I

104TH CONGRESS

1ST SESSION H. R. 1627

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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HR 1627 IH

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 Minor Use Crop Protection Act of

16 1995, 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 Minor Use Crop Protection Act of 1995 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 TITLE IV—AMENDMENTS TO THE FED6 ERAL FOOD, DRUG, AND COSMETIC

7 ACT

8 SEC. 401. REFERENCE.

9 Whenever in this title an amendment is expressed in

10 terms of an amendment to a section or other provision,

11 or refers to a section or other provision, the reference shall

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

13 of the Federal Food, Drug, and Cosmetic Act.

14 SEC. 402. DEFINITIONS.

15 (a) Section 201(q) (21 U.S.C. 321(q)) is amended to

16 read as follows:

17 ‘‘(q)(1) The term ‘pesticide chemical’ means—

18 ‘‘(A) any substance that is a pesticide within

19 the meaning of the Federal Insecticide, Fungicide,

20 and Rodenticide Act; or

21 ‘‘(B) any active ingredient of a pesticide within

22 the meaning of the Federal Insecticide, Fungicide,

23 and Rodenticide Act.
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1 ‘‘(2) The term ‘pesticide chemical residue’ means a

2 residue in or on raw agricultural commodity or processed

3 food of—

4 ‘‘(A) a pesticide chemical; or

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

6 in the commodity or food primarily as a result of the

7 metabolism or other degradation of a pesticide

8 chemical.

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

10 Administrator may by regulation except a substance from

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

12 residue’ if—

13 ‘‘(A) its occurrence as a residue on a raw agri14 cultural commodity or processed food is attributable

15 primarily to natural causes or to human activities

16 not involving the use of any substances for a pes17 ticidal purpose in the production, storage, process18 ing, or transportation of any raw agricultural com19 modity or processed food; and

20 ‘‘(B) the Administrator, after consultation with

21 the Secretary, determines that the substance more

22 appropriately should be regulated under one or more

23 provisions of this Act other than sections

24 402(a)(2)(B) and 408.’’.
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1 (b) Paragraphs (1) and (2) of section 201(s) (21

2 U.S.C. 321(s)) are amended to read as follows:

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

4 agricultural commodity or processed food; or

5 ‘‘(2) a pesticide chemical; or’’.

6 (c) Section 201 (21 U.S.C. 321) is amended by add7 ing at the end the following:

8 ‘‘(bb) The term ‘processed food’ means any food

9 other than a raw agricultural commodity and includes any

10 raw agricultural commodity that has been subject to proc11 essing, such as canning, cooking, freezing, dehydration, or

12 milling.

13 ‘‘(cc) The term ‘Administrator’ means the Adminis14 trator of the United States Environmental Protection

15 Agency.’’.

16 SEC. 403. PROHIBITED ACTS.

17 Section 301(j) (21 U.S.C. 331(j)) is amended—

18 (1) by striking the period at the end; and

19 (2) by inserting at the end ‘‘, or the violation

20 of section 408(g)(2) or any regulation issued under

21 that section.’’.

22 SEC. 404. ADULTERATED FOOD.

23 Section 402(a)(2) (21 U.S.C. 342(a)(2)) is amended

24 to read as follows:
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1 ‘‘(2)(A) if it bears or contains any added poi2 sonous or added deleterious substance (other than a

3 substance that is a pesticide chemical residue in or

4 on a raw agricultural commodity or processed food,

5 a food additive, a color additive, or a new animal

6 drug) that is unsafe within the meaning of section

7 406;

8 ‘‘(B) if it bears or contains a pesticide chemical

9 residue that is unsafe within the meaning of section

10 408(a); or

11 ‘‘(C) if it is or if it bears or contains—

12 ‘‘(i) any food additive that is unsafe within

13 the meaning of section 409; or

14 ‘‘(ii) a new animal drug (or conversion

15 product thereof) that is unsafe within the

16 meaning of section 512; or’’.

17 SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE

18 CHEMICAL RESIDUES.

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

20 follows:

21 ‘‘TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMI22 CAL RESIDUES

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

24 EXEMPTION.—
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1 ‘‘(1) GENERAL RULE.—For the purposes of this

2 section, the term ‘food,’ when used as a noun with3 out modification, shall mean a raw agricultural com4 modity or processed food. Except as provided in

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

6 in or on a food shall be deemed unsafe for the pur7 pose of section 402(a)(2)(B) unless—

8 ‘‘(A) a tolerance for such pesticide chemi9 cal residue in or on such food is in effect under

10 this section and the concentration of the residue

11 is within the limits of the tolerance; or

12 ‘‘(B) an exemption from the requirement

13 of a tolerance is in effect under this section for

14 the pesticide chemical residue.

15 ‘‘(2) PROCESSED FOOD.—Notwithstanding

16 paragraph (1)—

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

18 section for a pesticide chemical residue in or on

19 a raw agricultural commodity, a pesticide chem20 ical residue that is present in or on a processed

21 food because the food is made from that raw

22 agricultural commodity shall not be considered

23 unsafe within the meaning of section

24 402(a)(2)(B) despite the lack of a tolerance for

25 the pesticide chemical residue in or on the proc-
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1 essed food if the concentration of the pesticide

2 chemical residue in the processed food when

3 ready for consumption or use is not greater

4 than the tolerance prescribed for the pesticide

5 chemical residue in the raw agricultural com6 modity.

