Union Calendar No. 364

104TH CONGRESS

2D SESSION H. R. 1627

[Report No. 104–669, Parts I and II]

A BILL

To amend the Federal Insecticide, Fungicide, and

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

JULY 23, 1996

Reported from the Committee on Commerce with an

printedHouse on the State of the Union, and ordered to beamendment, committed to the Committee of the Whole
IB

Union Calendar No. 364

104TH CONGRESS

2D SESSION H. R. 1627

[Report No. 104–669, Parts I and II]

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

Federal Food, Drug, and Cosmetic Act, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

MAY 12, 1995

Mr. BLILEY (for himself, Mr. TOWNS, Mr. ROBERTS, Mr. DE LA GARZA, Mr.

EMERSON, Mr. CONDIT, Mr. BILIRAKIS, Mr. GUNDERSON, Mr. STENHOLM, Mr. COMBEST, Mr. MONTGOMERY, Mr. ALLARD, Mr. YOUNG of

Alaska, Mr. JOHNSON of South Dakota, Mr. WALKER, Mr. DOOLEY, Mr.

FIELDS of Texas, Mr. HALL of Texas, Mr. BARRETT of Nebraska, Mrs.

THURMAN, Mr. HASTERT, Mr. POMEROY, Mr. WOLF, Mr. BISHOP, Mr.

STUMP, Mrs. LINCOLN, Mr. EVERETT, Mr. PAXON, Mr. GOODLATTE, Mr.

DOOLITTLE, Mr. CANADY of Florida, Mr. POMBO, Mr. KINGSTON, Mr.

WALSH, Mr. HOEKSTRA, Mr. BAKER of Louisiana, Mr. CALVERT, Mr.

SMITH of Michigan, Mr. COX of California, Mr. CRAPO, Mr. LUCAS, Mr.

LEWIS of Kentucky, Mr. SHADEGG, Mr. HOSTETTLER, Mrs.

CHENOWETH, Mr. HUTCHINSON, Mr. CHAMBLISS, Mr. LATHAM, Mr.

LAHOOD, Mr. TAYLOR of North Carolina, Mr. BEREUTER, Mr.

WHITFIELD, Mr. NETHERCUTT, Mr. BOUCHER, Mr. OXLEY, Mr. SKEEN,

Mr. BOEHNER, Mr. STUPAK, Mr. THORNBERRY, Mr. BRYANT of Tennessee, Mr. HASTINGS of Washington, Mr. POSHARD, Mr. BURR, Mr.

SENSENBRENNER, Mr. TALENT, Ms. DANNER, Mr. HEFLEY, Mr. ORTON,

Mr. UPTON, Mr. BILBRAY, Mr. FOLEY, Mr. MCCRERY, Mr. COOLEY, Mr.

MCHUGH, Mr. GANSKE, Mr. EWING, Mr. HOLDEN, Mr. MANZULLO, Mr.

HAYWORTH, Mr. CHRYSLER, Mr. GILLMOR, Mr. METCALF, Mrs.

SEASTRAND, Mr. MINGE, Mr. DICKEY, Mr. NORWOOD, Mr. DUNCAN, Mr.

BARTON of Texas, Mr. GORDON, Mr. SCHAEFER, Mr. CLINGER, Mr.

MOORHEAD, Mr. RADANOVICH, Mr. HANCOCK, Mr. ROSE, Mr. BUYER,

and Mr. QUILLEN) introduced the following bill; Titles I–III, referred to

the Committee on Agriculture; Title IV, referred to the Committee on

Commerce
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JULY 11, 1996

Reported from the Committee on Agriculture with amendments

[Omit the part struck through and insert the part printed in italic]

JULY 23, 1996

Additional sponsors: Mr. HAYES, Mr. PETERSON of Minnesota, Mr. COBLE,

Mr. MCINTOSH, Mr. BALLENGER, Mr. BUNN of Oregon, Mr. LAUGHLIN,

Mr. FUNDERBURK, Mr. PICKETT, Mr. BARR of Georgia, Mr. FAZIO of

California, Mr. COLLINS of Georgia, Mr. SOLOMON, Mr. GEKAS, Mr.

BONO, Mr. JONES, Mr. BAKER of California, Mr. GUTKNECHT, Mr. SISISKY, Mr. KLUG, Mr. GALLEGLY, Mr. JACOBS, Mr. BURTON of Indiana,

Mr. ARCHER, Mr. CAMP, Mr. CHRISTENSEN, Mr. COBURN, Mr. HERGER,

Mr. KANJORSKI, Mr. COSTELLO, Mr. FRANKS of Connecticut, Mr.

THORNTON, Mr. HEFNER, Mr. THOMAS, Mr. BROWNBACK, Mr. ROGERS,

Mr. HEINEMAN, Mr. DORNAN, Mr. WATTS of Oklahoma, Mr. LINDER,

Mr. GOODLING, Mr. ROHRABACHER, Mr. CRANE, Mr. FORD, Mr.

SPENCE, Mr. PARKER, Mr. LEWIS of California, Mr. STOCKMAN, Mr.

DAVIS, Mr. MCKEON, Mr. WICKER, Mr. TIAHRT, Mr. HILLIARD, Mr.

THOMPSON, Mr. HOBSON, Mr. HOUGHTON, Mr. BONILLA, Mr. BUNNING

of Kentucky, Mr. LEACH, Ms. DUNN of Washington, Mr. MATSUI, Mr.

SPRATT, Mrs. SMITH of Washington, Mr. CLYBURN, Mr. TANNER, Mr.

PETERSON of Florida, Mr. MICA, Mr. PACKARD, Mr. PETE GEREN of

Texas, Mr. EHRLICH, Mr. BATEMAN, Mr. CHAPMAN, Mr. MILLER of

Florida, Mr. SKELTON, Mr. RIGGS, Mr. VOLKMER, Mr. MCCOLLUM, Mr.

FARR of California, Mr. TATE, Mr. PAYNE OF VIRGINIA, Mr. HUNTER,

Mr. CRAMER, Mr. BREWSTER, Mr. WELLER, Mr. MCINNIS, Mrs.

MYRICK, Mr. HILLEARY, Mrs. CUBIN, Mr. GILCHREST, Mr. NUSSLE, Mr.

WILIAMS, Mr. KNOLLENBERG, Mr. LARGENT, Mr. ENGEL, Mr. LIVINGSTON, Mr. ROTH, Mr. LIGHTFOOT, Mr. CALLAHAN, Mr. LIPINSKI, Mr.

DELAY, Mr. SHUSTER, Mr. GOSS, Mr. ROYCE, Mr. BEVILL, Mr. DEAL

of Georgia, Mr. WELDON of Florida, Mr. SOUDER, Mr. ANDREWS, Mr.

DREIER, Mr. BARTLETT of Maryland, Mr. CUNNINGHAM, Mr. STEARNS,

Mr. BACHUS, Mr. SCARBOROUGH, Mrs. FOWLER, Mr. TRAFICANT, Mr.

PORTER, Mr. BASS, Mr. ENGLISH of Pennsylvania, Mrs. VUCANOVICH,

Mr. CASTLE, Mr. KIM, Mr. SMITH of Texas, Ms. PRYCE, Mr. PETRI, Mr.

HANSEN, Mr. ISTOOK, Mr. WATT of North Carolina, Mr. LONGLEY, Mr.

HAMILTON, Mr. MANTON, Mr. MYERS of Indiana, Mr. LATOURETTE,

Mrs. CLAYTON, Mr. BARCIA of Michigan, Mr. BOEHLERT, Mr. DICKS,

Mr. WAMP, Mr. MCDADE, Mr. GRAHAM, Mr. KOLBE, Mr. NEY, Mrs.

ROUKEMA, Mr. CAMPBELL, Mr. GILMAN, Mr. DINGELL, and Mr. WAXMAN

JULY 23, 1996

Reported from the Committee on Commerce with an amendment, committed

to the Committee of the Whole House on the State of the Union, and

ordered to be printed

[Omit the part in bold brackets and insert the part printed in boldface roman]
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A BILL

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,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Food Quality Protec5 tion Act of 1995’’.

6 TITLE I—CANCELLATION AND

7 SUSPENSION

8 SEC. 101. REFERENCE.

9 Whenever in this title an amendment or repeal is ex10 pressed in terms of an amendment to, or repeal of, a sec11 tion or other provision, the reference shall be considered

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

13 Insecticide, Fungicide, and Rodenticide Act.

14 SEC. 102. CANCELLATION.

15 Section 6(b) (7 U.S.C. 136d(b)) is amended to read

16 as follows:

17 ‘‘(b) CANCELLATION AND CHANGE IN CLASSIFICA18 TION OR OTHER TERMS OR CONDITIONS OF REGISTRA19 TION.—

20 ‘‘(1) AUTHORITY.—Notwithstanding any other

21 provision of this Act, the Administrator may, by use
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1 of informal rulemaking under this subsection, pre2 scribe requirements regarding the composition, pack3 aging, and labeling of a pesticide (or a group of pes4 ticides containing a common active ingredient), or

5 may classify any such pesticide, or may prohibit the

6 registration or continued registration of any such

7 pesticide for some or all purposes, to the extent nec8 essary to assure that the pesticide, when used in ac9 cordance with widespread and commonly recognized

10 practice, does not generally cause unreasonable ad11 verse effects on the environment.

12 ‘‘(2) BASIS FOR RULE.—The Administrator

13 may not initiate a rulemaking under this subsection

14 unless the rulemaking is based on a validated test or

15 other significant evidence raising prudent concerns

16 of unreasonable adverse effects to man or to the en17 vironment.

18 ‘‘(3) PRENOTICE OF RULEMAKING PROCE19 DURES.—

20 ‘‘(A) The Administrator may not initiate a

21 rulemaking under paragraph (1) until the Ad22 ministrator has furnished to the registrant of

23 each affected pesticide a notice that includes a

24 summary of the validated test or other signifi25 cant evidence upon which the Administrator
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1 proposes to base the rulemaking and the basis

2 for a determination that such test or evidence

3 raises prudent concerns that the pesticide

4 causes unreasonable adverse risks to man or to

5 the environment. A registrant shall have 30

6 days after receipt of a notice provided under

7 this subparagraph to respond to such notice.

8 ‘‘(B) At the same time that the Adminis9 trator furnishes notice to registrants of the pes10 ticide under subparagraph (A), the Adminis11 trator shall also furnish such notice to the Sec12 retary of Agriculture and the Secretary of

13 Health and Human Services. Upon receipt of

14 such notification, the Secretary of Agriculture,

15 when an agricultural commodity is affected,

16 shall prepare an analysis of the benefit and use

17 data of the pesticide and provide the analysis to

18 the Administrator within the time limits of this

19 paragraph.

20 ‘‘(C) Not more than 60 days after issuing

21 a notice under this paragraph, the Adminis22 trator shall either—

23 ‘‘(i) issue a notice of proposed rule24 making under paragraph (5); or
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1 ‘‘(ii) issue a notice of a decision not to

2 initiate a rulemaking.

3 ‘‘(4) DOCKET.—For each rulemaking under

4 paragraph (1), the Administrator shall establish a

5 docket. The docket shall include a copy of the notice

6 under paragraph (3), of the notice of proposed rule7 making under paragraph (5), of each timely com8 ment filed with the Administrator, of the report of

9 the Scientific Advisory Panel under paragraph (7),

10 of a record of each hearing held by the Adminis11 trator in connection with the rulemaking of the deci12 sion of the hearing examiner under paragraph (6),

13 and of the final rule or decision to withdraw the

14 rule. Information in the docket shall be made avail15 able to the public consistent with the requirements

16 of section 10. No factual material that has not been

17 entered into the docket in a timely manner may be

18 relied upon by the Administrator in issuing a final

19 rule or in withdrawing a proposed rule or by any

20 person in a judicial review proceeding, except for—

21 ‘‘(A) information of which the Adminis22 trator may properly take official notice; or

23 ‘‘(B) information of which a court may

24 properly take judicial notice.

25 ‘‘(5) NOTICE OF PROPOSED RULEMAKING.—
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1 ‘‘(A) The notice of proposed rulemaking

2 shall include a statement of its basis and pur3 pose, a request for any additional data needed,

4 and a bibliography of all significant scientific

5 data and studies on which the proposed rule is

6 based. The statement of basis and purpose shall

7 include a summary of—

8 ‘‘(i) the factual data on which the pro9 posed rule is based;

10 ‘‘(ii) the major scientific assumptions,

11 legal interpretations, and policy consider12 ations underlying the proposed rule;

13 ‘‘(iii) a summary of available risk-ben14 efit information, including benefits and use

15 information as provided by the Secretary

16 of Agriculture; and

17 ‘‘(iv) the Administrator’s analysis and

18 tentative conclusions regarding the bal19 ancing of such risks and benefits.

20 ‘‘(B) Registrants of the pesticide and any

21 person who submits comments on the proposed

22 rule shall make a report to the Administrator of

23 all scientific data and studies in such person’s

24 possession concerning the risks and benefits of

25 the pesticide that are the subject of the rule-
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1 making and were not included in the bibliog2 raphy included in the notice required in sub3 paragraph (A). If such person receives addi4 tional scientific data or studies pertinent to the

5 rulemaking that were not included in such bibli6 ography, the person shall make a report of such

7 scientific data and studies to the Administrator

8 promptly after receipt. If the Administrator re9 ceives reports containing additional data con10 cerning risks or benefits, the Administrator

11 shall revise the bibliography to reflect such data

12 and make the revised bibliography available to

13 the public.

14 ‘‘(C) The Administrator shall provide a

15 comment period of not less than 90 days after

16 the publication of the notice of proposed rule17 making. During such period any person may

18 submit comments, data, or documentary infor19 mation on the proposed rule. Promptly upon re20 ceipt by the Administrator, all written com21 ments and documentary information on the pro22 posed rule received from any person for inclu23 sion in the docket during the comment period,

24 shall be place in the docket.
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1 ‘‘(D) At the same time that the Adminis2 trator publishes notice under subparagraph (A),

3 the Administrator shall provide the Secretary of

4 Agriculture and the Secretary of Health and

5 Human Services with a copy of the proposed

6 rule. Not later than 90 days after the publica7 tion of the notice of proposed rulemaking, the

8 Secretary of Agriculture and the Secretary of

9 Health and Human Services may provide com10 ments on such proposed rule. When an agricul11 tural commodity is affected, the Secretary of

12 Agriculture shall provide to the Administrator

13 an analysis of the impact of the proposed action

14 on the domestic and global availability, prices of

15 agricultural commodities and retail food prices,

16 and any associated societal impacts (including

17 consumer nutrition and health and low-income

18 consumers).

19 ‘‘(6) HEARING.—

20 ‘‘(A) Any person who has submitted a

21 comment may, not later than 15 days after the

22 close of the comment period, request of the Ad23 ministrator a hearing on questions of fact,

24 based on information submitted under para25 graph (5), and pertaining to the proposed rule
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1 or comments thereon. Upon such request, the

2 Administrator shall schedule a hearing not to

3 exceed 20 days duration, to commence not later

4 than 30 days and to conclude not later than 90

5 days after the close of the comment period. The

6 Administrator shall announce the time, place,

7 and purpose of the hearing in the Federal Reg8 ister. The hearing shall be limited to addressing

9 questions of fact raised by materials in the

10 docket. A transcript shall be made of any oral

11 presentation, discussion, or debate and included

12 in the docket.

13 ‘‘(B) The Administrator shall appoint a

14 hearing examiner who shall have the authority

15 to administer oaths, issue subpoenas, regulate

16 the course of the hearing, conduct prehearing

17 conferences, schedule presentations, and exclude

18 irrelevant, immaterial, or unduly repetitious evi19 dence, or evidence that should have been sub20 mitted under subparagraph (5)(B).

21 ‘‘(C) The hearing examiner shall conduct

22 the hearing in a manner that encourages dis23 cussion and debate on questions of fact regard24 ing the docket, and conforms with the deadlines

25 set in this paragraph. The Administrator shall
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1 designate one or more employees of the Envi2 ronmental Protection Agency to participate in

3 the hearing. Any person who submitted a com4 ment on the proposed rule may participate in

5 the hearing and shall be entitled to present evi6 dence and argument to support the partici7 pant’s position or rebut a contrary position and

8 may choose to present materials in oral or writ9 ten form. The presentation of evidence and ar10 gument shall not delay the conclusion of the

11 hearing beyond 20 days of its commencement.

12 ‘‘(D) Subject to subparagraph (B), an in13 terested person is entitled—

14 ‘‘(i) to present such person’s position

15 orally or by documentary submissions (or

16 both); and

17 ‘‘(ii) if the Administrator determines

18 that there are disputed issues of material

19 fact necessary to resolve, to present such

20 rebuttal submissions and to conduct such

21 cross-examination of persons as the hear22 ing examiner determines (I) to be appro23 priate, and (II) to be required for a full

24 and true disclosure with respect to such is25 sues.
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1 ‘‘(E) As soon as practicable after comple2 tion of the hearing but not later than 180 days

3 after the close of the public comment period,

4 the hearing examiner shall issue a decision.

5 Such decision shall be based only on substantial

6 evidence of record of such hearing (including

7 the report of the Scientific Advisory Panel) and

8 shall set forth detailed findings of fact upon

9 which the decision is based.

10 ‘‘(7) REVIEW BY SCIENTIFIC ADVISORY

11 PANEL.—At the time the Administrator issues a no12 tice of proposed rulemaking under paragraph (5),

13 the Administrator shall provide a copy of such notice

14 to the Scientific Advisory Panel established under

15 section 25(d). The hearing examiner (or Adminis16 trator if no hearing is requested) shall request the

17 comments, evaluations, and recommendations of the

18 Panel as to the impact on health and the environ19 ment of the proposed rule and on any disputed ma20 terial issues of fact or scientific policy that appear

21 to be of significance in the hearing. The Panel may

22 hold a public hearing to discuss the proposed rule.

23 The Panel shall provide a report to the hearing ex24 aminer (or Administrator if no hearing is requested)

25 not later than 120 days after the close of comment
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1 period. The Administrator shall allow a reasonable

2 time for written public comment on the Panel’s re3 port. A copy of the Panel’s report and any com4 ments shall be included in the rulemaking docket.

5 ‘‘(8) FINAL ACTION.—Not later than 365 days

6 after issuing a notice of proposed rulemaking and

7 after considering all material in the docket, the Ad8 ministrator shall publish in the Federal Register ei9 ther a final rule or a withdrawal of the proposed

10 rule. The Administrator may not prohibit a use of

11 a pesticide if alternative requirements will assure

12 that the pesticide, when used in accordance with

13 widespread and commonly recognized practice, will

14 not generally cause unreasonable adverse effects on

15 the environment. In taking any final action, the Ad16 ministrator shall take into account the impact of the

17 action on production and prices of agricultural com18 modities, retail food prices, and otherwise on agricul19 tural economy, and shall use the least burdensome

20 requirements to achieve the purposes of this Act.

21 The final rule or withdrawal of the proposal shall be

22 accompanied by a statement that—

23 ‘‘(A) explains the reasons for the action;

24 ‘‘(B) responds to any comments made by

25 the Secretary of Agriculture or the Secretary of
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1 Health and Human Services, and responds to

2 any report of the Scientific Advisory Panel;

3 ‘‘(C) responds to each significant comment

4 contained in the docket; and

5 ‘‘(D) in the case of a final rule—

6 ‘‘(i) explains the reasons for any

7 major difference between the final rule and

8 the proposed rule;

9 ‘‘(ii) describes the impact of the final

10 rule on production and prices of agricul11 tural commodities, retail food prices, and

12 otherwise on the agricultural economy; and

13 ‘‘(iii) explains any significant dis14 agreements the Administrator may have

15 with the comments, evaluations, or rec16 ommendations contained in the report

17 under paragraph (7) or the benefits and

18 use information described in paragraph

19 (5)(A)(iii) and analysis in paragraph

20 (5)(D) as it bears on the final rule.

21 A final rule issued under this subsection shall

22 be effective upon the date of its publication in

23 the Federal Register.

24 ‘‘(9) MODIFICATION OR CANCELLATION.—
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1 ‘‘(A) A final rule shall state any require2 ments, classifications, or prohibitions imposed

3 by the rule, and shall state that each affected

4 registrant shall have a 30-day period from the

5 date of publication of the rule in the Federal

6 Register to apply for an amendment to the reg7 istration to comply with the rule or to request

8 voluntary cancellation of the registration. How9 ever, if the rule unconditionally prohibits all

10 uses of a pesticide, the rule may provide that

11 cancellation of the registration of the pesticide

12 is effective upon publication of the rule.

13 ‘‘(B) Notwithstanding any other provision

14 of this Act, if an application for an amendment

15 to the registration to make it comply with a

16 rule issued under subparagraph (A) is not sub17 mitted within such 30-day period, the Adminis18 trator may issue and publish in the Federal

19 Register an order canceling the registration, ef20 fective upon the date of publication of the order

21 in the Federal Register.

22 ‘‘(10) DENIAL OF APPLICATIONS.—Notwith23 standing any other provision of this Act, no applica24 tion for initial or amended registration of any pes25 ticide under section 3 or 24(c) may be approved if
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1 the registration would be inconsistent with a rule in

2 effect under this subsection.

3 ‘‘(11) AMENDMENT OF RULE.—A registrant, or

4 other interested person with the concurrence of the

5 registrant, may petition for the amendment or rev6 ocation of a rule that has been issued under this

7 subsection. The petition shall state the factual mate8 rial and argument that form the basis for the peti9 tion. The Administrator shall publish a notice of the

10 petition in the Federal Register and allow a 60-day

11 comment period thereon. Not later than 180 days

12 after publication of the notice, the Administrator

13 shall determine whether to deny the petition or to

14 propose to amend or revoke the rule, and publish the

15 determination and its basis in the Federal Register.

16 In making such a determination, the Administrator

17 shall give due regard to the desirability of finality,

18 to the opportunity that the petitioner had to present

19 the factual material and argument in question in the

20 prior rulemaking proceeding, and to any new evi21 dence submitted by the petitioner. If the Adminis22 trator proposes to amend or revoke the rule, then

23 the procedures established by paragraph (1) and

24 paragraphs (5) through (8) apply. A denial of a peti-
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1 tion shall be judicially reviewable as provided in

2 paragraph (12).

3 ‘‘(12) JUDICIAL REVIEW.—A decision not to

4 initiate a rulemaking published under paragraph (3),

5 a final rule or a withdrawal of a proposed rule pub6 lished under paragraph (8) or a denial of a petition

7 under paragraph (11) shall be judicially reviewable

8 in the manner specified by section 16(b)(2).’’.

9 SEC. 103. PESTICIDES IN REVIEW.

10 If the Administrator, on or before January 1, 1995,

11 has published a document instituting a special review pro12 ceeding or public interim administrative review proceeding

13 with respect to a particular pesticide or active ingredient

14 thereof, the Administrator may, in lieu of proceeding

15 under section 6(b) of the Federal Insecticide, Fungicide,

16 and Rodenticide Act, as amended by the Food Quality

17 Protection Act of 1995, elect to continue such review pro18 ceeding and, upon its completion, take action as warranted

19 in accordance with sections 3(c)(6), 6(b), and 6(d) as

20 those sections were in effect on the day before the date

21 of enactment of the Food Quality Protection Act of 1995.

22 SEC. 104. SUSPENSION.

23 (a) SECTION 6(c)(1).—The second sentence of sec24 tion 6(c)(1) (7 U.S.C. 136d(c)(1)) is amended to read:

25 ‘‘Except as provided in paragraph (3), no order of suspen-
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1 sion may be issued under this subsection unless the Ad2 ministrator has issued, or at the same time issues, a pro3 posed rule under subsection (b).’’.

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

5 136d(c)(3)) is amended by inserting after the first sen6 tence the following new sentence: ‘‘The Administrator may

7 issue an emergency order under this paragraph before is8 suing a proposed rule under subsection (b), provided that

9 the Administrator shall proceed expeditiously to issue a

10 proposed rule.’’.

11 SEC. 105. TOLERANCE REEVALUATION AS PART OF REREG12 ISTRATION.

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

14 by adding at the end the following:

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

16 sufficient information with respect to the die17 tary risk of a particular active ingredient, but

18 in any event no later than the time the Admin19 istrator makes a determination under subpara20 graph (C) or (D) with respect to pesticides con21 taining a particular active ingredient, the Ad22 ministrator shall—

23 ‘‘(i) reassess each associated tolerance

24 and exemption from the requirement for a

25 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. 106. SCIENTIFIC ADVISORY PANEL.

16 The first sentence of section 25(d) (7 U.S.C.

17 136w(d)) is amended—

18 (1) by striking ‘‘The Administrator shall’’ and

19 inserting ‘‘(1) IN GENERAL.—The Administrator

20 shall’’; 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. The Scientific Advisory Panel shall select the

2 scientists from 60 nominations submitted each by

3 the National Science Foundation and the National

4 Institutes of Health. Members of the Board shall be

5 compensated in the same manner as members of the

6 Panel.’’.

7 SEC. 107 CONFORMING AMENDMENTS.

8 (a) SECTION 3(c)(6).—Section 3(c)(6) (7 U.S.C.

9 136a(c)(6)) is amended to read as follows:

10 ‘‘(6) DENIAL OF APPLICATION FOR REGISTRA11 TION.—

12 ‘‘(A) Except as provided in subparagraph

13 (B), if the Administrator proposes to deny an

14 application for registration because it does not

15 satisfy the requirements of paragraph (5), the

16 Administrator shall notify the applicant of the

17 proposal and the reasons (including the factual

18 basis thereof). Unless the applicant makes the

19 necessary corrections to the application and no20 tifies the Administrator thereof during the 30-

21 day period beginning with the day after the

22 date the applicant receives the notice, or unless

23 during that time the applicant submits a re24 quest for a hearing, the Administrator may

25 issue an order denying the application. If dur-
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1 ing that time the Administrator does not receive

2 such corrections to the application or such a re3 quest for hearing, the Administrator may issue

4 an order denying the application. Such an order

5 shall be published in the Federal Register and

6 shall not be subject to judicial review. If during

7 that time the Administrator receives a request

8 for a hearing, a hearing shall be conducted

9 under section 6(d) of the Act. If such a hearing

10 is held, a decision after completion of such

11 hearing shall be final and shall be subject to ju12 dicial review under section 16(b)(1) of this Act.

13 ‘‘(B) The Administrator may deny an ap14 plication for registration because it does not

15 comply with the requirements of a rule issued

16 under section 6(b) of this Act. The Adminis17 trator shall notify the applicant of such denial.

18 Such notice shall explain why the application

19 does not comply with such requirements and

20 shall state that the applicant may petition to

21 amend or revoke such rule under section

22 6(b)(12) of this Act.’’.

23 (b) SECTION 3(c)(8).—Section 3(c)(8) (7 U.S.C.

24 136a(c)(8)) is repealed.
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1 (c) SECTION 3(d).—Section 3(d) (7 U.S.C. 136a(d))

2 is amended—

3 (1) in paragraph (1)(A), by striking ‘‘on the

4 initial classification and registered pesticides’’ and

5 inserting ‘‘under section 6(b) of this Act. Registered

6 pesticides’’; and

7 (2) in paragraph (2), by striking ‘‘the Adminis8 trator shall notify the registrant’’ and all that fol9 lows through the end of the paragraph, and insert10 ing ‘‘the Administrator may initiate a proceeding

11 under section 6(b) of the Act.’’.

12 (d) SECTION 4(e).—Section 4(e)(3)(B)(iii)(III) (7

13 U.S.C. 136a–1(e)(3)(B)(iii)(III)) is amended—

14 (1) by striking ‘‘section 6(d), except that the’’

15 and inserting ‘‘section 6(d). The’’; and

16 (2) by inserting after ‘‘guidelines.’’ the follow17 ing: ‘‘If a hearing is held, a decision after completion

18 of such hearing shall be final.’’.

19 (e) SECTION 6(c).—Section 6(c) (7 U.S.C. 136d(c))

20 is amended in paragraph (4) by striking ‘‘section 16’’ and

21 inserting ‘‘section 16(b)(1)’’.

22 (f) SECTION 6(d).—Section 6(d) (7 U.S.C. 136d(d))

23 is amended—

24 (1) by amending the first sentence to read as

25 follows: ‘‘If a hearing is requested pursuant to sec-
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1 tion 3(c)(2)(B)(iv), 3(c)(6), 4(e)(3)(B)(iii)(III), 6(b),

2 6(c)(2), or 6(e)(2), such hearing shall be held for the

3 purpose of receiving evidence relevant and material

4 to the issues raised by the request for hearing.’’; and

5 (2) by striking the ninth sentence and all that

6 follows through the end of the subsection and insert7 ing the following: ‘‘A hearing under this subsection

8 shall be held in accordance with the provisions of

9 sections 554, 556, and 557 of title 5, United States

10 Code.’’.

11 (g) SECTION 16(b).—Section 16(b) (17 U.S.C.

