide,

17 and Rodenticide Act, suspends the use of each

18 registered pesticide that contains a particular

19 pesticide chemical and that is labeled for use on

20 a particular food, due in whole or in part to die21 tary risks to humans posed by residues of that

22 pesticide chemical on that food, the Adminis23 trator shall suspend any tolerance or exemption

24 that allows the presence of the pesticide chemi25 cal, or any pesticide chemical residue that re-
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1 sults from its use, in or on that food. Sub2 section (e) shall apply to actions taken under

3 this paragraph. A suspension under this para4 graph shall become effective not later than 60

5 days after the date by which each such suspen6 sion of use has become effective.

7 ‘‘(B) EFFECT OF SUSPENSION.—The sus8 pension of a tolerance or exemption under sub9 paragraph (A) shall be effective as long as the

10 use of each associated registration of a pesticide

11 is suspended under the Federal Insecticide,

12 Fungicide, and Rodenticide Act. While a sus13 pension of a tolerance or exemption is effective

14 the tolerance or exemption shall not be consid15 ered to be in effect. If the suspension of use of

16 the pesticide under that Act is terminated, leav17 ing the registration of the pesticide for such use

18 in effect under that Act, the Administrator

19 shall rescind any associated suspension of toler20 ance or exemption.

21 ‘‘(4) TOLERANCES FOR UNAVOIDABLE RESI22 DUES.—In connection with action taken under para23 graph (2) or (3), or with respect to pesticides whose

24 registrations were suspended or canceled prior to the

25 date of the enactment of this paragraph under the
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1 Federal Insecticide, Fungicide, and Rodenticide Act,

2 if the Administrator determines that a residue of the

3 canceled or suspended pesticide chemical will un4 avoidably persist in the environment and thereby be

5 present in or on a food, the Administrator may es6 tablish a tolerance for the pesticide chemical residue.

7 In establishing such a tolerance, the Administrator

8 shall take into account both the factors set forth in

9 subsection (b)(2) and the unavoidability of the resi10 due. Subsection (e) shall apply to the establishment

11 of such tolerance. The Administrator shall review

12 any such tolerance periodically and modify it as nec13 essary so that it allows no greater level of the pes14 ticide chemical residue than is unavoidable.

15 ‘‘(5) PESTICIDE RESIDUES RESULTING FROM

16 LAWFUL APPLICATION OF PESTICIDE.—Notwith17 standing any other provision of this Act, if a toler18 ance or exemption for a pesticide chemical residue in

19 or on a food has been revoked, suspended, or modi20 fied under this section, an article of that food shall

21 not be deemed unsafe solely because of the presence

22 of such pesticide chemical residue in or on such food

23 if it is shown to the satisfaction of the Secretary

24 that—
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1 ‘‘(A) the residue is present as the result of

2 an application or use of a pesticide at a time

3 and in a manner that was lawful under the

4 Federal Insecticide, Fungicide, and Rodenticide

5 Act; and

6 ‘‘(B) the residue does not exceed a level

7 that was authorized at the time of that applica8 tion or use to be present on the food under a

9 tolerance, exemption, food additive regulation,

10 or other sanction then in effect under this Act;

11 unless, in the case of any tolerance or exemption re12 voked, suspended, or modified under this subsection

13 or subsection (d) or (e), the Administrator has is14 sued a determination that consumption of the legally

15 treated food during the period of its likely availabil16 ity in commerce will pose an unreasonable dietary

17 risk.