7 ‘‘(B) If an exemption for the requirement

8 for a tolerance is in effect under this section for

9 a pesticide chemical residue in or on a raw agri10 cultural commodity, a pesticide chemical residue

11 that is present in or on a processed food be12 cause the food is made from that raw agricul13 tural commodity shall not be considered unsafe

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

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

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

17 food because it is a metabolite or other degradation

18 product of a precursor substance that itself is a pes19 ticide chemical or pesticide chemical residue, such a

20 residue shall not be considered to be unsafe within

21 the meaning of section 402(a)(2)(B) despite the lack

22 of a tolerance or exemption from the need for a tol23 erance for such residue in or on such food if—

24 ‘‘(A) the Administrator has not determined

25 that the degradation product is likely to pose
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1 any potential health risk from dietary exposure

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

3 significance than, any risk posed by dietary ex4 posure to the precursor substance; and

5 ‘‘(B) either—

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

7 section for residues of the precursor sub8 stance in or on the food, and the combined

9 level of residues of the degradation product

10 and the precursor substance in or on the

11 food is at or below the stoichiometrically

12 equivalent level that would be permitted by

13 the tolerance if the residue consisted only

14 of the precursor substance rather than the

15 degradation product; or

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

17 a tolerance is in effect under this section

18 for residues of the precursor substance in

19 or on the food; and

20 ‘‘(C) the tolerance or exemption for resi21 dues of the precursor substance does not state

22 that it applies only to particular named sub23 stances or states that it does not apply to resi24 dues of the degradation product.
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1 ‘‘(4) EFFECT OF TOLERANCE OR EXEMP2 TION.—While a tolerance or exemption from the re3 quirement for a tolerance is in effect under this sec4 tion for a pesticide chemical residue with respect to

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

6 containing any amount of such a residue be consid7 ered to be adulterated within the meaning of section

8 402(a)(1).

9 ‘‘(b) AUTHORITY AND STANDARD FOR TOLER10 ANCES.—

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

12 issue regulations establishing, modifying, or revoking

13 a tolerance for a pesticide chemical residue in or on

14 a food—

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

16 subsection (d); or

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

18 under subsection (e).

19 ‘‘(2) STANDARD.—(A) A tolerance may not be

20 established for a pesticide chemical residue in or on

21 a food at a level that is higher than a level that the

22 Administrator determines is adequate to protect the

23 public health.

24 ‘‘(B) The Administrator shall modify or revoke

25 a tolerance if it is at a level higher than the level
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1 that the Administrator determines is adequate to

2 protect the public health.

3 ‘‘(C) In making a determination under this

4 paragraph the Administrator shall take into account,

5 among other relevant factors, the validity, complete6 ness, and reliability of the available data from stud7 ies of the pesticide chemical residue, the nature of

8 any toxic effects shown to be caused by the pesticide

9 chemical in such studies, available information and

10 reasonable assumptions concerning the relationship

11 of the results of such studies to human risk, avail12 able information and reasonable assumptions con13 cerning the dietary exposure levels of food consum14 ers (and major identifiable subgroups of food con15 sumers, including infants and children) to the pes16 ticide chemical residue, and available information

17 and reasonable assumptions concerning the varia18 bility of the sensitivities of major identifiable groups,

19 including infants and children, and shall consider

20 other factors to the extent required by subparagraph

21 (F).

22 ‘‘(D) For purposes of subparagraph (A), a tol23 erance level for a pesticide chemical residue in or on

24 a food shall be deemed to be adequate to protect the

25 public health if the dietary risk posed to food con-
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1 sumers by such level of the pesticide chemical resi2 due is negligible. The Administrator shall by regula3 tion set forth the factors and methods, including

4 tests which are appropriate for the determination of

5 dietary risk and most likely dietary exposure, for the

6 determination of negligible dietary risk.

7 ‘‘(E) Procedures shall be developed and imple8 mented that ensure that pesticide tolerances ade9 quately safeguard the health of infants and children.

10 ‘‘(F) Where reliable data are available, the Ad11 ministrator shall calculate the dietary risk posed to

12 food consumers by a pesticide chemical on the basis

13 of the percent of food actually treated with the pes14 ticide chemical and the actual residue levels of the

15 pesticide chemical that occur in food. In particular,

16 the Administrator shall take into account aggregate

17 pesticide use and residue data collected by the De18 partment of Agriculture.

19 ‘‘(G) For purposes of subparagraph (A), a level

20 of a pesticide chemical residue in or on a food that

21 poses a greater than negligible dietary risk to con22 sumers of the food shall be deemed to be adequate

23 to protect the public health if the Administrator de24 termines that such risk is not unreasonable

25 because—
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1 ‘‘(i) use of the pesticide that produces the

2 residue protects humans or the environment

3 from adverse effects on public health or welfare

4 that would, directly or indirectly, result in

5 greater risk to the public or the environment

6 than the dietary risk from the pesticide chemi7 cal residue; or

8 ‘‘(ii) use of the pesticide avoids risks to

9 workers, the public, or the environment that

10 would be expected to result from the use of an11 other pesticide or pest control method on the

12 same food that are considered to be greater

13 than the risks that result from dietary exposure

14 to the pesticide chemical residue; or

15 ‘‘(iii) the availability of the pesticide would

16 enable domestic growers to maintain the avail17 ability of an adequate, wholesome, and economi18 cal food supply for consumers, taking into ac19 count national and regional effects.

20 In making the determination under this subpara21 graph, the Administrator shall not consider the ef22 fects on any pesticide registrant, manufacturer, or

23 marketer of a pesticide.