12 136n(b)) is amended—

13 (1) by striking ‘‘(b) REVIEW BY COURT OF AP14 PEALS.—In the case of’’ and inserting the following:

15 ‘‘(b) REVIEW BY COURT OF APPEALS.—

16 ‘‘(1) REVIEW OF CERTAIN ORDERS.—In the

17 case of’’;

18 (2) by striking ‘‘under this section’’ in the sixth

19 sentence of paragraph (1) (as so designated) and in20 serting ‘‘under this paragraph’’, and

21 (3) by adding at the end the following new

22 paragraph:

23 ‘‘(2) REVIEW OF CERTAIN RULES.—In the case

24 of actual controversy as to the validity of any rule

25 issued by the Administrator under section 6(b)(8),
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1 any decision by the Administrator under section

2 6(b)(8) not to issue a proposed rule or to withdraw

3 a proposed rule, or any denial of a petition to revoke

4 or amend a final rule under section 6(b)(11), any

5 person who will be adversely affected by such rule or

6 decision who filed comments in the proceedings lead7 ing to the rule or decision may obtain judicial review

8 by filing a petition in the United States court of ap9 peals for the circuit wherein such person resides or

10 has a place of business, within 60 days after the is11 suance of such rule or decision. The court shall hold

12 unlawful and set aside such rule or decision if it

13 finds that a rule of, or ruling by, the hearing exam14 iner under section 6(b)(6), limiting such petitioner’s

15 cross-examination or oral presentations, has pre16 cluded disclosure of disputed material facts which

17 was necessary to a full determination by the Admin18 istrator of the rulemaking proceeding taken as a

19 whole. A copy of the petition shall be forthwith

20 transmitted by the clerk of the court to the Adminis21 trator or any officer designated by the Administrator

22 for that purpose, and thereupon the Administrator

23 shall file in court the record of the proceedings on

24 which the Administrator based such rule or decision,

25 as provided in section 2112 of title 28, United
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1 States Code. Upon the filing of such petition the

2 court shall have exclusive jurisdiction to affirm or

3 set aside such rule or decision in whole or in part.

4 The standard of review shall be that set forth in sec5 tion 706 of title 5, United States Code. The judg6 ment of the court under this paragraph shall be

7 final, subject to review by the Supreme Court upon

8 certiorari or certification as provided in section 1254

9 of title 28, United States Code. The commencement

10 of proceedings under this section shall not, unless

11 specifically ordered by the court to the contrary, op12 erate as a stay of an order.’’.

13 (h) SECTION 25(a).—Section 25(a) (7 U.S.C.

14 136w(a)) is amended by adding at the end the following:

15 ‘‘(5) EXCEPTION.—The requirements of this

16 subsection shall not apply to any rule or rulemaking

17 proceeding under section 6(b).’’.

18 (i) SECTION 25(d).—Section 25(d) (7 U.S.C.

19 136w(d)) is amended—

20 (1) in the first sentence by striking ‘‘in notices

21 of intent issued under subsection 6(b) and’’; and

22 (2) in the second sentence by striking ‘‘notices

23 of intent and’’ and by striking ‘‘6(b) or’’.

24 (j) SECTION 25(e).—Section 25(e) (7 U.S.C.

25 136w(e)) is amended—
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1 (1) by striking the period at the end of the sec2 ond sentence; and

3 (2) by inserting at the end of the second sen4 tence ‘‘, except for any action that may be taken

5 under section 6(b).’’.

6 TITLE II—MINOR USE CROP PROTECTION

7 ACT OF 1995

8 SEC. 201. SHORT TITLE.

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

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

11 (b) REFERENCE.—Whenever in this title an amend12 ment or repeal is expressed in terms of an amendment

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

14 shall be considered to be made to a section or other provi15 sion of the Federal Insecticide, Fungicide, and

16 Rodenticide Act.

17 SEC. 202. MINOR CROP PROTECTION.

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

19 amended by adding at the end the following:

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

21 use of a pesticide on an animal, on a commercial agricul22 tural crop or site, or for the protection of public health

23 where—

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

25 crop is less than 300,000 acres; or
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1 ‘‘(2) the Administrator, in consultation with the

2 Secretary of Agriculture, determines that, based on

3 information provided by an applicant for registration

4 or a registrant, the use does not provide sufficient

5 economic incentive to support the initial registration

6 or continuing registration of a pesticide for such use;

7 and—

8 ‘‘(A) there are insufficient efficacious alter9 native registered pesticides available for the

10 use; or

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

12 greater risks to the environment or human

13 health; or

14 ‘‘(C) the pesticide plays or will play, a sig15 nificant part in managing pest resistance; or

16 ‘‘(D) the pesticide plays or will play a sig17 nificant part in an integrated pest management

18 program.

19 The status as a minor use under this subsection

20 shall continue as long as the Administrator has not

21 determined that, based on existing data, such use

22 may cause an unreasonable adverse effect on the en23 vironment and the use otherwise qualifies for such

24 status.’’.
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1 (b) EXCLUSIVE USE OF MINOR USE PESTICIDES.—

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

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

4 (iv), respectively, and by inserting after clause (i) the fol5 lowing:

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

7 for data submitted to support the applica8 tion for the original registration of a pes9 ticide under clause (i) shall be extended

10 one additional year for each 3 minor uses

11 registered after the date of enactment of

12 this clause and, before the expiration of

13 the period of exclusive use under this

14 clause, up to a total of 3 additional years

15 for all minor uses registered by the Admin16 istrator if the Administrator in consulta17 tion with the Secretary of Agriculture de18 termines that, based on information pro19 vided by an applicant for registration or a

20 registrant, that—

21 ‘‘(I) there are insufficient effica22 cious alternative registered pesticides

23 available for the use; or
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1 ‘‘(II) the alternatives to the pes2 ticide pose greater risks to the envi3 ronment or human health; or

4 ‘‘(III) the pesticide plays or will

5 play a significant part in managing

6 pest resistance; or

7 ‘‘(IV) the pesticide plays or will

8 play a significant part in an inte9 grated pest management program.

10 The registration of a pesticide for a minor

11 use on a crop grouping established by the

12 Administrator shall be considered for pur13 poses of this clause one minor use for each

14 representative crop for which data are pro15 vided in the crop grouping. Any additional

16 exclusive use period under this clause shall

17 be modified as appropriate or terminated if

18 the registrant voluntarily cancels the prod19 uct or deletes from the registration the

20 minor uses which formed the basis for the

21 extension of the additional exclusive use

22 period or if the Administrator determines

23 that the registrant is not actually market24 ing the product for such minor uses.’’.
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1 (c) TIME EXTENSIONS FOR DEVELOPMENT OF

2 MINOR USE DATA.—

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

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

5 end the following:

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

7 the Administrator shall, in the case of a

8 minor use, extend the deadline for the pro9 duction of residue chemistry data under

10 this subparagraph for data required solely

11 to support that minor use until the final

12 deadline for submission of data under sec13 tion 4 for the other use of the pesticide es14 tablished as of the date of enactment of

15 the Food Quality Protection Act of 1995,

16 if—

17 ‘‘(I) the data to support other

18 uses of the pesticide on a food are

19 being provided;

20 ‘‘(II) the registrant, in submit21 ting a request for such an extension,

22 provides a schedule, including interim

23 dates to measure progress, to assure

24 that the data production will be com-
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1 pleted before the expiration of the ex2 tension period;

3 ‘‘(III) the Administrator has de4 termined that such extension will not

5 significantly delay the Administrator’s

6 schedule for issuing a reregistration

7 eligibility determination required

8 under section 4; and

9 ‘‘(IV) the Administrator has de10 termined in writing that based on ex11 isting data, such extension would not

12 significantly increase the risk of any

13 unreasonable adverse effect on the en14 vironment. If the Administrator

15 grants an extension under this clause,

16 the Administrator shall monitor the

17 development of the data and shall en18 sure that the registrant is meeting the

19 schedule for the production of the

20 data. If the Administrator determines

21 that the registrant is not meeting or

22 has not met the schedule for the pro23 duction of such data, the Adminis24 trator may proceed in accordance with

25 clause (iv) regarding the continued
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1 registration of the affected products

2 with the minor use and shall inform

3 the public of such action. Notwith4 standing the provisions of this clause,

5 the Administrator may take action to

6 modify or revoke the extension under

7 this clause if the Administrator deter8 mines that the extension for the minor

9 use may cause an unreasonable ad10 verse effect on the environment. In

11 such circumstance, the Administrator

12 shall provide, in writing to the reg13 istrant, a notice revoking the exten14 sion of time for submission of data.

15 Such data shall instead be due in ac16 cordance with the date established by

17 the Administrator for the submission

18 of the data.’’.

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

20 4(e)(2)(B), and 4(f)(2)(B) (7 U.S.C. 136a–

21 1(d)(4)(B), (e)(2)(B), and (f)(2)(B)) are each

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

23 the request of a registrant, the Administrator shall,

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

25 the production of residue chemistry data under this
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1 subparagraph for data required solely to support

2 that minor use until the final deadline for submis3 sion of data under this section for the other uses of

4 the pesticide established as of the date of enactment

5 of the Food Quality Protection Act of 1996 if—

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

7 pesticide on a food are being provided;

8 ‘‘(ii) the registrant, in submitting a request

9 for such an extension provides a schedule, in10 cluding interim dates to measure progress, to

11 assure that the data production will be com12 pleted before the expiration of the extension

13 period;

14 ‘‘(iii) the Administrator has determined

15 that such extension will not significantly delay

16 the Administrator’s schedule for issuing a re17 registration eligibility determination required

18 under this section; and

19 ‘‘(iv) the Administrator has determined in

20 writing that based on existing data, such exten21 sion would not significantly increase the risk of

22 any unreasonable adverse effect on the environ23 ment. If the Administrator grants an extension

24 under this subparagraph, the Administrator

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

2 schedule for the production of the data. If the

3 Administrator determines that the registrant is

4 not meeting or has not met the schedule for the

5 production of such data, the Administrator may

6 proceed in accordance with clause (iv) of section

7 3(c)(2)(B) or other provisions of this section, as

8 appropriate, regarding the continued registra9 tion of the affected products with the minor use

10 and shall inform the public of such action. Not11 withstanding the provisions of this subpara12 graph, the Administrator may take action to

13 modify or revoke the extension under this sub14 paragraph if the Administrator determines that

15 the extension for the minor use may cause an

16 unreasonable adverse effect on the environment.

17 In such circumstance, the Administrator shall

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

20 data. Such data shall instead be due in accord21 ance with the date then established by the Ad22 ministrator for submission of the data.’’.

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

24 136a(c)(2)) is amended—

25 (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 non-minor 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

18 required by the Administrator, pursuant to

19 paragraph (2)(E), and if the Administrator de20 nies in whole or in part such data waiver re21 quest, the registrant shall have a full time pe22 riod for providing such data. For purposes of

23 this subparagraph, the term ‘full time period’

24 means the time period originally established by

25 the Administrator for submission of such data,
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1 beginning with the data of receipt by the reg2 istrant 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 Minor Use Crop Protection Act of 1995,

24 for the submission of data under this section

25 for the supported uses identified pursuant to
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1 this paragraph unless the Administrator deter2 mines 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 Minor

4 Use Crop Protection Act of 1995, for the sub5 mission of data under this section for the sup6 port uses identified pursuant to this subpara7 graph unless the Administrator determines that

8 the absence of the data is significant enough

9 to cause human health or environmental con10 cerns. On the basis of such determination the

11 Administrator may refuse the request for exten12 sion by the registrant. Upon receipt of the re13 quest from the registrant, the Administrator

14 shall publish in the Federal Register a notice

15 of the receipt of the request and the effective

16 date upon which the uses not being supported

17 will be voluntarily deleted from the registration

18 pursuant to section 6(f)(1). If the Adminis19 trator grants an extension under this subpara20 graph, the Administrator shall monitor the de21 velopment of the data for the uses being sup22 ported and shall ensure that the registrant is

23 meeting the schedule for the production of such

24 data. If the Administrator determines that the

25 registrant is not meeting or has not met the
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1 schedule for the production of such data, the

2 Administrator may proceed in accordance with

3 section 3(c)(2)(B)(iv) regarding the continued

4 registration of the affected products with the

5 minor and other uses and shall inform the pub6 lic of such action in accordance with section

7 6(f)(2). Notwithstanding this subparagraph, the

8 Administrator may deny, modify, or revoke the

9 temporary extension under this subparagraph if

10 the Administrator determines that the continu11 ation of the minor use may cause an unreason12 able adverse effect on the environment. In the

13 event of modification or revocation, the Admin14 istrator shall provide, in writing, to the reg15 istrant, a notice revoking the temporary exten16 sion and establish a new effective date by which

17 the minor use shall be deleted from the reg18 istration.’’.

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

20 136a(c)(2)(B)), as amended by subsection (c), is

21 further amended by adding at the end the following:

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

23 support a specific minor use of the pesticide,

24 but is supporting and providing data in a timely

25 and adequate fashion to support uses of the
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1 pesticide on a food, or if all uses of the pes2 ticide are nonfood uses and the registrant does

3 not commit to support a specific minor use of

4 the pesticide but is supporting and providing

5 data in a timely and adequate fashion to sup6 port other nonfood uses of the pesticide, the

7 Administrator, at the written request of the

8 registrant, shall not take any action pursuant

9 to this clause in regard to such unsupported

10 minor use until the final deadline established as

11 of the date of enactment of the Minor Use Crop

12 Production Act of 1995, for the submission of

13 data under section 4 for the supported uses

14 identified pursuant to this clause unless the Ad15 ministrator determines that the absence of the

16 data is significant enough to cause human

17 health or environmental concerns. On the basis

18 of such determination, the Administrator may

19 refuse the request for extension by the reg20 istrant. Upon receipt of the request from the

21 registrant, the Administrator shall publish in

22 the Federal Register a notice of receipt of the

23 request and the effective date upon which the

24 uses not being supported will be voluntarily de25 leted from the registration pursuant to section
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1 6(f)(1). If the Administrator grants an exten2 sion under this clause, the Administrator shall

3 monitor the development of the data for the

4 uses being supported and shall ensure that the

5 registrant is meeting the schedule for the pro6 duction of such data. If the Administrator de7 termines that the registrant is not meeting or

8 has not met the schedule for the production of

9 such data, the Administrator may proceed in

10 accordance with clause (iv) of this subpara11 graph regarding the continued registration of

12 the affected products with the minor and other

13 uses and shall inform the public of such action

14 in accordance with section 6(f)(2). Notwith15 standing the provisions of this clause, the Ad16 ministrator may deny, modify, or revoke the

17 temporary extension under this subparagraph if

18 the Administrator determines that the continu19 ation of the minor use may cause an unreason20 able adverse effect on the environment. In the

21 event of modification or revocation, the Admin22 istrator shall provide, in writing, to the reg23 istrant, a notice revoking the temporary exten24 sion and establish a new effective date by which
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1 the minor use shall be deleted from the reg2 istration.’’.

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

5 amended by adding at the end the following:

6 ‘‘(4) UTILIZATION OF DATA FOR VOLUNTARILY

7 CANCELED CHEMICALS.—When an application is

8 filed with the Administrator for the registration of

9 a pesticide for a minor use and another registrant

10 subsequently voluntarily cancels its registration for

11 an identical or substantially similar pesticide for an

12 identical or substantially similar use, the Adminis13 trator shall process, review, and evaluate the pend14 ing application as if the voluntary cancellation had

15 not yet taken place, except that the Administrator

16 shall not take such action if the Administrator deter17 mines that such minor use may cause an unreason18 able adverse effect on the environment. In order to

19 rely on this paragraph, the applicant must certify

20 that it agrees to satisfy any outstanding data re21 quirements necessary to support the reregistration of

22 the pesticide in accordance with the data submission

23 schedule established by the Administrator.’’.

24 (h) ENVIRONMENTAL PROTECTION AGENCY MINOR

25 USE PROGRAM.—The Federal Insecticide, Fungicide, and
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1 Rodenticide Act (7 U.S.C. 136 et seq.) is amended by re2 designating sections 30 and 31 as sections 32 and 33, re3 spectively, and adding after section 29 the following:

4 ‘‘SEC. 30. ENVIRONMENTAL PROTECTION AGENCY MINOR

5 USE PROGRAM.

6 ‘‘The Administrator shall assure coordination of

7 minor use issues through the establishment of a minor use

8 program within the Office of Pesticide Programs. Such of9 fice shall be responsible for coordinating the development

10 of minor use programs and policies and consulting with

11 growers regarding minor use issues and registrations and

12 amendments which are submitted to the Environmental

13 Protection Agency.’’.

14 (i) DEPARTMENT OF AGRICULTURE MINOR USE

15 PROGRAM.—The Federal Insecticide, Fungicide, and

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

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

18 following:

19 ‘‘SEC. 31. DEPARTMENT OF AGRICULTURE MINOR USE

20 PROGRAM.

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

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

23 shall ensure the coordination of the responsibilities of the

24 Department of Agriculture related to minor uses of pes25 ticides, including—
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1 ‘‘(1) carrying out the Inter-Regional Project

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

3 Act entitled ‘An Act to facilitate the work of the De4 partment of Agriculture, and for other purposes’ (7

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

6 monitoring program established under section 1651

7 of the Food, Agriculture, Conservation, and Trade

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

9 ‘‘(2) supporting integrated pest management

10 research;

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

12 minor uses; and

13 ‘‘(4) providing assistance for minor use reg14 istrations, tolerances, and reregistrations with the

15 Environmental Protection Agency.

16 ‘‘(b) MATCHING FUND PROGRAM.—

17 ‘‘(1) ESTABLISHMENT.—The Secretary of Agri18 culture, in consultation with the Administrator, shall

19 establish and administer a minor use matching fund

20 program. The matching fund program shall be uti21 lized to ensure the continued availability of minor

22 use crop protection chemicals, including the develop23 ment of data to support minor use pesticide registra24 tions and reregistrations. Access to the matching

25 fund program shall be available to any entity which
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1 desires to develop data to support minor use reg2 istrations. Priority for access to the fund shall be

3 given those entities that do not directly receive funds

4 from the sale of products registered on minor uses.

5 Any entity that seeks such funding under this para6 graph shall be required to match such funds with an

7 equal amount of its own funds. Any data developed

8 through the matching fund program shall be jointly

9 owned by the Department of Agriculture and by the

10 entity that receives such funding. Any data devel11 oped under this subsection shall be subject to the

12 provisions of section 3(c)(1)(F). All compensation

13 received by the Department of Agriculture in return

14 for the use of such data under the matching fund

15 program shall be returned to a revolving fund which

16 will support the matching fund program.

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

18 be appropriated for the revolving fund for the

19 matching fund program an annual sum not to ex20 ceed $10,000,000.’’.
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1 TITLE III—DATA COLLECTION ACTIVITIES

2 TO ASSURE THE HEALTH OF INFANTS

3 AND CHILDREN AND OTHER MEAS4 URES

5 SEC. 301. DATA COLLECTION ACTIVITIES TO ASSURE THE

6 HEALTH OF INFANTS AND CHILDREN.

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

8 consultation with the Administrator of the Environmental

9 Protection Agency and the Secretary of Health and

10 Human Services, shall coordinate the development and im11 plementation of survey procedures to ensure that adequate

12 data on food consumption patterns of infants and children

13 are collected.

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

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

16 collection of data on food consumption patterns of a statis17 tically valid sample of infants and children.

18 (c) RESIDUE SURVEILLANCE.—The Secretary of Ag19 riculture shall ensure that the residue surveillance activi20 ties conducted by the Department of Agriculture provide

21 for the improved surveillance of pesticide residues, includ22 ing guidelines for the use of comparable analytical and

23 standardized reporting methods, and the increased sam24 pling of foods most likely consumed by infants and chil25 dren.
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1 SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION.

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

3 collect data of statewide or regional significance on the

4 use of pesticides to control pests and diseases of major

5 crops and crops of dietary significance, including fruits

6 and vegetables.

7 (b) COLLECTION.—The data shall be collected by sur8 veys of farmers or from other sources offering statistically

9 reliable data.

10 (c) COORDINATION.—The Secretary shall, as appro11 priate, coordinate with the Administrator of the Environ12 mental Protection Agency in the design of the surveys and

13 make available to the Administrator the aggregate results

14 of the surveys to assist the Administrator in benefits de15 terminations with respect to pesticide regulatory decisions.

16 SEC. 303. INTEGRATED PEST MANAGEMENT.

17 The Secretary of Agriculture, in cooperation with the

18 Administrator, shall implement research, demonstration,

19 and education programs to support adoption of integrated

20 pest management. Integrated Pest Management is a sus21 tainable approach to managing pests by combining biologi22 cal, cultural, physical, and chemical tools in a way that

23 minimizes economic, health, and environmental risks. The

24 Secretary of Agriculture and the Administrator shall make

25 information on integrated pest management widely avail26 able to pesticide users, including Federal agencies. Federal
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1 agencies shall use integrated pest management techniques

2 in carrying out pest management activities and shall pro3 mote integrated pest management through procurement

4 and regulatory policies, and other activities.

5 SECTION 1. SHORT TITLE.

6 This Act may be cited as the ‘‘Food Quality Protection

7 Act of 1996’’.

8 TITLE I—SUSPENSION9 APPLICATORS

10 SEC. 101. REFERENCE.

11 Whenever in this title an amendment or repeal is ex12 pressed in terms of an amendment to, or repeal of, a section

13 or other provision, the reference shall be considered to be

14 made to a section or other provision of the Federal Insecti15 cide, Fungicide, and Rodenticide Act.

16 Subtitle A—Suspension

17 SEC. 102. SUSPENSION.

18 (a) SECTION 6(c)(1).—The second sentence of section

19 6(c)(1) (7 U.S.C. 136d(c)(1)) is amended to read: ‘‘Except

20 as provided in paragraph (3), no order of suspension may

21 be issued under this subsection unless the Administrator has

22 issued, or at the same time issues, a notice of intention to

23 cancel the registration or change the classification of the

24 pesticide under subsection (b).’’.
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1 (b) SECTION 6(c)(3).—Section 6(c)(3) (7 U.S.C.

2 136d(c)(3)) is amended by inserting after the first sentence

3 the following new sentence: ‘‘The Administrator may issue

4 an emergency order under this paragraph before issuing a

5 notice of intention to cancel the registration or change the

6 classification of the pesticide under subsection (b) and the

7 Administrator shall proceed to issue the notice under sub8 section (b) within 90 days of issuing an emergency order.

9 If the Administrator does not issue a notice under sub10 section (b) within 90 days of issuing an emergency order,

11 the emergency order shall expire.’’.

12 SEC. 103. TOLERANCE REEVALUATION AS PART OF REREG13 ISTRATION.

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

15 adding at the end the following:

16 ‘‘(E) As soon as the Administrator has suf17 ficient information with respect to the dietary

18 risk of a particular active ingredient, but in any

19 event no later than the time the Administrator

20 makes a determination under subparagraph (C)

21 or (D) with respect to pesticides containing a

22 particular active ingredient, the Administrator

23 shall—

24 ‘‘(i) reassess each associated tolerance

25 and exemption from the requirement for a
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1 tolerance issued under section 408 of the

2 Federal Food, Drug, and Cosmetic Act (21

3 U.S.C. 346a) taking into account available

4 information and reasonable assumptions

5 concerning the dietary exposure levels of

6 food consumers (and major identifiable sub7 groups of food consumers, including infants

8 and children) to residue of the pesticide in

9 food and available information and reason10 able assumptions concerning the variability

11 of the sensitivities of major identifiable

12 groups, including infants and children;

13 ‘‘(ii) determine whether such tolerance

14 or exemption meets the requirements of that

15 Act;

16 ‘‘(iii) determine whether additional tol17 erances or exemptions should be issued;

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

19 notice setting forth the determinations made

20 under this subparagraph; and

21 ‘‘(v) commence promptly such proceed22 ings under this Act and section 408 of the

23 Federal Food, Drug, and Cosmetic Act as

24 are warranted by such determinations.’’.
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1 SEC. 104. SCIENTIFIC ADVISORY PANEL.

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

3 (1) in the first sentence, by striking ‘‘The Ad4 ministrator shall’’ and inserting:

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

6 and

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

8 ‘‘(2) SCIENCE REVIEW BOARD.—There is estab9 lished a Science Review Board to consist of 60 sci10 entists who shall be available to the Scientific Advi11 sory Panel to assist in reviews conducted by the

12 Panel. Members of the Board shall be selected in the

13 same manner as members of temporary subpanels cre14 ated under paragraph (1). Members of the Board shall

15 be compensated in the same manner as members of

16 the Panel.’’.

17 SEC. 105. NITROGEN STABILIZER.

18 (a) SECTION 2.—Section 2 (7 U.S.C. 136) is amend19 ed—

20 (1) in subsection (a)—

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

22 ‘‘defoliant,’’ and inserting ‘‘, or nitrogen sta23 bilizer’’ after ‘‘desiccant’’;

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

25 ‘‘and’’;
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1 (C) at the end of paragraph (4) by striking

2 the period and inserting ‘‘; and’’; and

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

4 ‘‘(5) in the case of a nitrogen stabilizer, an in5 gredient which will prevent or hinder the process of

6 nitrification, denitrification, ammonia volatilization,

7 or urease production through action affecting soil bac8 teria.’’;

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

10 ‘‘(2)’’ and by inserting ‘‘and (3) any nitrogen sta11 bilizer,’’ after ‘‘desiccant,’’; and

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

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

14 stabilizer’ means any substance or mixture of substances in15 tended for preventing or hindering the process of nitrifica16 tion, denitrification, ammonia volatilization, or urease pro17 duction through action upon soil bacteria. Such term shall

18 not include—

19 ‘‘(1) dicyandiamide;

20 ‘‘(2) ammonium thiosulfate; or

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

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

23 section 3 prior to January 1, 1992; and

24 ‘‘(B) that was in commercial agronomic use

25 prior to January 1, 1992, with respect to which
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1 after January 1, 1992, the distributor or seller

2 of the substance or mixture has made no specific

3 claim of prevention or hindering of the process

4 of nitrification, denitrification, ammonia vola5 tilization urease production regardless of the ac6 tual use or purpose for, or future use or purpose

7 for, the substance or mixture.

8 Statements made in materials required to be submitted to

9 any State legislative or regulatory authority, or required

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

11 literature accompanying any such substance or mixture

12 shall not be deemed a specific claim within the meaning

13 of this subsection.’’.

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

15 amended by adding at the end the following:

16 ‘‘(4) MIXTURES OF NITROGEN STABILIZERS AND

17 FERTILIZER PRODUCTS.—Any mixture or other com18 bination of—

19 ‘‘(A) 1 or more nitrogen stabilizers reg20 istered under this Act; and

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

22 shall not be subject to the provisions of this section or

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

24 other combination is accompanied by the labeling re25 quired under this Act for the nitrogen stabilizer con-
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1 tained in the mixture or other combination, the mix2 ture or combination is mixed or combined in accord3 ance with such labeling, and the mixture or combina4 tion does not contain any active ingredient other than

5 the nitrogen stabilizer.’’.

6 SEC. 106. AUTHORITY OF STATES.

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

8 amended by section 105, is further amended—

9 (1) in subsection (aa), by adding at the end the

10 following new sentence: ‘‘The term ‘State’ does not in11 clude a local government, as defined in subsection

12 (ii), and is not intended to grant any authority or

13 to otherwise refer to local governments or political

14 subdivisions of a State.’’; and

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

16 ‘‘(ii) LOCAL GOVERNMENT.—The term ‘local govern17 ment’ means any political subdivision of a State including

18 counties, townships, cities, towns, parishes, and boroughs,

19 whether home rule entities or not, or any local agency or

20 body of any type which has an organized existence, govern21 mental character, and substantial autonomy including

22 independent or autonomous school districts, housing au23 thorities, and other special districts.’’.
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1 (b) RECORDS.—Section 8(b) (7 U.S.C. 136f(b)) is

2 amended by striking ‘‘or political subdivision’’ in the first

3 sentence.

4 (c) DELEGATION AND COOPERATION.—Section 22(b)

5 (7 U.S.C. 136t(b)) is amended by striking ‘‘or any political

6 subdivision thereof’’.

7 (d) AUTHORITY OF STATES.—Section 24 (7 U.S.C.

8 136v) is amended by adding at the end the following:

9 ‘‘(d) LOCAL REGULATION.—Subject to subsection (e),

10 a local government shall not impose or continue in effect

11 any requirement or regulation regarding pesticides or de12 vices.

13 ‘‘(e) LOCALLY SPECIFIC STATE REGULATION.—Noth14 ing in this section shall prohibit a State from enforcing

15 laws, enacting laws, or implementing regulations applica16 ble to local governments regarding the sale or use of any

17 federally registered pesticide or device.’’.

18 (e) AUTHORITY OF ADMINISTRATOR.—The first sen19 tence of section 25(e) (7 U.S.C. 136w(e)) is amended by

20 striking ‘‘or political subdivision thereof’’.

