II

103D CONGRESS

1ST SESSION S. 1478

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

that pesticide tolerances adequately safeguard the health of infants and

children, and for other purposes.

IN THE SENATE OF THE UNITED STATES

SEPTEMBER 21 (legislative day, SEPTEMBER 7), 1993

Mr. PRYOR (for himself, Mr. LUGAR, Mr. JOHNSTON, Mr. HEFLIN, Mrs.

KASSEBAUM, Mr. COCHRAN, Mr. NICKLES, Mr. DOLE, Mr. COATS, Mr.

HELMS, and Mr. BREAUX) introduced the following bill; which was read

twice and referred to the Committee on Agriculture, Nutrition, and Forestry

A BILL

To amend the Federal Insecticide, Fungicide, and

Rodenticide Act to ensure that pesticide tolerances adequately safeguard the health of infants and children,

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 1993’’.
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1 TITLE I—DATA COLLECTION

2 AND PROCEDURES TO EN3 SURE THAT TOLERANCES

4 SAFEGUARD THE HEALTH OF

5 INFANTS AND CHILDREN

6 SEC. 101. IMPLEMENTATION OF NRC REPORT.

7 (a) IN GENERAL.—The Administrator of the Envi8 ronmental Protection Agency, the Secretary of Agri9 culture, and the Secretary of Health and Human Services

10 shall coordinate the development and implementation of

11 procedures to ensure that pesticide tolerances adequately

12 safeguard the health of infants and children, based on the

13 conclusions and recommendations contained in the report

14 entitled ‘‘Pesticides in the Diets of Infants and Children’’

15 of the National Research Council of the National Academy

16 of Sciences.

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

18 procedures referred to in subsection (a) shall include—

19 (1) collection of data on food consumption pat20 terns of infants and children;

21 (2) improved surveillance of pesticide residues,

22 including guidelines for the use of comparable ana23 lytical and standardized reporting methods, the in24 creased sampling of foods most likely consumed by

25 infants and children, and the development of more
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1 complete information on the effects of food process2 ing on levels of pesticide residues;

3 (3) toxicity testing procedures that specifically

4 evaluate the vulnerability of infants and children;

5 (4) methods of risk assessment that take into

6 account unique characteristics of infants and chil7 dren; and

8 (5) other appropriate measures considered nec9 essary by the Administrator to ensure that pesticide

10 tolerances adequately safeguard the health of infants

11 and children.

12 SEC. 102. COLLECTION OF PESTICIDE USE INFORMATION.

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

14 collect data of Statewide or regional significance on the

15 use of pesticides to control pests and diseases of major

16 crops and crops of dietary significance, including fruits

17 and vegetables.

18 (b) COLLECTION.—The data shall be collected by sur19 veys of farmers or from other sources offering statistically

20 reliable data.

21 (c) COORDINATION.—The Secretary shall, as appro22 priate, coordinate with the Administrator of the Environ23 mental Protection Agency in the design of the surveys and

24 make available to the Administrator the aggregate results

25 of the surveys to assist the Administrator in developing
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1 exposure calculations and benefits determinations with re2 spect to pesticide regulatory decisions.

3 SEC. 103. INTEGRATED PEST MANAGEMENT.

4 Section 28(c) of the Federal Insecticide, Fungicide,

5 and Rodenticide Act (7 U.S.C. 136w–3(c)) is amended—

6 (1) by striking ‘‘(c) INTEGRATED PEST MAN7 AGEMENT.—The Administrator,’’ and inserting the

8 following:

9 ‘‘(c) INTEGRATED PEST MANAGEMENT.—

10 ‘‘(1) IN GENERAL.—The Administrator,’’; and

11 (2) by adding at the end the following new

12 paragraph:

13 ‘‘(2) JOINT RESEARCH AND DEVELOPMENT.—

14 The Administrator and the Secretary of Agriculture

15 shall research, develop, and disseminate information

16 concerning integrated pest management techniques

17 and other pest control methods that enable produc18 ers to reduce or eliminate applications of pesticides

19 that pose a greater than negligible dietary risk to

20 humans, with a special focus on crops critical to a

21 balanced, healthy diet and that are considered as

22 minor crops in terms of acreage produced.’’.
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1 TITLE II—CANCELLATION AND

2 SUSPENSION

3 SEC. 201. REFERENCE.

4 Whenever in this title an amendment or repeal is ex5 pressed in terms of an amendment to, or repeal of, a sec6 tion or other provision, the reference shall be considered

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

8 Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136

9 et seq.).

10 SEC. 202. CANCELLATION.

11 Subsection (b) of section 6 (7 U.S.C. 136d(b)) is

12 amended to read as follows:

13 ‘‘(b) CANCELLATION AND CHANGE IN CLASSIFICA14 TION OR OTHER TERMS OR CONDITIONS OF REGISTRA15 TION.—

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

17 provision of this Act, the Administrator may, by use

18 of informal rulemaking under this subsection, pre19 scribe requirements regarding the composition, pack20 aging, and labeling of a pesticide (or a group of pes21 ticides containing a common active or inert ingredi22 ent), may classify the pesticide, or may prohibit the

23 registration or continued registration of the pesticide

24 for some or all purposes, to the extent necessary to

25 ensure that the pesticide, when used in accordance
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1 with widespread and commonly recognized practice,

2 does not generally cause unreasonable adverse ef3 fects on the environment.

4 ‘‘(2) BASIS FOR RULE.—

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

6 rulemaking under this subsection unless the

7 rulemaking is based on a validated test or other

8 significant evidence raising a prudent concern

9 that the pesticide causes unreasonable adverse

10 effects on the environment.

11 ‘‘(B)(i) The Administrator shall submit, to

12 a scientific peer review committee established

13 by the Administrator, the validated test or

14 other significant evidence on which the Admin15 istrator proposes to base a rulemaking under

16 paragraph (1).

17 ‘‘(ii) The scientific peer review committee

18 shall provide written recommendations to the

19 Administrator as to whether the test or evi20 dence reviewed satisfies the criteria under sub21 paragraph (A) for initiating a rulemaking under

22 paragraph (1).

23 ‘‘(iii) The scientific peer review committee

24 shall consist of employees of or consultants to

25 the Environmental Protection Agency who have
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1 not been involved in a previous analysis of the

2 validated test or significant evidence presented

3 to the committee and who are experts in the

4 physical or biological disciplines involved in the

5 proposed rulemaking.