24 ‘‘(3) LIMITATIONS.—(A) A tolerance may be is25 sued under the authority of paragraph (2)(E) only
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1 if the Administrator has assessed the extent to

2 which efforts are being made to develop either an al3 ternative method of pest control or an alternative

4 pesticide chemical for use on such commodity or

5 food that would meet the requirements of paragraph

6 (2)(D).

7 ‘‘(B) A tolerance for a pesticide chemical resi8 due in or on a food shall not be established by the

9 Administrator unless the Administrator determines,

10 after consultation with the Secretary, that there is

11 a practical method for detecting and measuring the

12 levels of the pesticide chemical residue in or on the

13 food, or that a practical method is unavailable or not

14 feasible.

15 ‘‘(C) A tolerance for a pesticide chemical resi16 due in or on a food shall not be established at a level

17 lower than the limit of detection of the method for

18 detecting and measuring the pesticide chemical resi19 due specified by the Administrator under subpara20 graph (B).

21 ‘‘(4) INTERNATIONAL STANDARDS.—In estab22 lishing a tolerance for a pesticide chemical residue in

23 or on a food, the Administrator shall determine

24 whether a maximum residue level for the chemical

25 has been established by the Codex Alimentarius
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1 Commission. If a Codex maximum residue level has

2 been established for the chemical and the Adminis3 trator does not propose to adopt the Codex level, the

4 Administrator shall publish for public comment a

5 notice explaining the reasons for departing from the

6 Codex level. If the Administrator determines not to

7 adopt a Codex level, the Administrator shall publish

8 as part of the final tolerance decision a determina9 tion with supporting data that the Codex level is not

10 supported by adequate and reliable scientific data,

11 or is inadequate to protect the health of the United

12 States’ consumers and that the effect of the toler13 ance on the availability to consumers of an adequate,

14 wholesome and economical food supply, does not out15 weigh the risk posed by the pesticide residue.

16 ‘‘(c) AUTHORITY AND STANDARD FOR EXEMP17 TIONS.—

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

19 issue a regulation establishing, modifying, or revok20 ing an exemption from the requirement for a toler21 ance for a pesticide chemical residue in or on a

22 food—

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

24 subsection (d); or
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1 ‘‘(B) on the Administrator’s initiative

2 under subsection (e).

3 ‘‘(2) STANDARD.—(A) An exemption from the

4 requirement for a tolerance for a pesticide chemical

5 residue in or on a food may be established only if

6 the Administrator determines that a tolerance is not

7 needed to protect the public health, in view of the

8 levels of dietary exposure to the pesticide chemical

9 residue that could reasonably be expected to occur.

10 ‘‘(B) An exemption from the requirement for a

11 tolerance for a pesticide chemical residue in or on a

12 food shall be revoked if the Administrator, in re13 sponse to a petition for the revocation of the exemp14 tion or at the Administrator’s own initiative deter15 mines that the exemption does not satisfy the cri16 terion of subparagraph (A).

17 ‘‘(C) In making a determination under this

18 paragraph, the Administrator shall take into ac19 count, among other relevant factors, the factors set

20 forth in subsection (b)(2)(C).

21 ‘‘(3) LIMITATION.—An exemption from the re22 quirement for a tolerance for a pesticide chemical

23 residue in or on a food shall not be established by

24 the Administrator unless the Administrator deter25 mines, after consultation with the Secretary—
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1 ‘‘(A) that there is a practical method for

2 detecting and measuring the levels of such pes3 ticide chemical residue in or on such food; or

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

5 method, and states the reasons for such deter6 mination in the order issuing the regulation es7 tablishing or modifying the regulation.

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

9 ‘‘(1) PETITIONS AND PETITIONERS.—Any per10 son may file with the Administrator a petition pro11 posing the issuance of a regulation—

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

13 tolerance for a pesticide chemical residue in or

14 on a food; or

15 ‘‘(B) establishing or revoking an exemption

16 from the requirement of a tolerance for such a

17 residue.

18 ‘‘(2) PETITION CONTENTS.—

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

20 paragraph (1) to establish a tolerance or ex21 emption for a pesticide chemical residue shall

22 be supported by such data and information as

23 are specified in regulations issued by the Ad24 ministrator, including—
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1 ‘‘(i)(I) an informative summary of the

2 petition and of the data, information, and

3 arguments submitted or cited in support of

4 the petition;

5 ‘‘(II) a statement that the petitioner

6 agrees that such summary or any informa7 tion it contains may be published as a part

8 of the notice of filing of the petition to be

9 published under this subsection and as

10 part of a proposed or final regulation is11 sued under this section;

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

13 composition of the pesticide chemical resi14 due and of the pesticide chemical that pro15 duces the residue;

16 ‘‘(iii) data showing the recommended

17 amount, frequency, method, and time of

18 application of that pesticide chemical;

19 ‘‘(iv) full reports of tests and inves20 tigations made with respect to the safety of

21 the pesticide chemical, including full infor22 mation as to the methods and controls

23 used in conducting those tests and inves24 tigations;
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1 ‘‘(v) full reports of tests and inves2 tigations made with respect to the nature

3 and amount of the pesticide chemical resi4 due that is likely to remain in or on the

5 food, including a description of the analyt6 ical methods used;

7 ‘‘(vi) a practical method for detecting

8 and measuring the levels of the pesticide

9 chemical residue in or on the food, or a

10 statement why such a method is not need11 ed;