21 SEC. 107. PERIODIC REGISTRATION REVIEW.

22 (a) SECTION 6.—Section 6 (7 U.S.C. 136d) is amend23 ed—

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

25 and inserting the following:
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1 ‘‘(a) EXISTING STOCKS AND INFORMATION.—’’; and

2 (2) by amending paragraph (1) of subsection (a)

3 to read as follows:

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

5 may permit the continued sale and use of existing

6 stocks of a pesticide whose registration is suspended

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

8 such extent, under such conditions, and for such uses

9 as the Administrator determines that such sale or use

10 is not inconsistent with the purposes of this Act.’’.

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

12 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 Admin16 istrator shall by regulation establish a procedure for

17 accomplishing the periodic review of registrations.

18 The goal of these regulations shall be a review of a

19 pesticide’s registration every 15 years. No registration

20 shall be canceled as a result of the registration review

21 process unless the Administrator follows the proce22 dures and substantive requirements of section 6.

23 ‘‘(B) LIMITATION.—Nothing in this subsection

24 shall prohibit the Administrator from undertaking

25 any other review of a pesticide pursuant to this Act.
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1 ‘‘(2)(A) DATA.—The Administrator shall use the

2 authority in subsection (c)(2)(B) to require the sub3 mission of data when such data are necessary for a

4 registration review.

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

6 EXEMPTION.—For purposes of this subsection, the pro7 visions of subsections (c)(1), (c)(2)(B), and (c)(2)(D)

8 shall be utilized for and be applicable to any data re9 quired for registration review.’’.

10 Subtitle B—Training for Mainte11 nance Applicators and Service

12 Technicians

13 SEC. 120. MAINTENANCE APPLICATORS AND SERVICE TECH14 NICIANS DEFINITIONS.

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

16 is amended by adding at the end the following:

17 ‘‘(jj) MAINTENANCE APPLICATOR.—The term ‘mainte18 nance applicator’ means any individual who, in the prin19 cipal course of such individual’s employment, uses, or su20 pervises the use of, a pesticide not classified for restricted

21 use (other than a ready to use consumer products pes22 ticides); for the purpose of providing structural pest control

23 or lawn pest control including janitors, general mainte24 nance personnel, sanitation personnel, and grounds mainte25 nance personnel. The term ‘maintenance applicator’ does
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1 not include private applicators as defined in section 2(e)(2);

2 individuals who use antimicrobial pesticides, sanitizers or

3 disinfectants; individuals employed by Federal, State, and

4 local governments or any political subdivisions thereof, or

5 individuals who use pesticides not classified for restricted

6 use in or around their homes, boats, sod farms, nurseries,

7 greenhouses, or other noncommercial property.

8 ‘‘(kk) SERVICE TECHNICIAN.—The term ‘service tech9 nician’ means any individual who uses or supervises the

10 use of pesticides (other than a ready to use consumer prod11 ucts pesticide) for the purpose of providing structural pest

12 control or lawn pest control on the property of another for

13 a fee. The term ‘service technician’ does not include individ14 uals who use antimicrobial pesticides, sanitizers or dis15 infectants; or who otherwise apply ready to use consumer

16 products pesticides.’’.

17 SEC. 121. MINIMUM REQUIREMENTS FOR TRAINING OF

18 MAINTENANCE APPLICATORS AND SERVICE

19 TECHNICIANS.

20 The Federal Insecticide, Fungicide, and Rodenticide

21 Act (7 U.S.C. 136 et seq.) is amended—

22 (1) by redesignating sections 30 and 31 as sec23 tions 33 and 34, respectively; and

24 (2) by adding after section 29 the following:
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1 ‘‘SEC. 30. MINIMUM REQUIREMENTS FOR TRAINING OF

2 MAINTENANCE APPLICATORS AND SERVICE

3 TECHNICIANS.

4 ‘‘Each State may establish minimum requirements for

5 training of maintenance applicators and service techni6 cians. Such training may include instruction in the safe

7 and effective handling and use of pesticides in accordance

8 with the Environmental Protection Agency approved label9 ing, and instruction in integrated pest management tech10 niques. The authority of the Administrator with respect to

11 minimum requirements for training of maintenance appli12 cators and service technicians shall be limited to ensuring

13 that each State understands the provisions of this section.’’.

14 TITLE II—MINOR USE CROP PRO15 TECTION, ANTIMICROBIAL

16 PESTICIDE REGISTRATION

17 REFORM, AND PUBLIC

18 HEALTH PESTICIDES

19 SEC. 201. REFERENCE.

20 Whenever in this title an amendment or repeal is ex21 pressed in terms of an amendment to, or repeal of, a section

22 or other provision, the reference shall be considered to be

23 made to a section or other provision of the Federal Insecti24 cide, Fungicide, and Rodenticide Act.
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1 Subtitle A—Minor Use Crop

2 Protection

3 SEC. 210. MINOR CROP PROTECTION.

4 (a) DEFINITION.—Section 2 (7 U.S.C. 136), as amend5 ed by section 120, is further amended by adding at the end

6 the following:

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

8 use of a pesticide on an animal, on a commercial agricul9 tural crop or site, or for the protection of public health

10 where—

11 ‘‘(1) the total United States acreage for the crop

12 is less than 300,000 acres, as determined by the Sec13 retary of Agriculture; or

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

15 Secretary of Agriculture, determines that, based on

16 information provided by an applicant for registration

17 or a registrant, the use does not provide sufficient eco18 nomic incentive to support the initial registration or

19 continuing registration of a pesticide for such use

20 and—

21 ‘‘(A) there are insufficient efficacious alter22 native registered pesticides available for the use;

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

24 pose greater risks to the environment or human

25 health;
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1 ‘‘(C) the minor use pesticide plays or will

2 play a significant part in managing pest resist3 ance; or

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

5 play a significant part in an integrated pest

6 management program.

7 The status as a minor use under this subsection shall con8 tinue as long as the Administrator has not determined that,

9 based on existing data, such use may cause an unreasonable

10 adverse effect on the environment and the use otherwise

11 qualifies for such status.’’.

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

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

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

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

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

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

18 provided under clause (i) shall be extended

19 1 additional year for each 3 minor uses reg20 istered after the date of enactment of this

21 clause and within 7 years of the commence22 ment of the exclusive use period, up to a

23 total of 3 additional years for all minor

24 uses registered by the Administrator if the

25 Administrator, in consultation with the
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1 Secretary of Agriculture, determines that,

2 based on information provided by an appli3 cant for registration or a registrant, that—

4 ‘‘(I) there are insufficient effica5 cious alternative registered pesticides

6 available for the use;

7 ‘‘(II) the alternatives to the minor

8 use pesticide pose greater risks to the

9 environment or human health;

10 ‘‘(III) the minor use pesticide

11 plays or will play a significant part in

12 managing pest resistance; or

13 ‘‘(IV) the minor use pesticide

14 plays or will play a significant part in

15 an integrated pest management pro16 gram.

17 The registration of a pesticide for a minor

18 use on a crop grouping established by the

19 Administrator shall be considered for pur20 poses of this clause 1 minor use for each

21 representative crop for which data are pro22 vided in the crop grouping. Any additional

23 exclusive use period under this clause shall

24 be modified as appropriate or terminated if

25 the registrant voluntarily cancels the prod-
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1 uct or deletes from the registration the

2 minor uses which formed the basis for the

3 extension of the additional exclusive use pe4 riod or if the Administrator determines that

5 the registrant is not actually marketing the

6 product for such minor uses.’’;

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

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

9 (iii)’’; and

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

11 paragraph (1), by adding the following:

12 ‘‘(v) The period of exclusive use pro13 vided under clause (ii) shall not take into

14 effect until 1 year after enactment of this

15 clause, except where an applicant or reg16 istrant is applying for the registration of a

17 pesticide containing an active ingredient

18 not previously registered.

19 ‘‘(vi) With respect to data submitted

20 after the date of enactment of this clause by

21 an applicant or registrant to support an

22 amendment adding a new use to an existing

23 registration that does not retain any period

24 of exclusive use, if such data relates solely

25 to a minor use of a pesticide, such data
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1 shall not, without the written permission of

2 the original data submitter, be considered

3 by the Administrator to support an appli4 cation for a minor use by another person

5 during the period of 10 years following the

6 date of submission of such data. The appli7 cant or registrant at the time the new

8 minor use is requested shall notify the Ad9 ministrator that to the best of their knowl10 edge the exclusive use period for the pes11 ticide has expired and that the data per12 taining solely to the minor use of a pes13 ticide is eligible for the provisions of this

14 paragraph. If the minor use registration

15 which is supported by data submitted pur16 suant to this subsection is voluntarily can17 celed or if such data are subsequently used

18 to support a nonminor use, the data shall

19 no longer be subject to the exclusive use pro20 visions of this clause but shall instead be

21 considered by the Administrator in accord22 ance with the provisions of clause (i), as

23 appropriate.’’.

24 (c) TIME EXTENSIONS FOR DEVELOPMENT OF MINOR

25 USE DATA.—
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1 (1) DATA CALL-IN.—Section 3(c)(2)(B) (7 U.S.C.

2 136a(c)(2)(B)) is amended by adding at the end the

3 following:

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

5 the Administrator shall, in the case of a

6 minor use, extend the deadline for the pro7 duction of residue chemistry data under this

8 subparagraph for data required solely to

9 support that minor use until the final dead10 line for submission of data under section 4

11 for the other uses of the pesticide established

12 as of the date of enactment of the Minor Use

13 Crop Protection Act of 1996, if—

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

15 of the pesticide on a food are being

16 provided;

17 ‘‘(II) the registrant, in submitting

18 a request for such an extension, pro19 vides a schedule, including interim

20 dates to measure progress, to assure

21 that the data production will be com22 pleted before the expiration of the ex23 tension period;

24 ‘‘(III) the Administrator has de25 termined that such extension will not
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1 significantly delay the Administrator’s

2 schedule for issuing a reregistration

3 eligibility determination required

4 under section 4; and

5 ‘‘(IV) the Administrator has de6 termined that based on existing data,

7 such extension would not significantly

8 increase the risk of any unreasonable

9 adverse effect on the environment. If

10 the Administrator grants an extension

11 under this clause, the Administrator

12 shall monitor the development of the

13 data and shall ensure that the reg14 istrant is meeting the schedule for the

15 production of the data. If the Adminis16 trator determines that the registrant is

17 not meeting or has not met the sched18 ule for the production of such data, the

19 Administrator may proceed in accord20 ance with clause (iv) regarding the

21 continued registration of the affected

22 products with the minor use and shall

23 inform the public of such action. Not24 withstanding the provisions of this

25 clause, the Administrator may take ac-
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1 tion to modify or revoke the extension

2 under this clause if the Administrator

3 determines that the extension for the

4 minor use may cause an unreasonable

5 adverse effect on the environment. In

6 such circumstance, the Administrator

7 shall provide, in writing to the reg8 istrant, a notice revoking the extension

9 of time for submission of data. Such

10 data shall instead be due in accordance

11 with the date established by the Ad12 ministrator for the submission of the

13 data.’’.

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

15 4(e)(2)(B), and 4(f)(2)(B) (7 U.S.C. 136a–1(d)(4)(B),

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

17 at the end the following: ‘‘Upon the request of a reg18 istrant, the Administrator shall, in the case of a

19 minor use, extend the deadline for the production of

20 residue chemistry data under this subparagraph for

21 data required solely to support that minor use until

22 the final deadline for submission of data under this

23 section for the other uses of the pesticide established

24 as of the date of enactment of the Food Quality Pro25 tection Act of 1996 if—
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1 ‘‘(i) the data to support other uses of the

2 pesticide on a food are being provided;

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

4 for such an extension provides a schedule, includ5 ing interim dates to measure progress, to assure

6 that the data production will be completed before

7 the expiration of the extension period;

8 ‘‘(iii) the Administrator has deter9 mined that such extension will not signifi10 cantly delay the Administrator’s schedule

11 for issuing a reregistration eligibility deter12 mination required under this section; and

13 ‘‘(iv) the Administrator has determined

14 that based on existing data, such extension

15 would not significantly increase the risk of

16 any unreasonable adverse effect on the envi17 ronment. If the Administrator grants an ex18 tension under this subparagraph, the Ad19 ministrator shall monitor the development

20 of the data and shall ensure that the reg21 istrant is meeting the schedule for the pro22 duction of the data. If the Administrator

23 determines that the registrant is not meet24 ing or has not met the schedule for the pro25 duction of such data, the Administrator
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1 may proceed in accordance with clause (iv)

2 of section 3(c)(2)(B) or other provisions of

3 this section, as appropriate, regarding the

4 continued registration of the affected prod5 ucts with the minor use and shall inform

6 the public of such action. Notwithstanding

7 the provisions of this subparagraph, the Ad8 ministrator may take action to modify or

9 revoke the extension under this subpara10 graph if the Administrator determines that

11 the extension for the minor use may cause

12 an unreasonable adverse affect on the envi13 ronment. In such circumstance, the Admin14 istrator shall provide written notice to the

15 registrant revoking the extension of time for

16 submission of data. Such data shall instead

17 be due in accordance with the date then es18 tablished by the Administrator for submis19 sion of the data.’’.

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

21 136a(c)(2)) is amended—

22 (1) by inserting ‘‘IN GENERAL.—’’ after ‘‘(A)’’;

23 (2) by inserting ‘‘ADDITIONAL DATA.—’’ after

24 ‘‘(B)’’;
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1 (3) by inserting ‘‘SIMPLIFIED PROCEDURES.—’’

2 after ‘‘(C)’’; and

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

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

5 registration of a pesticide for a minor use, the

6 Administrator may waive otherwise applicable

7 data requirements if the Administrator deter8 mines that the absence of such data will not pre9 vent the Administrator from determining—

10 ‘‘(i) the incremental risk presented by

11 the minor use of the pesticide; and

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

13 be an unreasonable adverse effect on the en14 vironment.’’.

15 (e) EXPEDITING MINOR USE REGISTRATIONS.—Sec16 tion 3(c)(3) (7 U.S.C. 136a(c)(3)) is amended —

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

18 GENERAL.—’’;

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

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

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

22 ‘‘(C) MINOR USE REGISTRATION.—

23 ‘‘(i) The Administrator shall, as expe24 ditiously as possible, review and act on any

25 complete application—
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1 ‘‘(I) that proposes the initial reg2 istration of a new pesticide active in3 gredient if the active ingredient is pro4 posed to be registered solely for minor

5 uses, or proposes a registration amend6 ment solely for minor uses to an exist7 ing registration; or

8 ‘‘(II) for a registration or a reg9 istration amendment that proposes sig10 nificant minor uses.

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

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

13 possible’ means that the Administrator

14 shall, to the greatest extent practicable,

15 complete a review and evaluation of all

16 data, submitted with a complete appli17 cation, within 12 months after the sub18 mission of the complete application,

19 and the failure of the Administrator to

20 complete such a review and evaluation

21 under clause (i) shall not be subject to

22 judicial review; and

23 ‘‘(II) the term ‘significant minor

24 uses’ means 3 or more minor uses pro25 posed for every nonminor use, a minor
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1 use that would, in the judgment of the

2 Administrator, serve as a replacement

3 for any use which has been canceled in

4 the 5 years preceding the receipt of the

5 application, or a minor use that in the

6 opinion of the Administrator would

7 avoid the reissuance of an emergency

8 exemption under section 18 for that

9 minor use.

10 ‘‘(D) ADEQUATE TIME FOR SUBMISSION OF

11 MINOR USE DATA.—If a registrant makes a re12 quest for a minor use waiver, regarding data re13 quired by the Administrator, pursuant to para14 graph (2)(E), and if the Administrator denies in

15 whole or in part such data waiver request, the

16 registrant shall have a full-time period for pro17 viding such data. For purposes of this subpara18 graph, the term ‘full-time period’ means the time

19 period originally established by the Adminis20 trator for submission of such data, beginning

21 with the date of receipt by the registrant of the

22 Administrator’s notice of denial.’’.

23 (f) TEMPORARY EXTENSION OF REGISTRATION FOR

24 UNSUPPORTED MINOR USES.—

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

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

3 adding at the end the following: ‘‘If the reg4 istrant does not commit to support a specific

5 minor use of the pesticide, but is supporting and

6 providing data in a timely and adequate fashion

7 to support uses of the pesticide on a food, or if

8 all uses of the pesticide are nonfood uses and the

9 registrant does not commit to support a specific

10 minor use of the pesticide but is supporting and

11 providing data in a timely and adequate fashion

12 to support other nonfood uses of the pesticide, the

13 Administrator, at the written request of the reg14 istrant, shall not take any action pursuant to

15 this paragraph in regard to such unsupported

16 minor use until the final deadline established as

17 of the date of enactment of the Food Quality Pro18 tection Act of 1996, for the submission of data

19 under this section for the supported uses identi20 fied pursuant to this paragraph unless the Ad21 ministrator determines that the absence of the

22 data is significant enough to cause human health

23 or environmental concerns. On such a deter24 mination the Administrator may refuse the re25 quest for extension by the registrant. Upon re-
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1 ceipt of the request from the registrant, the Ad2 ministrator shall publish in the Federal Register

3 a notice of the receipt of the request and the ef4 fective date upon which the uses not being sup5 ported will be voluntarily deleted from the reg6 istration pursuant to section 6(f)(1). If the Ad7 ministrator grants an extension under this para8 graph, the Administrator shall monitor the devel9 opment of the data for the uses being supported

10 and shall ensure that the registrant is meeting

11 the schedule for the production of such data. If

12 the Administrator determines that the registrant

13 is not meeting or has not met the schedule for

14 the production of such data, the Administrator

15 may proceed in accordance with section

16 3(c)(2)(B)(iv) regarding the continued registra17 tion of the affected products with the minor and

18 other uses and shall inform the public of such

19 action in accordance with section 6(f)(2). Not20 withstanding this subparagraph, the Adminis21 trator may deny, modify, or revoke the tem22 porary extension under this paragraph if the Ad23 ministrator determines that the continuation of

24 the minor use may cause an unreasonable ad25 verse effect on the environment. In the event of
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1 modification or revocation, the Administrator

2 shall provide, in writing, to the registrant a no3 tice revoking the temporary extension and estab4 lish a new effective date by which the minor use

5 shall be deleted from the registration.’’.

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

7 1(e)(3)(A)) is amended by adding at the end the

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

9 support a specific minor use of the pesticide, but

10 is supporting and providing data in a timely

11 and adequate fashion to support uses of the pes12 ticide on a food, or if all uses of the pesticide are

13 nonfood uses and the registrant does not commit

14 to support a specific minor use of the pesticide

15 but is supporting and providing data in a time16 ly and adequate fashion to support other nonfood

17 uses of the pesticide, the Administrator, at the

18 written request of the registrant, shall not take

19 any action pursuant to this subparagraph in re20 gard to such unsupported minor use until the

21 final deadline established as of the date of enact22 ment of the Food Quality Protection Act of 1996,

23 for the submission of data under this section for

24 the supported uses identified pursuant to this

25 subparagraph unless the Administrator deter-
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1 mines that the absence of the data is significant

2 enough to cause human health or environmental

3 concerns. On the basis of such determination, the

4 Administrator may refuse the request for exten5 sion by the registrant. Upon receipt of the re6 quest from the registrant, the Administrator

7 shall publish in the Federal Register a notice of

8 the receipt of the request and the effective date

9 upon which the uses not being supported will be

10 voluntarily deleted from the registration pursu11 ant to section 6(f)(1). If the Administrator

12 grants an extension under this subparagraph, the

13 Administrator shall monitor the development of

14 the data for the uses being supported and shall

15 ensure that the registrant is meeting the schedule

16 for the production of such data. If the Adminis17 trator determines that the registrant is not meet18 ing or has not met the schedule for the produc19 tion of such data, the Administrator may pro20 ceed in accordance with section 3(c)(2)(B)(iv) re21 garding the continued registration of the affected

22 products with the minor and other uses and shall

23 inform the public of such action in accordance

24 with section 6(f)(2). Notwithstanding this sub25 paragraph, the Administrator may deny,modify,
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1 or revoke the temporary extension under this

2 subparagraph if the Administrator determines

3 that the continuation of the minor use may

4 cause an unreasonable adverse effect on the envi5 ronment. In The event of modification or revoca6 tion, the Administrator shall provide, in writing,

7 to the registrant a notice revoking the temporary

8 extension and establish a new effective date by

9 which the minor use shall be deleted from the

10 registration.’’.

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

12 136a(c)(2)(B)), as amended by subsection (c)(1), is

13 further amended by adding at the end the following:

14 ‘‘(vii) If the registrant does not commit

15 to support a specific minor use of the pes16 ticide, but is supporting and providing data

17 in a timely and adequate fashion to support

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

19 of the pesticide are nonfood uses and the

20 registrant does not commit to support a

21 specific minor use of the pesticide but is

22 supporting and providing data in a timely

23 and adequate fashion to support other

24 nonfood uses of the pesticide, the Adminis25 trator, at the written request of the reg-
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1 istrant, shall not take any action pursuant

2 to this clause in regard to such unsupported

3 minor use until the final deadline estab4 lished as of the date of enactment of the

5 Food Quality Protection Act of 1996, for the

6 submission of data under section 4 for the

7 supported use identified pursuant to this

8 clause unless the Administrator determines

9 that the absence of the data is significant

10 enough to cause human health or environ11 mental concerns. On the basis of such deter12 mination, the Administrator may refuse the

13 request for extension by the registrant.

14 Upon receipt of the request from the reg15 istrant, the Administrator shall publish in

16 the Federal Register a notice of the receipt

17 of the request and the effective date upon

18 which the uses not being supported will be

19 voluntarily deleted from the registration

20 pursuant to section 6(f)(1). If the Adminis21 trator grants an extension under this

22 clause, the Administrator shall monitor the

23 development of the data for the uses being

24 supported and shall ensure that the reg25 istrant is meeting the schedule for the pro-
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1 duction of such data. If the Administrator

2 determines that the registrant is not meet3 ing or has not met the schedule for the pro4 duction of such data, the Administrator

5 may proceed in accordance with clause (iv)

6 of this subparagraph regarding the contin7 ued registration of the affected products

8 with the minor and other uses and shall in9 form the public of such action in accordance

10 with section 6(f)(2). Notwithstanding the

11 provisions of this clause, the Administrator

12 may deny, modify, or revoke the temporary

13 extension under this subparagraph if the

14 Administrator determines that the continu15 ation of the minor use may cause an unrea16 sonable adverse effect on the environment.

17 In the event of modification or revocation,

18 the Administrator shall provide, in writing,

19 to the registrant a notice revoking the tem20 porary extension and establish a new effec21 tive date by which the minor use shall be

22 deleted from the registration.’’.

23 (g) Section 6(f) (7 U.S.C. 136d(f)) is amended—

24 (1) in paragraph (1)(C)(ii) by striking ‘‘90-day’’

25 each place it appears and inserting ‘‘180-day’’; and
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1 (2) in paragraph (3)(A) by striking ‘‘90-day’’

2 and inserting ‘‘180-day’’.

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

5 amended by adding at the end the following:

6 ‘‘(4) UTILIZATION OF DATA FOR VOLUNTARILY

7 CANCELED PESTICIDE.—When an application is filed

8 with the Administrator for the registration of a pes9 ticide for a minor use and another registrant subse10 quently voluntarily cancels its registration for an

11 identical or substantially similar pesticide for an

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

14 application as if the voluntary cancellation had not

15 yet taken place except that the Administrator shall

16 not take such action if the Administrator determines

17 that such minor use may cause an unreasonable ad18 verse effect on the environment. In order to rely on

19 this subsection, the applicant must certify that it

20 agrees to satisfy any outstanding data requirements

21 necessary to support the reregistration of the pesticide

22 in accordance with the data submission schedule es23 tablished by the Administrator.’’.

24 (i) ENVIRONMENTAL PROTECTION AGENCY 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 sec2 tion 121, is amended by adding after section 30 the follow3 ing:

4 ‘‘SEC. 31. ENVIRONMENTAL PROTECTION AGENCY MINOR

5 USE PROGRAM.

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

7 minor use issues through the establishment of a minor use

8 program within the Office of Pesticide Programs. Such of9 fice shall be responsible for coordinating the development

10 of minor use programs and policies and consulting with

11 growers regarding minor use issues and registrations and

12 amendments which are submitted to the Environmental

13 Protection Agency.

14 ‘‘(b) The Office of Pesticide Programs shall prepare a

15 public report concerning the progress made on the registra16 tion of minor uses, including implementation of the exclu17 sive use as an incentive for registering new minor uses,

18 within 3 years of the passage of the Food Quality Protection

19 Act of 1996.’’.

20 (j) DEPARTMENT OF AGRICULTURE MINOR USE PRO21 GRAM.—The Federal Insecticide, Fungicide, and

22 Rodenticide Act (7 U.S.C. 136 et seq.), as amended by sub23 section (i), is amended by adding after section 31 the follow24 ing:
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1 ‘‘SEC. 32. DEPARTMENT OF AGRICULTURE MINOR USE PRO2 GRAM.

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

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

5 shall assure the coordination of the responsibilities of the

6 Department of Agriculture related to minor uses of pes7 ticides, including—

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

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

10 Law 89–106 (7 U.S.C. 450i(e)) and the national pes11 ticide resistance monitoring program established

12 under section 1651 of the Food, Agriculture, Con13 servation, and Trade Act of 1990 (7 U.S.C. 5882);

14 ‘‘(2) supporting integrated pest management re15 search;

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

17 minor uses; and

18 ‘‘(4) providing assistance for minor use registra19 tions, tolerances, and reregistrations with the Envi20 ronmental Protection Agency.

21 ‘‘(b)(1) MINOR USE PESTICIDE DATA.—

22 ‘‘(A) GRANT AUTHORITY.—The Secretary, in

23 consultation with the Administrator, shall establish a

24 program to make grants for the development of data

25 to support minor use pesticide registrations and re26 registrations. The amount of any such grant shall not
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exceed 1 1 ⁄2 of the cost of the project for which the grant

2 is made.

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

4 develop data to support minor use pesticide registra5 tions and reregistrations may apply for a grant

6 under subparagraph (A). Priority shall be given to an

7 applicant for such a grant who does not directly re8 ceive funds from the sale of pesticides registered for

9 minor uses.

10 ‘‘(C) DATA OWNERSHIP.—Any data that is devel11 oped under a grant under subparagraph (A) shall be

12 jointly owned by the Department of Agriculture and

13 the person who received the grant. Such a person shall

14 enter into an agreement with the Secretary under

15 which such person shall share any fee paid to such

16 person under section 3(c)(1)(F).

17 ‘‘(2) MINOR USE PESTICIDE DATA REVOLVING FUND.—

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

19 the Treasury of the United States a revolving fund to

20 be known as the Minor Use Pesticide Data Revolving

21 Fund. The Fund shall be available without fiscal year

22 limitation to carry out the authorized purposes of this

23 subsection.

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

25 deposited in the Fund—
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1 ‘‘(i) such amounts as may be appropriated

2 to support the purposes of this subsection; and

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

4 data developed under a grant under paragraph

5 (1)(A).

6 ‘‘(C) AUTHORIZATIONS OF APPROPRIATIONS.—

7 There are authorized to be appropriated for each fis8 cal year to carry out the purposes of this subsection

9 $10,000,000 to remain available until expended.’’.

10 Subtitle B—Antimicrobial Pesticide

11 Registration Reform

12 SEC. 221. DEFINITIONS.

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

14 210(a) is further amended—

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

16 following: ‘‘The term ‘pesticide’ does not include liq17 uid chemical sterilant products (including any

18 sterilant or subordinate disinfectant claims on such

19 products) for use on a critical or semi-critical device,

20 as defined in section 201 of the Federal Food, Drug,

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

22 the preceding sentence, the term ‘critical device’ in23 cludes any device which is introduced directly into

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

25 bloodstream or normally sterile areas of the body and
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1 the term ‘semi-critical device’ includes any device

2 which contacts intact mucous membranes but which

3 does not ordinarily penetrate the blood barrier or oth4 erwise enter normally sterile areas of the body.’’; and

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

6 ‘‘(mm) ANTIMICROBIAL PESTICIDE.—

7 ‘‘(1) IN GENERAL.—The term ‘antimicrobial pes8 ticide’ means a pesticide that—

9 ‘‘(A) is intended to—

10 ‘‘(i) disinfect, sanitize, reduce, or miti11 gate growth or development of micro12 biological organisms; or

13 ‘‘(ii) protect inanimate objects, indus14 trial processes or systems, surfaces, water,

15 or other chemical substances from contami16 nation, fouling, or deterioration caused by

17 bacteria, viruses, fungi, protozoa, algae, or

18 slime; and

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

20 otherwise not subject to, a tolerance under section

21 408 of the Federal Food, Drug, and Cosmetic Act

22 (21 U.S.C. 346a and 348) or a food additive reg23 ulation under section 409 of such Act.

24 ‘‘(2) EXCLUDED PRODUCTS.—The term

25 ‘antimicrobial pesticide’ does not include —
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1 ‘‘(A) a wood preservative or antifouling

2 paint product for which a claim of pesticidal ac3 tivity other than or in addition to an activity

4 described in paragraph (1) is made;

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

6 ‘‘(C) an aquatic herbicide product.