6 ‘‘(3) PRENOTICE PROCEDURES.—

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

8 rulemaking under paragraph (1) until the Ad9 ministrator has provided, to the registrant of

10 each affected pesticide, a notice that includes a

11 summary of the validated test or other signifi12 cant evidence on which the Administrator pro13 poses to base the rulemaking and the basis for

14 a determination that the test or evidence raises

15 a prudent concern that the pesticide causes un16 reasonable adverse effects on the environment.

17 A registrant may respond to a notice provided

18 under this subparagraph not later than 30 days

19 after receipt of the notice.

20 ‘‘(B) At the same time as the Adminis21 trator provides the notice to a registrant of the

22 pesticide under subparagraph (A), the Adminis23 trator shall also provide the notice to the Sec24 retary of Agriculture and the Secretary of

25 Health and Human Services. If an agricultural
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1 commodity is affected, on receipt of the notice,

2 the Secretary of Agriculture shall prepare an

3 analysis of the benefit and use of the pesticide

4 and provide the analysis to the Administrator.

5 ‘‘(4) ADVANCE NOTICE TO PUBLIC.—

6 ‘‘(A) After receiving the recommendation

7 of the peer review committee established under

8 paragraph (2)(B), together with any comments

9 submitted by the Secretary of Agriculture, the

10 Secretary of Health and Human Services, and

11 a registrant, the Administrator shall—

12 ‘‘(i) issue an advance notice of pro13 posed rulemaking; or

14 ‘‘(ii) issue a notice of a proposed deci15 sion not to initiate a rulemaking under

16 paragraph (1).

17 ‘‘(B) The Administrator shall publish the

18 notice in the Federal Register and provide a pe19 riod of not less than 60 days for comment on

20 the notice. The notice shall contain a statement

21 of the basis and purpose of the notice and a

22 summary of—

23 ‘‘(i) the factual data on which the no24 tice is based;
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1 ‘‘(ii) the major scientific assumptions

2 underlying the notice; and

3 ‘‘(iii) the notice provided under para4 graph (3) and any significant comments

5 received from a registrant, the Secretary of

6 Agriculture, and the Secretary of Health

7 and Human Services.

8 ‘‘(C) If the Administrator, after consider9 ing any comments received, decides not to issue

10 a notice of proposed rulemaking, the Adminis11 trator shall publish in the Federal Register a

12 notice setting forth the decision and the basis

13 for the decision.

14 ‘‘(5) DOCKET.—

15 ‘‘(A) For each rulemaking under para16 graph (1), the Administrator shall establish a

17 docket.

18 ‘‘(B) The docket shall include a copy of—

19 ‘‘(i) the notice provided under para20 graph (3);

21 ‘‘(ii) any notice issued under para22 graph (4);

23 ‘‘(iii) the notice of proposed rule24 making issued under paragraph (6);
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1 ‘‘(iv) each timely comment filed with

2 the Administrator;

3 ‘‘(v) the report of the Scientific Advi4 sory Panel under paragraph (8);

5 ‘‘(vi) a record of each hearing held by

6 the Administrator in connection with the

7 rulemaking; and

8 ‘‘(vii) the final rule or decision to

9 withdraw the rule.

10 ‘‘(C) Information in the docket shall be

11 made available to the public consistent with sec12 tion 10.

13 ‘‘(D) No factual material that has not been

14 entered into the docket in a timely manner may

15 be relied on by the Administrator in issuing a

16 final rule or in withdrawing a proposed rule or

17 by a person in a judicial review proceeding, ex18 cept for—

19 ‘‘(i) information of which the Admin20 istrator may properly take official notice;

21 or

22 ‘‘(ii) information of which a court may

23 properly take judicial notice.

24 ‘‘(6) NOTICE OF PROPOSED RULEMAKING.—
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1 ‘‘(A) Not less than 60 days after an ad2 vance notice of proposed rulemaking, except as

3 provided in paragraph (14), the Administrator

4 may issue a notice of proposed rulemaking. The

5 notice of proposed rulemaking shall include a

6 statement of the basis and purpose of the pro7 posed rulemaking, a request for any additional

8 data needed, and a bibliography of all signifi9 cant scientific data and studies on which the

10 proposed rule is based. The statement of basis

11 and purpose shall include a summary of—

12 ‘‘(i) the factual data on which the pro13 posed rule is based;

14 ‘‘(ii) the major scientific assumptions,

15 legal interpretations, and policy consider16 ations underlying the proposed rule;

17 ‘‘(iii) a summary of available risk-ben18 efit information, including benefits and use

19 information as provided by the Secretary

20 of Agriculture; and

21 ‘‘(iv) the analysis and tentative con22 clusions of the Administrator regarding the

23 balancing of the risks and benefits.

24 ‘‘(B)(i) A registrant of the pesticide and a

25 person who submits comments on the proposed
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1 rule shall make a report to the Administrator of

2 all scientific data and studies possessed by the

3 person concerning the risks and benefits of the

4 pesticide that is the subject of the rulemaking

5 that were not included in the bibliography in6 cluded in the notice required under subpara7 graph (A).

8 ‘‘(ii) If, after the date of the report made

9 under clause (i), the registrant or the person

10 receives additional scientific data or studies per11 tinent to the rulemaking that were not included

12 in the bibliography, the person shall make a re13 port of the scientific data and studies to the

14 Administrator promptly after receipt.

15 ‘‘(iii) If the Administrator receives reports

16 containing additional data concerning risks or

17 benefits, the Administrator shall revise the bib18 liography to reflect the data and make the re19 vised bibliography available to the public.

20 ‘‘(C)(i) The Administrator shall provide a

21 comment period of not less than 90 days after

22 the publication of the notice of proposed rule23 making.
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1 ‘‘(ii) During the period, a person may sub2 mit comments, data, or documentary informa3 tion on the proposed rule.

4 ‘‘(iii) Promptly on receipt by the Adminis5 trator, all written comments and documentary

6 information on the proposed rule received from

7 a person for inclusion in the docket during the

8 comment period, shall be placed in the docket.

9 ‘‘(D)(i) At the same time as the Adminis10 trator publishes notice under subparagraph (A),

11 the Administrator shall provide the Secretary of

12 Agriculture and the Secretary of Health and

13 Human Services with a copy of the proposed

14 rule.

15 ‘‘(ii) Not later than 90 days after the pub16 lication of the notice of proposed rulemaking,

17 the Secretary of Agriculture and the Secretary

18 of Health and Human Services may provide

19 comments on the proposed rule.