12 ‘‘(vii) practical methods for removing

13 any amount of the residue that would ex14 ceed any proposed tolerance;

15 ‘‘(viii) a proposed tolerance for the

16 pesticide chemical residue, if a tolerance is

17 proposed;

18 ‘‘(ix) all relevant data bearing on the

19 physical or other technical effect that the

20 pesticide chemical is intended to have and

21 the quantity of the pesticide chemical that

22 is required to produce the effect;

23 ‘‘(x) if the petition relates to a toler24 ance for a processed food, reports of inves-
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1 tigations conducted using the processing

2 method(s) used to produce that food;

3 ‘‘(xi) such information as the Admin4 istrator may require to make the deter5 mination under subsection (b)(2)(E); and

6 ‘‘(xii) such other data and information

7 as the Administrator requires by regulation

8 to support the petition.

9 If information or data required by this subpara10 graph is available to the Administrator, the per11 son submitting the petition may cite the avail12 ability of the information or data in lieu of sub13 mitting it. The Administrator may require a pe14 tition to be accompanied by samples of the pes15 ticide chemical with respect to which the peti16 tion is filed.

17 ‘‘(B) MODIFICATION OR REVOCATION.—

18 The Administrator may by regulation establish

19 the requirements for information and data to

20 support a petition to modify or revoke a toler21 ance or to revoke an exemption from the re22 quirement for a tolerance.

23 ‘‘(3) NOTICE.—A notice of the filing of a peti24 tion that the Administrator determines has met the

25 requirements of paragraph (2) shall be published by
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1 the Administrator within 30 days after such deter2 mination. The notice shall announce the availability

3 of a description of the analytical methods available

4 to the Administrator for the detection and measure5 ment of the pesticide chemical residue with respect

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

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

8 needed. The notice shall include the summary re9 quired by paragraph (2)(A)(i).

10 ‘‘(4) ACTIONS BY THE ADMINISTRATOR.—The

11 Administrator shall, after giving due consideration

12 to a petition filed under paragraph (1) and any

13 other information available to the Administrator—

14 ‘‘(A) issue a final regulation (which may

15 vary from that sought by the petition) estab16 lishing, modifying, or revoking a tolerance for

17 the pesticide chemical residue or an exemption

18 of the pesticide chemical residue from the re19 quirement of a tolerance;

20 ‘‘(B) issue a proposed regulation under

21 subsection (e), and thereafter either issue a

22 final regulation under subsection (e) or an

23 order denying the petition; or

24 ‘‘(C) issue an order denying the petition.
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1 ‘‘(5) EFFECTIVE DATE.—A regulation issued

2 under paragraph (4) shall take effect upon publica3 tion.

4 ‘‘(6) FURTHER PROCEEDINGS.—

5 ‘‘(A) Within 60 days after a regulation or

6 order is issued under paragraph (4), subsection

7 (e)(1), or subsection (f)(1), any person may file

8 objections thereto with the Administrator, speci9 fying with particularity the provisions of the

10 regulation or order deemed objectionable and

11 stating reasonable grounds therefor. If the reg12 ulation or order was issued in response to a pe13 tition under paragraph (d)(1), a copy of each

14 objection filed by a person other than the peti15 tioner shall be served by the Administrator on

16 the petitioner.

17 ‘‘(B) An objection may include a request

18 for a public evidentiary hearing upon the objec19 tion. The Administrator shall, upon the initia20 tive of the Administrator or upon the request of

21 an interested person and after due notice, hold

22 a public evidentiary hearing if and to the extent

23 the Administrator determines that such a public

24 hearing is necessary to receive factual evidence

25 relevant to material issues of fact raised by the
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1 objections. The presiding officer in such a hear2 ing may authorize a party to obtain discovery

3 from other persons and may upon a showing of

4 good cause made by a party issue a subpoena

5 to compel testimony or production of documents

6 from any person. The presiding officer shall be

7 governed by the Federal Rules of Civil Proce8 dure in making any order for the protection of

9 the witness or the content of documents pro10 duced and shall order the payment of a reason11 able fees and expenses as a condition to requir12 ing testimony of the witness. On contest, such

13 a subpoena may be enforced by a Federal dis14 trict court.

15 ‘‘(C) As soon as practicable after receiving

16 the arguments of the parties, the Administrator

17 shall issue an order stating the action taken

18 upon each such objection and setting forth any

19 revision to the regulation or prior order that the

20 Administrator has found to be warranted. If a

21 hearing was held under subparagraph (B), such

22 order and any revision to the regulation or prior

23 order shall, with respect to questions of fact at

24 issue in the hearing, be based only on substan25 tial evidence of record at such hearing, and
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1 shall set forth in detail the findings of facts and

2 the conclusions of law or policy upon which the

3 order or regulation is based.

4 ‘‘(D) An order issued under this paragraph

5 ruling on an objection shall not take effect be6 fore the 90th day after its publication unless

7 the Administrator finds that emergency condi8 tions exist necessitating an earlier effective

9 date, in which event the Administrator shall

10 specify in the order the Administrator’s find11 ings as to such conditions.

12 ‘‘(7) JUDICIAL REVIEW.—(A) In a case of ac13 tual controversy as to the validity of any order is14 sued under paragraph (6) or any regulation that is

15 the subject of such an order, any person who will be

16 adversely affected by such order or regulation may

17 obtain judicial review by filing in the United States

18 Court of Appeals for the circuit wherein that person

19 resides or has its principal place of business, or in

20 the United States Court of Appeals for the District

21 of Columbia Circuit, within 60 days after publication

22 of such order, a petition praying that the order or

23 regulation be set aside in whole or in part.