7 ‘‘(3) INCLUDED PRODUCTS.—The term

8 ‘antimicrobial pesticide’ does include any other chem9 ical sterilant product (other than liquid chemical

10 sterilant products exempt under subsection (u)), any

11 other disinfectant product, any other industrial

12 microbiocide product, and any other preservative

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

14 SEC. 222. FEDERAL AND STATE DATA COORDINATION.

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

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

17 end the following:

18 ‘‘(viii)(I) If data required to support reg19 istration of a pesticide under subparagraph (A)

20 is requested by a Federal or State regulatory au21 thority, the Administrator shall, to the extent

22 practicable, coordinate data requirements, test

23 protocols, timetables, and standards of review

24 and reduce burdens and redundancy caused to
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1 the registrant by multiple requirements on the

2 registrant.

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

4 cooperative agreement with a State to carry out

5 subclause (I).

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

7 of enactment of this clause, the Administrator

8 shall develop a process to identify and assist in

9 alleviating future disparities between Federal

10 and State data requirements.’’.

11 SEC. 223. LABEL AND LABELING.

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

13 at the end the following:

14 ‘‘(9) LABELING.—

15 ‘‘(A) ADDITIONAL STATEMENTS.—Subject to

16 subparagraphs (B) and (C), it shall not be a vio17 lation of this Act for a registrant to modify the

18 labeling of an antimicrobial pesticide product to

19 include relevant information on product efficacy,

20 product composition, container composition or

21 design, or other characteristics that do not relate

22 to any pesticidal claim or pesticidal activity.

23 ‘‘(B) REQUIREMENTS.—Proposed labeling

24 information under subparagraph (A) shall not be

25 false or misleading, shall not conflict with or de-
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1 tract from any statement required by law or the

2 Administrator as a condition of registration,

3 and shall be substantiated on the request of the

4 Administrator.

5 ‘‘(C) NOTIFICATION AND DISAPPROVAL.—

6 ‘‘(i) NOTIFICATION.—A registration

7 may be modified under subparagraph (A)

8 if—

9 ‘‘(I) the registrant notifies the Ad10 ministrator in writing not later than

11 60 days prior to distribution or sale of

12 a product bearing the modified label13 ing; and

14 ‘‘(II) the Administrator does not

15 disapprove of the modification under

16 clause (ii).

17 ‘‘(ii) DISAPPROVAL.—Not later than 30

18 days after receipt of a notification under

19 clause (i), the Administrator may dis20 approve the modification by sending the

21 registrant notification in writing stating

22 that the proposed language is not acceptable

23 and stating the reasons why the Adminis24 trator finds the proposed modification unac25 ceptable.
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1 ‘‘(iii) RESTRICTION ON SALE.—A reg2 istrant may not sell or distribute a product

3 bearing a disapproved modification.

4 ‘‘(iv) OBJECTION.—A registrant may

5 file an objection in writing to a disapproval

6 under clause (ii) not later than 30 days

7 after receipt of notification of the dis8 approval.

9 ‘‘(v) FINAL ACTION.—A decision by the

10 Administrator following receipt and consid11 eration of an objection filed under clause

12 (iv) shall be considered a final agency ac13 tion.

14 ‘‘(D) USE DILUTION.—The label or labeling

15 required under this Act for an antimicrobial pes16 ticide that is or may be diluted for use may have

17 a different statement of caution or protective

18 measures for use of the recommended diluted so19 lution of the pesticide than for use of a con20 centrate of the pesticide if the Administrator de21 termines that—

22 ‘‘(i) adequate data have been submitted

23 to support the statement proposed for the

24 diluted solution uses; and
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1 ‘‘(ii) the label or labeling provides ade2 quate protection for exposure to the diluted

3 solution of the pesticide.’’.

4 SEC. 224. REGISTRATION REQUIREMENTS FOR

5 ANTIMICROBIAL PESTICIDES.

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

7 107(b), is further amended by adding at the end the follow8 ing:

9 ‘‘(h) REGISTRATION REQUIREMENTS FOR

10 ANTIMICROBIAL PESTICIDES.—

11 ‘‘(1) EVALUATION OF PROCESS.—To the maxi12 mum extent practicable consistent with the degrees of

13 risk presented by a antimicrobial pesticide and the

14 type of review appropriate to evaluate the risks, the

15 Administrator shall identify and evaluate reforms to

16 the antimicrobial registration process that would re17 duce review periods existing as of the date of enact18 ment of this subsection for antimicrobial pesticide

19 product registration applications and applications for

20 amended registration of antimicrobial pesticide prod21 ucts, including—

22 ‘‘(A) new antimicrobial active ingredients;

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

24 ‘‘(C) substantially similar or identical

25 antimicrobial pesticides; and
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1 ‘‘(D) amendments to antimicrobial pesticide

2 registrations.

3 ‘‘(2) REVIEW TIME PERIOD REDUCTION GOAL.—

4 Each reform identified under paragraph (1) shall be

5 designed to achieve the goal of reducing the review pe6 riod following submission of a complete application,

7 consistent with the degree of risk, to a period of not

8 more than—

9 ‘‘(A) 540 days for a new antimicrobial ac10 tive ingredient pesticide registration;

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

12 of a registered active ingredient;

13 ‘‘(C) 120 days for any other new

14 antimicrobial product;

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

16 identical antimicrobial product;

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

18 antimicrobial registration that does not require

19 scientific review of data; and

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

21 an antimicrobial registration that requires sci22 entific review of data and that is not otherwise

23 described in this paragraph.

24 ‘‘(3) IMPLEMENTATION.—

25 ‘‘(A) PROPOSED RULEMAKING.—
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1 ‘‘(i) ISSUANCE.—Not later than 270

2 days after the date of enactment of this sub3 section, the Administrator shall publish in

4 the Federal Register proposed regulations to

5 accelerate and improve the review of

6 antimicrobial pesticide products designed to

7 implement, to the extent practicable, the

8 goals set forth in paragraph (2).

9 ‘‘(ii) REQUIREMENTS.—Proposed regu10 lations issued under clause (i) shall—

11 ‘‘(I) define the various classes of

12 antimicrobial use patterns, including

13 household, industrial, and institutional

14 disinfectants and sanitizing pesticides,

15 preservatives, water treatment, and

16 pulp and paper mill additives, and

17 other such products intended to dis18 infect, sanitize, reduce, or mitigate

19 growth or development of micro20 biological organisms, or protect inani21 mate objects, industrial processes or

22 systems, surfaces, water, or other chem23 ical substances from contamination,

24 fouling, or deterioration caused by bac-
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1 teria, viruses, fungi, protozoa, algae, or

2 slime;

3 ‘‘(II) differentiate the types of re4 view undertaken for antimicrobial pes5 ticides;

6 ‘‘(III) conform the degree and

7 type of review to the risks and benefits

8 presented by antimicrobial pesticides

9 and the function of review under this

10 Act, considering the use patterns of the

11 product, toxicity, expected exposure,

12 and product type;

13 ‘‘(IV) ensure that the registration

14 process is sufficient to maintain

15 antimicrobial pesticide efficacy and

16 that antimicrobial pesticide products

17 continue to meet product performance

18 standards and effectiveness levels for

19 each type of label claim made; and

20 ‘‘(V) implement effective and reli21 able deadlines for process management.

22 ‘‘(iii) COMMENTS.—In developing the

23 proposed regulations, the Administrator

24 shall solicit the views from registrants and
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1 other affected parties to maximize the effec2 tiveness of the rule development process.

3 ‘‘(B) FINAL REGULATIONS.—

4 ‘‘(i) ISSUANCE.—The Administrator

5 shall issue final regulations not later than

6 240 days after the close of the comment pe7 riod for the proposed regulations.

8 ‘‘(ii) FAILURE TO MEET GOAL.—If a

9 goal described in paragraph (2) is not met

10 by the final regulations, the Administrator

11 shall identify the goal, explain why the goal

12 was not attained, describe the element of the

13 regulations included instead, and identify

14 future steps to attain the goal.

15 ‘‘(iii) REQUIREMENTS.—In issuing

16 final regulations, the Administrator shall—

17 ‘‘(I) consider the establishment of

18 a certification process for regulatory

19 actions involving risks that can be re20 sponsibly managed, consistent with the

21 degree of risk, in the most cost-efficient

22 manner;

23 ‘‘(II) consider the establishment of

24 a certification process by approved lab-
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1 oratories as an adjunct to the review

2 process;

3 ‘‘(III) use all appropriate and

4 cost-effective review mechanisms, in5 cluding—

6 ‘‘(aa) expanded use of notifi7 cation and non-notification proce8 dures;

9 ‘‘(bb) revised procedures for

10 application review; and

11 ‘‘(cc) allocation of appro12 priate resources to ensure stream13 lined management of

14 antimicrobial pesticide registra15 tions; and

16 ‘‘(IV) clarify criteria for deter17 mination of the completeness of an ap18 plication.

19 ‘‘(C) EXPEDITED REVIEW.—This subsection

20 does not affect the requirements or extend the

21 deadlines or review periods contained in sub22 section (c)(3).

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

24 the final regulations to carry out this paragraph

25 are not effective 630 days after the date of enact-
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1 ment of this subsection, until the final regula2 tions become effective, the review period, begin3 ning on the date of receipt by the Agency of a

4 complete application, shall be—

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

6 active ingredient pesticide registration;

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

8 use of a registered active ingredient;

9 ‘‘(iii) 180 days for any other new

10 antimicrobial product;

11 ‘‘(iv) 90 days for a substantially simi12 lar or identical antimicrobial product;

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

14 antimicrobial registration that does not re15 quire scientific review of data; and

16 ‘‘(vi) 240 days for an amendment to

17 an antimicrobial registration that requires

18 scientific review of data and that is not oth19 erwise described in this subparagraph.

20 ‘‘(E) WOOD PRESERVATIVES.—An applica21 tion for the registration, or for an amendment to

22 the registration, of a wood preservative product

23 for which a claim of pesticidal activity listed in

24 section 2(mm) is made (regardless of any other

25 pesticidal claim that is made with respect to the
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1 product) shall be reviewed by the Administrator

2 within the same period as that established under

3 this paragraph for an antimicrobial pesticide

4 product application, consistent with the degree of

5 risk posed by the use of the wood preservative

6 product, if the application requires the applicant

7 to satisfy the same data requirements as are re8 quired to support an application for a wood pre9 servative product that is an antimicrobial pes10 ticide.

11 ‘‘(F) NOTIFICATION.—

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

13 (iii), the Administrator shall notify an ap14 plicant whether an application has been

15 granted or denied not later than the final

16 day of the appropriate review period under

17 this paragraph, unless the applicant and

18 the Administrator agree to a later date.

19 ‘‘(ii) FINAL DECISION.—If the Admin20 istrator fails to notify an applicant within

21 the period of time required under clause (i),

22 the failure shall be considered an agency ac23 tion unlawfully withheld or unreasonably

24 delayed for purposes of judicial review
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1 under chapter 7 of title 5, United States

2 Code.

3 ‘‘(iii) EXEMPTION.—This subpara4 graph does not apply to an application for

5 an antimicrobial pesticide that is filed

6 under subsection (c)(3)(B) prior to 90 days

7 after the date of enactment of this sub8 section.

9 ‘‘(4) ANNUAL REPORT.—

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

11 of enactment of this subsection and ending on the

12 date that the goals under paragraph (2) are

13 achieved, the Administrator shall, not later than

14 March 1 of each year, prepare and submit an

15 annual report to the Committee on Agriculture

16 of the House of Representatives and the Commit17 tee on Agriculture, Nutrition, and Forestry of the

18 Senate.

19 ‘‘(B) REQUIREMENTS.—A report submitted

20 under subparagraph (A) shall include a descrip21 tion of—

22 ‘‘(i) measures taken to reduce the back23 log of pending registration applications;

24 ‘‘(ii) progress toward achieving reforms

25 under this subsection; and
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1 ‘‘(iii) recommendations to improve the

2 activities of the Agency pertaining to

3 antimicrobial registrations.’’.

4 SEC. 225. DISPOSAL OF HOUSEHOLD, INDUSTRIAL, OR IN5 STITUTIONAL ANTIMICROBIAL PRODUCTS.

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

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

8 following:

9 ‘‘(1) IN GENERAL.—Nothing in’’; and

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

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

12 industrial, or institutional antimicrobial product that

13 is not subject to regulation under the Solid Waste

14 Disposal Act (42 U.S.C. 6901 et seq.) shall not be sub15 ject to the provisions of subsections (a), (e), and (f),

16 unless the Administrator determines that such prod17 uct must be subject to such provisions to prevent an

18 unreasonable adverse effect on the environment.’’.

19 Subtitle C—Public Health

20 Pesticides

21 SEC. 230. DEFINITIONS.

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

23 136(bb)) is amended by adding at the end the following:

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

25 public health pesticides separate from the risks and benefits
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1 of other pesticides. In weighing any regulatory action con2 cerning a public health pesticide under this Act, the Admin3 istrator shall weigh any risks of the pesticide against the

4 health risks such as the diseases transmitted by the vector

5 to be controlled by the pesticide.’’.

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

7 amended by section 221, is amended by adding at the end

8 the following:

9 ‘‘(nn) PUBLIC HEALTH PESTICIDE.—The term ‘public

10 health pesticide’ means any minor use pesticide product

11 registered for use and used predominantly in public health

12 programs for vector control or for other recognized health

13 protection uses, including the prevention or mitigation of

14 viruses, bacteria, or other microorganisms (other than vi15 ruses, bacteria, or other microorganisms on or in living

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

17 health.

18 ‘‘(oo) VECTOR.—The term ‘vector’ means any orga19 nism capable of transmitting the causative agent of human

20 disease or capable of producing human discomfort or in21 jury, including mosquitoes, flies, fleas, cockroaches, or other

22 insects and ticks, mites, or rats.’’.

23 SEC. 231. REGISTRATION.

24 Section 3(c)(2)(A) (7 U.S.C. 136a(c)(2)(A)) is amend25 ed—
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1 (1) by inserting after ‘‘pattern of use,’’ the fol2 lowing: ‘‘the public health and agricultural need for

3 such minor use,’’; and

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

5 the environment to the pesticide’’ and inserting ‘‘po6 tential beneficial or adverse effects on man and the

7 environment’’.

8 SEC. 232. REREGISTRATION.

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

10 (1) in subsection (i)(4), by redesignating sub11 paragraphs (B) and (C) as subparagraphs (C) and

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

13 (A) the following:

14 ‘‘(B) 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

18 Human 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 (2) in subsection (i)(5), by redesignating sub24 paragraphs (F) and (G) as subparagraphs (G) and
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1 (H), respectively, and by adding after subparagraph

2 (E) the following:

3 ‘‘(F) The Administrator shall exempt any

4 public health pesticide from the payment of the

5 fee prescribed under paragraph (3) if, in con6 sultation with the Secretary of Health and Hu7 mans Services, the Administrator determines,

8 based on information supplied by the registrant,

9 that the economic return to the registrant from

10 sales of the pesticide does not support the reg11 istration or reregistration of the pesticide.’’;

12 (3) in subsection (i)(7)(B), by striking ‘‘or to de13 termine’’ and inserting ‘‘, to determine’’ and by in14 serting before the period the following: ‘‘, or to deter15 mine the volume usage for public health pesticides’’;

16 and

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

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

19 of clause (ii) and inserting thereof ‘‘; or’’, and by

20 adding after clause (ii) the following:

21 ‘‘(iii) proposes the initial or amended

22 registration of an end use pesticide that, if

23 registered as proposed, would be used for a

24 public health pesticide.’’.
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1 SEC. 233. CANCELLATION.

2 Section 6(b) (7 U.S.C. 136d(b)) is amended by adding

3 after the eighth sentence the following: ‘‘When a public

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

5 Services should provide available benefits and use informa6 tion, or an analysis thereof, in accordance with the proce7 dures followed and subject to the same conditions as the Sec8 retary of Agriculture in the case of agricultural pesticides.’’.

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

10 HUMAN SERVICES.

11 Section 21 (7 U.S.C. 136s) is amended by redesignat12 ing subsections (b) and (c) as subsections (c) and (d), re13 spectively, and by adding after subsection (a) the following:

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

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

17 the views of the Secretary of Health and Human Services

18 in the same manner as the views of the Secretary of Agri19 culture are solicited under section 25(a)(2).’’.

20 SEC. 235. AUTHORITY OF ADMINISTRATOR.

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

22 (1) by inserting after ‘‘various classes of pes23 ticides’’ the following: ‘‘, including public health pes24 ticides,’’; and
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1 (2) by striking ‘‘and nonagricultural pesticides’’

2 and inserting ‘‘, nonagricultural, and public health

3 pesticides’’.

4 SEC. 236. IDENTIFICATION OF PESTS.

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

6 at the end the following:

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

8 coordination with the Secretary of Agriculture and the Sec9 retary of Health and Human Services, shall identify pests

10 of significant public health importance and, in coordina11 tion with the Public Health Service, develop and implement

12 programs to improve and facilitate the safe and necessary

13 use of chemical, biological, and other methods to combat and

14 control such pests of public health importance.’’.

15 SEC. 237. PUBLIC HEALTH DATA.

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

17 at the end the following:

18 ‘‘(m) AUTHORIZATION OF FUNDS TO DEVELOP PUB19 LIC HEALTH DATA.—

20 ‘‘(1) DEFINITION.—For the purposes of this sec21 tion, ‘Secretary’ means the Secretary of Health and

22 Human Services, acting through the Public Health

23 Service.

24 ‘‘(2) CONSULTATION.—In the case of a pesticide

25 registered for use in public health programs for vector
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1 control or for other uses the Administrator determines

2 to be human health protection uses, the Administrator

3 shall, upon timely request by the registrant or any

4 other interested person, or on the Administrator’s own

5 initiative may, consult with the Secretary prior to

6 taking final action to suspend registration under sec7 tion 3(c)(2)(B)(iv), or cancel a registration under sec8 tion 4, 6(e), or 6(f). In consultation with the Sec9 retary, the Administrator shall prescribe the form and

10 content of requests under this section.

11 ‘‘(3) BENEFITS TO SUPPORT FAMILY.—The Ad12 ministrator, after consulting with the Secretary, shall

13 make a determination whether the potential benefits

14 of continued use of the pesticide for public health or

15 health protection purposes are of such significance as

16 to warrant a commitment by the Secretary to conduct

17 or to arrange for the conduct of the studies required

18 by the Administrator to support continued registra19 tion under section 3 or registration under section 4.

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

21 determines that such a commitment is warranted and

22 in the public interest, the Administrator shall notify

23 the Secretary and shall, to the extent necessary,

24 amend a notice issued under section 3(c)(2)(B) to
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1 specify additional reasonable time periods for submis2 sion of the data.

3 ‘‘(5) ARRANGEMENTS.—The Secretary shall make

4 such arrangements for the conduct of required studies

5 as the Secretary finds necessary and appropriate to

6 permit submission of data in accordance with the

7 time periods prescribed by the Administrator. Such

8 arrangements may include Public Health Service in9 tramural research activities, grants, contracts, or co10 operative agreements with academic, public health, or

11 other organizations qualified by experience and train12 ing to conduct such studies.

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

14 support of the required studies using funds authorized

15 to be appropriated under this section, the Public

16 Health Service Act, or other appropriate authorities.

17 After a determination is made under subsection (d),

18 the Secretary shall notify the Committees on Appro19 priations of the House Representatives and the Senate

20 of the sums required to conduct the necessary studies.

21 ‘‘(7) AUTHORIZATION OF APPROPRIATIONS.—

22 There is authorized to be appropriated to carry out

23 the purposes of this section $12,000,000 for fiscal year

24 1997, and such sums as may be necessary for succeed25 ing fiscal years.’’.
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1 Subtitle D—Expedited Registration

2 of Reduced Risk Pesticides

3 SEC. 250. EXPEDITED REGISTRATION OF PESTICIDES .

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

5 223, is amended—

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

7 following:

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

9 registration or amendment to the registration of

10 a pesticide be expedited, an explanation of the

11 basis for the request must be submitted, in ac12 cordance with paragraph (10) of this sub13 section.’’; and

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

15 ‘‘(10) EXPEDITED REGISTRATION OF PES16 TICIDES.—

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

18 enactment of this paragraph, the Administrator

19 shall, utilizing public comment, develop proce20 dures and guidelines, and expedite the review of

21 an application for registration of a pesticide or

22 an amendment to a registration that satisfies

23 such guidelines.

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

25 amendment, including biological and conven-
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1 tional pesticides, will be considered for expedited

2 review under this paragraph. An application for

3 registration or an amendment shall qualify for

4 expedited review if use of the pesticide proposed

5 by the application may reasonably be expected to

6 accomplish 1 or more of the following:

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

8 human health.

9 ‘‘(ii) Reduce the risks of pesticides to

10 nontarget organisms.

11 ‘‘(iii) Reduce the potential for con12 tamination of groundwater, surface water,

13 or other valued environmental resources.

14 ‘‘(iv) Broaden the adoption of inte15 grated pest management strategies, or make

16 such strategies more available or more effec17 tive.

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

19 days after receipt of an application for expedited

20 review, shall notify the applicant whether the ap21 plication is complete. If it is found to be incom22 plete, the Administrator may either reject the re23 quest for expedited review or ask the applicant

24 for additional information to satisfy the guide25 lines 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 Human

11 Services, shall coordinate the development and implementa12 tion of survey procedures to ensure that adequate data on

13 food consumption patterns of infants and children are col14 lected.

15 (b) PROCEDURES.—To the extent practicable, the pro16 cedures referred to in subsection (a) shall include the collec17 tion of data on food consumption patterns of a statistically

18 valid sample of infants and children.

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

20 Agriculture shall ensure that the residue data collection ac21 tivities conducted by the Department of Agriculture in co22 operation with the Environmental Protection Agency and

23 the Department of Health and Human Services, provide for

24 the improved data collection of pesticide residues, including

25 guidelines for the use of comparable analytical and stand-
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1 ardized reporting methods, and the increased sampling of

2 foods most likely consumed by infants and children.

3 SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION.

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

5 collect data of statewide or regional significance on the use

6 of pesticides to control pests and diseases of major crops

7 and crops of dietary significance, including fruits and vege8 tables.

9 (b) COLLECTION.—The data shall be collected by sur10 veys of farmers or from other sources offering statistically

11 reliable data.

12 (c) COORDINATION.—The Secretary of Agriculture

13 shall, as appropriate, coordinate with the Administrator of

14 the Environmental Protection Agency in the design of the

15 surveys and make available to the Administrator the aggre16 gate results of the surveys to assist the Administrator.

17 SEC. 303. INTEGRATED PEST MANAGEMENT.

18 The Secretary of Agriculture, in cooperation with the

19 Administrator, shall implement research, demonstration,

20 and education programs to support adoption of Integrated

21 Pest Management. Integrated Pest Management is a sus22 tainable approach to managing pests by combining biologi23 cal, cultural, physical, and chemical tools in a way that

24 minimizes economic, health, and environmental risks. The

25 Secretary of Agriculture and the Administrator shall make
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1 information on Integrated Pest Management widely avail2 able to pesticide users, including Federal agencies. Federal

3 agencies shall use Integrated Pest Management techniques

4 in carrying out pest management activities and shall pro5 mote Integrated Pest Management through procurement

6 and regulatory policies, and other activities.

7 SEC. 304. COORDINATION OF CANCELLATION.

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

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

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

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

12 from residues that result from a use of a pesticide in

13 or on any food inconsistent with the standard the Ad14 ministrator determines is adequate to protect the pub15 lic health under section 408 of the Federal Food,

16 Drug, and Cosmetic Act (21 U.S.C. 346a).’’.

17 SEC. 305. PESTICIDE USE INFORMATION STUDY.

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

19 with the Administrator of the Environmental Protection

20 Agency, prepare a report to Congress evaluating the current

21 status and potential improvements in Federal pesticide use

22 information gathering activities. This report shall at least

23 include—

24 (1) an analysis of the quality and reliability of

25 the information collected by the Department of Agri-
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1 culture, the Environmental Protection Agency, and

2 other Federal agencies regarding the agricultural use

3 of pesticides; and

4 (2) an analysis of options to increase the effec5 tiveness of national pesticide use information collec6 tion, including an analysis of costs, burdens placed

7 on agricultural producers and other pesticide users,

8 and effectiveness in tracking risk reduction by those

9 options.

10 (b) The Secretary shall submit this report to Congress

11 not later than 1 year following the date of enactment of

12 this section.

13 øTITLE IV—AMENDMENTS TO THE FED14 ERAL FOOD, DRUG, AND COSMETIC

15 ACT

16 øSEC. 401. REFERENCE.

17 øWhenever in this title an amendment is expressed

18 in terms of an amendment to a section or other provision,

19 or refers to a section or other provision, the reference shall

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

21 of the Federal Food, Drug, and Cosmetic Act.

22 øSEC. 402. DEFINITIONS.

23 ø(a) Section 201(q) (21 U.S.C. 321(q)) is amended

24 to read as follows:

25 ø‘‘(q)(1) The term ‘pesticide chemical’ means—
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1 ø‘‘(A) any substance that is a pesticide within

2 the meaning of the Federal Insecticide, Fungicide,

3 and Rodenticide Act; or

4 ø‘‘(B) any active ingredient of a pesticide with5 in the meaning of the Federal Insecticide, Fungicide,

6 and Rodenticide Act.

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

8 residue in or on raw agricultural commodity or processed

9 food of—

10 ø‘‘(A) a pesticide chemical; or

11 ø‘‘(B) any other added substance that is

12 present in the commodity or food primarily as a re13 sult of the metabolism or other degradation of a pes14 ticide chemical.

15 ø‘‘(3) Notwithstanding paragraphs (1) and (2), the

16 Administrator may by regulation except a substance from

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

18 residue’ if—

19 ø‘‘(A) its occurrence as a residue on a raw agri20 cultural commodity or processed food is attributable

21 primarily to natural causes or to human activities

22 not involving the use of any substances for a pes23 ticidal purpose in the production, storage, process24 ing, or transportation of any raw agricultural com25 modity or processed food; and
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1 ø‘‘(B) the Administrator, after consultation

2 with the Secretary, determines that the substance

3 more appropriately should be regulated under one or

4 more provisions of this Act other than sections

5 402(a)(2)(B) and 408.’’.

6 ø(b) Paragraphs (1) and (2) of section 201(s) (21

7 U.S.C. 321(s)) are amended to read as follows:

8 ø‘‘(1) a pesticide chemical residue in or on a

9 raw agricultural commodity or processed food; or

10 ø‘‘(2) a pesticide chemical; or’’.

11 ø(c) Section 201 (21 U.S.C. 321) is amended by add12 ing at the end the following:

13 ø‘‘(bb) The term ‘processed food’ means any food

14 other than a raw agricultural commodity and includes any

15 raw agricultural commodity that has been subject to proc16 essing, such as canning, cooking, freezing, dehydration, or

17 milling.

18 ø‘‘(cc) The term ‘Administrator’ means the Adminis19 trator of the United States Environmental Protection

20 Agency.’’.

21 øSEC. 403. PROHIBITED ACTS.

22 øSection 301(j) (21 U.S.C. 331(j)) is amended—

23 ø(1) by striking the period at the end; and
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1 ø(2) by inserting at the end ‘‘, or the violation

2 of section 408(g)(2) or any regulation issued under

3 that section.’’.

4 øSEC. 404. ADULTERATED FOOD.

5 øSection 402(a)(2) (21 U.S.C. 342(a)(2)) is amended

6 to read as follows:

7 ø‘‘(2)(A) if it bears or contains any added poi8 sonous or added deleterious substance (other than a

9 substance that is a pesticide chemical residue in or

10 on a raw agricultural commodity or processed food,

11 a food additive, a color additive, or a new animal

12 drug) that is unsafe within the meaning of section

13 406;

14 ø‘‘(B) if it bears or contains a pesticide chemi15 cal residue that is unsafe within the meaning of sec16 tion 408(a); or

17 ø‘‘(C) if it is or if it bears or contains—

18 ø‘‘(i) any food additive that is unsafe with19 in the meaning of section 409; or

20 ø‘‘(ii) a new animal drug (or conversion

21 product thereof) that is unsafe within the

22 meaning of section 512; or’’.
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1 øSEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE

2 CHEMICAL RESIDUES.

3 øSection 408 (21 U.S.C. 346a) is amended to read

4 as follows:

5 ø‘‘TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMI6 CAL RESIDUES

7 ø‘‘SEC. 408. (a) REQUIREMENT FOR TOLERANCE OR

8 EXEMPTION.—

9 ø‘‘(1) GENERAL RULE.—For the purposes of

10 this section, the term ‘food,’ when used as a noun

11 without modification, shall mean a raw agricultural

12 commodity or processed food. Except as provided in

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

14 in or on a food shall be deemed unsafe for the pur15 pose of section 402(a)(2)(B) unless—

16 ø‘‘(A) a tolerance for such pesticide chemi17 cal residue in or on such food is in effect under

18 this section and the concentration of the residue

19 is within the limits of the tolerance; or

20 ø‘‘(B) an exemption from the requirement

21 of a tolerance is in effect under this section for

22 the pesticide chemical residue.