20 ‘‘(iii) If an agricultural commodity is af21 fected, the Secretary of Agriculture shall pro22 vide to the Administrator an analysis of the im23 pact of the proposed action on the domestic and

24 global availability and prices of agricultural

25 commodities and retail food prices and any as-
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1 sociated societal impacts (including impacts on

2 consumer nutrition and health and low-income

3 consumers).

4 ‘‘(7) INFORMAL HEARING.—

5 ‘‘(A)(i) A person who has submitted a

6 comment may, not later than 15 days after the

7 close of the comment period, request the Ad8 ministrator to conduct an informal hearing on

9 questions of fact pertaining to the proposed rule

10 or comments on the rule.

11 ‘‘(ii) The Administrator shall—

12 ‘‘(I) on receipt of the request, sched13 ule an informal hearing of not to exceed 20

14 days duration; and

15 ‘‘(II) not later than 60 days after the

16 close of the comment period, conduct the

17 hearing.

18 ‘‘(iii) The Administrator shall publish the

19 time, place, and purpose of the hearing in the

20 Federal Register.

21 ‘‘(iv) The informal hearing shall be limited

22 to addressing questions of fact raised by mate23 rials in the docket.
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1 ‘‘(v) A transcript shall be made of any oral

2 presentation, discussion, or debate and included

3 in the docket.

4 ‘‘(B) The Administrator shall appoint a

5 presiding officer who shall have the authority to

6 administer oaths, regulate the course of the

7 hearing, conduct prehearing conferences, sched8 ule presentations, and exclude irrelevant, imma9 terial, or unduly repetitious evidence.

10 ‘‘(C)(i) The presiding officer shall conduct

11 the informal hearing in a manner that encour12 ages discussion and debate on questions of fact

13 regarding the docket.

14 ‘‘(ii) The Administrator shall designate 1

15 or more employees of the Environmental Pro16 tection Agency to participate in the hearing.

17 ‘‘(iii) A person who submitted a comment

18 on the proposed rule may participate in the

19 hearing and shall be entitled to present evidence

20 and argument to support the position of the

21 person or rebut a contrary position and may

22 choose to present materials in oral or written

23 form.

24 ‘‘(8) REVIEW BY SCIENTIFIC ADVISORY

25 PANEL.—
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1 ‘‘(A) At the time the Administrator issues

2 a notice of proposed rulemaking under para3 graph (6), the Administrator shall provide a

4 copy of the notice to the Scientific Advisory

5 Panel established under section 25(d) (referred

6 to in this paragraph as the ‘Panel’).

7 ‘‘(B) If a person submits comments under

8 paragraph (6) in opposition to the proposed

9 rule, the Administrator shall request the com10 ments, evaluations, and recommendations of the

11 Panel as to the impact on health and the envi12 ronment of the proposed rule and on any dis13 puted issues of fact or scientific policy that ap14 pear to be of significance in the rulemaking.

15 ‘‘(C) The Panel may hold a public hearing

16 to discuss the proposed rule.

17 ‘‘(D) The Panel shall provide a report to

18 the Administrator not later than 30 days after

19 the close of the comment period (or, if a hear20 ing has been requested under paragraph (7),

21 not later than 30 days after the end of the

22 hearing).

23 ‘‘(E) The Administrator shall allow a rea24 sonable time for written public comment on the

25 report of the Panel. A copy of the report of the
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1 Panel and any comments on the report shall be

2 included in the rulemaking docket.

3 ‘‘(9) FINAL ACTION.—

4 ‘‘(A) After considering all material in the

5 docket, the Administrator shall publish in the

6 Federal Register a final rule or a withdrawal of

7 the proposed rule.

8 ‘‘(B) The Administrator may not prohibit

9 a use of a pesticide if an alternative require10 ment will ensure that the pesticide, when used

11 in accordance with widespread and commonly

12 recognized practice, will not generally cause un13 reasonable adverse effects on the environment.

14 ‘‘(C) In taking a final action, the Adminis15 trator shall take into account the impact of the

16 action on production and prices of agricultural

17 commodities, retail food prices, and otherwise

18 on the agricultural economy.

19 ‘‘(D) The final rule or withdrawal of the

20 proposed rule shall be accompanied by a state21 ment that—

22 ‘‘(i) explains the reasons for the ac23 tion;

24 ‘‘(ii) responds to any comments made

25 by the Secretary of Agriculture or the Sec-
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1 retary of Health and Human Services, and

2 to any report of the Scientific Advisory

3 Panel established under section 25(d);

4 ‘‘(iii) responds to each significant

5 comment contained in the docket; and

6 ‘‘(iv) in the case of a final rule—

7 ‘‘(I) explains the reason for any

8 major difference between the final

9 rule and the proposed rule;

10 ‘‘(II) describes the impact of the

11 final rule on production and prices of

12 agricultural commodities, retail food

13 prices, and otherwise on the agricul14 tural economy; and

15 ‘‘(III) explains any significant

16 disagreement the Administrator may

17 have with any comment, evaluation, or

18 recommendation contained in the re19 port under paragraph (8), the benefits

20 and use information described in

21 paragraph (6)(A)(iii), or the analysis

22 described in paragraph (6)(D) as the

23 analysis bears on the final rule.

24 ‘‘(E) A final rule issued under this sub25 section shall become effective on the date of the
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1 publication of the final rule in the Federal Reg2 ister.

3 ‘‘(10) MODIFICATION OR CANCELLATION.—

4 ‘‘(A)(i) Subject to clause (ii), a final rule

5 shall state any requirement, classification, or

6 prohibition imposed by the rule, and shall state

7 that each affected registrant shall have a 30-

8 day period from the date of the publication of

9 the rule in the Federal Register to apply for an

10 amendment to the registration to comply with

11 the rule or to request voluntary cancellation of

12 the registration.

13 ‘‘(ii) If the rule unconditionally prohibits

14 all uses of a pesticide, the rule may provide that

15 cancellation of the registration of the pesticide

16 is effective beginning on the date of the publica17 tion of the rule.

18 ‘‘(iii) The final rule may prohibit or limit

19 distribution or sale by the registrant of the af20 fected pesticide to any other person in a State

21 during the 30-day period.

22 ‘‘(B) Notwithstanding any other provision

23 of this Act, if an application for an amendment

24 to the registration to make the registration

25 comply with a rule issued under subparagraph
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1 (A) is not submitted within the 30-day period,

2 the Administrator may issue and publish in the

3 Federal Register an order canceling the reg4 istration, effective beginning on the date of the

5 publication of the order in the Federal Register.