18 ‘‘(6) TOLERANCE FOR USE OF PESTICIDES

19 UNDER AN EMERGENCY EXEMPTION.—If the Admin20 istrator grants an exemption under section 18 of the

21 Federal Insecticide, Fungicide, and Rodenticide Act

22 (7 U.S.C. 136p) for a pesticide chemical, the Admin23 istrator shall establish a tolerance or exemption from

24 the requirement for a tolerance for the pesticide

25 chemical residue. Such a tolerance or exemption
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1 from a tolerance shall have an expiration date. The

2 Administrator may establish such a tolerance or ex3 emption without providing notice or a period for

4 comment on the tolerance or exemption. The Admin5 istrator shall promulgate regulations within 365

6 days after the date of the enactment of this para7 graph governing the establishment of tolerances and

8 exemptions under this paragraph. Such regulations

9 shall be consistent with the safety standard under

10 subsections (b)(2) and (c)(2) and with section 18 of

11 the Federal Insecticide, Fungicide, and Rodenticide

12 Act.

13 ‘‘(m) FEES.—

14 ‘‘(1) AMOUNT.—The Administrator shall by

15 regulation require the payment of such fees as will

16 in the aggregate, in the judgment of the Adminis17 trator, be sufficient over a reasonable term to pro18 vide, equip, and maintain an adequate service for the

19 performance of the Administrator’s functions under

20 this section. Under the regulations, the performance

21 of the Administrator’s services or other functions

22 under this section, including—

23 ‘‘(A) the acceptance for filing of a petition

24 submitted under subsection (d);
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1 ‘‘(B) establishing, modifying, leaving in ef2 fect, or revoking a tolerance or establishing,

3 modifying, leaving in effect, or revoking an ex4 emption from the requirement for a tolerance

5 under this section;

6 ‘‘(C) the acceptance for filing of objections

7 under subsection (g); or

8 ‘‘(D) the certification and filing in court of

9 a transcript of the proceedings and the record

10 under subsection (h);

11 may be conditioned upon the payment of such fees.

12 The regulations may further provide for waiver or

13 refund of fees in whole or in part when in the judg14 ment of the Administrator such a waiver or refund

15 is equitable and not contrary to the purposes of this

16 subsection.

17 ‘‘(2) DEPOSIT.—All fees collected under para18 graph (1) shall be deposited in the Reregistration

19 and Expedited Processing Fund created by section

20 4(k) of the Federal Insecticide, Fungicide, and

21 Rodenticide Act. Such fees shall be available to the

22 Administrator, without fiscal year limitation, for the

23 performance of the Administrator’s services or func24 tions as specified in paragraph (1).

25 ‘‘(n) NATIONAL UNIFORMITY OF TOLERANCES.—
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1 ‘‘(1) QUALIFYING PESTICIDE CHEMICAL RESI2 DUE.—For purposes of this subsection, the term

3 ‘qualifying pesticide chemical residue’ means a pes4 ticide chemical residue resulting from the use, in

5 production, processing, or storage of a food, of a

6 pesticide chemical that is an active ingredient and

7 that—

8 ‘‘(A) was first approved for such use in a

9 registration of a pesticide issued under section

10 3(c)(5) of the Federal Insecticide, Fungicide,

11 Rodenticide Act on or after April 25, 1985, on

12 the basis of data determined by the Adminis13 trator to meet all applicable requirements for

14 data prescribed by regulations in effect under

15 that Act on April 25, 1985; or

16 ‘‘(B) was approved for such use in a rereg17 istration eligibility determination issued under

18 section 4(g) of that Act on or after the date of

19 enactment of this subsection.

20 ‘‘(2) QUALIFYING FEDERAL DETERMINATION.—

21 For purposes of this subsection, the term ‘qualifying

22 Federal determination’ means a tolerance or exemp23 tion from the requirement for a tolerance for a

24 qualifying pesticide chemical residue that—
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1 ‘‘(A) is issued under this section after the

2 date of the enactment of this subsection and de3 termined by the Administrator to meet the

4 standard under subsection (b)(2)(A) (in the

5 case of a tolerance) or (c)(2) (in the case of an

6 exemption); or

7 ‘‘(B)(i) pursuant to subsection (j) is re8 maining in effect or is deemed to have been is9 sued under this section, or is regarded under

10 subsection (k) as exempt from the requirement

11 for a tolerance; and

12 ‘‘(ii) is determined by the Administrator to

13 meet the standard under subsection (b)(2)(A)

14 (in the case of a tolerance) or (c)(2) (in the

15 case of an exemption).