23 ø‘‘(2) PROCESSED FOOD.—Notwithstanding

24 paragraph (1)—

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

26 section for a pesticide chemical residue in or on
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1 a raw agricultural commodity, a pesticide chem2 ical residue that is present in or on a processed

3 food because the food is made from that raw

4 agricultural commodity shall not be considered

5 unsafe within the meaning of section

6 402(a)(2)(B) despite the lack of a tolerance for

7 the pesticide chemical residue in or on the proc8 essed food if the concentration of the pesticide

9 chemical residue in the processed food when

10 ready for consumption or use is not greater

11 than the tolerance prescribed for the pesticide

12 chemical residue in the raw agricultural com13 modity.

14 ø‘‘(B) If an exemption for the requirement

15 for a tolerance is in effect under this section for

16 a pesticide chemical residue in or on a raw agri17 cultural commodity, a pesticide chemical residue

18 that is present in or on a processed food be19 cause the food is made from that raw agricul20 tural commodity shall not be considered unsafe

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

22 ø‘‘(3) RESIDUES OF DEGRADATION PROD23 UCTS.—If a pesticide chemical residue is present in

24 or on a food because it is a metabolite or other deg25 radation product of a precursor substance that itself
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1 is a pesticide chemical or pesticide chemical residue,

2 such a residue shall not be considered to be unsafe

3 within the meaning of section 402(a)(2)(B) despite

4 the lack of a tolerance or exemption from the need

5 for a tolerance for such residue in or on such food

6 if—

7 ø‘‘(A) the Administrator has not deter8 mined that the degradation product is likely to

9 pose any potential health risk from dietary ex10 posure that is of a different type than, or of a

11 greater significance than, any risk posed by die12 tary exposure to the precursor substance; and

13 ø‘‘(B) either—

14 ø‘‘(i) a tolerance is in effect under

15 this section for residues of the precursor

16 substance in or on the food, and the com17 bined level of residues of the degradation

18 product and the precursor substance in or

19 on the food is at or below the

20 stoichiometrically equivalent level that

21 would be permitted by the tolerance if the

22 residue consisted only of the precursor sub23 stance rather than the degradation prod24 uct; or
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1 ø‘‘(ii) an exemption from the need for

2 a tolerance is in effect under this section

3 for residues of the precursor substance in

4 or on the food; and

5 ø‘‘(C) the tolerance or exemption for resi6 dues of the precursor substance does not state

7 that it applies only to particular named sub8 stances or states that it does not apply to resi9 dues of the degradation product.

10 ø‘‘(4) EFFECT OF TOLERANCE OR EXEMP11 TION.—While a tolerance or exemption from the re12 quirement for a tolerance is in effect under this sec13 tion for a pesticide chemical residue with respect to

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

15 containing any amount of such a residue be consid16 ered to be adulterated within the meaning of section

17 402(a)(1).

18 ø‘‘(b) AUTHORITY AND STANDARD FOR TOLER19 ANCES.—

20 ø‘‘(1) AUTHORITY.—The Administrator may

21 issue regulations establishing, modifying, or revoking

22 a tolerance for a pesticide chemical residue in or on

23 a food—

24 ø‘‘(A) in response to a petition filed under

25 subsection (d); or
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1 ø‘‘(B) on the Administrator’s initiative

2 under subsection (e).

3 ø‘‘(2) STANDARD.—(A) A tolerance may not be

4 established for a pesticide chemical residue in or on

5 a food at a level that is higher than a level that the

6 Administrator determines is adequate to protect the

7 public health.

8 ø‘‘(B) The Administrator shall modify or revoke

9 a tolerance if it is at a level higher than the level

10 that the Administrator determines is adequate to

11 protect the public health.

12 ø‘‘(C) In making a determination under this

13 paragraph the Administrator shall take into account,

14 among other relevant factors, the validity, complete15 ness, and reliability of the available data from stud16 ies of the pesticide chemical residue, the nature of

17 any toxic effects shown to be caused by the pesticide

18 chemical in such studies, available information and

19 reasonable assumptions concerning the relationship

20 of the results of such studies to human risk, avail21 able information and reasonable assumptions con22 cerning the dietary exposure levels of food consum23 ers (and major identifiable subgroups of food con24 sumers, including infants and children) to the pes25 ticide chemical residue, and available information
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1 and reasonable assumptions concerning the varia2 bility of the sensitivities of major identifiable groups,

3 including infants and children, and shall consider

4 other factors to the extent required by subparagraph

5 (F).

6 ø‘‘(D) For purposes of subparagraph (A), a tol7 erance level for a pesticide chemical residue in or on

8 a food shall be deemed to be adequate to protect the

9 public health if the dietary risk posed to food con10 sumers by such level of the pesticide chemical resi11 due is negligible. The Administrator shall by regula12 tion set forth the factors and methods, including

13 tests which are appropriate for the determination of

14 dietary risk and most likely dietary exposure, for the

15 determination of negligible dietary risk.

16 ø‘‘(E) Procedures shall be developed and imple17 mented that ensure that pesticide tolerances ade18 quately safeguard the health of infants and children.

19 ø‘‘(F) Where reliable data are available, the

20 Administrator shall calculate the dietary risk posed

21 to food consumers by a pesticide chemical on the

22 basis of the percent of food actually treated with the

23 pesticide chemical and the actual residue levels of

24 the pesticide chemical that occur in food. In particu25 lar, the Administrator shall take into account aggre-
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1 gate pesticide use and residue data collected by the

2 Department of Agriculture.

3 ø‘‘(G) For purposes of subparagraph (A), a

4 level of a pesticide chemical residue in or on a food

5 that poses a greater than negligible dietary risk to

6 consumers of the food shall be deemed to be ade7 quate to protect the public health if the Adminis8 trator determines that such risk is not unreasonable

9 because—

10 ø‘‘(i) use of the pesticide that produces the

11 residue protects humans or the environment

12 from adverse effects on public health or welfare

13 that would, directly or indirectly, result in

14 greater risk to the public or the environment

15 than the dietary risk from the pesticide chemi16 cal residue; or

17 ø‘‘(ii) use of the pesticide avoids risks to

18 workers, the public, or the environment that

19 would be expected to result from the use of an20 other pesticide or pest control method on the

21 same food that are considered to be greater

22 than the risks that result from dietary exposure

23 to the pesticide chemical residue; or

24 ø‘‘(iii) the availability of the pesticide

25 would enable domestic growers to maintain the
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1 availability of an adequate, wholesome, and eco2 nomical food supply for consumers, taking into

3 account national and regional effects.

4 In making the determination under this subpara5 graph, the Administrator shall not consider the ef6 fects on any pesticide registrant, manufacturer, or

7 marketer of a pesticide.

8 ø‘‘(3) LIMITATIONS.—(A) A tolerance may be

9 issued under the authority of paragraph (2)(E) only

10 if the Administrator has assessed the extent to

11 which efforts are being made to develop either an al12 ternative method of pest control or an alternative

13 pesticide chemical for use on such commodity or

14 food that would meet the requirements of paragraph

15 (2)(D).

16 ø‘‘(B) A tolerance for a pesticide chemical resi17 due in or on a food shall not be established by the

18 Administrator unless the Administrator determines,

19 after consultation with the Secretary, that there is

20 a practical method for detecting and measuring the

21 levels of the pesticide chemical residue in or on the

22 food, or that a practical method is unavailable or not

23 feasible.

24 ø‘‘(C) A tolerance for a pesticide chemical resi25 due in or on a food shall not be established at a level
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1 lower than the limit of detection of the method for

2 detecting and measuring the pesticide chemical resi3 due specified by the Administrator under subpara4 graph (B).

5 ø‘‘(4) INTERNATIONAL STANDARDS.—In estab6 lishing a tolerance for a pesticide chemical residue in

7 or on a food, the Administrator shall determine

8 whether a maximum residue level for the chemical

9 has been established by the Codex Alimentarius

10 Commission. If a Codex maximum residue level has

11 been established for the chemical and the Adminis12 trator does not propose to adopt the Codex level, the

13 Administrator shall publish for public comment a

14 notice explaining the reasons for departing from the

15 Codex level. If the Administrator determines not to

16 adopt a Codex level, the Administrator shall publish

17 as part of the final tolerance decision a determina18 tion with supporting data that the Codex level is not

19 supported by adequate and reliable scientific data, or

20 is inadequate to protect the health of the United

21 States’ consumers and that the effect of the toler22 ance on the availability to consumers of an adequate,

23 wholesome and economical food supply, does not out24 weigh the risk posed by the pesticide residue.
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1 ø‘‘(c) AUTHORITY AND STANDARD FOR EXEMP2 TIONS.—

3 ø‘‘(1) AUTHORITY.—The Administrator may

4 issue a regulation establishing, modifying, or revok5 ing an exemption from the requirement for a toler6 ance for a pesticide chemical residue in or on a

7 food—

8 ø‘‘(A) in response to a petition filed under

9 subsection (d); or

10 ø‘‘(B) on the Administrator’s initiative

11 under subsection (e).

12 ø‘‘(2) STANDARD.—(A) An exemption from the

13 requirement for a tolerance for a pesticide chemical

14 residue in or on a food may be established only if

15 the Administrator determines that a tolerance is not

16 needed to protect the public health, in view of the

17 levels of dietary exposure to the pesticide chemical

18 residue that could reasonably be expected to occur.

19 ø‘‘(B) An exemption from the requirement for

20 a tolerance for a pesticide chemical residue in or on

21 a food shall be revoked if the Administrator, in re22 sponse to a petition for the revocation of the exemp23 tion or at the Administrator’s own initiative deter24 mines that the exemption does not satisfy the cri25 terion of subparagraph (A).
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1 ø‘‘(C) In making a determination under this

2 paragraph, the Administrator shall take into ac3 count, among other relevant factors, the factors set

4 forth in subsection (b)(2)(C).

5 ø‘‘(3) LIMITATION.—An exemption from the re6 quirement for a tolerance for a pesticide chemical

7 residue in or on a food shall not be established by

8 the Administrator unless the Administrator deter9 mines, after consultation with the Secretary—

10 ø‘‘(A) that there is a practical method for

11 detecting and measuring the levels of such pes12 ticide chemical residue in or on such food; or

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

14 method, and states the reasons for such deter15 mination in the order issuing the regulation es16 tablishing or modifying the regulation.

17 ø‘‘(d) PETITION FOR TOLERANCE OR EXEMPTION.—

18 ø‘‘(1) PETITIONS AND PETITIONERS.—Any per19 son may file with the Administrator a petition pro20 posing the issuance of a regulation—

21 ø‘‘(A) establishing, modifying, or revoking

22 a tolerance for a pesticide chemical residue in

23 or on a food; or
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1 ø‘‘(B) establishing or revoking an exemp2 tion from the requirement of a tolerance for

3 such a residue.

4 ø‘‘(2) PETITION CONTENTS.—

5 ø‘‘(A) ESTABLISHMENT.—A petition under

6 paragraph (1) to establish a tolerance or ex7 emption for a pesticide chemical residue shall

8 be supported by such data and information as

9 are specified in regulations issued by the Ad10 ministrator, including—

11 ø‘‘(i)(I) an informative summary of

12 the petition and of the data, information,

13 and arguments submitted or cited in sup14 port of the petition;

15 ø‘‘(II) a statement that the petitioner

16 agrees that such summary or any informa17 tion it contains may be published as a part

18 of the notice of filing of the petition to be

19 published under this subsection and as

20 part of a proposed or final regulation is21 sued under this section;

22 ø‘‘(ii) the name, chemical identity,

23 and composition of the pesticide chemical

24 residue and of the pesticide chemical that

25 produces the residue;
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1 ø‘‘(iii) data showing the recommended

2 amount, frequency, method, and time of

3 application of that pesticide chemical;

4 ø‘‘(iv) full reports of tests and inves5 tigations made with respect to the safety of

6 the pesticide chemical, including full infor7 mation as to the methods and controls

8 used in conducting those tests and inves9 tigations;

10 ø‘‘(v) full reports of tests and inves11 tigations made with respect to the nature

12 and amount of the pesticide chemical resi13 due that is likely to remain in or on the

14 food, including a description of the analyt15 ical methods used;

16 ø‘‘(vi) a practical method for detect17 ing and measuring the levels of the pes18 ticide chemical residue in or on the food,

19 or a statement why such a method is not

20 needed;

21 ø‘‘(vii) practical methods for removing

22 any amount of the residue that would ex23 ceed any proposed tolerance;
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1 ø‘‘(viii) a proposed tolerance for the

2 pesticide chemical residue, if a tolerance is

3 proposed;

4 ø‘‘(ix) all relevant data bearing on the

5 physical or other technical effect that the

6 pesticide chemical is intended to have and

7 the quantity of the pesticide chemical that

8 is required to produce the effect;

9 ø‘‘(x) if the petition relates to a toler10 ance for a processed food, reports of inves11 tigations conducted using the processing

12 method(s) used to produce that food;

13 ø‘‘(xi) such information as the Admin14 istrator may require to make the deter15 mination under subsection (b)(2)(E); and

16 ø‘‘(xii) such other data and informa17 tion as the Administrator requires by regu18 lation to support the petition.

19 If information or data required by this subpara20 graph is available to the Administrator, the per21 son submitting the petition may cite the avail22 ability of the information or data in lieu of sub23 mitting it. The Administrator may require a pe24 tition to be accompanied by samples of the pes-
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1 ticide chemical with respect to which the peti2 tion is filed.

3 ø‘‘(B) MODIFICATION OR REVOCATION.—

4 The Administrator may by regulation establish

5 the requirements for information and data to

6 support a petition to modify or revoke a toler7 ance or to revoke an exemption from the re8 quirement for a tolerance.

9 ø‘‘(3) NOTICE.—A notice of the filing of a peti10 tion that the Administrator determines has met the

11 requirements of paragraph (2) shall be published by

12 the Administrator within 30 days after such deter13 mination. The notice shall announce the availability

14 of a description of the analytical methods available

15 to the Administrator for the detection and measure16 ment of the pesticide chemical residue with respect

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

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

19 needed. The notice shall include the summary re20 quired by paragraph (2)(A)(i).

21 ø‘‘(4) ACTIONS BY THE ADMINISTRATOR.—The

22 Administrator shall, after giving due consideration

23 to a petition filed under paragraph (1) and any

24 other information available to the Administrator—
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1 ø‘‘(A) issue a final regulation (which may

2 vary from that sought by the petition) estab3 lishing, modifying, or revoking a tolerance for

4 the pesticide chemical residue or an exemption

5 of the pesticide chemical residue from the re6 quirement of a tolerance;

7 ø‘‘(B) issue a proposed regulation under

8 subsection (e), and thereafter either issue a

9 final regulation under subsection (e) or an

10 order denying the petition; or

11 ø‘‘(C) issue an order denying the petition.

12 ø‘‘(5) EFFECTIVE DATE.—A regulation issued

13 under paragraph (4) shall take effect upon publica14 tion.

15 ø‘‘(6) FURTHER PROCEEDINGS.—

16 ø‘‘(A) Within 60 days after a regulation or

17 order is issued under paragraph (4), subsection

18 (e)(1), or subsection (f)(1), any person may file

19 objections thereto with the Administrator, speci20 fying with particularity the provisions of the

21 regulation or order deemed objectionable and

22 stating reasonable grounds therefor. If the reg23 ulation or order was issued in response to a pe24 tition under paragraph (d)(1), a copy of each

25 objection filed by a person other than the peti-
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1 tioner shall be served by the Administrator on

2 the petitioner.

3 ø‘‘(B) An objection may include a request

4 for a public evidentiary hearing upon the objec5 tion. The Administrator shall, upon the initia6 tive of the Administrator or upon the request of

7 an interested person and after due notice, hold

8 a public evidentiary hearing if and to the extent

9 the Administrator determines that such a public

10 hearing is necessary to receive factual evidence

11 relevant to material issues of fact raised by the

12 objections. The presiding officer in such a hear13 ing may authorize a party to obtain discovery

14 from other persons and may upon a showing of

15 good cause made by a party issue a subpoena

16 to compel testimony or production of documents

17 from any person. The presiding officer shall be

18 governed by the Federal Rules of Civil Proce19 dure in making any order for the protection of

20 the witness or the content of documents pro21 duced and shall order the payment of a reason22 able fees and expenses as a condition to requir23 ing testimony of the witness. On contest, such

24 a subpoena may be enforced by a Federal dis25 trict court.
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1 ø‘‘(C) As soon as practicable after receiv2 ing the arguments of the parties, the Adminis3 trator shall issue an order stating the action

4 taken upon each such objection and setting

5 forth any revision to the regulation or prior

6 order that the Administrator has found to be

7 warranted. If a hearing was held under sub8 paragraph (B), such order and any revision to

9 the regulation or prior order shall, with respect

10 to questions of fact at issue in the hearing, be

11 based only on substantial evidence of record at

12 such hearing, and shall set forth in detail the

13 findings of facts and the conclusions of law or

14 policy upon which the order or regulation is

15 based.

16 ø‘‘(D) An order issued under this para17 graph ruling on an objection shall not take ef18 fect before the 90th day after its publication

19 unless the Administrator finds that emergency

20 conditions exist necessitating an earlier effective

21 date, in which event the Administrator shall

22 specify in the order the Administrator’s find23 ings as to such conditions.

24 ø‘‘(7) JUDICIAL REVIEW.—(A) In a case of ac25 tual controversy as to the validity of any order is-
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1 sued under paragraph (6) or any regulation that is

2 the subject of such an order, any person who will be

3 adversely affected by such order or regulation may

4 obtain judicial review by filing in the United States

5 Court of Appeals for the circuit wherein that person

6 resides or has its principal place of business, or in

7 the United States Court of Appeals for the District

8 of Columbia Circuit, within 60 days after publication

9 of such order, a petition praying that the order or

10 regulation be set aside in whole or in part.

11 ø‘‘(B) A copy of the petition shall be forthwith

12 transmitted by the clerk of the court to the Adminis13 trator, or any officer designated by the Adminis14 trator for that purpose, and thereupon the Adminis15 trator shall file in the court the record of the pro16 ceedings on which the Administrator based the order

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

18 United States Code. Upon the filing of such a peti19 tion, the court shall have exclusive jurisdiction to af20 firm or set aside the order or regulation complained

21 of in whole or in part. The findings of the Adminis22 trator with respect to questions of fact shall be sus23 tained only if supported by substantial evidence

24 when considered on the record as a whole.
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1 ø‘‘(C) If a party applies to the court for leave

2 to adduce additional evidence, and shows to the sat3 isfaction of the court that the additional evidence is

4 material and that there were reasonable grounds for

5 the failure to adduce the evidence in the proceeding

6 before the Administrator, the court may order that

7 the additional evidence (and evidence in rebuttal

8 thereof) shall be taken before the Administrator in

9 the manner and upon the terms and conditions the

10 court deems proper. The Administrator may modify

11 prior findings as to the facts by reason of the addi12 tional evidence so taken and may modify the order

13 or regulation accordingly. The Administrator shall

14 file with the court any such modified finding, order,

15 or regulation.

16 ø‘‘(D) The judgment of the court affirming or

17 setting aside, in whole or in part, any order under

18 paragraph (6) and any regulation which is the sub19 ject of such an order shall be final, subject to review

20 by the Supreme Court of the United States as pro21 vided in section 1254 of title 28 of the United States

22 Code. The commencement of proceedings under this

23 paragraph shall not, unless specifically ordered by

24 the court to the contrary, operate as a stay of a reg25 ulation or order.
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1 ø‘‘(E) Any issue as to which review is or was

2 obtainable under paragraph (6) and this paragraph

3 shall not be the subject of judicial review under any

4 other provision of law.

5 ø‘‘(e) ACTION ON ADMINISTRATOR’S OWN INITIA6 TIVE.—

7 ø‘‘(1) GENERAL RULE.—The Administrator

8 may issue a regulation—

9 ø‘‘(A) establishing, modifying, or revoking

10 a tolerance for a pesticide chemical or a pes11 ticide chemical residue;

12 ø‘‘(B) establishing or revoking an exemp13 tion of a pesticide chemical residue from the re14 quirement of a tolerance; or

15 ø‘‘(C) establishing general procedures and

16 requirements to implement this section.

17 A regulation issued under this paragraph shall be18 come effective upon its publication.

19 ø‘‘(2) NOTICE.—Before issuing a final regula20 tion under paragraph (1), the Administrator shall

21 issue a notice of proposed rulemaking and provide a

22 period of not less than 60 days for public comment

23 on the proposed regulation, except that a shorter pe24 riod for comment may be provided if the Adminis25 trator for good cause finds that it would be contrary
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1 to the public interest to do so and states the reasons

2 for the finding in the notice of proposed rulemaking.

3 The Administrator shall provide an opportunity for

4 a public hearing during the rulemaking under proce5 dures provided in subsection (d)(6)(B).

6 ø‘‘(f) SPECIAL DATA REQUIREMENTS.—

7 ø‘‘(1) REQUIRING SUBMISSION OF ADDITIONAL

8 DATA.—If the Administrator determines that addi9 tional data or information are reasonably required to

10 support the continuation of a tolerance or exemption

11 that is in effect under this section for a pesticide

12 chemical residue on a food, the Administrator

13 shall—

14 ø‘‘(A) issue a notice requiring the persons

15 holding the pesticide registrations associated

16 with such tolerance or exemption to submit the

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

18 the Federal Insecticide, Fungicide, and

19 Rodenticide Act;

20 ø‘‘(B) issue a rule requiring that testing

21 be conducted on a substance or mixture under

22 section 4 of the Toxic Substances Control Act;

23 or

24 ø‘‘(C) publish in the Federal Register,

25 after first providing notice and an opportunity
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1 for comment of not less than 90 days’ duration,

2 an order—

3 ø‘‘(i) requiring the submission to the

4 Administrator by one or more interested

5 persons of a notice identifying the person

6 or persons who will submit the required

7 data and information;

8 ø‘‘(ii) describing the type of data and

9 information requiring to be submitted to

10 the Administrator and stating why the

11 data and information could not be obtained

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

13 of the Federal Insecticide, Fungicide, and

14 Rodenticide Act or section 4 of the Toxic

15 Substances Control Act;

16 ø‘‘(iii) describing the reports of the

17 Administrator required to be prepared dur18 ing and after the collection of the data and

19 information;

20 ø‘‘(iv) requiring the submission to the

21 Administrator of the data, information,

22 and reports referred to in clauses (ii) and

23 (iii); and
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1 ø‘‘(v) establishing dates by which the

2 submissions described in clauses (i) and

3 (iv) must be made.

4 The Administrator may revise any such order

5 to correct an error.

6 ø‘‘(2) NONCOMPLIANCE.—If a submission re7 quired by a notice issued in accordance with para8 graph (1)(A) or an order issued under paragraph

9 (1)(B) is not made by the time specified in such no10 tice or order, the Administrator may by order pub11 lished in the Federal Register modify or revoke the

12 tolerance or exemption in question.

13 ø‘‘(3) REVIEW.—An order issued under this

14 subsection shall be effective upon publication and

15 shall be subject to review in accordance with para16 graphs (6) and (7) of subsection (d).

17 ø‘‘(g) CONFIDENTIALITY AND USE OF DATA.—

18 ø‘‘(1) GENERAL RULE.—Data and information

19 that are submitted to the Administrator under this

20 section in support of a tolerance or an exemption

21 from a tolerance shall be entitled to confidential

22 treatment for reasons of business confidentiality and

23 to exclusive use and data compensation, to the same

24 extent provided by sections 3 and 10 of the Federal

25 Insecticide, Fungicide, and Rodenticide Act.
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1 ø‘‘(2) EXCEPTIONS.—Data that are entitled to

2 confidential treatment under paragraph (1) may

3 nonetheless be disclosed to the Congress of the

4 United States, and may be disclosed, under such se5 curity requirements as the Administrator may pro6 vide by regulation, to—

7 ø‘‘(A) employees of the United States au8 thorized by the Administrator to examine such

9 data in the carrying out of their official duties

10 under this Act or other Federal statutes in11 tended to protect the public health; or

12 ø‘‘(B) contractors with the United States

13 authorized by the Administrator to examine

14 such data in the carrying out of contracts under

15 such statutes.

16 ø‘‘(3) SUMMARIES.—Notwithstanding any pro17 vision of this subsection or other law, the Adminis18 trator may publish the informative summary re19 quired by subsection (d)(2)(A)(i) and may, in issu20 ing a proposed or final regulation or order under

21 this section, publish an informative summary of the

22 data relating to the regulation or order.

23 ø‘‘(h) STATUS OF PREVIOUSLY ISSUED REGULA24 TIONS.—
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1 ø‘‘(1) REGULATIONS UNDER SECTION 406.—

2 Regulations affecting pesticide chemical residues in

3 or on raw agricultural commodities promulgated, in

4 accordance with section 701(e), under the authority

5 of section 406(a) upon the basis of public hearings

6 instituted before January 1, 1953, shall be deemed

7 to be regulations issued under this section and shall

8 be subject to modification or revocation under sub9 sections (d) and (e).

10 ø‘‘(2) REGULATIONS UNDER SECTION 409.—

11 Regulations that established tolerances for sub12 stances that are pesticide chemical residues on or in

13 processed food, or that otherwise stated the condi14 tions under which such pesticide chemicals could be

15 safely used, and that were issued under section 409

16 on or before the date of the enactment of this para17 graph, shall be deemed to be regulations issued

18 under this section and shall be subject to modifica19 tion or revocation under subsection (d) or (e).

20 ø‘‘(3) REGULATIONS UNDER SECTION 408.—

21 Regulations that established tolerances or exemp22 tions under this section that were issued on or be23 fore the date of the enactment of this paragraph

24 shall remain in effect unless modified or revoked

25 under subsection (d) or (e).
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1 ø‘‘(i) TRANSITIONAL PROVISION.—If, on the day be2 fore the date of the enactment of this subsection, a sub3 stance that is a pesticide chemical was, with respect to

4 a particular pesticidal use of the substance and any result5 ing pesticide chemical residue in or on a particular food—

6 ø‘‘(1) regarded by the Administrator or the

7 Secretary as generally recognized as safe for use

8 within the meaning of the provisions of section

9 408(a) or 201(s) as then in effect; or

10 ø‘‘(2) regarded by the Secretary as a substance

11 described by section 201(s)(4), such a pesticide

12 chemical residue shall be regarded as exempt from

13 the requirement for a tolerance, as of the date of en14 actment of this subsection. The Administrator shall

15 by regulation indicate which substances are de16 scribed by this subsection. All exemption under this

17 subsection may be revoked or modified as if it had

18 been issued under subsection (c).

19 ø‘‘(j) HARMONIZATION WITH ACTION UNDER OTHER

20 LAWS.—

21 ø‘‘(1) LIMITATION.—Notwithstanding any other

22 provision of this Act, a final rule under this section

23 that revokes, modifies, or suspends a tolerance or

24 exemption for a pesticide chemical residue in or on

25 a food may be issued only if the Administrator has
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1 first taken any necessary action under the Federal

2 Insecticide, Fungicide, and Rodenticide Act with re3 spect to the registration of the pesticide(s) whose

4 use results in such residue to ensure that any au5 thorized use of the pesticide in producing, storing,

6 processing, or transporting food that occurs after

7 the issuance of such final rule under this section will

8 not result in pesticide chemical residues on such

9 food that are unsafe within the meaning of sub10 section (a).

11 ø‘‘(2) REVOCATION OF TOLERANCE OR EXEMP12 TION FOLLOWING CANCELLATION OF ASSOCIATED

13 REGISTRATIONS.—If the Administrator, acting under

14 the Federal Insecticide, Fungicide, and Rodenticide

15 Act, cancels the registration of each pesticide that

16 contains a particular pesticide chemical and that is

17 labeled for use on a particular food, or requires that

18 the registration of each such pesticide be modified to

19 prohibit its use in connection with the production,

20 storage, or transportation of such food, due in whole

21 or in part to dietary risks to humans posed by resi22 dues of that pesticide chemical on that food, the Ad23 ministrator shall revoke any tolerance or exemption

24 that allows the presence of the pesticide chemical, or

25 any pesticide chemical residue that results from its
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1 use, in or on that food. The Administrator shall use

2 the procedures set forth in subsection (e) in taking

3 action under this paragraph. A revocation under this

4 paragraph shall become effective not later than 180

5 days after—

6 ø‘‘(A) the date by which each such can7 cellation of a registration has become effective;

8 or

9 ø‘‘(B) the date on which the use of the

10 canceled pesticide becomes unlawful under the

11 terms of the cancellation, whichever is later.

12 ø‘‘(3) SUSPENSION OF TOLERANCE OR EXEMP13 TION FOLLOWING SUSPENSION OF ASSOCIATED REG14 ISTRATIONS.—

15 ø‘‘(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. The Ad2 ministrator shall use the procedures set forth in

3 subsection (e) in taking action under this para4 graph. A suspension under this paragraph shall

5 become effective not later than 60 days after

6 the date by which each such suspension of use

7 has become effective.