6 ‘‘(11) DENIAL OF APPLICATIONS.—Notwith7 standing any other provision of this Act, no applica8 tion for initial or amended registration of a pesticide

9 under section 3 or 24(c) may be approved if the reg10 istration would be inconsistent with a rule in effect

11 under this subsection.

12 ‘‘(12) AMENDMENT OF RULE.—

13 ‘‘(A) A registrant, or other interested per14 son with the concurrence of the registrant, may

15 petition for the amendment or revocation of a

16 rule that has been issued under this subsection.

17 ‘‘(B) The petition shall state the factual

18 material and argument that form the basis for

19 the petition.

20 ‘‘(C) The Administrator shall publish a no21 tice of the petition in the Federal Register and

22 allow a 60-day comment period on the petition.

23 ‘‘(D) Not later than 180 days after publi24 cation of the notice, the Administrator shall de25 termine whether to deny the petition or to pro-
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1 pose to amend or revoke the rule, and publish

2 the determination and the basis for the deter3 mination in the Federal Register.

4 ‘‘(E) In making the determination, the Ad5 ministrator shall give due regard to—

6 ‘‘(i) the desirability of finality;

7 ‘‘(ii) the opportunity that the peti8 tioner had to present the factual material

9 and argument in question in the prior rule10 making proceeding; and

11 ‘‘(iii) any new evidence submitted by

12 the petitioner.

13 ‘‘(F) If the Administrator proposes to

14 amend or revoke the rule, the procedures estab15 lished by paragraph (1) and paragraphs (6)

16 through (9) shall apply.

17 ‘‘(G) A denial of a petition shall be judi18 cially reviewable as provided in paragraph (13).

19 ‘‘(13) JUDICIAL REVIEW.—A decision not to

20 initiate a rulemaking published under paragraph (4),

21 a final rule or a withdrawal of a proposed rule pub22 lished under paragraph (9), or a denial of a petition

23 under paragraph (12) shall be judicially reviewable

24 in the manner specified by section 16(b)(2).
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1 ‘‘(14) EXCEPTION TO REQUIREMENTS.—If the

2 Administrator finds it is necessary to issue a suspen3 sion order under subsection (c), the Administrator

4 may waive the requirements of paragraphs (3) and

5 (4).’’.

6 SEC. 203. PESTICIDES IN REVIEW.

7 If the Administrator of the Environmental Protection

8 Agency, on or before January 1, 1993, publishes a docu9 ment instituting a special review proceeding or public in10 terim administrative review proceeding with respect to a

11 pesticide or an active ingredient of a pesticide, the Admin12 istrator may, in lieu of proceeding under section 6(b) of

13 the Federal Insecticide, Fungicide, and Rodenticide Act

14 (as amended by section 202 of this Act), elect to continue

15 the review proceeding and, on completion of the proceed16 ing, take such action as is warranted in accordance with

17 section 3(c)(6) and subsections (b) and (d) of section 6

18 of the Federal Insecticide, Fungicide, and Rodenticide Act

19 (as in effect on the day before the date of enactment of

20 this Act).

21 SEC. 204. SUSPENSION.

22 (a) ORDER.—Section 6(c)(1) (7 U.S.C. 136d(c)(1))

23 is amended by striking the second sentence and inserting

24 the following new sentence: ‘‘Except as provided in para25 graph (3), no order of suspension may be issued under
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1 this subsection unless the Administrator has issued, or at

2 the same time issues, a proposed rule under subsection

3 (b).’’.

4 (b) EMERGENCY ORDER.—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), if the Adminis9 trator proceeds expeditiously to issue a proposed rule.’’.

10 SEC. 205. TOLERANCE REEVALUATION AS PART OF REREG11 ISTRATION.

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

13 by adding at the end the following new subparagraph:

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

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

17 in any event no later than the time the Admin18 istrator makes a determination under subpara19 graph (C) or (D) with respect to a pesticide

20 containing a particular active ingredient, the

21 Administrator shall—

22 ‘‘(i) reassess each associated tolerance

23 and exemption from the requirement for a

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

2 U.S.C. 346a);

3 ‘‘(ii) determine whether the tolerance

4 or exemption meets the requirements of

5 such 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 (21 U.S.C. 346a) as are warranted by the

15 determinations.’’.

16 SEC. 206. SCIENTIFIC ADVISORY PANEL.

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

18 (1) by striking ‘‘(d) SCIENTIFIC ADVISORY

19 PANEL.—The Administrator shall’’ and inserting the

20 following:

21 ‘‘(d) SCIENTIFIC ADVISORY PANEL.—

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

23 and

24 (2) by adding at the end the following new

25 paragraph:
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1 ‘‘(2) SCIENCE REVIEW BOARD.—

2 ‘‘(A) There is established a Science Review

3 Board to consist of 60 scientists who shall be

4 available to the Scientific Advisory Panel to as5 sist in reviews conducted by the Panel.

6 ‘‘(B) The Scientific Advisory Panel shall

7 select the scientists from 60 nominations sub8 mitted by each of the National Science Founda9 tion and the National Institutes of Health.

10 ‘‘(C) A member of the Board shall be com11 pensated in the same manner as a member of

12 the Panel.’’.

13 SEC. 207. CONFORMING AMENDMENTS.

14 (a) Paragraph (6) of section 3(c) (7 U.S.C.

15 136a(c)(6)) is amended to read as follows:

16 ‘‘(6) DENIAL OF APPLICATION FOR REGISTRA17 TION.—

18 ‘‘(A)(i) Except as provided in subpara19 graph (B), if the Administrator proposes to

20 deny an application for registration because the

21 application does not satisfy the requirements of

22 paragraph (5), the Administrator shall notify

23 the applicant of the proposal and the reasons

24 for the denial (including the factual basis of the

25 proposal).
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1 ‘‘(ii) Unless the applicant makes the nec2 essary corrections to the application and noti3 fies the Administrator of the corrections during

4 the 30-day period beginning on the day after

5 the date the applicant receives the notice, or

6 during the period the applicant submits a re7 quest for a hearing, the Administrator may

8 issue an order denying the application.

9 ‘‘(iii) If during the period referred to in

10 clause (ii), the Administrator does not receive

11 the corrections to the application or a request

12 for a hearing, the Administrator may issue an

13 order denying the application.

14 ‘‘(iv) The order denying the application

15 shall be published in the Federal Register and

16 shall not be subject to judicial review.

17 ‘‘(v) If during the period referred to in

18 clause (ii), the Administrator receives a request

19 for a hearing, a hearing shall be conducted

20 under section 6(d).