16 ‘‘(3) LIMITATION.—The Administrator may

17 make the determination described in paragraph

18 (2)(B)(ii) only by issuing a rule in accordance with

19 the procedure set forth in subsection (d) or (e) and

20 only if the Administrator issues a proposed rule and

21 allows a period of not less than 30 days for comment

22 on the proposed rule. Any such rule shall be

23 reviewable in accordance with subsections (g) and

24 (h).
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1 ‘‘(4) STATE AUTHORITY.—Except as provided

2 in paragraphs (5), (6), and (8) no State or political

3 subdivision may establish or enforce any regulatory

4 limit on a qualifying pesticide chemical residue in or

5 on any food if a qualifying Federal determination

6 applies to the presence of such pesticide chemical

7 residue in or on such food, unless such State regu8 latory limit is identical to such qualifying Federal

9 determination. A State or political subdivision shall

10 be deemed to establish or enforce a regulatory limit

11 on a pesticide chemical residue in or on a food if it

12 purports to prohibit or penalize the production, proc13 essing, shipping, or other handling of a food because

14 it contains a pesticide residue (in excess of a pre15 scribed limit).

16 ‘‘(5) PETITION PROCEDURE.—

17 ‘‘(A) IN GENERAL.—Any State may peti18 tion the Administrator for authorization to es19 tablish in such State a regulatory limit on a

20 qualifying pesticide chemical residue in or on

21 any food that is not identical to the qualifying

22 Federal determination applicable to such quali23 fying pesticide chemical residue.

24 ‘‘(B) PETITION REQUIREMENTS.—Any pe25 tition under subparagraph (A) shall—
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1 ‘‘(i) satisfy any requirements pre2 scribed, by rule, by the Administrator; and

3 ‘‘(ii) be supported by scientific data

4 about the pesticide chemical residue that is

5 the subject of the petition or about chemi6 cally related pesticide chemical residues,

7 data on the consumption within such State

8 of food bearing the pesticide chemical resi9 due, and data on exposure of humans with10 in such State to the pesticide chemical res11 idue.

12 ‘‘(C) AUTHORIZATION.—The Adminis13 trator may, by order, grant the authorization

14 described in subparagraph (A) if the Adminis15 trator determines that the proposed State regu16 latory limit—

17 ‘‘(i) is justified by compelling local

18 conditions; and

19 ‘‘(ii) would not cause any food to be

20 a violation of Federal law.

21 ‘‘(D) TREATMENT.—In lieu of any action

22 authorized under subparagraph (C), the Admin23 istrator may treat a petition under this para24 graph as a petition under subsection (d) to

25 modify or revoke a tolerance or an exemption.
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1 If the Administrator determines to treat a peti2 tion under this paragraph as a petition under

3 subsection (d), the Administrator shall there4 after act on the petition pursuant to subsection

5 (d).

6 ‘‘(E) REVIEW.—Any order of the Adminis7 trator granting or denying the authorization de8 scribed in subparagraph (A) shall be subject to

9 review in the manner described in subsections

10 (g) and (h).

11 ‘‘(6) URGENT PETITION PROCEDURE.—Any

12 State petition to the Administrator pursuant to

13 paragraph (5) that demonstrates that consumption

14 of a food containing such pesticide residue level dur15 ing the period of the food’s likely availability in the

16 State will pose a significant public health threat

17 from acute exposure shall be considered an urgent

18 petition. If an order by the Administrator to grant

19 or deny the requested authorization in an urgent pe20 tition is not made within 30 days of receipt of the

21 petition, the petitioning State may establish and en22 force a temporary regulatory limit on a qualifying

23 pesticide chemical residue in or on the food. The

24 temporary regulatory limit shall be validated or ter-
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1 minated by the Administrator’s final order on the

2 petition.