8 ø‘‘(B) EFFECT OF SUSPENSION.—The sus9 pension of a tolerance or exemption under sub10 paragraph (A) shall be effective as long as the

11 use of each associated registration of a pesticide

12 is suspended under the Federal Insecticide,

13 Fungicide, and Rodenticide Act. While a sus14 pension of a tolerance or exemption is effective

15 the tolerance or exemption shall not be consid16 ered to be in effect. If the suspension of use of

17 the pesticide under that Act is terminated, leav18 ing the registration of the pesticide for such use

19 in effect under that Act, the Administrator

20 shall rescind any associated suspension of toler21 ance or exemption.

22 ø‘‘(4) TOLERANCES FOR UNAVOIDABLE RESI23 DUES.—In connection with action taken under para24 graph (2) or (3), or with respect to pesticides whose

25 registrations were canceled prior to the effective date
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1 of this paragraph, if the Administrator determines

2 that a residue of the canceled or suspended pesticide

3 chemical will unavoidably persist in the environment

4 and thereby be present in or on a food, the Adminis5 trator may establish a tolerance for the pesticide

6 chemical residue at a level that permits such un7 avoidable residue to remain in such food. In estab8 lishing such a tolerance, the Administrator shall

9 take into account the factors set forth in subsection

10 (b)(2)(A)(iii) and shall use the procedures set forth

11 in subsection (e). The Administrator shall review

12 any such tolerance periodically and modify it as nec13 essary so that it allows only that level of the pes14 ticide chemical residue that is unavoidable.

15 ø‘‘(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 ø‘‘(A) the residue is present as the result

2 of 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 ø‘‘(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 ø‘‘(k) FEES.—The Administrator shall by regulation

19 require the payment of such fees as will in the aggregate,

20 in the judgment of the Administrator, be sufficient over

21 a reasonable term to provide, equip, and maintain an ade22 quate service for the performance of the Administrator’s

23 functions under this section. Under the regulations, the

24 performance of the Administrator’s services or other func25 tions under this section, including—
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1 ø‘‘(1) the acceptance for filing of a petition

2 submitted under subsection (d);

3 ø‘‘(2) the promulgation of a regulation estab4 lishing, modifying, or revoking a tolerance or estab5 lishing or revoking an exemption from the require6 ment of a tolerance under this section;

7 ø‘‘(3) the acceptance for filing of objections

8 under subsection (d)(6); or

9 ø‘‘(4) the certification and filing in court of a

10 transcript of the proceedings and the record under

11 subsection (d)(7);

12 may be conditioned upon the payment of such fees. The

13 regulations may further provide for waiver or refund of

14 fees in whole or in part when in the judgment of the Ad15 ministrator such a waiver or refund is equitable and not

16 contrary to the purposes of this subsection.

17 ø‘‘(l) NATIONAL UNIFORMITY OF TOLERANCES.—

18 ø‘‘(1) QUALIFYING PESTICIDE CHEMICAL RESI19 DUE.—For purposes of this subsection, the term

20 ‘qualifying pesticide chemical residue’ means a pes21 ticide chemical residue resulting from the use, in

22 production, processing, or storage of a food, of a

23 pesticide chemical that is an active ingredient and

24 that—
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1 ø‘‘(A) was first approved for such use in a

2 registration of a pesticide issued under section

3 3(c)(5) of the Federal Insecticide, Fungicide,

4 Rodenticide Act on or after April 25, 1985, on

5 the basis of data determined by the Adminis6 trator to meet all applicable requirements for

7 data prescribed by regulations in effect under

8 that Act on April 25, 1985; or

9 ø‘‘(B) was approved for such use in a re10 registration eligibility determination issued

11 under section 4(g) of that Act on or after the

12 date of enactment of the Food Quality Protec13 tion Act of 1995.

14 ø‘‘(2) QUALIFYING FEDERAL DETERMINA15 TION.—For purposes of this subsection, the term

16 ‘qualifying Federal determination’ means—

17 ø‘‘(A) a tolerance or exemption from the

18 requirement for a tolerance for a qualifying pes19 ticide chemical residue that was—

20 ø‘‘(i) issued under this section after

21 the date of enactment of the Food Quality

22 Protection Act of 1995; (or)

23 ø‘‘(ii) issued (or, pursuant to sub24 section (h) or (i), deemed to have been is25 sued) under this section, and determined
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1 by the Administrator to meet the standard

2 under subsection (b)(2) (in the case of a

3 tolerance) or (c)(2) (in the case of an ex4 emption); and

5 ø‘‘(B) any statement, issued by the Sec6 retary, of the residue level below which enforce7 ment action will not be taken under this Act

8 with respect to any qualifying pesticide chemi9 cal residue, if the Secretary finds that such pes10 ticide chemical residue level permitted by such

11 statement during the period to which such

12 statement applies protects human health.

13 ø‘‘(3) LIMITATION.—The Administrator may

14 make the determination described in paragraph

15 (2)(A)(ii) only by issuing a rule in accordance with

16 the procedure set forth in subsection (d) or (e) and

17 only if the Administrator issues a proposed rule and

18 allows a period of not less than 30 days for comment

19 on the proposed rule. Any such rule shall be

20 reviewable in accordance with subsections (d)(6) and

21 (d)(7).

22 ø‘‘(4) STATE AUTHORITY.—Except as provided

23 in paragraph (5), no State or political subdivision

24 may establish or enforce any regulatory limit on a

25 qualifying pesticide chemical residue in or on any
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1 food if a qualifying Federal determination applies to

2 the presence of such pesticide chemical residue in or

3 on such food, unless such State regulatory limit is

4 identical to such qualifying Federal determination. A

5 State or political subdivision shall be deemed to es6 tablish or enforce a regulatory limit on a pesticide

7 chemical residue in or on food if it purports to pro8 hibit or penalize the production, processing, ship9 ping, or other handling of a food because it contains

10 a pesticide residue (in excess of a prescribed limit),

11 or if it purports to require that a food containing a

12 pesticide residue be the subject of a warning or

13 other statement relating to the presence of the pes14 ticide residue in the food.

15 ø‘‘(5) PETITION PROCEDURE.—

16 ø‘‘(A) Any State may petition the Admin17 istrator for authorization to establish in such

18 State a regulatory limit on a qualifying pes19 ticide chemical residue in or on any food that

20 is not identical to the qualifying Federal deter21 mination applicable to such qualifying pesticide

22 chemical residue.

23 ø‘‘(B) Any petition under subparagraph

24 (A) shall—
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1 ø‘‘(i) satisfy any requirements pre2 scribed, by rule, by the Administrator; and

3 ø‘‘(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 ø‘‘(C) Subject to paragraph (6), the Ad13 ministrator may, by order, grant the authoriza14 tion described in subparagraph (A) if the Ad15 ministrator determines that the proposed State

16 regulatory limit—

17 ø‘‘(i) is justified by compelling local

18 conditions;

19 ø‘‘(ii) would not unduly burden inter20 state commerce; and

21 ø‘‘(iii) would not cause any food to be

22 in violation of Federal law.

23 ø‘‘(D) In lieu of any action authorized

24 under subparagraph (C), the Administrator

25 may treat a petition under this paragraph as a
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1 petition under subsection (d) to revoke or mod2 ify a tolerance or to revoke an exemption. If the

3 Administrator determines to treat a petition

4 under this paragraph as a petition under sub5 section (d), the Administrator shall thereafter

6 act on the petition pursuant to subsection (d).

7 ø‘‘(E) Any order of the Administrator

8 granting or denying the authorization described

9 in subparagraph (A) shall be subject to review

10 in the manner described in subsections (d)(6)

11 and (d)(7).

12 ø‘‘(6) RESIDUES FROM LAWFUL APPLICA13 TION.—No State or political subdivision may enforce

14 any regulatory limit on the level of a pesticide chem15 ical residue that may appear in or on any food if,

16 at the time of the application of the pesticide that

17 resulted in such residue, the sale of such food with

18 such residue level was lawful under this Act and

19 under the law of such State, unless the State dem20 onstrates that consumption of the food containing

21 such pesticide residue level during the period of the

22 food’s likely availability in the State will pose an un23 reasonable dietary risk to the health of persons with24 in such State.’’.
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1 øSEC. 406. AUTHORIZATION FOR INCREASE MONITORING.

2 øThere is authorized to be appropriated an additional

3 $12,000,000 for increased monitoring by the Secretary of

4 Health and Human Services of pesticide residues in im5 ported and domestic food.¿

6 TITLE IV—AMENDMENTS TO THE

7 FEDERAL FOOD, DRUG, AND

8 COSMETIC ACT

9 SEC 401. SHORT TITLE AND REFERENCE.

10 (a) SHORT TITLE.—This title may be cited

11 as the ‘‘Food Quality Protection Act of 1996 ’’.

12 (b) REFERENCE.—Whenever in this title an

13 amendment or repeal is expressed in terms of

14 an amendment to, or repeal of, a section or

15 other provision, the reference shall be consid16 ered to be made to a section or other provi17 sion of the Federal Food, Drug, and Cosmetic

18 Act.

19 SEC. 402. DEFINITIONS.

20 (a) SECTION 201(q).—Section 201(q) (21

21 U.S.C. 321(q)) is amended to read as follows:

22 ‘‘(q)(1) The term ‘pesticide chemical’

23 means any substance that is a pesticide with24 in the meaning of the Federal Insecticide,

25 Fungicide, and Rodenticide Act, including all

26 active and inert ingredients of such pesticide.
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1 ‘‘(2) The term ‘pesticide chemical residue’

2 means a residue in or on raw agricultural

3 commodity or processed food of—

4 ‘‘(A) a pesticide chemical; or

5 ‘‘(B) any other added substance that

6 is present on or in the commodity or food

7 primarily as a result of the metabolism or

8 other degradation of a pesticide chemi9 cal.

10 ‘‘(3) Notwithstanding paragraphs (1) and

11 (2), the Administrator may by regulation ex12 cept a substance from the definition of ‘pes13 ticide chemical’ or ‘pesticide chemical resi14 due’ if—

15 ‘‘(A) its occurrence as a residue on or

16 in a raw agricultural commodity or proc17 essed food is attributable primarily to

18 natural causes or to human activities not

19 involving the use of any substances for a

20 pesticidal purpose in the production,

21 storage, processing, or transportation of

22 any raw agricultural commodity or proc23 essed food; and

24 ‘‘(B) the Administrator, after con25 sultation with the Secretary, determines
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1 that the substance more appropriately

2 should be regulated under one or more

3 provisions of this Act other than sections

4 402(a)(2)(B) and 408.’’.

5 (b) SECTION 201(s).—Paragraphs (1) and (2)

6 of section 201(s) (21 U.S.C. 321(s)) are amend7 ed to read as follows:

8 ‘‘(1) a pesticide chemical residue in or

9 on a raw agricultural commodity or proc10 essed food; or

11 ‘‘(2) a pesticide chemical; or’’.

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

13 321) is amended by adding at the end the fol14 lowing:

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

16 food other than a raw agricultural commodity

17 and includes any raw agricultural commodity

18 that has been subject to processing, such as

19 canning, cooking, freezing, dehydration, or

20 milling.

21 ‘‘(hh) The term ‘Administrator’ means the

22 Administrator of the United States Environ23 mental Protection Agency.’’.
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1 SEC. 403. PROHIBITED ACTS.

2 Section 301(j) (21 U.S.C. 331(j)) is amended

3 in the first sentence by inserting before the

4 period the following: ‘‘; or the violating of sec5 tion 408(i)(2) or any regulation issued under

6 that section.’’.

7 SEC. 404. ADULTERATED FOOD.

8 Section 402(a) (21 U.S.C. 342(a)) is amend9 ed by striking ‘‘(2)(A) if it bears’’ and all that

10 follows through ‘‘(3) if it consists’’ and insert11 ing the following: ‘‘(2)(A) if it bears or con12 tains any added poisonous or added delete13 rious substance (other than a substance that

14 is a pesticide chemical residue in or on a raw

15 agricultural commodity or processed food, a

16 food additive, a color additive, or a new ani17 mal drug) that is unsafe within the meaning

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

19 pesticide chemical residue that is unsafe

20 within the meaning of section 408(a); or (C) if

21 it is or if it bears or contains (i) any food addi22 tive that is unsafe within the meaning of sec23 tion 409; or (ii) a new animal drug (or conver24 sion product thereof) that is unsafe within the

25 meaning of section 512; or (3) if it consists’’.
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1 SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE

2 CHEMICAL RESIDUES.

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

4 read as follows:

5 ‘‘TOLERANCES AND EXEMPTIONS FOR PESTICIDE

6 CHEMICAL RESIDUES

7 ‘‘SEC. 408. (a) REQUIREMENT FOR TOLER8 ANCE OR EXEMPTION.—

9 ‘‘(1) GENERAL RULE.—Except as pro10 vided in paragraph (2) or (3), any pes11 ticide chemical residue in or on a food

12 shall be deemed unsafe for the purpose of

13 section 402(a)(2)(B) unless—

14 ‘‘(A) a tolerance for such pesticide

15 chemical residue in or on such food is

16 in effect under this section and the

17 quantity of the residue is within the

18 limits of the tolerance; or

19 ‘‘(B) an exemption from the re20 quirement of a tolerance is in effect

21 under this section for the pesticide

22 chemical residue.

23 For the purposes of this section, the term

24 ‘food’, when used as a noun without

25 modification, shall mean a raw agricul26 tural commodity or processed food.
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1 ‘‘(2) PROCESSED FOOD.—Notwithstand2 ing paragraph (1)—

3 ‘‘(A) if a tolerance is in effect

4 under this section for a pesticide

5 chemical residue in or on a raw agri6 cultural commodity, a pesticide chem7 ical residue that is present in or on a

8 processed food because the food is

9 made from that raw agricultural com10 modity shall not be considered unsafe

11 within the meaning of section

12 402(a)(2)(B) despite the lack of a tol13 erance for the pesticide chemical res14 idue in or on the processed food if the

15 pesticide chemical has been used in

16 or on the raw agricultural commodity

17 in conformity with a tolerance under

18 this section, such residue in or on the

19 raw agricultural commodity has been

20 removed to the extent possible in

21 good manufacturing practice, and the

22 concentration of the pesticide chemi23 cal residue in the processed food is

24 not greater than the tolerance pre25 scribed for the pesticide chemical res-
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1 idue in the raw agricultural commod2 ity; or

3 ‘‘(B) if an exemption for the re4 quirement for a tolerance is in effect

5 under this section for a pesticide

6 chemical residue in or on a raw agri7 cultural commodity, a pesticide chem8 ical residue that is present in or on a

9 processed food because the food is

10 made from that raw agricultural com11 modity shall not be considered unsafe

12 within the meaning of section

13 402(a)(2)(B).

14 ‘‘(3) RESIDUES OF DEGRADATION PROD15 UCTS.—If a pesticide chemical residue is

16 present in or on a food because it is a

17 metabolite or other degradation product

18 of a precursor substance that itself is a

19 pesticide chemical or pesticide chemical

20 residue, such a residue shall not be con21 sidered to be unsafe within the meaning

22 of section 402(a)(2)(B) despite the lack of

23 a tolerance or exemption from the need

24 for a tolerance for such residue in or on

25 such food if—
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1 ‘‘(A) the Administrator has not de2 termined that the degradation prod3 uct is likely to pose any potential

4 health risk from dietary exposure

5 that is of a different type than, or of

6 a greater significance than, any risk

7 posed by dietary exposure to the pre8 cursor substance;

9 ‘‘(B) either—

10 ‘‘(i) a tolerance is in effect

11 under this section for residues of

12 the precursor substance in or on

13 the food, and the combined level

14 of residues of the degradation

15 product and the precursor sub16 stance in or on the food is at or

17 below the stoichiometrically

18 equivalent level that would be

19 permitted by the tolerance if the

20 residue consisted only of the pre21 cursor substance rather than the

22 degradation product; or

23 ‘‘(ii) an exemption from the

24 need for a tolerance is in effect

25 under this section for residues of
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1 the precursor substance in or on

2 the food; and

3 ‘‘(C) the tolerance or exemption

4 for residues of the precursor sub5 stance does not state that it applies

6 only to particular named substances

7 and does not state that it does not

8 apply to residues of the degradation

9 product.

10 ‘‘(4) EFFECT OF TOLERANCE OR EXEMP11 TION.—While a tolerance or exemption

12 from the requirement for a tolerance is in

13 effect under this section for a pesticide

14 chemical residue with respect to any

15 food, the food shall not by reason of bear16 ing or containing any amount of such a

17 residue be considered to be adulterated

18 within the meaning of section 402(a)(1).

19 ‘‘(b) AUTHORITY AND STANDARD FOR TOLER20 ANCE.—

21 ‘‘(1) AUTHORITY.—The Administrator

22 may issue regulations establishing, modi23 fying, or revoking a tolerance for a pes24 ticide chemical residue in or on a food—
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1 ‘‘(A) in response to a petition filed

2 under subsection (d); or

3 ‘‘(B) on the Administrator’s own

4 initiative under subsection (e).

5 As used in this section, the term ‘modify’

6 shall not mean expanding the tolerance

7 to cover additional foods.

8 ‘‘(2) STANDARD.—

9 ‘‘(A) GENERAL RULE.—

10 ‘‘(i) STANDARD.—The Adminis11 trator may establish or leave in

12 effect a tolerance for a pesticide

13 chemical residue in or on a food

14 only if the Administrator deter15 mines that the tolerance is safe.

16 The Administrator shall modify or

17 revoke a tolerance if the Adminis18 trator determines it is not safe.

19 ‘‘(ii) DETERMINATION OF SAFE20 TY.—As used in this section, the

21 term ‘safe’, with respect to a toler22 ance for a pesticide chemical resi23 due’, means that the Adminis24 trator has determined that there

25 is a reasonable certainty that no
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1 harm will result from aggregate

2 exposure to the pesticide chemi3 cal residue, including all antici4 pated dietary exposures and all

5 other exposures for which there

6 is reliable information.

7 ‘‘(iii) RULE OF CONSTRUCTION.—

8 With respect to a tolerance, a pes9 ticide chemical residue meeting

10 the standard under clause (i) is

11 not an eligible pesticide chemical

12 residue for purposes of subpara13 graph (B).

14 ‘‘(B) TOLERANCES FOR ELIGIBLE PES15 TICIDE CHEMICAL RESIDUES.—

16 ‘‘(i) DEFINITION.—As used in

17 this subparagraph, the term ‘eligi18 ble pesticide chemical residue’

19 means a pesticide chemical resi20 due as to which—

21 ‘‘(I) the Administrator is

22 not able to identify a level of

23 exposure to the residue at

24 which the residue will not

25 cause or contribute to a
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1 known or anticipated harm to

2 human health (referred to in

3 this section as a ‘nonthreshold

4 effect’);

5 ‘‘(II) the lifetime risk of

6 experiencing the nonthresh7 old effect is appropriately as8 sessed by quantitative risk as9 sessment; and

10 ‘‘(III) with regard to any

11 known or anticipated harm to

12 human health for which the

13 Administrator is able to iden14 tify a level at which the resi15 due will not cause such harm

16 (referred to in this section as

17 a ‘threshold effect’), the Ad18 ministrator determines that

19 the level of aggregate expo20 sure is safe.

21 ‘‘(ii) DETERMINATION OF TOLER22 ANCE.—Notwithstanding subpara23 graph (A)(i), a tolerance for an eli24 gible pesticide chemical residue
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1 may be left in effect or modified

2 under this subparagraph if—

3 ‘‘(I) at least one of the con4 ditions described in clause

5 (iii) is met; and

6 ‘‘(II) both of the condi7 tions described in clause (iv)

8 are met.

9 ‘‘(iii) CONDITIONS REGARDING

10 USE.—For purposes of clause (ii),

11 the conditions described in this

12 clause with respect to a tolerance

13 for an eligible pesticide chemical

14 residue are the following:

15 ‘‘(I) Use of the pesticide

16 chemical that produces the

17 residue protects consumers

18 from adverse effects on health

19 that would pose a greater risk

20 than the dietary risk from the

21 residue.

22 ‘‘(II) Use of the pesticide

23 chemical that produces the

24 residue is necessary to avoid

25 a significant disruption in do-
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1 mestic production of an ade2 quate, wholesome, and eco3 nomical food supply.

4 ‘‘(iv) CONDITIONS REGARDING

5 RISK.—For purposes of clause (ii),

6 the conditions described in this

7 clause with respect to a tolerance

8 for an eligible pesticide chemical

9 residue are the following:

10 ‘‘(I) The yearly risk associ11 ated with the nonthreshold ef12 fect from aggregate exposure

13 to the residue does not exceed

14 10 times the yearly risk that

15 would be allowed under sub16 paragraph (A) for such effect.

17 ‘‘(II) The tolerance is lim18 ited so as to ensure that the

19 risk over a lifetime associated

20 with the nonthreshold effect

21 from aggregate exposure to

22 the residue is not greater

23 than twice the lifetime risk

24 that would be allowed under
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1 subparagraph (A) for such ef2 fect.

3 ‘‘(v) REVIEW.—Five years after

4 the date on which the Adminis5 trator makes a determination to

6 leave in effect or modify a toler7 ance under this subparagraph,

8 and thereafter as the Adminis9 trator deems appropriate, the Ad10 ministrator shall determine, after

11 notice and opportunity for com12 ment, whether it has been dem13 onstrated to the Administrator

14 that a condition described in

15 clause (iii)(I) or clause (iii)(II)

16 continues to exist with respect to

17 the tolerance and that the yearly

18 and lifetime risks from aggregate

19 exposure to such residue con20 tinue to comply with the limits

21 specified in clause (iv). If the Ad22 ministrator determines by such

23 date that such demonstration has

24 not been made, the Administrator

25 shall, not later than 180 days after
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1 the date of such determination,

2 issue a regulation under sub3 section (e)(1) to modify or revoke

4 the tolerance.

5 ‘‘(vi) INFANTS AND CHILDREN.—

6 Any tolerance under this subpara7 graph shall meet the require8 ments of subparagraph (C).

9 ‘‘(C) EXPOSURE OF INFANTS AND

10 CHILDREN.—In establishing, modify11 ing, leaving in effect, or revoking a

12 tolerance or exemption for a pesticide

13 chemical residue, the Administrator—

14 ‘‘(i) shall assess the risk of the

15 pesticide chemical residue based

16 on—

17 ‘‘(I) available information

18 about consumption patterns

19 among infants and children

20 that are likely to result in dis21 proportionately high con22 sumption of foods containing

23 or bearing such residue

24 among infants and children in
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1 comparison to the general

2 population;

3 ‘‘(II) available information

4 concerning the special suscep5 tibility of infants and children

6 to the pesticide chemical resi7 dues, including neurological

8 differences between infants

9 and children and adults, and

10 effects of in utero exposure to

11 pesticide chemicals; and

12 ‘‘(III) available informa13 tion concerning the cumu14 lative effects on infants and

15 children of such residues and

16 other substances that have a

17 common mechanism of tox18 icity; and

19 ‘‘(ii) shall—

20 ‘‘(I) ensure that there is a

21 reasonable certainty that no

22 harm will result to infants

23 and children from aggregate

24 exposure to the pesticide

25 chemical residue; and
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1 ‘‘(II) publish a specific de2 termination regarding the

3 safety of the pesticide chemi4 cal residue for infants and

5 children.

6 The Secretary of Health and Human

7 Services and the Secretary of Agri8 culture, in consultation with the Ad9 ministrator, shall conduct surveys to

10 document dietary exposure to pes11 ticides among infants and children.

12 In the case of threshold effects, for

13 purposes of clause (ii)(I) an addi14 tional tenfold margin of safety for the

15 pesticide chemical residue and other

16 sources of exposure shall be applied

17 for infants and children to take into

18 account potential pre- and post-natal

19 toxicity and completeness of the data

20 with respect to exposure and toxicity

21 to infants and children. Notwith22 standing such requirement for an ad23 ditional margin of safety, the Admin24 istrator may use a different margin of

25 safety for the pesticide chemical resi-
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1 due only if, on the basis of reliable

2 data, such margin will be safe for in3 fants and children.

4 ‘‘(D) FACTORS.—In establishing,

5 modifying, leaving in effect, or revok6 ing a tolerance or exemption for a

7 pesticide chemical residue, the Ad8 ministrator shall consider, among

9 other relevant factors—

10 ‘‘(i) the validity, completeness,

11 and reliability of the available

12 data from studies of the pesticide

13 chemical and pesticide chemical

14 residue;

15 ‘‘(ii) the nature of any toxic ef16 fect shown to be caused by the

17 pesticide chemical or pesticide

18 chemical residue in such studies;

19 ‘‘(iii) available information

20 concerning the relationship of the

21 results of such studies to human

22 risk;

23 ‘‘(iv) available information

24 concerning the dietary consump25 tion patterns of consumers (and
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1 major identifiable subgroups of

2 consumers);

3 ‘‘(v) available information

4 concerning the cumulative effects

5 of such residues and other sub6 stances that have a common

7 mechanism of toxicity;

8 ‘‘(vi) available information

9 concerning the aggregate expo10 sure levels of consumers (and

11 major identifiable subgroups of

12 consumers) to the pesticide chem13 ical residue and to other related

14 substances, including dietary ex15 posure under the tolerance and

16 all other tolerances in effect for

17 the pesticide chemical residue,

18 and exposure from other non-oc19 cupational sources;

20 ‘‘(vii) available information

21 concerning the variability of the

22 sensitivities of major identifiable

23 subgroups of consumers;

24 ‘‘(viii) such information as the

25 Administrator may require on
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1 whether the pesticide chemical

2 may have an effect in humans

3 that is similar to an effect pro4 duced by a naturally occurring

5 estrogen or other endocrine ef6 fects; and

7 ‘‘(ix) safety factors which in

8 the opinion of experts qualified

9 by scientific training and experi10 ence to evaluate the safety of food

11 additives are generally recog12 nized as appropriate for the use

13 of animal experimentation data.

14 ‘‘(E) DATA AND INFORMATION RE15 GARDING ANTICIPATED AND ACTUAL RESI16 DUE LEVELS.—

17 ‘‘(i) AUTHORITY.—In establishing,

18 modifying, leaving in effect, or revok19 ing a tolerance for a pesticide chemi20 cal residue, the Administrator may

21 consider available data and informa22 tion on the anticipated residue levels

23 of the pesticide chemical in or on

24 food and the actual residue levels of

25 the pesticide chemical that have been
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1 measured in food, including residue

2 data collected by the Food and Drug

3 Administration.

4 ‘‘(ii) REQUIREMENT.—If the Admin5 istrator relies on anticipated or ac6 tual residue levels in establishing,

7 modifying, or leaving in effect a toler8 ance, the Administrator shall pursu9 ant to subsection (f)(1) require that

10 data be provided five years after the

11 date on which the tolerance is estab12 lished, modified, or left in effect, and

13 thereafter as the Administrator

14 deems appropriate, demonstrating

15 that such residue levels are not above

16 the levels so relied on. If such data

17 are not so provided, or if the data do

18 not demonstrate that the residue lev19 els are not above the levels so relied

20 on, the Administrator shall, not later

21 than 180 days after the date on which

22 the data were required to be pro23 vided, issue a regulation under sub24 section (e)(1), or an order under sub-
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1 section (f)(2), as appropriate, to mod2 ify or revoke the tolerance.

3 ‘‘(F) PERCENT OF FOOD ACTUALLY

4 TREATED.—In establishing, modifying,

5 leaving in effect, or revoking a toler6 ance for a pesticide chemical residue,

7 the Administrator may, when assess8 ing chronic dietary risk, consider

9 available data and information on the

10 percent of food actually treated with

11 the pesticide chemical (including ag12 gregate pesticide use data collected

13 by the Department of Agriculture)

14 only if the Administrator—

15 ‘‘(i) finds that the data are re16 liable and provide a valid basis to

17 show what percentage of the food

18 derived from such crop is likely

19 to contain such pesticide chemi20 cal residue;

21 ‘‘(ii) finds that the exposure

22 estimate does not understate ex23 posure for any significant sub24 population group;
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1 ‘‘(iii) finds that, if data are

2 available on pesticide use and

3 consumption of food in a particu4 lar area, the population in such

5 area is not dietarily exposed to

6 residues above those estimated by

7 the Administrator; and

8 ‘‘(iv) provides for the periodic

9 reevaluation of the estimate of

10 anticipated dietary exposure.

11 ‘‘(3) DETECTION METHODS.—

12 ‘‘(A) GENERAL RULE.—A tolerance

13 for a pesticide chemical residue in or

14 on a food shall not be established or

15 modified by the Administrator unless

16 the Administrator determines, after

17 consultation with the Secretary, that

18 there is a practical method for detect19 ing and measuring the levels of the

20 pesticide chemical residue in or on

21 the food.

22 ‘‘(B) DETECTION LIMIT.—A toler23 ance for a pesticide chemical residue

24 in or on a food shall not be estab25 lished at or modified to a level lower
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1 than the limit of detection of the

2 method for detecting and measuring

3 the pesticide chemical residue speci4 fied by the Administrator under sub5 paragraph (A).