21 ‘‘(vi) If a hearing is held, a decision after

22 completion of the hearing shall be final and

23 shall be subject to judicial review under section

24 16(b)(1).
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1 ‘‘(B)(i) The Administrator may deny an

2 application for registration because the applica3 tion does not comply with the requirements of

4 a rule issued under section 6(b).

5 ‘‘(ii) The Administrator shall notify the ap6 plicant of the denial.

7 ‘‘(iii) The notice shall explain why the ap8 plication does not comply with the requirements

9 and shall state that the applicant may petition

10 to amend or revoke the rule under section

11 6(b)(12).’’.

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

13 striking paragraph (8).

14 (c) Section 3(d) (7 U.S.C. 136a(d)) is amended—

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

16 initial classification and registered pesticides’’ and

17 inserting ‘‘under section 6(b). A registered pes18 ticide’’; and

19 (2) in paragraph (2), by striking all that follows

20 ‘‘on the environment,’’ and inserting ‘‘the Adminis21 trator may initiate a proceeding under section

22 6(b).’’.

23 (d) Section 4(e)(3)(B)(iii)(III) (7 U.S.C. 136a–

24 1(e)(3)(B)(iii)(III)) is amended—
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1 (1) by striking ‘‘section 6(d), except that the’’

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

3 (2) by inserting after ‘‘guidelines.’’ the follow4 ing new sentence: ‘‘If a hearing is held, a decision

5 after completion of the hearing shall be final.’’.

6 (e) Section 6(c)(4) (7 U.S.C. 136d(c)(4)) is amended

7 by striking ‘‘Section 16 of this Act’’ and inserting ‘‘section

8 16(b)(1)’’.

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

10 (1) by striking the first sentence and inserting

11 the following new sentence: ‘‘If a hearing is re12 quested pursuant to section 3(c)(2)(B)(iv), 3(c)(6),

13 or 4(e)(3)(B)(iii)(III), or subsection (c)(2) or (e)(2),

14 the hearing shall be held for the purpose of receiving

15 evidence relevant and material to the issues raised

16 by the request for the hearing.’’; and

17 (2) by striking all that follows the eighth sen18 tence and inserting the following new sentence: ‘‘A

19 hearing under this subsection shall be held in ac20 cordance with sections 554, 556, and 557 of title 5,

21 United States Code. As soon as practicable after the

22 completion of the hearing, the Administrator shall

23 issue a final order setting forth the decision of the

24 Administrator. The order and decision shall be based

25 only on substantial evidence of the record of the
29

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1 hearing, shall set forth detailed findings of fact on

2 which the order is based, and shall be subject to ju3 dicial review under section 16(b)(1).’’.

4 (g) Section 16(a) (7 U.S.C. 136n(a)) is amended by

5 inserting after ‘‘a hearing’’ the following: ‘‘or a proceeding

6 under section 6(b)’’.

7 (h) Section 16(b) (17 U.S.C. 136n(b)) is amended—

8 (1) by striking ‘‘(b) REVIEW BY COURT OF AP9 PEALS.—In the case of’’ and inserting the following:

10 ‘‘(b) REVIEW BY COURT OF APPEALS.—

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

12 case of’’;

13 (2) in the last sentence of paragraph (1) (as so

14 designated), by striking ‘‘under this section’’ and in15 serting ‘‘under this paragraph’’; and

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

17 paragraph:

18 ‘‘(2) REVIEW OF CERTAIN RULES.—

19 ‘‘(A) In the case of actual controversy as

20 to the validity of a rule issued by the Adminis21 trator under section 6(b)(9), a decision by the

22 Administrator under paragraph (4) or (9) of

23 section 6(b) not to issue a proposed rule or to

24 withdraw a proposed rule, or a denial of a peti25 tion to revoke or amend a final rule under sec-
30

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1 tion 6(b)(12), a person who will be adversely af2 fected by the rule or decision and who has filed

3 comments in the proceeding leading to the rule

4 or decision may obtain judicial review by filing

5 a petition in the United States court of appeals

6 for the circuit in which the person resides or

7 has a place of business, not later than 60 days

8 after the entry of the order.

9 ‘‘(B) A copy of the petition shall be trans10 mitted to the Administrator or an officer des11 ignated by the Administrator.

12 ‘‘(C) On receipt of the copy of the petition,

13 the Administrator shall file in court the record

14 of the proceedings on which the Administrator

15 based the rule or decision, as provided in sec16 tion 2112 of title 28, United States Code.

17 ‘‘(D) On the filing of the petition, the

18 court shall have exclusive jurisdiction to affirm

19 or set aside the rule or decision in whole or in

20 part.

21 ‘‘(E) The standard of review shall be the

22 standard set forth in section 706 of title 5,

23 United States Code.

24 ‘‘(F) The judgment of the court under this

25 paragraph shall be final, subject to review by
31

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1 the Supreme Court on certiorari or certification

2 as provided in section 1254 of title 28, United

3 States Code.

4 ‘‘(G) The commencement of proceedings

5 under this section shall not, unless specifically

6 ordered by the court to the contrary, operate as

7 a stay of an order.’’.

8 (i) Section 25(a) (7 U.S.C. 136w(a)) is amended by

9 adding at the end the following new paragraph:

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

11 subsection shall not apply to a rule or rulemaking

12 proceeding under section 6(b).’’.

13 (j) Section 25(d)(1) (as designated by section 206)

14 is further amended—

15 (1) in the first sentence, by striking ‘‘of the ac16 tion proposed in notices of intent issued under sec17 tion 6(b) and’’; and

18 (2) in the second sentence—

19 (A) by striking ‘‘notices of intent and’’;

20 and

21 (B) by striking ‘‘6(b) or 25(a), as applica22 ble,’’ and inserting ‘‘25(a),’’.

23 (k) The second sentence of section 25(e) (7 U.S.C.

24 136w(e)) is amended by inserting before the period at the
32

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1 end the following: ‘‘, except for an action that may be

2 taken under section 6(b)’’.

3 SEC. 208. CONFORMING AMENDMENTS TO FIFRA TABLE OF

4 CONTENTS.

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

6 121) is amended—

7 (1) by striking the item relating to section

8 3(c)(6) and inserting the following new item:

‘‘(6) Denial of application for registration.’’;

9 (2) by striking the item relating to section

10 3(c)(8);

11 (3) by striking the item relating to section 6(b)

12 and inserting the following new items:

‘‘(b) Cancellation and change in classification or other terms or

conditions of registration.

‘‘(1) Authority.

‘‘(2) Basis for rule.

‘‘(3) Prenotice procedures.