3 ‘‘(7) RESIDUES FROM LAWFUL APPLICATION.—

4 No State or political subdivision may enforce any

5 regulatory limit on the level of a pesticide chemical

6 residue that may appear in or on any food if, at the

7 time of the application of the pesticide that resulted

8 in such residue, the sale of such food with such resi9 due level was lawful under this section and under

10 the law of such State, unless the State demonstrates

11 that consumption of the food containing such pes12 ticide residue level during the period of the food’s

13 likely availability in the State will pose an unreason14 able dietary risk to the health of persons within such

15 State.

16 ‘‘(8) SAVINGS.—Nothing in this Act preempts

17 the authority of any State or political subdivision to

18 require that a food containing a pesticide chemical

19 residue bear or be the subject of a warning or other

20 statement relating to the presence of the pesticide

21 chemical residue in or on such food.

22 ‘‘(o) CONSUMER RIGHT TO KNOW.—Not later than

23 2 years after the date of the enactment of the Food Qual24 ity Protection Act of 1996, and annually thereafter, the

25 Administrator shall, in consultation with the Secretary of
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1 Agriculture and the Secretary of Health and Human Serv2 ices, publish in a format understandable to a lay person,

3 and distribute to large retail grocers for public display (in

4 a manner determined by the grocer), the following infor5 mation, at a minimum:

6 ‘‘(1) A discussion of the risks and benefits of

7 pesticide chemical residues in or on food purchased

8 by consumers.

9 ‘‘(2) A listing of actions taken under subpara10 graph (B) of subsection (b)(2) that may result in

11 pesticide chemical residues in or on food that

12 present a yearly or lifetime risk above the risk al13 lowed under subparagraph (A) of such subsection,

14 and the food on which the pesticide chemicals pro15 ducing the residues are used.

16 ‘‘(3) Recommendations to consumers for reduc17 ing dietary exposure to pesticide chemical residues in

18 a manner consistent with maintaining a healthy diet,

19 including a list of food that may reasonably sub20 stitute for food listed under paragraph (2).

21 Nothing in this subsection shall prevent retail grocers

22 from providing additional information.

23 ‘‘(p) ESTROGENIC SUBSTANCES SCREENING PRO24 GRAM.—
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1 ‘‘(1) DEVELOPMENT.—Not later than 2 years

2 after the date of enactment of this section, the Ad3 ministrator shall in consultation with the Secretary

4 of Health and Human Services develop a screening

5 program, using appropriate validated test systems

6 and other scientifically relevant information, to de7 termine whether certain substances may have an ef8 fect in humans that is similar to an effect produced

9 by a naturally occurring estrogen, or such other en10 docrine effect as the Administrator may designate.

11 ‘‘(2) IMPLEMENTATION.—Not later than 3

12 years after the date of enactment of this section,

13 after obtaining public comment and review of the

14 screening program described in paragraph (1) by the

15 scientific advisory panel established under section

16 25(d) of the Federal Insecticide, Fungicide, and

17 Rodenticide Act or the science advisory board estab18 lished by section 8 of the Environmental Research,

19 Development, and Demonstration Act of 1978 (42

20 U.S.C. 4365), the Administrator shall implement the

21 program.

22 ‘‘(3) SUBSTANCES.—In carrying out the screen23 ing program described in paragraph (1), the Admin24 istrator—
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1 ‘‘(A) shall provide for the testing of all

2 pesticide chemicals; and

3 ‘‘(B) may provide for the testing of any

4 other substance that may have an effect that is

5 cumulative to an effect of a pesticide chemical

6 if the Administrator determines that a substan7 tial population may be exposed to such sub8 stance.

9 ‘‘(4) EXEMPTION.—Notwithstanding paragraph

10 (3), the Administrator may, by order, exempt from

11 the requirements of this section a biologic substance

12 or other substance if the Administrator determines

13 that the substance is anticipated not to produce any

14 effect in humans similar to an effect produced by a

15 naturally occurring estrogen.

16 ‘‘(5) COLLECTION OF INFORMATION.—

17 ‘‘(A) IN GENERAL.—The Administrator

18 shall issue an order to a registrant of a sub19 stance for which testing is required under this

20 subsection, or to a person who manufactures or

21 imports a substance for which testing is re22 quired under this subsection, to conduct testing

23 in accordance with the screening program de24 scribed in paragraph (1), and submit informa25 tion obtained from the testing to the Adminis-
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1 trator, within a reasonable time period that the

2 Administrator determines is sufficient for the

3 generation of the information.