24 ‘‘(B) A copy of the petition shall be forthwith

25 transmitted by the clerk of the court to the Adminis-
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1 trator, or any officer designated by the Adminis2 trator for that purpose, and thereupon the Adminis3 trator shall file in the court the record of the pro4 ceedings on which the Administrator based the order

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

6 United States Code. Upon the filing of such a peti7 tion, the court shall have exclusive jurisdiction to af8 firm or set aside the order or regulation complained

9 of in whole or in part. The findings of the Adminis10 trator with respect to questions of fact shall be sus11 tained only if supported by substantial evidence

12 when considered on the record as a whole.

13 ‘‘(C) If a party applies to the court for leave to

14 adduce additional evidence, and shows to the satis15 faction of the court that the additional evidence is

16 material and that there were reasonable grounds for

17 the failure to adduce the evidence in the proceeding

18 before the Administrator, the court may order that

19 the additional evidence (and evidence in rebuttal

20 thereof) shall be taken before the Administrator in

21 the manner and upon the terms and conditions the

22 court deems proper. The Administrator may modify

23 prior findings as to the facts by reason of the addi24 tional evidence so taken and may modify the order

25 or regulation accordingly. The Administrator shall
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1 file with the court any such modified finding, order,

2 or regulation.

3 ‘‘(D) The judgment of the court affirming or

4 setting aside, in whole or in part, any order under

5 paragraph (6) and any regulation which is the sub6 ject of such an order shall be final, subject to review

7 by the Supreme Court of the United States as pro8 vided in section 1254 of title 28 of the United States

9 Code. The commencement of proceedings under this

10 paragraph shall not, unless specifically ordered by

11 the court to the contrary, operate as a stay of a reg12 ulation or order.

13 ‘‘(E) Any issue as to which review is or was ob14 tainable under paragraph (6) and this paragraph

15 shall not be the subject of judicial review under any

16 other provision of law.

17 ‘‘(e) ACTION ON ADMINISTRATOR’S OWN INITIA18 TIVE.—

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

20 issue a regulation—

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

22 tolerance for a pesticide chemical or a pesticide

23 chemical residue;
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1 ‘‘(B) establishing or revoking an exemption

2 of a pesticide chemical residue from the require3 ment of a tolerance; or

4 ‘‘(C) establishing general procedures and

5 requirements to implement this section.

6 A regulation issued under this paragraph shall be7 come effective upon its publication.

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

9 under paragraph (1), the Administrator shall issue

10 a notice of proposed rulemaking and provide a pe11 riod of not less than 60 days for public comment on

12 the proposed regulation, except that a shorter period

13 for comment may be provided if the Administrator

14 for good cause finds that it would be contrary to the

15 public interest to do so and states the reasons for

16 the finding in the notice of proposed rulemaking.

17 The Administrator shall provide an opportunity for

18 a public hearing during the rulemaking under proce19 dures provided in subsection (d)(6)(B).

20 ‘‘(f) SPECIAL DATA REQUIREMENTS.—

21 ‘‘(1) REQUIRING SUBMISSION OF ADDITIONAL

22 DATA.—If the Administrator determines that addi23 tional data or information are reasonably required to

24 support the continuation of a tolerance or exemption

25 that is in effect under this section for a pesticide
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1 chemical residue on a food, the Administrator

2 shall—

3 ‘‘(A) issue a notice requiring the persons

4 holding the pesticide registrations associated

5 with such tolerance or exemption to submit the

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

7 the Federal Insecticide, Fungicide, and

8 Rodenticide Act;

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

10 conducted on a substance or mixture under sec11 tion 4 of the Toxic Substances Control Act; or

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

13 first providing notice and an opportunity for

14 comment of not less than 90 days’ duration, an

15 order—

16 ‘‘(i) requiring the submission to the

17 Administrator by one or more interested

18 persons of a notice identifying the person

19 or persons who will submit the required

20 data and information;

21 ‘‘(ii) describing the type of data and

22 information requiring to be submitted to

23 the Administrator and stating why the

24 data and information could not be obtained

25 under the authority of section 3(c)(2)(B)
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1 of the Federal Insecticide, Fungicide, and

2 Rodenticide Act or section 4 of the Toxic

3 Substances Control Act;

4 ‘‘(iii) describing the reports of the Ad5 ministrator required to be prepared during

6 and after the collection of the data and in7 formation;

8 ‘‘(iv) requiring the submission to the

9 Administrator of the data, information,

10 and reports referred to in clauses (ii) and

11 (iii); and

12 ‘‘(v) establishing dates by which the

13 submissions described in clauses (i) and

14 (iv) must be made.

15 The Administrator may revise any such order

16 to correct an error.

17 ‘‘(2) NONCOMPLIANCE.—If a submission re18 quired by a notice issued in accordance with para19 graph (1)(A) or an order issued under paragraph

20 (1)(B) is not made by the time specified in such no21 tice or order, the Administrator may by order pub22 lished in the Federal Register modify or revoke the

23 tolerance or exemption in question.

24 ‘‘(3) REVIEW.—An order issued under this subsection

25 shall be effective upon publication and shall be subject to
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1 review in accordance with paragraphs (6) and (7) of sub2 section (d).