‘‘(4) Advance notice to public.

‘‘(5) Docket.

‘‘(6) Notice of proposed rulemaking.

‘‘(7) Informal hearing.

‘‘(8) Review by Scientific Advisory Panel.

‘‘(9) Final action.

‘‘(10) Modification or cancellation.

‘‘(11) Denial of applications.

‘‘(12) Amendment of rule.

‘‘(13) Judicial review.

‘‘(14) Exception to requirements.’’;

13 (4) by striking the item relating to section

14 16(b) and inserting the following new items:
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•S 1478 IS

‘‘(b) Review by court of appeals.

‘‘(1) Review of certain orders.

‘‘(2) Review of certain rules.’’;

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

2 to section 25(a) the following new item:

‘‘(5) Exception.’’;

3 (6) by striking the item relating to section

4 25(d) and inserting the following new items:

‘‘(d) Scientific Advisory Panel.

‘‘(1) In general.

‘‘(2) Science Review Board.’’;

5 and

6 (7) by striking the item relating to section

7 28(c) and inserting the following new items:

‘‘(c) Integrated pest management.

‘‘(1) In general.

‘‘(2) Joint research and development.’’.

8 TITLE III—AMENDMENTS TO

9 THE FEDERAL FOOD, DRUG,

10 AND COSMETIC ACT

11 SEC. 301. REFERENCE.

12 Whenever in this title an amendment is expressed in

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

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

15 or other provision of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 321 et seq.).
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1 SEC. 302. DEFINITIONS.

2 (a) PESTICIDE CHEMICAL; PESTICIDE CHEMICAL

3 RESIDUE.—Section 201(q) (21 U.S.C. 321(q)) is amended

4 to read as follows:

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

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

7 the meaning of section 2(u) of the Federal Insecti8 cide, Fungicide, and Rodenticide Act (7 U.S.C.

9 136(u)),

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

11 the meaning of section 2(a) of the Federal Insecti12 cide, Fungicide, and Rodenticide Act (7 U.S.C.

13 136(a)), or

14 ‘‘(C) any inert ingredient of a pesticide within

15 the meaning of section 2(m) of the Federal Insecti16 cide, Fungicide, and Rodenticide Act (7 U.S.C.

17 136(m)).

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

19 residue in or on raw agricultural commodity or processed

20 food of—

21 ‘‘(A) a pesticide chemical, or

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

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

24 metabolism or other degradation of a pesticide

25 chemical.
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1 ‘‘(3) Notwithstanding subparagraphs (1) and (2), the

2 Administrator may by regulation except a substance from

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

4 residue’ if—

5 ‘‘(A) the substance’s occurrence as a residue on

6 a raw agricultural commodity or processed food is

7 attributable primarily to natural causes or to human

8 activities not involving the use of any substances for

9 a pesticidal purpose in the production, storage, proc10 essing, or transportation of any raw agricultural

11 commodity or processed food, and

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

13 the Secretary, determines that the substance more

14 appropriately should be regulated under one or more

15 provisions of this Act other than sections

16 402(a)(2)(B) and 408.’’.

17 (b) FOOD ADDITIVE.—Subparagraphs (1) and (2) of

18 section 201(s) (21 U.S.C. 321(s)) are amended to read

19 as follows:

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

21 agricultural commodity or processed food; or

22 ‘‘(2) a pesticide chemical; or’’.

23 (c) PROCESSED FOOD.—Section 201 (21 U.S.C. 321)

24 is amended by adding at the end the following:
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1 ‘‘(gg) The term ‘processed food’ means any food

2 other than a raw agricultural commodity and includes any

3 raw agricultural commodity that has been subject to proc4 essing, such as canning, cooking, freezing, dehydration, or

5 milling.

6 ‘‘(hh) The term ‘Administrator’ means the Adminis7 trator of the United States Environmental Protection

8 Agency.’’.

9 SEC. 303. PROHIBITED ACTS.

10 Section 301(j) (21 U.S.C. 331(j)) is amended by in11 serting before the first period the following: ‘‘, or the viola12 tion of section 408(g)(2) or any regulation issued under

13 such section.’’.

14 SEC. 304. ADULTERATED FOOD.

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

16 to read as follows:

17 ‘‘(2) if—

18 ‘‘(A) it bears or contains any added poi19 sonous or added deleterious substance (other

20 than a substance that is a pesticide chemical

21 residue in or on a raw agricultural commodity

22 or processed food, a food additive, a color addi23 tive, or a new animal drug) that is unsafe with24 in the meaning of section 406;
37

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1 ‘‘(B) it bears or contains a pesticide chemi2 cal residue that is unsafe within the meaning of

3 section 408(a); or

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

5 ‘‘(i) any food additive that is unsafe

6 within the meaning of section 409; or

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

8 product thereof) that is unsafe within the

9 meaning of section 512; or’’.

10 SEC. 305. TOLERANCES AND EXEMPTIONS FOR PESTICIDE

11 CHEMICAL RESIDUES.

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

13 follows:

14 ‘‘SEC. 408. TOLERANCES AND EXEMPTIONS FOR PESTICIDE

15 CHEMICAL RESIDUES.

16 ‘‘(a) REQUIREMENT FOR TOLERANCE OR EXEMP17 TION.—

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

19 section, the term ‘food,’ when used as a noun with20 out modification, shall mean a raw agricultural com21 modity or processed food.

22 ‘‘(2) GENERAL RULE.—Except as provided in

23 paragraph (3) or (4), any pesticide chemical residue

24 in or on a food shall be deemed unsafe for the pur25 pose of section 402(a)(2)(B) unless—
38

•S 1478 IS

1 ‘‘(A) a tolerance for such pesticide chemi2 cal residue in or on such food is in effect under

3 this section and the concentration of the residue

4 is within the limits of the tolerance; or

5 ‘‘(B) an exemption from the requirement

6 of a tolerance is in effect under this section for

7 the pesticide chemical residue.