4 ‘‘(B) PROCEDURES.—To the extent prac5 ticable the Administrator shall minimize dupli6 cative testing of the same substance for the

7 same endocrine effect, develop, as appropriate,

8 procedures for fair and equitable sharing of test

9 costs, and develop, as necessary, procedures for

10 handling of confidential business information.

11 ‘‘(C) FAILURE OF REGISTRANTS TO SUB12 MIT INFORMATION.—

13 ‘‘(i) SUSPENSION.—If a registrant of

14 a substance referred to in paragraph

15 (3)(A) fails to comply with an order under

16 subparagraph (A) of this paragraph, the

17 Administrator shall issue a notice of intent

18 to suspend the sale or distribution of the

19 substance by the registrant. Any suspen20 sion proposed under this paragraph shall

21 become final at the end of the 30-day pe22 riod beginning on the date that the reg23 istrant receives the notice of intent to sus24 pend, unless during that period a person

25 adversely affected by the notice requests a
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1 hearing or the Administrator determines

2 that the registrant has complied fully with

3 this paragraph.

4 ‘‘(ii) HEARING.—If a person requests

5 a hearing under clause (i), the hearing

6 shall be conducted in accordance with sec7 tion 554 of title 5, United States Code.

8 The only matter for resolution at the hear9 ing shall be whether the registrant has

10 failed to comply with an order under sub11 paragraph (A) of this paragraph. A deci12 sion by the Administrator after completion

13 of a hearing shall be considered to be a

14 final agency action.

15 ‘‘(iii) TERMINATION OF SUSPEN16 SIONS.—The Administrator shall terminate

17 a suspension under this subparagraph is18 sued with respect to a registrant if the Ad19 ministrator determines that the registrant

20 has complied fully with this paragraph.

21 ‘‘(D) NONCOMPLIANCE BY OTHER PER22 SONS.—Any person (other than a registrant)

23 who fails to comply with an order under sub24 paragraph (A) shall be liable for the same pen25 alties and sanctions as are provided under sec-
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1 tion 16 of the Toxic Substances Control Act

2 (15 U.S.C. 2601 and following) in the case of

3 a violation referred to in that section. Such pen4 alties and sanctions shall be assessed and im5 posed in the same manner as provided in such

6 section 16.

7 ‘‘(6) AGENCY ACTION.—In the case of any sub8 stance that is found, as a result of testing and eval9 uation under this section, to have an endocrine ef10 fect on humans, the Administrator shall, as appro11 priate, take action under such statutory authority as

12 is available to the Administrator, including consider13 ation under other sections of this Act, as is nec14 essary to ensure the protection of public health.

15 ‘‘(7) REPORT TO CONGRESS.—Not later than 4

16 years after the date of enactment of this section, the

17 Administrator shall prepare and submit to Congress

18 a report containing—

19 ‘‘(A) the findings of the Administrator re20 sulting from the screening program described in

21 paragraph (1);

22 ‘‘(B) recommendations for further testing

23 needed to evaluate the impact on human health

24 of the substances tested under the screening

25 program; and
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1 ‘‘(C) recommendations for any further ac2 tions (including any action described in para3 graph (6)) that the Administrator determines

4 are appropriate based on the findings.

5 ‘‘(q) SCHEDULE FOR REVIEW.—

6 ‘‘(1) IN GENERAL.—The Administrator shall re7 view tolerances and exemptions for pesticide chemi8 cal residues in effect on the day before the date of

9 the enactment of the Food Quality Protection Act of

10 1996, as expeditiously as practicable, assuring

11 that—

12 ‘‘(A) 33 percent of such tolerances and ex13 emptions are reviewed within 3 years of the

14 date of enactment of such Act;

15 ‘‘(B) 66 percent of such tolerances and ex16 emptions are reviewed within 6 years of the

17 date of enactment of such Act; and

18 ‘‘(C) 100 percent of such tolerances and

19 exemptions are reviewed within 10 years of the

20 date of enactment of such Act.