6 ‘‘(4) INTERNATIONAL STANDARDS.—In es7 tablishing a tolerance for a pesticide

8 chemical residue in or on a food, the Ad9 ministrator shall determine whether a

10 maximum residue level for the pesticide

11 chemical has been established by the

12 Codex Alimentarius Commission. If a

13 Codex maximum residue level has been

14 established for the pesticide chemical

15 and the Administrator does not propose

16 to adopt the Codex level, the Adminis17 trator shall publish for public comment a

18 notice explaining the reasons for depart19 ing from the Codex level.

20 ‘‘(c) AUTHORITY AND STANDARD FOR EXEMP21 TIONS.—

22 ‘‘(1) AUTHORITY.—The Administrator

23 may issue a regulation establishing,

24 modifying, or revoking an exemption

25 from the requirement for a tolerance for
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1 a pesticide chemical residue in or on

2 food—

3 ‘‘(A) in response to a petition filed

4 under subsection (d); or

5 ‘‘(B) on the Administrator’s initia6 tive under subsection (e).

7 ‘‘(2) STANDARD.—

8 ‘‘(A) GENERAL RULE.—

9 ‘‘(i) STANDARD.—The Adminis10 trator may establish or leave in

11 effect an exemption from the re12 quirement for a tolerance for a

13 pesticide chemical residue in or

14 on food only if the Administrator

15 determines that the exemption is

16 safe. The Administrator shall

17 modify or revoke an exemption if

18 the Administrator determines it is

19 not safe.

20 ‘‘(ii) DETERMINATION OF SAFE21 TY.—The term ‘safe’, with respect

22 to an exemption for a pesticide

23 chemical residue, means that the

24 Administrator has determined

25 that there is a reasonable cer-
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1 tainty that no harm will result

2 from aggregate exposure to the

3 pesticide chemical residue, in4 cluding all anticipated dietary ex5 posures and all other exposures

6 for which there is reliable infor7 mation.

8 ‘‘(B) FACTORS.—In making a deter9 mination under this paragraph, the

10 Administrator shall take into ac11 count, among other relevant consid12 erations, the considerations set forth

13 in subparagraphs (C) and (D) of sub14 section (b)(2).

15 ‘‘(3) LIMITATION.—An exemption from

16 the requirement for a tolerance for a pes17 ticide chemical residue in or on food

18 shall not be established or modified by

19 the Administrator unless the Adminis20 trator determines, after consultation with

21 the Secretary—

22 ‘‘(A) that there is a practical

23 method for detecting and measuring

24 the levels of such pesticide chemical

25 residue in or on food; or
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1 ‘‘(B) that there is no need for such

2 a method, and states the reasons for

3 such determination in issuing the

4 regulation establishing or modifying

5 the exemption.

6 ‘‘(d) PETITION FOR TOLERANCE OR EXEMP7 TION.—

8 ‘‘(1) PETITIONS AND PETITIONERS.—Any

9 person may file with the Administrator a

10 petition proposing the issuance of a regu11 lation—

12 ‘‘(A) establishing, modifying, or

13 revoking a tolerance for a pesticide

14 chemical residue in or on a food; or

15 ‘‘(B) establishing, modifying, or

16 revoking an exemption from the re17 quirement of a tolerance for such a

18 residue.

19 ‘‘(2) PETITION CONTENTS.—

20 ‘‘(A) ESTABLISHMENT.—A petition

21 under paragraph (1) to establish a tol22 erance or exemption for a pesticide

23 chemical residue shall be supported

24 by such data and information as are
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1 specified in regulations issued by the

2 Administrator, including—

3 ‘‘(i)(I) an informative sum4 mary of the petition and of the

5 data, information, and arguments

6 submitted or cited in support of

7 the petition; and

8 ‘‘(II) a statement that the peti9 tioner agrees that such summary

10 or any information it contains

11 may be published as a part of the

12 notice of filing of the petition to

13 be published under this sub14 section and as part of a proposed

15 or final regulation issued under

16 this section;

17 ‘‘(ii) the name, chemical iden18 tity, and composition of the pes19 ticide chemical residue and of the

20 pesticide chemical that produces

21 the residue;

22 ‘‘(iii) data showing the rec23 ommended amount, frequency,

24 method, and time of application

25 of that pesticide chemical;
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1 ‘‘(iv) full reports of tests and

2 investigations made with respect

3 to the safety of the pesticide

4 chemical, including full informa5 tion as to the methods and con6 trols used in conducting those

7 tests and investigations;

8 ‘‘(v) full reports of tests and

9 investigations made with respect

10 to the nature and amount of the

11 pesticide chemical residue that is

12 likely to remain in or on the food,

13 including a description of the an14 alytical methods used;

15 ‘‘(vi) a practical method for

16 detecting and measuring the lev17 els of the pesticide chemical resi18 due in or on the food, or for ex19 emptions, a statement why such a

20 method is not needed;

21 ‘‘(vii) a proposed tolerance for

22 the pesticide chemical residue, if

23 a tolerance is proposed;

24 ‘‘(viii) if the petition relates to

25 a tolerance for a processed food,
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1 reports of investigations con2 ducted using the processing

3 method(s) used to produce that

4 food;

5 ‘‘(ix) such information as the

6 Administrator may require to

7 make the determination under

8 subsection (b)(2)(C);

9 ‘‘(x) such information as the

10 Administrator may require on

11 whether the pesticide chemical

12 may have an effect in humans

13 that is similar to an effect pro14 duced by a naturally occurring

15 estrogen or other endocrine ef16 fects;

17 ‘‘(xi) information regarding

18 exposure to the pesticide chemi19 cal residue due to any tolerance

20 or exemption already granted for

21 such residue;

22 ‘‘(xii) practical methods for re23 moving any amount of the residue

24 that would exceed any proposed

25 tolerance; and
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1 ‘‘(xiii) such other data and in2 formation as the Administrator

3 requires by regulation to support

4 the petition.

5 If information or data required by

6 this subparagraph is available to the

7 Administrator, the person submitting

8 the petition may cite the availability

9 of the information or data in lieu of

10 submitting it. The Administrator may

11 require a petition to be accompanied

12 by samples of the pesticide chemical

13 with respect to which the petition is

14 filed.

15 ‘‘(B) MODIFICATION OR REVOCA16 TION.—The Administrator may by reg17 ulation establish the requirements for

18 information and data to support a pe19 tition to modify or revoke a tolerance

20 or to modify or revoke an exemption

21 from the requirement for a tolerance.

22 ‘‘(3) NOTICE.—A notice of the filing of

23 a petition that the Administrator deter24 mines has met the requirements of para25 graph (2) shall be published by the Ad-
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1 ministrator within 30 days after such de2 termination. The notice shall announce

3 the availability of a description of the an4 alytical methods available to the Admin5 istrator for the detection and measure6 ment of the pesticide chemical residue

7 with respect to which the petition is filed

8 or shall set forth the petitioner’s state9 ment of why such a method is not need10 ed. The notice shall include the summary

11 required by paragraph (2)(A)(i)(I).

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

13 ‘‘(A) IN GENERAL.—The Adminis14 trator shall, after giving due consid15 eration to a petition filed under para16 graph (1) and any other information

17 available to the Administrator—

18 ‘‘(i) issue a final regulation

19 (which may vary from that sought

20 by the petition) establishing,

21 modifying, or revoking a toler22 ance for the pesticide chemical

23 residue or an exemption of the

24 pesticide chemical residue from

25 the requirement of a tolerance
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1 (which final regulation shall be is2 sued without further notice and

3 without further period for public

4 comment);

5 ‘‘(ii) issue a proposed regula6 tion under subsection (e), and

7 thereafter issue a final regulation

8 under such subsection; or

9 ‘‘(iii) issue an order denying

10 the petition.

11 ‘‘(B) PRIORITIES.—The Adminis12 trator shall give priority to petitions

13 for the establishment or modification

14 of a tolerance or exemption for a pes15 ticide chemical residue that appears

16 to pose a significantly lower risk to

17 human health from dietary exposure

18 than pesticide chemical residues that

19 have tolerances in effect for the same

20 or similar uses.

21 ‘‘(C) EXPEDITED REVIEW OF CERTAIN

22 PETITIONS.—

23 ‘‘(i) DATE CERTAIN FOR RE24 VIEW.—If a person files a complete

25 petition with the Administrator
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1 proposing the issuance of a regu2 lation establishing a tolerance or

3 exemption for a pesticide chemi4 cal residue that presents a lower

5 risk to human health than a pes6 ticide chemical residue for which

7 a tolerance has been left in effect

8 or modified under subsection

9 (b)(2)(B), the Administrator shall

10 complete action on such petition

11 under this paragraph within 1

12 year.

13 ‘‘(ii) REQUIRED DETERMINA14 TIONS.—If the Administrator is15 sues a final regulation establish16 ing a tolerance or exemption for a

17 safer pesticide chemical residue

18 under clause (i), the Adminis19 trator shall, not later than 180

20 days after the date on which the

21 regulation is issued, determine

22 whether a condition described in

23 subclause (I) or (II) of subsection

24 (b)(2)(B)(iii) continues to exist

25 with respect to a tolerance that
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1 has been left in effect or modified

2 under subsection (b)(2)(B). If such

3 condition does not continue to

4 exist, the Administrator shall, not

5 later than 180 days after the date

6 on which the determination

7 under the preceding sentence is

8 made, issue a regulation under

9 subsection (e)(1) to modify or re10 voke the tolerance.

11 ‘‘(e) ACTION ON ADMINISTRATOR’S OWN INI12 TIATIVE.—

13 ‘‘(1) GENERAL RULE.—The Adminis14 trator may issue a regulation—

15 ‘‘(A) establishing, modifying, sus16 pending under subsection (l)(3), or re17 voking a tolerance for a pesticide

18 chemical or a pesticide chemical resi19 due;

20 ‘‘(B) establishing, modifying, sus21 pending under subsection (l)(3), or re22 voking an exemption of a pesticide

23 chemical residue from the require24 ment of a tolerance; or
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1 ‘‘(C) establishing general proce2 dures and requirements to implement

3 this section.

4 ‘‘(2) NOTICE.—Before issuing a final

5 regulation under paragraph (1), the Ad6 ministrator shall issue a notice of pro7 posed rulemaking and provide a period

8 of not less than 60 days for public com9 ment on the proposed regulation, except

10 that a shorter period for comment may

11 be provided if the Administrator for good

12 cause finds that it would be in the public

13 interest to do so and states the reasons

14 for the finding in the notice of proposed

15 rulemaking.

16 ‘‘(f) SPECIAL DATA REQUIREMENTS.—

17 ‘‘(1) REQUIRING SUBMISSION OF ADDI18 TIONAL DATA.—If the Administrator deter19 mines that additional data or information

20 are reasonably required to support the

21 continuation of a tolerance or exemption

22 that is in effect under this section for a

23 pesticide chemical residue on a food, the

24 Administrator shall—
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1 ‘‘(A) issue a notice requiring the

2 person holding the pesticide registra3 tions associated with such tolerance

4 or exemption to submit the data or

5 information under section 3(c)(2)(B)

6 of the Federal Insecticide, Fungicide,

7 and Rodenticide Act;

8 ‘‘(B) issue a rule requiring that

9 testing be conducted on a substance

10 or mixture under section 4 of the

11 Toxic Substances Control Act; or

12 ‘‘(C) publish in the Federal Reg13 ister, after first providing notice and

14 an opportunity for comment of not

15 less than 60 days’ duration, an

16 order—

17 ‘‘(i) requiring the submission

18 to the Administrator by one or

19 more interested persons of a no20 tice identifying the person or per21 sons who will submit the required

22 data and information;

23 ‘‘(ii) describing the type of

24 data and information required to

25 be submitted to the Administrator
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1 and stating why the data and in2 formation could not be obtained

3 under the authority of section

4 3(c)(2)(B) of the Federal Insecti5 cide, Fungicide, and Rodenticide

6 Act or section 4 of the Toxic Sub7 stances Control Act;

8 ‘‘(iii) describing the reports of

9 the Administrator required to be

10 prepared during and after the

11 collection of the data and infor12 mation;

13 ‘‘(iv) requiring the submission

14 to the Administrator of the data,

15 information, and reports referred

16 to in clauses (ii) and (iii); and

17 ‘‘(v) establishing dates by

18 which the submissions described

19 in clauses (i) and (iv) must be

20 made.

21 The Administrator may under sub22 paragraph (C) revise any such order

23 to correct an error. The Adminis24 trator may under this paragraph re25 quire data or information pertaining
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1 to whether the pesticide chemical

2 may have an effect in humans that is

3 similar to an effect produced by a

4 naturally occurring estrogen or other

5 endocrine effects.

6 ‘‘(2) NONCOMPLIANCE.—If a submission

7 required by a notice issued in accordance

8 with paragraph (1)(A), a rule issued

9 under paragraph (1)(B), or an order is10 sued under paragraph (1)(C) is not made

11 by the time specified in such notice, rule,

12 or order, the Administrator may by order

13 published in the Federal Register modify

14 or revoke the tolerance or exemption in

15 question. In any review of such an order

16 under subsection (g)(2), the only material

17 issue shall be whether a submission re18 quired under paragraph (1) was not made

19 by the time specified.

20 ‘‘(g) EFFECTIVE DATE, OBJECTIONS, HEAR21 INGS, AND ADMINISTRATIVE REVIEW.—

22 ‘‘(1) EFFECTIVE DATE.—A regulation or

23 order issued under subsection (d)(4),

24 (e)(1), or (f)(2) shall take effect upon pub25 lication unless the regulation or order
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1 specifies otherwise. The Administrator

2 may stay the effectiveness of the regula3 tion or order if, after issuance of such

4 regulation or order, objections are filed

5 with respect to such regulation or order

6 pursuant to paragraph (2).

7 ‘‘(2) FURTHER PROCEEDINGS.—

8 ‘‘(A) OBJECTIONS.—Within 60 days

9 after a regulation or order is issued

10 under subsection (d)(4), (e)(1)(A),

11 (e)(1)(B), (f)(2), (n)(3), or (n)(5)(C), any

12 person may file objections thereto

13 with the Administrator, specifying

14 with particularity the provisions of

15 the regulation or order deemed objec16 tionable and stating reasonable

17 grounds therefor. If the regulation or

18 order was issued in response to a pe19 tition under subsection (d)(1), a copy

20 of each objection filed by a person

21 other than the petitioner shall be

22 served by the Administrator on the

23 petitioner.

24 ‘‘(B) HEARING.—An objection may

25 include a request for a public evi-
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1 dentiary hearing upon the objection.

2 The Administrator shall, upon the ini3 tiative of the Administrator or upon

4 the request of an interested person

5 and after due notice, hold a public

6 evidentiary hearing if and to the ex7 tent the Administrator determines

8 that such a public hearing is nec9 essary to receive factual evidence rel10 evant to material issues of fact raised

11 by the objections. The presiding offi12 cer in such a hearing may authorize a

13 party to obtain discovery from other

14 persons and may upon a showing of

15 good cause made by a party issue a

16 subpoena to compel testimony or pro17 duction of documents from any per18 son. The presiding officer shall be

19 governed by the Federal Rules of

20 Civil Procedure in making any order

21 for the protection of the witness or

22 the content of documents produced

23 and shall order the payment of a rea24 sonable fees and expenses as a condi25 tion to requiring testimony of the wit-
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1 ness. On contest, such a subpoena

2 may be enforced by a Federal district

3 court.

4 ‘‘(C) FINAL DECISION.—As soon as

5 practicable after receiving the argu6 ments of the parties, the Adminis7 trator shall issue an order stating the

8 action taken upon each such objec9 tion and setting forth any revision to

10 the regulation or prior order that the

11 Administrator has found to be war12 ranted. If a hearing was held under

13 subparagraph (B), such order and any

14 revision to the regulation or prior

15 order shall, with respect to questions

16 of fact at issue in the hearing, be

17 based only on substantial evidence of

18 record at such hearing, and shall set

19 forth in detail the findings of facts

20 and the conclusions of law or policy

21 upon which the order or regulation is

22 based.

23 ‘‘(h) JUDICIAL REVIEW.—

24 ‘‘(1) PETITION.—In a case of actual

25 controversy as to the validity of any reg-
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1 ulation issued under subsection (e)(1)(C),

2 or any order issued under subsection

3 (f)(1)(C) or (g)(2)(C), or any regulation

4 that is the subject of such an order, any

5 person who will be adversely affected by

6 such order or regulation may obtain judi7 cial review by filing in the United States

8 Court of Appeals for the circuit wherein

9 that person resides or has its principal

10 place of business, or in the United States

11 Court of Appeals for the District of Co12 lumbia Circuit, within 60 days after pub13 lication of such order or regulation, a pe14 tition praying that the order or regula15 tion be set aside in whole or in part.

16 ‘‘(2) RECORD AND JURISDICTION.—A

17 copy of the petition under paragraph (1)

18 shall be forthwith transmitted by the

19 clerk of the court to the Administrator,

20 or any officer designated by the Adminis21 trator for that purpose, and thereupon

22 the Administrator shall file in the court

23 the record of the proceedings on which

24 the Administrator based the order or reg25 ulation, as provided in section 2112 of
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1 title 28, United States Code. Upon the fil2 ing of such a petition, the court shall

3 have exclusive jurisdiction to affirm or

4 set aside the order or regulation com5 plained of in whole or in part. As to or6 ders issued following a public evidentiary

7 hearing, the findings of the Adminis8 trator with respect to questions of fact

9 shall be sustained only if supported by

10 substantial evidence when considered on

11 the record as a whole.

12 ‘‘(3) ADDITIONAL EVIDENCE.—If a party

13 applies to the court for leave to adduce

14 additional evidence and shows to the sat15 isfaction of the court that the additional

16 evidence is material and that there were

17 reasonable grounds for the failure to ad18 duce the evidence in the proceeding be19 fore the Administrator, the court may

20 order that the additional evidence (and

21 evidence in rebuttal thereof) shall be

22 taken before the Administrator in the

23 manner and upon the terms and condi24 tions the court deems proper. The Admin25 istrator may modify prior findings as to
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1 the facts by reason of the additional evi2 dence so taken and may modify the order

3 or regulation accordingly. The Adminis4 trator shall file with the court any such

5 modified finding, order, or regulation.

6 ‘‘(4) FINAL JUDGMENT; SUPREME COURT

7 REVIEW.—The judgment of the court af8 firming or setting aside, in whole or in

9 part, any regulation or any order and any

10 regulation which is the subject of such an

11 order shall be final, subject to review by

12 the Supreme Court of the United States

13 as provided in section 1254 of title 28 of

14 the United States Code. The commence15 ment of proceedings under this sub16 section shall not, unless specifically or17 dered by the court to the contrary, oper18 ate as a stay of a regulation or order.

19 ‘‘(5) APPLICATION.—Any issue as to

20 which review is or was obtainable under

21 this subsection shall not be the subject of

22 judicial review under any other provision

23 of law.

24 ‘‘(i) CONFIDENTIALITY AND USE OF DATA.—
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1 ‘‘(1) GENERAL RULE.—Data and infor2 mation that are or have been submitted

3 to the Administrator under this section

4 or section 409 in support of a tolerance or

5 an exemption from a tolerance shall be

6 entitled to confidential treatment for rea7 sons of business confidentiality and to ex8 clusive use and data compensation to the

9 same extent provided by sections 3 and

10 10 of the Federal Insecticide, Fungicide,

11 and Rodenticide Act.

12 ‘‘(2) EXCEPTIONS.—

13 ‘‘(A) IN GENERAL.—Data and infor14 mation that are entitled to confiden15 tial treatment under paragraph (1)

16 may be disclosed, under such security

17 requirements as the Administrator

18 may provide by regulation, to—

19 ‘‘(i) employees of the United

20 States authorized by the Adminis21 trator to examine such data and

22 information in the carrying out of

23 their official duties under this Act

24 or other Federal statutes in-
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1 tended to protect the public

2 health; or

3 ‘‘(ii) contractors with the

4 United States authorized by the

5 Administrator to examine such

6 data and information in the car7 rying out of contracts under this

8 Act or such statutes.

9 ‘‘(B) CONGRESS.—This subsection

10 does not authorize the withholding of

11 data or information from either

12 House of Congress or from, to the ex13 tent of matter within its jurisdiction,

14 any committee or subcommittee of

15 such committee or any joint commit16 tee of Congress or any subcommittee

17 of such joint committee.

18 ‘‘(3) SUMMARIES.—Notwithstanding

19 any provision of this subsection or other

20 law, the Administrator may publish the

21 informative summary required by sub22 section (d)(2)(A)(i) and may, in issuing a

23 proposed or final regulation or order

24 under this section, publish an inform-
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1 ative summary of the data relating to the

2 regulation or order.

3 ‘‘(j) STATUS OF PREVIOUSLY ISSUED REGULA4 TIONS.—

5 ‘‘(1) REGULATIONS UNDER SECTION 406.—

6 Regulations affecting pesticide chemical

7 residues in or on raw agricultural com8 modities promulgated, in accordance

9 with section 701(e), under the authority

10 of section 406(a) upon the basis of public

11 hearings instituted before January 1,

12 1953, shall be deemed to be regulations

13 issued under this section and shall be

14 subject to modification or revocation

15 under subsections (d) and (e), and shall

16 be subject to review under subsection (q).

17 ‘‘(2) REGULATIONS UNDER SECTION 409.—

18 Regulations that established tolerances

19 for substances that are pesticide chemi20 cal residues in or on processed food, or

21 that otherwise stated the conditions

22 under which such pesticide chemicals

23 could be safely used, and that were is24 sued under section 409 on or before the

25 date of the enactment of this paragraph,
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1 shall be deemed to be regulations issued

2 under this section and shall be subject to

3 modification or revocation under sub4 section (d) or (e), and shall be subject to

5 review under subsection (q).

6 ‘‘(3) REGULATIONS UNDER SECTION 408.—

7 Regulations that established tolerances

8 or exemptions under this section that

9 were issued on or before the date of the

10 enactment of this paragraph shall remain

11 in effect unless modified or revoked

12 under subsection (d) or (e), and shall be

13 subject to review under subsection (q).

14 ‘‘(k) TRANSITIONAL PROVISION.—If, on the

15 day before the date of the enactment of this

16 subsection, a substance that is a pesticide

17 chemical was, with respect to a particular

18 pesticidal use of the substance and any result19 ing pesticide chemical residue in or on a par20 ticular food—

21 ‘‘(1) regarded by the Administrator or

22 the Secretary as generally recognized as

23 safe for use within the meaning of the

24 provisions of subsection (a) or section

25 201(s) as then in effect; or
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1 ‘‘(2) regarded by the Secretary as a

2 substance described by section 201(s)(4);

3 such a pesticide chemical residue shall be re4 garded as exempt from the requirement for a

5 tolerance, as of the date of enactment of this

6 subsection. The Administrator shall by regu7 lation indicate which substances are de8 scribed by this subsection. Any exemption

9 under this subsection may be modified or re10 voked as if it had been issued under sub11 section (c).

12 ‘‘(l) HARMONIZATION WITH ACTION UNDER

13 OTHER LAWS.—

14 ‘‘(1) COORDINATION WITH FIFRA.—To the

15 extent practicable and consistent with

16 the review deadlines in subsection (q), in

17 issuing a final rule under this subsection

18 that suspends or revokes a tolerance or

19 exemption for a pesticide chemical resi20 due in or on food, the Administrator shall

21 coordinate such action with any related

22 necessary action under the Federal Insec23 ticide, Fungicide, and Rodenticide Act.

24 ‘‘(2) REVOCATION OF TOLERANCE OR EX25 EMPTION FOLLOWING CANCELLATION OF AS-
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1 SOCIATED REGISTRATIONS.—If the Adminis2 trator, acting under the Federal Insecti3 cide, Fungicide, and Rodenticide Act,

4 cancels the registration of each pesticide

5 that contains a particular pesticide chem6 ical and that is labeled for use on a par7 ticular food, or requires that the registra8 tion of each such pesticide be modified to

9 prohibit its use in connection with the

10 production, storage, or transportation of

11 such food, due in whole or in part to die12 tary risks to humans posed by residues of

13 that pesticide chemical on that food, the

14 Administrator shall revoke any tolerance

15 or exemption that allows the presence of

16 the pesticide chemical, or any pesticide

17 chemical residue that results from its

18 use, in or on that food. Subsection (e)

19 shall apply to actions taken under this

20 paragraph. A revocation under this para21 graph shall become effective not later

22 than 180 days after—

23 ‘‘(A) the date by which each such

24 cancellation of a registration has be25 come effective; or
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1 ‘‘(B) the date on which the use of

2 the canceled pesticide becomes un3 lawful under the terms of the can4 cellation, whichever is later.

5 ‘‘(3) SUSPENSION OF TOLERANCE OR EX6 EMPTION FOLLOWING SUSPENSION OF ASSOCI7 ATED REGISTRATIONS.—

8 ‘‘(A) SUSPENSION.—If the Adminis9 trator, acting under the Federal In10 secticide, Fungicide, and Rodenticide

11 Act, suspends the use of each reg12 istered pesticide that contains a par13 ticular pesticide chemical and that is

14 labeled for use on a particular food,

15 due in whole or in part to dietary

16 risks to humans posed by residues of

17 that pesticide chemical on that food,

18 the Administrator shall suspend any

19 tolerance or exemption that allows

20 the presence of the pesticide chemi21 cal, or any pesticide chemical residue

22 that results from its use, in or on that

23 food. Subsection (e) shall apply to ac24 tions taken under this paragraph. A

25 suspension under this paragraph
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1 shall become effective not later than

2 60 days after the date by which each

3 such suspension of use has become ef4 fective.

5 ‘‘(B) EFFECT OF SUSPENSION.—The

6 suspension of a tolerance or exemp7 tion under subparagraph (A) shall be

8 effective as long as the use of each as9 sociated registration of a pesticide is

10 suspended under the Federal Insecti11 cide, Fungicide, and Rodenticide Act.

12 While a suspension of a tolerance or

13 exemption is effective the tolerance

14 or exemption shall not be considered

15 to be in effect. If the suspension of

16 use of the pesticide under that Act is

17 terminated, leaving the registration

18 of the pesticide for such use in effect

19 under that Act, the Administrator

20 shall rescind any associated suspen21 sion of tolerance or exemption.

22 ‘‘(4) TOLERANCES FOR UNAVOIDABLE

23 RESIDUES.—In connection with action

24 taken under paragraph (2) or (3), or with

25 respect to pesticides whose registrations
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1 were suspended or canceled prior to the

2 date of the enactment of this paragraph

3 under the Federal Insecticide, Fungicide,

4 and Rodenticide Act, if the Administrator

5 determines that a residue of the canceled

6 or suspended pesticide chemical will un7 avoidably persist in the environment and

8 thereby be present in or on a food, the

9 Administrator may establish a tolerance

10 for the pesticide chemical residue. In es11 tablishing such a tolerance, the Adminis12 trator shall take into account both the

13 factors set forth in subsection (b)(2) and

14 the unavoidability of the residue. Sub15 section (e) shall apply to the establish16 ment of such tolerance. The Adminis17 trator shall review any such tolerance pe18 riodically and modify it as necessary so

19 that it allows no greater level of the pes20 ticide chemical residue than is unavoid21 able.

22 ‘‘(5) PESTICIDE RESIDUES RESULTING

23 FROM LAWFUL APPLICATION OF PESTICIDE.—

24 Notwithstanding any other provision of

25 this Act, if a tolerance or exemption for a
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1 pesticide chemical residue in or on a food

2 has been revoked, suspended, or modified

3 under this section, an article of that food

4 shall not be deemed unsafe solely be5 cause of the presence of such pesticide

6 chemical residue in or on such food if it

7 is shown to the satisfaction of the Sec8 retary that—

9 ‘‘(A) the residue is present as the

10 result of an application or use of a

11 pesticide at a time and in a manner

12 that was lawful under the Federal In13 secticide, Fungicide, and Rodenticide

14 Act; and

15 ‘‘(B) the residue does not exceed a

16 level that was authorized at the time

17 of that application or use to be

18 present on the food under a toler19 ance, exemption, food additive regu20 lation, or other sanction then in ef21 fect under this Act;

22 unless, in the case of any tolerance or ex23 emption revoked, suspended, or modified

24 under this subsection or subsection (d) or

25 (e), the Administrator has issued a deter-
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1 mination that consumption of the legally

2 treated food during the period of its like3 ly availability in commerce will pose an

4 unreasonable dietary risk.

5 ‘‘(6) TOLERANCE FOR USE OF PESTICIDES

6 UNDER AN EMERGENCY EXEMPTION.—If the

7 Administrator grants an exemption

8 under section 18 of the Federal Insecti9 cide, Fungicide, and Rodenticide Act (7

10 U.S.C. 136p) for a pesticide chemical, the

11 Administrator shall establish a tolerance

12 or exemption from the requirement for a

13 tolerance for the pesticide chemical resi14 due. Such a tolerance or exemption from

15 a tolerance shall have an expiration date.