8 ‘‘(3) PROCESSED FOOD.—Notwithstanding

9 paragraph (2), the following provisions shall apply

10 with respect to processed food:

11 ‘‘(A) If a tolerance is in effect under this

12 section for a pesticide chemical residue in or on

13 a raw agricultural commodity, a pesticide chem14 ical residue that is present in or on a processed

15 food because the food is made from that raw

16 agricultural commodity shall not be considered

17 unsafe within the meaning of section

18 402(a)(2)(B) despite the lack of a tolerance for

19 the pesticide chemical residue in or on the proc20 essed food if the concentration of the pesticide

21 chemical residue in the processed food when

22 ready for consumption or use is not greater

23 than the tolerance prescribed for the pesticide

24 chemical residue in the raw agricultural com25 modity.
39

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1 ‘‘(B) If an exemption from the requirement

2 for a tolerance is in effect under this section for

3 a pesticide chemical residue in or on a raw agri4 cultural commodity, a pesticide chemical residue

5 that is present in or on a processed food be6 cause the food is made from that raw agricul7 tural commodity shall not be considered unsafe

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

9 ‘‘(4) RESIDUES OF DEGRADATION PRODUCTS.—

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

11 food because it is a metabolite or other degradation

12 product of a precursor substance that itself is a pes13 ticide chemical or pesticide chemical residue, such a

14 residue shall not be considered to be unsafe within

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

16 of a tolerance or exemption from the need for a tol17 erance for such residue in or on such food if—

18 ‘‘(A) the Administrator has not determined

19 that the degradation product is likely to pose

20 any potential health risk from dietary exposure

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

22 significance than, any risk posed by dietary ex23 posure to the precursor substance;

24 ‘‘(B) either—
40

•S 1478 IS

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

2 section for residues of the precursor sub3 stance in or on the food, and the combined

4 level of residues of the degradation product

5 and the precursor substance in or on the

6 food is at or below the stoichiometrically

7 equivalent level that would be permitted by

8 the tolerance if the residue consisted only

9 of the precursor substance rather than the

10 degradation product; or

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

12 a tolerance is in effect under this section

13 for residues of the precursor substance in

14 or on the food; and

15 ‘‘(C) the tolerance or exemption for resi16 dues of the precursor substance does not state

17 that it applies only to particular named sub18 stances or states that it does not apply to resi19 dues of the degradation product.

20 ‘‘(5) EFFECT OF TOLERANCE OR EXEMP21 TION.—While a tolerance or exemption from the re22 quirement for a tolerance is in effect under this sec23 tion for a pesticide chemical residue with respect to

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

25 containing any amount of such a residue be consid-
41

•S 1478 IS

1 ered to be adulterated within the meaning of section

2 402(a)(1).

3 ‘‘(b) AUTHORITY AND STANDARD FOR TOLER4 ANCES.—

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

6 issue regulations establishing, modifying, or revoking

7 a tolerance for a pesticide chemical residue in or on

8 a food—

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

10 subsection (d); or

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

12 under subsection (e).

13 ‘‘(2) STANDARD.—

14 ‘‘(A) IN GENERAL.—A tolerance may not

15 be established for a pesticide chemical residue

16 in or on a food at a level that is higher than

17 a level that the Administrator determines is

18 adequate to protect the public health.

19 ‘‘(B) MODIFICATION OR REVOCATION OF A

20 TOLERANCE.—The Administrator shall modify

21 or revoke a tolerance if it is at a level higher

22 than the level that the Administrator deter23 mines is adequate to protect the public health.

24 ‘‘(C) DETERMINATION FACTORS.—In mak25 ing a determination under this paragraph, the
42

•S 1478 IS

1 Administrator shall take into account, among

2 other relevant factors, the validity, complete3 ness, and reliability of the available data from

4 studies of the pesticide chemical residue, the

5 nature of any toxic effects shown to be caused

6 by the pesticide chemical in such studies, avail7 able information and reasonable assumptions

8 concerning the relationship of the results of

9 such studies to human risk, available informa10 tion and reasonable assumptions concerning the

11 dietary exposure levels of food consumers (and

12 major identifiable subgroups of food consumers,

13 including infants and children) to the pesticide

14 chemical residue, and available information and

15 reasonable assumptions concerning the varia16 bility of the sensitivities of major identifiable

17 groups, including infants and children, and

18 shall consider other factors to the extent re19 quired by subparagraph (F).

20 ‘‘(D) NEGLIGIBLE DIETARY RISK STAND21 ARD.—For purposes of subparagraph (A), a tol22 erance level for a pesticide chemical residue in

23 or on a food shall be considered to be adequate

24 to protect the public health if the dietary risk

25 posed to food consumers by such level of the
43

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1 pesticide chemical residue is negligible. The Ad2 ministrator shall by regulation set forth the fac3 tors and methods for determining whether such

4 a risk is negligible.

5 ‘‘(E) CALCULATION OF DIETARY RISK.—

6 Where reliable data are available, the Adminis7 trator shall calculate the dietary risk posed to

8 food consumers by a pesticide chemical on the

9 basis of the percent of food actually treated

10 with the pesticide chemical and the actual resi11 due levels of the pesticide chemical that occur

12 in food. In particular, the Administrator shall

13 take into account aggregate pesticide use and

14 residue data collected by the Department of Ag15 riculture.

16 ‘‘(F) EXCEPTIONS TO THE NEGLIGIBLE DI17 ETARY RISK STANDARD.—For purposes of sub18 paragraph (A), a level of a pesticide chemical

19 residue in or on a food that poses a greater

20 than negligible dietary risk to consumers of the

21 food shall be considered to be adequate to pro22 tect the public health if the Administrator de23 termines that such risk is not unreasonable be24 cause—
44

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1 ‘‘(i) use of the pesticide that produces

2 the residue protects humans or the envi3 ronment from adverse effects on public

4 health or welfare that would, directly or in5 directly, result in greater risk to the public

6 or the environment than the dietary risk

7 from the pesticide chemical residue;

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

9 to workers, the public, or the environment

10 that would be expected to result from the

11 use of another pesticide or pest control

12 method on the same food and that are

13 greater than the risks that result from die14 tary exposure to the pesticide chemical res15 idue; or

16 ‘‘(iii) the unavailability of the pes17 ticide would limit the availability to con18 sumers of an adequate, wholesome, and ec19 onomical food supply, taking into account

20 regional and domestic effects, and such ad21 verse effects are likely to outweigh the risk

22 posed by the pesticide residue.

23 In making the determination under this sub24 paragraph, the Administrator shall not consider
45

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1 the effects on any pesticide registrant, manu2 facturer, or marketer of a pesticide.

3 ‘‘(3) LIMITATIONS.—

4 ‘‘(A) ISSUANCE OF TOLERANCE.—A toler5 ance may be issued under the authority of para6 graph (2)(f) only if the Administrator has as7 sessed the extent to which efforts are being

8 made to develop either an alternative method of

9 pest control or an alternative pesticide chemical

10 for use on such commodity or food that would

11 meet the requirements of paragraph (2)(D).