21 In conducting a review of a tolerance or exemption,

22 the Administrator shall determine whether the toler23 ance or exemption meets the requirements of sub24 sections (b)(2) or (c)(2) and shall, by the deadline

25 for the review of the tolerance or exemption, issue
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1 a regulation under subsection (d)(4) or (e)(1) to

2 modify or revoke the tolerance or exemption if the

3 tolerance or exemption does not meet such require4 ments.

5 ‘‘(2) PRIORITIES.—In determining priorities for

6 reviewing tolerances and exemptions under para7 graph (1), the Administrator shall give priority to

8 the review of the tolerances or exemptions that ap9 pear to pose the greatest risk to public health.

10 ‘‘(3) PUBLICATION OF SCHEDULE.—Not later

11 than 12 months after the date of the enactment of

12 the Food Quality Protection Act of 1996, the Ad13 ministrator shall publish a schedule for review of tol14 erances and exemptions established prior to the date

15 of the enactment of the Food Quality Protection Act

16 of 1996. The determination of priorities for the re17 view of tolerances and exemptions pursuant to this

18 subsection is not a rulemaking and shall not be sub19 ject to judicial review, except that failure to take

20 final action pursuant to the schedule established by

21 this paragraph shall be subject to judicial review.

22 ‘‘(r) TEMPORARY TOLERANCE OR EXEMPTION.—The

23 Administrator may, upon the request of any person who

24 has obtained an experimental permit for a pesticide chemi25 cal under the Federal Insecticide, Fungicide, and
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1 Rodenticide Act or upon the Administrator’s own initia2 tive, establish a temporary tolerance or exemption for the

3 pesticide chemical residue for the uses covered by the per4 mit. Subsections (b)(2), (c)(2), (d), and (e) shall apply to

5 actions taken under this subsection.

6 ‘‘(s) SAVINGS CLAUSE.—Nothing in this section shall

7 be construed to amend or modify the provisions of the

8 Toxic Substances Control Act or the Federal Insecticide,

9 Fungicide, and Rodenticide Act.’’.

10 SEC. 406. AUTHORIZATION FOR INCREASED MONITORING.

11 For the fiscal years 1997 through 1999, there is au12 thorized to be appropriated in the aggregate an additional

13 $12,000,000 for increased monitoring by the Secretary of

14 Health and Human Services of pesticide residues in im15 ported and domestic food.

16 SEC. 407. ALTERNATIVE ENFORCEMENT.

17 Section 303(g) (21 U.S.C. 333(f)) is amended—

18 (1) by redesignating paragraphs (2), (3), and

19 (4) as paragraphs (3), (4), and (5), respectively,

20 (2) by inserting after paragraph (1) the follow21 ing:

22 ‘‘(2)(A) Any person who introduces into interstate

23 commerce or delivers for introduction into interstate com24 merce an article of food that is adulterated within the

25 meaning of section 402(a)(2)(B) shall be subject to a civil
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1 money penalty of not more than $50,000 in the case of

2 an individual and $250,000 in the case of any other person

3 for such introduction or delivery, not to exceed $500,000

4 for all such violations adjudicated in a single proceeding.

5 ‘‘(B) This paragraph shall not apply to any person

6 who grew the article of food that is adulterated. If the

7 Secretary assesses a civil penalty against any person under

8 this paragraph, the Secretary may not use the criminal

9 authorities under this section to sanction such person for

10 the introduction or delivery for introduction into interstate

11 commerce of the article of food that is adulterated. If the

12 Secretary assesses a civil penalty against any person under

13 this paragraph, the Secretary may not use the seizure au14 thorities of section 304 or the injunction authorities of sec15 tion 302 with respect to the article of food that is adulter16 ated.