3 ‘‘(g) CONFIDENTIALITY AND USE OF DATA.—

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

5 that are submitted to the Administrator under this

6 section in support of a tolerance or an exemption

7 from a tolerance shall be entitled to confidential

8 treatment for reasons of business confidentiality and

9 to exclusive use and data compensation, to the same

10 extent provided by sections 3 and 10 of the Federal

11 Insecticide, Fungicide, and Rodenticide Act.

12 ‘‘(2) EXCEPTIONS.—Data that are entitled to

13 confidential treatment under paragraph (1) may

14 nonetheless be disclosed to the Congress of the

15 United States, and may be disclosed, under such se16 curity requirements as the Administrator may pro17 vide by regulation, to—

18 ‘‘(A) employees of the United States au19 thorized by the Administrator to examine such

20 data in the carrying out of their official duties

21 under this Act or other Federal statutes in22 tended to protect the public health; or

23 ‘‘(B) contractors with the United States

24 authorized by the Administrator to examine
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1 such data in the carrying out of contracts under

2 such statutes.

3 ‘‘(3) SUMMARIES.—Notwithstanding any provi4 sion of this subsection or other law, the Adminis5 trator may publish the informative summary re6 quired by subsection (d)(2)(A)(i) and may, in issu7 ing a proposed or final regulation or order under

8 this section, publish an informative summary of the

9 data relating to the regulation or order.

10 ‘‘(h) STATUS OF PREVIOUSLY ISSUED REGULA11 TIONS.—

12 ‘‘(1) REGULATIONS UNDER SECTION 406.—Reg13 ulations affecting pesticide chemical residues in or

14 on raw agricultural commodities promulgated, in ac15 cordance with section 701(e), under the authority of

16 section 406(a) upon the basis of public hearings in17 stituted before January 1, 1953, shall be deemed to

18 be regulations issued under this section and shall be

19 subject to modification or revocation under sub20 sections (d) and (e).

21 ‘‘(2) REGULATIONS UNDER SECTION 409.—Reg22 ulations that established tolerances for substances

23 that are pesticide chemical residues on or in proc24 essed food, or that otherwise stated the conditions

25 under which such pesticide chemicals could be safely
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1 used, and that were issued under section 409 on or

2 before the date of the enactment of this paragraph,

3 shall be deemed to be regulations issued under this

4 section and shall be subject to modification or rev5 ocation under subsection (d) or (e).

6 ‘‘(3) REGULATIONS UNDER SECTION 408.—Reg7 ulations that established tolerances or exemptions

8 under this section that were issued on or before the

9 date of the enactment of this paragraph shall remain

10 in effect unless modified or revoked under subsection

11 (d) or (e).

12 ‘‘(i) TRANSITIONAL PROVISION.—If, on the day be13 fore the date of the enactment of this subsection, a sub14 stance that is a pesticide chemical was, with respect to

15 a particular pesticidal use of the substance and any result16 ing pesticide chemical residue in or on a particular food—

17 ‘‘(1) regarded by the Administrator or the Sec18 retary as generally recognized as safe for use within

19 the meaning of the provisions of section 408(a) or

20 201(s) as then in effect; or

21 ‘‘(2) regarded by the Secretary as a substance

22 described by section 201(s)(4), such a pesticide

23 chemical residue shall be regarded as exempt from

24 the requirement for a tolerance, as of the date of en25 actment of this subsection. The Administrator shall
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1 by regulation indicate which substances are de2 scribed by this subsection. All exemption under this

3 subsection may be revoked or modified as if it had

4 been issued under subsection (c).

5 ‘‘(j) HARMONIZATION WITH ACTION UNDER OTHER

6 LAWS.—

7 ‘‘(1) LIMITATION.—Notwithstanding any other

8 provision of this Act, a final rule under this section

9 that revokes, modifies, or suspends a tolerance or

10 exemption for a pesticide chemical residue in or on

11 a food may be issued only if the Administrator has

12 first taken any necessary action under the Federal

13 Insecticide, Fungicide, and Rodenticide Act with re14 spect to the registration of the pesticide(s) whose

15 use results in such residue to ensure that any au16 thorized use of the pesticide in producing, storing,

17 processing, or transporting food that occurs after

18 the issuance of such final rule under this section will

19 not result in pesticide chemical residues on such

20 food that are unsafe within the meaning of sub21 section (a).

22 ‘‘(2) REVOCATION OF TOLERANCE OR EXEMP23 TION FOLLOWING CANCELLATION OF ASSOCIATED

24 REGISTRATIONS.—If the Administrator, acting under

25 the Federal Insecticide, Fungicide, and Rodenticide
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1 Act, cancels the registration of each pesticide that

2 contains a particular pesticide chemical and that is

3 labeled for use on a particular food, or requires that

4 the registration of each such pesticide be modified to

5 prohibit its use in connection with the production,

6 storage, or transportation of such food, due in whole

7 or in part to dietary risks to humans posed by resi8 dues of that pesticide chemical on that food, the Ad9 ministrator shall revoke any tolerance or exemption

10 that allows the presence of the pesticide chemical, or

11 any pesticide chemical residue that results from its

12 use, in or on that food. The Administrator shall use

13 the procedures set forth in subsection (e) in taking

14 action under this paragraph. A revocation under this

15 paragraph shall become effective not later than 180

16 days after—

17 ‘‘(A) the date by which each such cancella18 tion of a registration has become effective; or

19 ‘‘(B) the date on which the use of the can20 celed pesticide becomes unlawful under the

21 terms of the cancellation, whichever is later.