16 The Administrator may establish such a

17 tolerance or exemption without provid18 ing notice or a period for comment on the

19 tolerance or exemption. The Adminis20 trator shall promulgate regulations with21 in 365 days after the date of the enact22 ment of this paragraph governing the es23 tablishment of tolerances and exemptions

24 under this paragraph. Such regulations

25 shall be consistent with the safety stand-
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1 ard under subsections (b)(2) and (c)(2)

2 and with section 18 of the Federal Insec3 ticide, Fungicide, and Rodenticide Act.

4 ‘‘(m) FEES.—

5 ‘‘(1) AMOUNT.—The Administrator

6 shall by regulation require the payment

7 of such fees as will in the aggregate, in

8 the judgment of the Administrator, be

9 sufficient over a reasonable term to pro10 vide, equip, and maintain an adequate

11 service for the performance of the Ad12 ministrator’s functions under this sec13 tion. Under the regulations, the perform14 ance of the Administrator’s services or

15 other functions under this section, in16 cluding—

17 ‘‘(A) the acceptance for filing of a

18 petition submitted under subsection

19 (d);

20 ‘‘(B) establishing, modifying, leav21 ing in effect, or revoking a tolerance

22 or establishing, modifying, leaving in

23 effect, or revoking an exemption from

24 the requirement for a tolerance

25 under this section;
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1 ‘‘(C) the acceptance for filing of

2 objections under subsection (g); or

3 ‘‘(D) the certification and filing in

4 court of a transcript of the proceed5 ings and the record under subsection

6 (h);

7 may be conditioned upon the payment of

8 such fees. The regulations may further

9 provide for waiver or refund of fees in

10 whole or in part when in the judgment of

11 the Administrator such a waiver or re12 fund is equitable and not contrary to the

13 purposes of this subsection.

14 ‘‘(2) DEPOSIT.—All fees collected under

15 paragraph (1) shall be deposited in the

16 Reregistration and Expedited Processing

17 Fund created by section 4(k) of the Fed18 eral Insecticide, Fungicide, and

19 Rodenticide Act. Such fees shall be avail20 able to the Administrator, without fiscal

21 year limitation, for the performance of

22 the Administrator’s services or functions

23 as specified in paragraph (1).

24 ‘‘(n) NATIONAL UNIFORMITY OF TOLER25 ANCES.—
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1 ‘‘(1) QUALIFYING PESTICIDE CHEMICAL

2 RESIDUE.—For purposes of this sub3 section, the term ‘qualifying pesticide

4 chemical residue’ means a pesticide

5 chemical residue resulting from the use,

6 in production, processing, or storage of a

7 food, of a pesticide chemical that is an ac8 tive ingredient and that—

9 ‘‘(A) was first approved for such

10 use in a registration of a pesticide is11 sued under section 3(c)(5) of the Fed12 eral Insecticide, Fungicide,

13 Rodenticide Act on or after April 25,

14 1985, on the basis of data determined

15 by the Administrator to meet all ap16 plicable requirements for data pre17 scribed by regulations in effect under

18 that Act on April 25, 1985; or

19 ‘‘(B) was approved for such use in

20 a reregistration eligibility determina21 tion issued under section 4(g) of that

22 Act on or after the date of enactment

23 of this subsection.

24 ‘‘(2) QUALIFYING FEDERAL DETERMINA25 TION.—For purposes of this subsection,
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1 the term ‘qualifying Federal determina2 tion’ means a tolerance or exemption

3 from the requirement for a tolerance for

4 a qualifying pesticide chemical residue

5 that—

6 ‘‘(A) is issued under this section

7 after the date of the enactment of this

8 subsection and determined by the Ad9 ministrator to meet the standard

10 under subsection (b)(2)(A) (in the

11 case of a tolerance) or (c)(2) (in the

12 case of an exemption); or

13 ‘‘(B)(i) pursuant to subsection (j)

14 is remaining in effect or is deemed to

15 have been issued under this section,

16 or is regarded under subsection (k) as

17 exempt from the requirement for a

18 tolerance; and

19 ‘‘(ii) is determined by the Admin20 istrator to meet the standard under

21 subsection (b)(2)(A) (in the case of a

22 tolerance) or (c)(2) (in the case of an

23 exemption).

24 ‘‘(3) LIMITATION.—The Administrator

25 may make the determination described in
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1 paragraph (2)(B)(ii) only by issuing a rule

2 in accordance with the procedure set

3 forth in subsection (d) or (e) and only if

4 the Administrator issues a proposed rule

5 and allows a period of not less than 30

6 days for comment on the proposed rule.

7 Any such rule shall be reviewable in ac8 cordance with subsections (g) and (h).

9 ‘‘(4) STATE AUTHORITY.—Except as pro10 vided in paragraphs (5), (6), and (8) no

11 State or political subdivision may estab12 lish or enforce any regulatory limit on a

13 qualifying pesticide chemical residue in

14 or on any food if a qualifying Federal de15 termination applies to the presence of

16 such pesticide chemical residue in or on

17 such food, unless such State regulatory

18 limit is identical to such qualifying Fed19 eral determination. A State or political

20 subdivision shall be deemed to establish

21 or enforce a regulatory limit on a pes22 ticide chemical residue in or on a food if

23 it purports to prohibit or penalize the

24 production, processing, shipping, or

25 other handling of a food because it con-
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1 tains a pesticide residue (in excess of a

2 prescribed limit).

3 ‘‘(5) PETITION PROCEDURE.—

4 ‘‘(A) IN GENERAL.—Any State may

5 petition the Administrator for author6 ization to establish in such State a

7 regulatory limit on a qualifying pes8 ticide chemical residue in or on any

9 food that is not identical to the quali10 fying Federal determination applica11 ble to such qualifying pesticide chem12 ical residue.

13 ‘‘(B) PETITION REQUIREMENTS.—Any

14 petition under subparagraph (A)

15 shall—

16 ‘‘(i) satisfy any requirements

17 prescribed, by rule, by the Admin18 istrator; and

19 ‘‘(ii) be supported by scientific

20 data about the pesticide chemical

21 residue that is the subject of the

22 petition or about chemically re23 lated pesticide chemical residues,

24 data on the consumption within

25 such State of food bearing the
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1 pesticide chemical residue, and

2 data on exposure of humans with3 in such State to the pesticide

4 chemical residue.

5 ‘‘(C) AUTHORIZATION.—The Admin6 istrator may, by order, grant the au7 thorization described in subpara8 graph (A) if the Administrator deter9 mines that the proposed State regu10 latory limit—

11 ‘‘(i) is justified by compelling

12 local conditions; and

13 ‘‘(ii) would not cause any food

14 to be a violation of Federal law.

15 ‘‘(D) TREATMENT.—In lieu of any

16 action authorized under subpara17 graph (C), the Administrator may

18 treat a petition under this paragraph

19 as a petition under subsection (d) to

20 modify or revoke a tolerance or an

21 exemption. If the Administrator de22 termines to treat a petition under

23 this paragraph as a petition under

24 subsection (d), the Administrator
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1 shall thereafter act on the petition

2 pursuant to subsection (d).

3 ‘‘(E) REVIEW.—Any order of the

4 Administrator granting or denying

5 the authorization described in sub6 paragraph (A) shall be subject to re7 view in the manner described in sub8 sections (g) and (h).

9 ‘‘(6) URGENT PETITION PROCEDURE.—

10 Any State petition to the Administrator

11 pursuant to paragraph (5) that dem12 onstrates that consumption of a food con13 taining such pesticide residue level dur14 ing the period of the food’s likely avail15 ability in the State will pose a significant

16 public health threat from acute exposure

17 shall be considered an urgent petition. If

18 an order by the Administrator to grant or

19 deny the requested authorization in an

20 urgent petition is not made within 30

21 days of receipt of the petition, the peti22 tioning State may establish and enforce a

23 temporary regulatory limit on a qualify24 ing pesticide chemical residue in or on

25 the food. The temporary regulatory limit
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1 shall be validated or terminated by the

2 Administrator’s final order on the peti3 tion.

4 ‘‘(7) RESIDUES FROM LAWFUL APPLICA5 TION.—No State or political subdivision

6 may enforce any regulatory limit on the

7 level of a pesticide chemical residue that

8 may appear in or on any food if, at the

9 time of the application of the pesticide

10 that resulted in such residue, the sale of

11 such food with such residue level was

12 lawful under this section and under the

13 law of such State, unless the State dem14 onstrates that consumption of the food

15 containing such pesticide residue level

16 during the period of the food’s likely

17 availability in the State will pose an un18 reasonable dietary risk to the health of

19 persons within such State.

20 ‘‘(8) SAVINGS.—Nothing in this Act pre21 empts the authority of any State or politi22 cal subdivision to require that a food con23 taining a pesticide chemical residue bear

24 or be the subject of a warning or other

25 statement relating to the presence of the
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1 pesticide chemical residue in or on such

2 food.

3 ‘‘(o) CONSUMER RIGHT TO KNOW.—Not later

4 than 2 years after the date of the enactment

5 of the Food Quality Protection Act of 1996,

6 and annually thereafter, the Administrator

7 shall, in consultation with the Secretary of

8 Agriculture and the Secretary of Health and

9 Human Services, publish in a format under10 standable to a lay person, and distribute to

11 large retail grocers for public display (in a

12 manner determined by the grocer), the follow13 ing information, at a minimum:

14 ‘‘(1) A discussion of the risks and ben15 efits of pesticide chemical residues in or

16 on food purchased by consumers.

17 ‘‘(2) A listing of actions taken under

18 subparagraph (B) of subsection (b)(2)

19 that may result in pesticide chemical res20 idues in or on food that present a yearly

21 or lifetime risk above the risk allowed

22 under subparagraph (A) of such sub23 section, and the food on which the pes24 ticide chemicals producing the residues

25 are used.
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1 ‘‘(3) Recommendations to consumers

2 for reducing dietary exposure to pes3 ticide chemical residues in a manner con4 sistent with maintaining a healthy diet,

5 including a list of food that may reason6 ably substitute for food listed under para7 graph (2).

8 Nothing in this subsection shall prevent retail

9 grocers from providing additional informa10 tion.

11 ‘‘(p) ESTROGENIC SUBSTANCES SCREENING

12 PROGRAM.—

13 ‘‘(1) DEVELOPMENT.—Not later than 2

14 years after the date of enactment of this

15 section, the Administrator shall in con16 sultation with the Secretary of Health

17 and Human Services develop a screening

18 program, using appropriate validated

19 test systems and other scientifically rel20 evant information, to determine whether

21 certain substances may have an effect in

22 humans that is similar to an effect pro23 duced by a naturally occurring estrogen,

24 or such other endocrine effect as the Ad25 ministrator may designate.
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1 ‘‘(2) IMPLEMENTATION.—Not later than

2 3 years after the date of enactment of this

3 section, after obtaining public comment

4 and review of the screening program de5 scribed in paragraph (1) by the scientific

6 advisory panel established under section

7 25(d) of the Federal Insecticide, Fun8 gicide, and Rodenticide Act or the

9 science advisory board established by

10 section 8 of the Environmental Research,

11 Development, and Demonstration Act of

12 1978 (42 U.S.C. 4365), the Administrator

13 shall implement the program.

14 ‘‘(3) SUBSTANCES.—In carrying out the

15 screening program described in para16 graph (1), the Administrator—

17 ‘‘(A) shall provide for the testing

18 of all pesticide chemicals; and

19 ‘‘(B) may provide for the testing

20 of any other substance that may have

21 an effect that is cumulative to an ef22 fect of a pesticide chemical if the Ad23 ministrator determines that a sub24 stantial population may be exposed to

25 such substance.
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1 ‘‘(4) EXEMPTION.—Notwithstanding

2 paragraph (3), the Administrator may, by

3 order, exempt from the requirements of

4 this section a biologic substance or other

5 substance if the Administrator deter6 mines that the substance is anticipated

7 not to produce any effect in humans simi8 lar to an effect produced by a naturally

9 occurring estrogen.

10 ‘‘(5) COLLECTION OF INFORMATION.—

11 ‘‘(A) IN GENERAL.—The Adminis12 trator shall issue an order to a reg13 istrant of a substance for which test14 ing is required under this subsection,

15 or to a person who manufactures or

16 imports a substance for which testing

17 is required under this subsection, to

18 conduct testing in accordance with

19 the screening program described in

20 paragraph (1), and submit informa21 tion obtained from the testing to the

22 Administrator, within a reasonable

23 time period that the Administrator

24 determines is sufficient for the gen25 eration of the information.
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1 ‘‘(B) PROCEDURES.—To the extent

2 practicable the Administrator shall

3 minimize duplicative testing of the

4 same substance for the same endo5 crine effect, develop, as appropriate,

6 procedures for fair and equitable

7 sharing of test costs, and develop, as

8 necessary, procedures for handling of

9 confidential business information.

10 ‘‘(C) FAILURE OF REGISTRANTS TO

11 SUBMIT INFORMATION.—

12 ‘‘(i) SUSPENSION.—If a reg13 istrant of a substance referred to

14 in paragraph (3)(A) fails to com15 ply with an order under subpara16 graph (A) of this paragraph, the

17 Administrator shall issue a notice

18 of intent to suspend the sale or

19 distribution of the substance by

20 the registrant. Any suspension

21 proposed under this paragraph

22 shall become final at the end of

23 the 30-day period beginning on

24 the date that the registrant re25 ceives the notice of intent to sus-
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1 pend, unless during that period a

2 person adversely affected by the

3 notice requests a hearing or the

4 Administrator determines that

5 the registrant has complied fully

6 with this paragraph.

7 ‘‘(ii) HEARING.—If a person re8 quests a hearing under clause (i),

9 the hearing shall be conducted in

10 accordance with section 554 of

11 title 5, United States Code. The

12 only matter for resolution at the

13 hearing shall be whether the reg14 istrant has failed to comply with

15 an order under subparagraph (A)

16 of this paragraph. A decision by

17 the Administrator after comple18 tion of a hearing shall be consid19 ered to be a final agency action.

20 ‘‘(iii) TERMINATION OF SUSPEN21 SIONS.—The Administrator shall

22 terminate a suspension under this

23 subparagraph issued with respect

24 to a registrant if the Adminis25 trator determines that the reg-
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1 istrant has complied fully with

2 this paragraph.

3 ‘‘(D) NONCOMPLIANCE BY OTHER

4 PERSONS.—Any person (other than a

5 registrant) who fails to comply with

6 an order under subparagraph (A)

7 shall be liable for the same penalties

8 and sanctions as are provided under

9 section 16 of the Toxic Substances

10 Control Act (15 U.S.C. 2601 and fol11 lowing) in the case of a violation re12 ferred to in that section. Such pen13 alties and sanctions shall be assessed

14 and imposed in the same manner as

15 provided in such section 16.

16 ‘‘(6) AGENCY ACTION.—In the case of

17 any substance that is found, as a result of

18 testing and evaluation under this section,

19 to have an endocrine effect on humans,

20 the Administrator shall, as appropriate,

21 take action under such statutory author22 ity as is available to the Administrator,

23 including consideration under other sec24 tions of this Act, as is necessary to ensure

25 the protection of public health.
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1 ‘‘(7) REPORT TO CONGRESS.—Not later

2 than 4 years after the date of enactment

3 of this section, the Administrator shall

4 prepare and submit to Congress a report

5 containing—

6 ‘‘(A) the findings of the Adminis7 trator resulting from the screening

8 program described in paragraph (1);

9 ‘‘(B) recommendations for further

10 testing needed to evaluate the impact

11 on human health of the substances

12 tested under the screening program;

13 and

14 ‘‘(C) recommendations for any

15 further actions (including any action

16 described in paragraph (6)) that the

17 Administrator determines are appro18 priate based on the findings.

19 ‘‘(q) SCHEDULE FOR REVIEW.—

20 ‘‘(1) IN GENERAL.—The Administrator

21 shall review tolerances and exemptions

22 for pesticide chemical residues in effect

23 on the day before the date of the enact24 ment of the Food Quality Protection Act
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1 of 1996, as expeditiously as practicable,

2 assuring that—

3 ‘‘(A) 33 percent of such tolerances

4 and exemptions are reviewed within

5 3 years of the date of enactment of

6 such Act;

7 ‘‘(B) 66 percent of such tolerances

8 and exemptions are reviewed within

9 6 years of the date of enactment of

10 such Act; and

11 ‘‘(C) 100 percent of such toler12 ances and exemptions are reviewed

13 within 10 years of the date of enact14 ment of such Act.

15 In conducting a review of a tolerance or

16 exemption, the Administrator shall deter17 mine whether the tolerance or exemption

18 meets the requirements of subsection

19 (b)(2) or (c)(2) and shall, by the deadline

20 for the review of the tolerance or exemp21 tion, issue a regulation under subsection

22 (d)(4) or (e)(1) to modify or revoke the

23 tolerance or exemption if the tolerance or

24 exemption does not meet such require25 ments.
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1 ‘‘(2) PRIORITIES.—In determining pri2 orities for reviewing tolerances and ex3 emptions under paragraph (1), the Ad4 ministrator shall give priority to the re5 view of the tolerances or exemptions that

6 appear to pose the greatest risk to public

7 health.

8 ‘‘(3) PUBLICATION OF SCHEDULE.—Not

9 later than 12 months after the date of the

10 enactment of the Food Quality Protection

11 Act of 1996, the Administrator shall pub12 lish a schedule for review of tolerances

13 and exemptions established prior to the

14 date of the enactment of the Food Quality

15 Protection Act of 1996. The determination

16 of priorities for the review of tolerances

17 and exemptions pursuant to this sub18 section is not a rulemaking and shall not

19 be subject to judicial review, except that

20 failure to take final action pursuant to

21 the schedule established by this para22 graph shall be subject to judicial review.

23 ‘‘(r) TEMPORARY TOLERANCE OR EXEMP24 TION.—The Administrator may, upon the re25 quest of any person who has obtained an ex-
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1 perimental permit for a pesticide chemical

2 under the Federal Insecticide, Fungicide, and

3 Rodenticide Act or upon the Administrator’s

4 own initiative, establish a temporary toler5 ance or exemption for the pesticide chemical

6 residue for the uses covered by the permit.

7 Subsections (b)(2), (d) and (c)(2), (e) shall

8 apply to actions taken under this subsection.

9 ‘‘(s) SAVINGS CLAUSE.—Nothing in this sec10 tion shall be construed to amend or modify

11 the provisions of the Toxic Substances Con12 trol Act or the Federal Insecticide, Fungicide,

13 and Rodenticide Act.’’.

14 SEC. 406. AUTHORIZATION FOR INCREASED MONITORING.

15 For the fiscal years 1997 through 1999,

16 there is authorized to be appropriated in the

17 aggregate an additional $12,000,000 for in18 creased monitoring by the Secretary of

19 Health and Human Services of pesticide resi20 dues in imported and domestic food.

21 SEC. 407. ALTERNATIVE ENFORCEMENT.

22 Section 303(g) (21 U.S.C. 333(f)) is amend23 ed—
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1 (1) by redesignating paragraphs (2),

2 (3), and (4) as paragraphs (3), (4), and (5),

3 respectively,

4 (2) by inserting after paragraph (1)

5 the following:

6 ‘‘(2)(A) Any person who introduces into

7 interstate commerce or delivers for introduc8 tion into interstate commerce an article of

9 food that is adulterated within the meaning of

10 section 402(a)(2)(B) shall be subject to a civil

11 money penalty of not more than $50,000 in the

12 case of an individual and $250,000 in the case

13 of any other person for such introduction or

14 delivery, not to exceed $500,000 for all such

15 violations adjudicated in a single proceeding.

16 ‘‘(B) This paragraph shall not apply to any

17 person who grew the article of food that is

18 adulterated. If the Secretary assesses a civil

19 penalty against any person under this para20 graph, the Secretary may not use the criminal

21 authorities under this section to sanction

22 such person for the introduction or delivery

23 for introduction into interstate commerce of

24 the article of food that is adulterated. If the

25 Secretary assesses a civil penalty against any
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1 person under this paragraph, the Secretary

2 may not use the seizure authorities of section

3 304 or the injunction authorities of section

4 302 with respect to the article of food that is

5 adulterated.

6 ‘‘(C) In a hearing to assess a civil penalty

7 under this paragraph, the presiding officer

8 shall have the same authority with regard to

9 compelling testimony or production of docu10 ments as a presiding officer has under section

11 408(g)(2)(B). The third sentence of paragraph

12 (3)(A) shall not apply to any investigation

13 under this paragraph.’’;

14 (3) in paragraph (3), as so redesig15 nated, by striking ‘‘paragraph (1)’’ each

16 place it occurs and inserting ‘‘paragraph

17 (1) or (2)’’;

18 (4) in paragraph (4), as so redesig19 nated, by striking ‘‘(2)(A)’’ and inserting

20 ‘‘(3)(A)’’; and

21 (5) in paragraph (5), as so redesig22 nated, by striking ‘‘(3)’’ each place it oc23 curs and inserting ‘‘(4)’’.
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1 TITLE V—FEES

2 SEC. 501. REREGISTRATION FEES.

3 (a) SECTION 4(i).—Section 4(i) (7 U.S.C. 136a–1(i)),

4 as amended by section 232(2), is amended—

5 (1) in paragraphs (5)(H) and (6), by striking

6 ‘‘1997’’ and inserting ‘‘2001’’; and

7 (2) in paragraph (5)(C), by inserting ‘‘(i)’’ after

8 ‘‘(C)’’ and by adding at the end the following:

9 ‘‘(ii) in each of the fiscal years 1998, 1999,

10 and 2000, the Administrator is authorized to col11 lect up to an additional $2,000,000 in a manner

12 consistent with subsection (k)(5) and the rec13 ommendations of the Inspector General of the

14 Environmental Protection Agency. The total fees

15 that may be collected under this clause shall not

16 exceed $6,000,000.’’.

17 (b) SECTION 4(k)(1).—Section 4(k)(1) (7 U.S.C. 136a–

18 1(k)(1) is amended by inserting before the period the follow19 ing: ‘‘which shall be known as the Reregistration and Expe20 dited Processing Fund’’.

21 (c) SECTION 4(k)(2).—Section 4(k)(2) (7 136a–

22 1(k)(2)) is amended to read as follows:

23 ‘‘(2) SOURCE AND USE.—

24 ‘‘(A) All moneys derived from fees collected

25 by the Administrator under subsection (i) shall
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1 be deposited in the fund and shall be available

2 to the Administrator, without fiscal year limita3 tion, specifically to offset the costs of reregistra4 tion and expedited processing of the applications

5 specified in paragraph (3). Such moneys derived

6 from fees may not be expended in any fiscal year

7 to the extent such moneys derived from fees

8 would exceed money appropriated for use by the

9 Administrator and expended in such year for

10 such costs of reregistration and expedited proc11 essing of such applications. The Administrator

12 shall, prior to expending any such moneys de13 rived from fees—

14 ‘‘(i) effective October 1, 1997, adopt

15 specific and cost accounting rules and pro16 cedures as approved by the General Ac17 counting Office and the Inspector General of

18 the Environmental Protection Agency to en19 sure that moneys derived from fees are allo20 cated solely to the costs of reregistration and

21 expedited processing of the applications

22 specified in paragraph (3) in the same por23 tion as appropriated funds;

24 ‘‘(ii) prohibit the use of such moneys

25 derived from fees to pay for any costs other
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1 than those necessary to achieve reregistra2 tion and expedited processing of the appli3 cations specified in paragraph (3); and

4 ‘‘(iii) ensure that personnel and facil5 ity costs associated with the functions to be

6 carried out under this paragraph do not ex7 ceed agency averages for comparable person8 nel and facility costs.

9 ‘‘(B) The Administrator shall also—

10 ‘‘(i) complete the review of unreviewed

11 reregistration studies required to support

12 the reregistration eligibility decisions sched13 uled for completion in accordance with sub14 section (l)(2); and

15 ‘‘(ii) contract for such outside assist16 ance as may be necessary for review of re17 quired studies, using a generally accepted

18 competitive process for the selection of ven19 dors of such assistance.’’.

20 (d) SECTION 4(k)(3).—Section 4(k)(3) (7 U.S.C.

21 136a–1(k)(3)) is amended—

22 (1) in subparagraph (A), by striking out ‘‘for

each of the fiscal years 1992, 1993, and 1994, 1 23 ⁄7th of

24 the maintenance fees collected, up to 2 million each

25 year’’ and inserting in lieu thereof ‘‘for each of the
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fiscal years 1997 through 2001, not more than 1 1 ⁄7 of

2 the maintenance fees collected in such fiscal year’’;

3 and

4 (2) by adding a new subparagraph (C) to read

5 as follows:

6 ‘‘(C) The Administrator shall complete the

7 processing of the unprocessed expedited review

8 applications within 5 years from the date of en9 actment of the Food Quality Protection Act of

10 1996.’’.

11 (e) SECTION 4(k)(5).—Section 4(k)(5) (7 U.S.C. 136a–

12 1(k)(5)) is amended to read as follows:

13 ‘‘(5) ACCOUNTING AND PERFORMANCE.—The Ad14 ministrator shall take all steps necessary to ensure

15 that expenditures from fees authorized by subsection

16 (i)(5)(C)(ii) are used only to carry out the goals es17 tablished under subsection (l). The Reregistration and

18 Expedited Processing Fund shall be designated as an

19 Environmental Protection Agency component for pur20 poses of section 3515(c) of title 31, United States

21 Code. The annual audit required under section 3521

22 of such title of the financial statements of activities

23 under this Act under section 3515(b) of such title

24 shall include an audit of the fees collected under sub25 section (i)(5)(C) and disbursed, of the amount appro-
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1 priated to match such fees, and of the Administrator’s

2 attainment of performance measure and goals estab3 lished under subsection (l). Such an audit shall also

4 include a review of the reasonableness of the overhead

5 allocation and adequacy of disclosures of direct and

6 indirect costs associated with carrying out the rereg7 istration and expedited processing of the applications

8 specified in paragraph (3), and the basis for and ac9 curacy of all costs paid with moneys derived from

10 such fees. The Inspector General shall conduct the an11 nual audit and report the findings and recommenda12 tions of such audit to the Administrator and to the

13 Committees on Agriculture of the House of Represent14 atives and the Senate. The cost of such audit shall be

15 paid for out of the fees collected under subsection

16 (i)(5)(C).’’.

17 (f) GOALS.—Subsections (l) and (m) of section 4 (7

18 U.S.C. 136a–1), as amended by section 237, are redesig19 nated as subsections (m) and (n) respectively and the fol20 lowing is inserted after subsection (k):

21 ‘‘(l) PERFORMANCE MEASURES AND GOAL.—The Ad22 ministrator shall establish and publish annually in the

23 Federal Register performance measures and goals. Such

24 measures and goals shall include—
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1 ‘‘(1) the number of products reregistered, can2 celed, or amended, the status of reregistration, the

3 number and type of data requests under section

4 3(c)(2)(B) issued to support product reregistration by

5 active ingredient, the progress in reducing the number

6 of unreviewed, required reregistration studies, the ag7 gregate status of tolerances reassessed, and the number

8 of applications for registration submitted under sub9 section (k)(3) that were approved or disapproved;

10 ‘‘(2) the future schedule for reregistrations, in11 cluding the projection for such schedules that will be

12 issued under subsection (g)(2) (A) and (B) in the cur13 rent fiscal year and the succeeding fiscal year; and

14 ‘‘(3) the projected year of completion of the rereg15 istrations under this section.’’.

16 TITLE VI—INDIAN TRIBES

17 SEC. 601. AUTHORITY OF INDIAN TRIBES.

18 (a) IN GENERAL.—Section 24 (7 U.S.C. 136v) is

19 amended—

20 (1) in subsection (a), by inserting before the

21 comma the following: ‘‘and an Indian tribe may only

22 regulate the sale or use of any federally registered pes23 ticide or device within the boundaries of a Federal

24 Indian reservation for such tribe if at least 50 percent
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•HR 1627 RH

1 of the lands in such reservation are owned by mem2 bers of the tribe or the tribe’’;

3 (2) in subsections (b) and (c), by inserting ‘‘or

4 Indian tribe’’ after ‘‘State’’ each time it occurs; and

5 (3) in the section heading, by inserting before the

6 period the following: ‘‘AND INDIAN TRIBES’’.

7 (b) ENFORCEMENT.—Section 26 (7 U.S.C. 136w–1) is

8 amended—

9 (1) in subsection (a), by inserting ‘‘and an In10 dian tribe with respect to violations which occur

11 within the boundaries of a Federal Indian reservation

12 for such tribe, but only if at least 50 percent of the

13 lands in such reservation are owned by members of

14 the tribe or the tribe’’ after ‘‘violations’’ and by in15 serting ‘‘or Indian tribe’’ after ‘‘State’’ each place it

16 occurs;

17 (2) in subsection (b), by inserting ‘‘or Indian

18 tribe’’ after ‘‘State’’ in the first sentence;

19 (3) in subsection (c), by inserting ‘‘or Indian

20 tribes’’ after ‘‘States’’; and

21 (4) in the section heading, by inserting ‘‘AND

22 INDIAN TRIBE’’ after ‘‘STATE’’.