17 ‘‘(C) In a hearing to assess a civil penalty under this

18 paragraph, the presiding officer shall have the same au19 thority with regard to compelling testimony or production

20 of documents as a presiding officer has under section

21 408(g)(2)(B). The third sentence of paragraph (3)(A)

22 shall not apply to any investigation under this para23 graph.’’;
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1 (3) in paragraph (3), as so redesignated, by

2 striking ‘‘paragraph (1)’’ each place it occurs and

3 inserting ‘‘paragraph (1) or (2)’’;

4 (4) in paragraph (4), as so redesignated, by

5 striking ‘‘(2)(A)’’ and inserting ‘‘(3)(A)’’; and

6 (5) in paragraph (5), as so redesignated, by

7 striking ‘‘(3)’’ each place it occurs and inserting

8 ‘‘(4)’’.

9 TITLE V—FEES

10 SEC. 501. REREGISTRATION FEES.

11 (a) SECTION 4(i).—Section 4(i) (7 U.S.C. 136a–

12 1(i)), as amended by section 232(2), is amended—

13 (1) in paragraphs (5)(H) and (6), by striking

14 ‘‘1997’’ and inserting ‘‘2001’’; and

15 (2) in paragraph (5)(C), by inserting ‘‘(i)’’ after

16 ‘‘(C)’’ and by adding at the end the following:

17 ‘‘(ii) in each of the fiscal years 1998,

18 1999, and 2000, the Administrator is author19 ized to collect up to an additional $2,000,000 in

20 a manner consistent with subsection (k)(5) and

21 the recommendations of the Inspector General

22 of the Environmental Protection Agency. The

23 total fees that may be collected under this

24 clause shall not exceed $6,000,000.’’.
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1 (b) SECTION 4(k)(1).—Section 4(k)(1) (7 U.S.C.

2 136a–1(k)(1) is amended by inserting before the period

3 the following: ‘‘which shall be known as the Reregistration

4 and Expedited Processing Fund’’.

5 (c) SECTION 4(k)(2).—Section 4(k)(2) (7 136a–

6 1(k)(2)) is amended to read as follows:

7 ‘‘(2) SOURCE AND USE.—

8 ‘‘(A) All moneys derived from fees collected

9 by the Administrator under subsection (i) shall

10 be deposited in the fund and shall be available

11 to the Administrator, without fiscal year limita12 tion, specifically to offset the costs of rereg13 istration and expedited processing of the appli14 cations specified in paragraph (3). Such moneys

15 derived from fees may not be expended in any

16 fiscal year to the extent such moneys derived

17 from fees would exceed money appropriated for

18 use by the Administrator and expended in such

19 year for such costs of reregistration and expe20 dited processing of such applications. The Ad21 ministrator shall, prior to expending any such

22 moneys derived from fees—

23 ‘‘(i) effective October 1, 1997, adopt

24 specific and cost accounting rules and pro25 cedures as approved by the General Ac-
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1 counting Office and the Inspector General

2 of the Environmental Protection Agency to

3 ensure that moneys derived from fees are

4 allocated solely to the costs of reregistra5 tion and expedited processing of the appli6 cations specified in paragraph (3) in the

7 same portion as appropriated funds;

8 ‘‘(ii) prohibit the use of such moneys

9 derived from fees to pay for any costs

10 other than those necessary to achieve re11 registration and expedited processing of

12 the applications specified in paragraph (3);

13 and

14 ‘‘(iii) ensure that personnel and facil15 ity costs associated with the functions to

16 be carried out under this paragraph do not

17 exceed agency averages for comparable

18 personnel and facility costs.

19 ‘‘(B) The Administrator shall also—

20 ‘‘(i) complete the review of unreviewed

21 reregistration studies required to support

22 the reregistration eligibility decisions

23 scheduled for completion in accordance

24 with subsection (l)(2); and
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1 ‘‘(ii) contract for such outside assist2 ance as may be necessary for review of re3 quired studies, using a generally accepted

4 competitive process for the selection of

5 vendors of such assistance.’’.

6 (d) SECTION 4(k)(3).—Section 4(k)(3) (7 U.S.C.