22 ‘‘(3) SUSPENSION OF TOLERANCE OR EXEMP23 TION FOLLOWING SUSPENSION OF ASSOCIATED REG24 ISTRATIONS.—
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1 ‘‘(A) SUSPENSION.—If the Administrator,

2 acting under the Federal Insecticide, Fungicide,

3 and Rodenticide Act, suspends the use of each

4 registered pesticide that contains a particular

5 pesticide chemical and that is labeled for use on

6 a particular food, due in whole or in part to die7 tary risks to humans posed by residues of that

8 pesticide chemical on that food, the Adminis9 trator shall suspend any tolerance or exemption

10 that allows the presence of the pesticide chemi11 cal, or any pesticide chemical residue that re12 sults from its use, in or on that food. The Ad13 ministrator shall use the procedures set forth

14 in subsection (e) in taking action under this

15 paragraph. A suspension under this paragraph

16 shall become effective not later than 60 days

17 after the date by which each such suspension

18 of use has become effective.

19 ‘‘(B) EFFECT OF SUSPENSION.—The sus20 pension of a tolerance or exemption under sub21 paragraph (A) shall be effective as long as the

22 use of each associated registration of a pesticide

23 is suspended under the Federal Insecticide,

24 Fungicide, and Rodenticide Act. While a sus25 pension of a tolerance or exemption is effective
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1 the tolerance or exemption shall not be consid2 ered to be in effect. If the suspension of use of

3 the pesticide under that Act is terminated, leav4 ing the registration of the pesticide for such use

5 in effect under that Act, the Administrator

6 shall rescind any associated suspension of toler7 ance or exemption.

8 ‘‘(4) TOLERANCES FOR UNAVOIDABLE RESI9 DUES.—In connection with action taken under para10 graph (2) or (3), or with respect to pesticides whose

11 registrations were canceled prior to the effective date

12 of this paragraph, if the Administrator determines

13 that a residue of the canceled or suspended pesticide

14 chemical will unavoidably persist in the environment

15 and thereby be present in or on a food, the Adminis16 trator may establish a tolerance for the pesticide

17 chemical residue at a level that permits such un18 avoidable residue to remain in such food. In estab19 lishing such a tolerance, the Administrator shall

20 take into account the factors set forth in subsection

21 (b)(2)(A)(iii) and shall use the procedures set forth

22 in subsection (e). The Administrator shall review

23 any such tolerance periodically and modify it as nec24 essary so that it allows only that level of the pes25 ticide chemical residue that is unavoidable.
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1 ‘‘(5) PESTICIDE RESIDUES RESULTING FROM

2 LAWFUL APPLICATION OF PESTICIDE.—Notwith3 standing any other provision of this Act, if a toler4 ance or exemption for a pesticide chemical residue in

5 or on a food has been revoked, suspended, or modi6 fied under this section, an article of that food shall

7 not be deemed unsafe solely because of the presence

8 of such pesticide chemical residue in or on such food

9 if it is shown to the satisfaction of the Secretary

10 that—

11 ‘‘(A) the residue is present as the result of

12 an application or use of a pesticide at a time

13 and in a manner that was lawful under the

14 Federal Insecticide, Fungicide, and Rodenticide

15 Act; and

16 ‘‘(B) the residue does not exceed a level

17 that was authorized at the time of that applica18 tion or use to be present on the food under a

19 tolerance, exemption, food additive regulation,

20 or other sanction then in effect under this Act;

21 unless, in the case of any tolerance or exemption re22 voked, suspended, or modified under this subsection

23 or subsection (d) or (e), the Administrator has is24 sued a determination that consumption of the legally

25 treated food during the period of its likely availabil-
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1 ity in commerce will pose an unreasonable dietary

2 risk.

3 ‘‘(k) FEES.—The Administrator shall by regulation

4 require the payment of such fees as will in the aggregate,

5 in the judgment of the Administrator, be sufficient over

6 a reasonable term to provide, equip, and maintain an ade7 quate service for the performance of the Administrator’s

8 functions under this section. Under the regulations, the

9 performance of the Administrator’s services or other func10 tions under this section, including—

11 ‘‘(1) the acceptance for filing of a petition sub12 mitted under subsection (d);

13 ‘‘(2) the promulgation of a regulation establish14 ing, modifying, or revoking a tolerance or establish15 ing or revoking an exemption from the requirement

16 of a tolerance under this section;

17 ‘‘(3) the acceptance for filing of objections

18 under subsection (d)(6); or

19 ‘‘(4) the certification and filing in court of a

20 transcript of the proceedings and the record under

21 subsection (d)(7);

22 may be conditioned upon the payment of such fees. The

23 regulations may further provide for waiver or refund of

24 fees in whole or in part when in the judgment of the Ad-
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1 ministrator such a waiver or refund is equitable and not

2 contrary to the purposes of this subsection.