7 136a–1(k)(3)) is amended—

8 (1) in subparagraph (A), by striking out ‘‘for

each of the fiscal years 1992, 1993, and 1994, 1 9 ⁄7th

10 of the maintenance fees collected, up to 2 million

11 each year’’ and inserting in lieu thereof ‘‘for each of

12 the fiscal years 1997 through 2001, not more than

1 13 ⁄7 of the maintenance fees collected in such fiscal

14 year’’; and

15 (2) by adding a new subparagraph (C) to read

16 as follows:

17 ‘‘(C) So long as the Administrator has not

18 met the time frames specified in clause (ii) of

19 section 3(c)(3)(B) with respect to any applica20 tion subject to section 3(c)(3)(B) that was re21 ceived prior to the date of enactment of the

22 Food Quality Protection Act of 1996, the Ad23 ministrator shall use the full amount of the fees

24 specified in subparagraph (A) for the purposes

25 specified therein. Once all applications subject
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1 to section 3(c)(3)(B) that were received prior to

2 such date of enactment have been acted upon,

3 no limitation shall be imposed by the preceding

4 sentence of this subparagraph so long as the

5 Administrator meets the time frames specified

6 in clause (ii) of section 3(c)(3)(B) on 90 per7 cent of affected applications in a fiscal year.

8 Should the Administrator not meet such time

9 frames in a fiscal year, the limitations imposed

10 by the first sentence of this subparagraph shall

11 apply until all overdue applications subject to

12 section 3(c)(3)(B) have been acted upon.’’.

13 (e) SECTION 4(k)(5).—Section 4(k)(5) (7 U.S.C.

14 136a–1(k)(5)) is amended to read as follows:

15 ‘‘(5) ACCOUNTING AND PERFORMANCE.—The

16 Administrator shall take all steps necessary to en17 sure that expenditures from fees authorized by sub18 section (i)(5)(C)(ii) are used only to carry out the

19 goals established under subsection (l). The Rereg20 istration and Expedited Processing Fund shall be

21 designated as an Environmental Protection Agency

22 component for purposes of section 3515(c) of title

23 31, United States Code. The annual audit required

24 under section 3521 of such title of the financial

25 statements of activities under this Act under section
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1 3515(b) of such title shall include an audit of the

2 fees collected under subsection (i)(5)(C) and dis3 bursed, of the amount appropriated to match such

4 fees, and of the Administrator’s attainment of per5 formance measure and goals established under sub6 section (l). Such an audit shall also include a review

7 of the reasonableness of the overhead allocation and

8 adequacy of disclosures of direct and indirect costs

9 associated with carrying out the reregistration and

10 expedited processing of the applications specified in

11 paragraph (3), and the basis for and accuracy of all

12 costs paid with moneys derived from such fees. The

13 Inspector General shall conduct the annual audit

14 and report the findings and recommendations of

15 such audit to the Administrator and to the Commit16 tees on Agriculture of the House of Representatives

17 and the Senate. The cost of such audit shall be paid

18 for out of the fees collected under subsection

19 (i)(5)(C).’’.

20 (f) GOALS.—Subsections (l) and (m) of section 4 (7

21 U.S.C. 136a–1), as amended by section 237, are redesig22 nated as subsections (m) and (n) respectively and the fol23 lowing is inserted after subsection (k):

24 ‘‘(l) PERFORMANCE MEASURES AND GOAL.—The

25 Administrator shall establish and publish annually in the
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1 Federal Register performance measures and goals. Such

2 measures and goals shall include—

3 ‘‘(1) the number of products reregistered, can4 celed, or amended, the status of reregistration, the

5 number and type of data requests under section

6 3(c)(2)(B) issued to support product reregistration

7 by active ingredient, the progress in reducing the

8 number of unreviewed, required reregistration stud9 ies, the aggregate status of tolerances reassessed,

10 and the number of applications for registration sub11 mitted under subsection (k)(3) that were approved

12 or disapproved;

13 ‘‘(2) the future schedule for reregistrations, in14 cluding the projection for such schedules that will be

15 issued under subsection (g)(2)(A) and (B) in the

16 current fiscal year and the succeeding fiscal year;

17 and

18 ‘‘(3) the projected year of completion of the re19 registrations under this section.’’.

Passed the House of Representatives July 23, 1996.

Attest:

Clerk.