3 ‘‘(l) NATIONAL UNIFORMITY OF TOLERANCES.—

4 ‘‘(1) QUALIFYING PESTICIDE CHEMICAL RESI5 DUE.—For purposes of this subsection, the term

6 ‘qualifying pesticide chemical residue’ means a pes7 ticide chemical residue resulting from the use, in

8 production, processing, or storage of a food, of a

9 pesticide chemical that is an active ingredient and

10 that—

11 ‘‘(A) was first approved for such use in a

12 registration of a pesticide issued under section

13 3(c)(5) of the Federal Insecticide, Fungicide,

14 Rodenticide Act on or after April 25, 1985, on

15 the basis of data determined by the Adminis16 trator to meet all applicable requirements for

17 data prescribed by regulations in effect under

18 that Act on April 25, 1985; or

19 ‘‘(B) was approved for such use in a rereg20 istration eligibility determination issued under

21 section 4(g) of that Act on or after the date of

22 enactment of the Food Quality Protection Act

23 of 1995.
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1 ‘‘(2) QUALIFYING FEDERAL DETERMINATION.—

2 For purposes of this subsection, the term ‘qualifying

3 Federal determination’ means—

4 ‘‘(A) a tolerance or exemption from the re5 quirement for a tolerance for a qualifying pes6 ticide chemical residue that was—

7 ‘‘(i) issued under this section after the

8 date of enactment of the Food Quality

9 Protection Act of 1995; (or)

10 ‘‘(ii) issued (or, pursuant to sub11 section (h) or (i), deemed to have been is12 sued) under this section, and determined

13 by the Administrator to meet the standard

14 under subsection (b)(2) (in the case of a

15 tolerance) or (c)(2) (in the case of an ex16 emption); and

17 ‘‘(B) any statement, issued by the Sec18 retary, of the residue level below which enforce19 ment action will not be taken under this Act

20 with respect to any qualifying pesticide chemi21 cal residue, if the Secretary finds that such pes22 ticide chemical residue level permitted by such

23 statement during the period to which such

24 statement applies protects human health.
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1 ‘‘(3) LIMITATION.—The Administrator may

2 make the determination described in paragraph

3 (2)(A)(ii) only by issuing a rule in accordance with

4 the procedure set forth in subsection (d) or (e) and

5 only if the Administrator issues a proposed rule and

6 allows a period of not less than 30 days for comment

7 on the proposed rule. Any such rule shall be

8 reviewable in accordance with subsections (d)(6) and

9 (d)(7).

10 ‘‘(4) STATE AUTHORITY.—Except as provided

11 in paragraph (5), no State or political subdivision

12 may establish or enforce any regulatory limit on a

13 qualifying pesticide chemical residue in or on any

14 food if a qualifying Federal determination applies to

15 the presence of such pesticide chemical residue in or

16 on such food, unless such State regulatory limit is

17 identical to such qualifying Federal determination. A

18 State or political subdivision shall be deemed to es19 tablish or enforce a regulatory limit on a pesticide

20 chemical residue in or on food if it purports to pro21 hibit or penalize the production, processing, ship22 ping, or other handling of a food because it contains

23 a pesticide residue (in excess of a prescribed limit),

24 or if it purports to require that a food containing a

25 pesticide residue be the subject of a warning or
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1 other statement relating to the presence of the pes2 ticide residue in the food.

3 ‘‘(5) PETITION PROCEDURE.—

4 ‘‘(A) Any State may petition the Adminis5 trator for authorization to establish in such

6 State a regulatory limit on a qualifying pes7 ticide chemical residue in or on any food that

8 is not identical to the qualifying Federal deter9 mination applicable to such qualifying pesticide

10 chemical residue.

11 ‘‘(B) Any petition under subparagraph (A)

12 shall—

13 ‘‘(i) satisfy any requirements pre14 scribed, by rule, by the Administrator; and

15 ‘‘(ii) be supported by scientific data

16 about the pesticide chemical residue that is

17 the subject of the petition or about chemi18 cally related pesticide chemical residues,

19 data on the consumption within such State

20 of food bearing the pesticide chemical resi21 due, and data on exposure of humans with22 in such State to the pesticide chemical res23 idue.

24 ‘‘(C) Subject to paragraph (6), the Admin25 istrator may, by order, grant the authorization
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1 described in subparagraph (A) if the Adminis2 trator determines that the proposed State regu3 latory limit—

4 ‘‘(i) is justified by compelling local

5 conditions;

6 ‘‘(ii) would not unduly burden inter7 state commerce; and

8 ‘‘(iii) would not cause any food to be

9 in violation of Federal law.

10 ‘‘(D) In lieu of any action authorized

11 under subparagraph (C), the Administrator

12 may treat a petition under this paragraph as a

13 petition under subsection (d) to revoke or mod14 ify a tolerance or to revoke an exemption. If the

15 Administrator determines to treat a petition

16 under this paragraph as a petition under sub17 section (d), the Administrator shall thereafter

18 act on the petition pursuant to subsection (d).

19 ‘‘(E) Any order of the Administrator

20 granting or denying the authorization described

21 in subparagraph (A) shall be subject to review

22 in the manner described in subsections (d)(6)

23 and (d)(7).

24 ‘‘(6) RESIDUES FROM LAWFUL APPLICATION.—

25 No State or political subdivision may enforce any
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1 regulatory limit on the level of a pesticide chemical

2 residue that may appear in or on any food if, at the

3 time of the application of the pesticide that resulted

4 in such residue, the sale of such food with such resi5 due level was lawful under this Act and under the

6 law of such State, unless the State demonstrates

7 that consumption of the food containing such pes8 ticide residue level during the period of the food’s

9 likely availability in the State will pose an unreason10 able dietary risk to the health of persons within such

11 State.’’.

12 SEC. 406. AUTHORIZATION FOR INCREASE MONITORING.

13 There is authorized to be appropriated an additional

14 $12,000,000 for increased monitoring by the Secretary of

15 Health and Human Services of pesticide residues in im16 ported and domestic food.

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