12 ‘‘(B) ESTABLISHMENT OF A TOLER13 ANCE.—A tolerance for a pesticide chemical

14 residue in or on a food shall not be established

15 by the Administrator unless the Administrator

16 determines, after consultation with the Sec17 retary, that there is a practical method for de18 tecting and measuring the levels of the pesticide

19 chemical residue in or on the food.

20 ‘‘(C) ESTABLISHMENT OF A TOLERANCE

21 LEVEL.—A tolerance for a pesticide chemical

22 residue in or on a food shall not be established

23 at a level lower than the limit of detection of

24 the method for detecting and measuring the
46

•S 1478 IS

1 pesticide chemical residue specified by the Ad2 ministrator under subparagraph (B).

3 ‘‘(4) INTERNATIONAL STANDARDS.—In estab4 lishing a tolerance for a pesticide chemical residue in

5 or on a food, the Administrator shall take into ac6 count any maximum residue level for the chemical in

7 or on the food that has been established by the

8 Codex Alimentarius Commission. The Administrator

9 shall determine whether the Codex maximum residue

10 level is adequate to protect the health of United

11 States’ consumers and whether the data supporting

12 the maximum residue level are valid, complete, and

13 reliable. If the Administrator determines not to

14 adopt a Codex maximum residue level, the Adminis15 trator shall publish a notice in the Federal Register

16 setting forth the reasons.

17 ‘‘(c) AUTHORITY AND STANDARD FOR EXEMP18 TIONS.—

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

20 issue a regulation establishing, modifying, or revok21 ing an exemption from the requirement for a toler22 ance for a pesticide chemical residue in or on a

23 food—

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

25 subsection (d); or
47

•S 1478 IS

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

2 under subsection (e).

3 ‘‘(2) STANDARD.—

4 ‘‘(A) IN GENERAL.—An exemption from

5 the requirement for a tolerance for a pesticide

6 chemical residue in or on a food may be estab7 lished only if the Administrator determines that

8 a tolerance is not needed to protect the public

9 health, in view of the levels of dietary exposure

10 to the pesticide chemical residue that could rea11 sonably be expected to occur.

12 ‘‘(B) REVOCATION OF EXEMPTION.—An

13 exemption from the requirement for a tolerance

14 for a pesticide chemical residue in or on a food

15 shall be revoked if the Administrator, in re16 sponse to a petition for the revocation of the ex17 emption or at the Administrator’s own initiative

18 determines that the exemption does not satisfy

19 the criterion of subparagraph (A).

20 ‘‘(C) DETERMINATION FACTORS.—In mak21 ing a determination under this subparagraph,

22 the Administrator shall take into account,

23 among other relevant factors, the factors set

24 forth in subsection (b)(2)(C).
48

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1 ‘‘(3) LIMITATION.—An exemption from the re2 quirement for a tolerance for a pesticide chemical

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

4 the Administrator unless the Administrator deter5 mines, after consultation with the Secretary—

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

7 detecting and measuring the levels of such pes8 ticide chemical residue in or on such food; or

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

10 method, and states the reasons for such deter11 mination in the order issuing the regulation es12 tablishing or modifying the regulation.

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

14 ‘‘(1) PETITIONS AND PETITIONERS.—Any per15 son may file with the Administrator a petition pro16 posing the issuance of a regulation—

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

18 tolerance for a pesticide chemical residue in or

19 on a food; or

20 ‘‘(B) establishing or revoking an exemption

21 from the requirement of a tolerance for such a

22 residue.

23 ‘‘(2) PETITION CONTENTS.—

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

25 paragraph (1) to establish a tolerance or ex-
49

•S 1478 IS

1 emption for a pesticide chemical residue shall

2 be supported by such data and information as

3 are specified in regulations issued by the Ad4 ministrator, including—

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

6 petition and of the data, information, and

7 arguments submitted or cited in support of

8 the petition; and

9 ‘‘(II) a statement that the petitioner

10 agrees that such summary or any informa11 tion it contains may be published as a part

12 of the notice of filing of the petition to be

13 published under this subsection and as

14 part of a proposed or final regulation is15 sued under this section;

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

17 composition of the pesticide chemical resi18 due and of the pesticide chemical that pro19 duces the residue;

20 ‘‘(iii) data showing the recommended

21 amount, frequency, method, and time of

22 application of that pesticide chemical;

23 ‘‘(iv) full reports of tests and inves24 tigations made with respect to the safety of

25 the pesticide chemical, including full infor-
50

•S 1478 IS

1 mation as to the methods and controls

2 used in conducting such tests and inves3 tigations;

4 ‘‘(v) full reports of tests and inves5 tigations made with respect to the nature

6 and amount of the pesticide chemical resi7 due that is likely to remain in or on the

8 food, including a description of the analyt9 ical methods used;

10 ‘‘(vi) a practical method for detecting

11 and measuring the levels of the pesticide

12 chemical residue in or on the food, or a

13 statement why such a method is not need14 ed;

15 ‘‘(vii) practical methods for removing

16 any amount of the residue that would ex17 ceed any proposed tolerance;

18 ‘‘(viii) a proposed tolerance for the

19 pesticide chemical residue, if a tolerance is

20 proposed;

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

22 physical or other technical effect that the

23 pesticide chemical is intended to have and

24 the quantity of the pesticide chemical that

25 is required to produce the effect;
51

•S 1478 IS

1 ‘‘(x) if the petition relates to a toler2 ance for a processed food, reports of inves3 tigations conducted using the processing

4 method or methods used to produce such

5 food;

6 ‘‘(xi) such information as the Admin7 istrator may require to make the deter8 mination under subsection (b)(2)(E); and

9 ‘‘(xii) such other data and information

10 as the Administrator requires by regulation

11 to support the petition.

12 If information or data required by this subpara13 graph is available to the Administrator, the per14 son submitting the petition may cite the avail15 ability of the information or data in lieu of sub16 mitting it. The Administrator may require a pe17 tition to be accompanied by samples of the pes18 ticide chemical with respect to which the peti19 tion is filed.

20 ‘‘(B) MODIFICATION OR REVOCATION.—

21 The Administrator may by regulation establish

22 the requirements for information and data to

23 support a petition to modify or revoke a toler24 ance or to revoke an exemption from the re25 quirement for a tolerance.
52

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1 ‘‘(3) NOTICE.—A notice of the filing of a peti2 tion that the Administrator determines has met the

3 requirements of paragraph (2) shall be published by

4 the Administrator within 30 days after such deter5 mination. The notice shall announce the availability

6 of a description of the analytical methods available

7 to the Administrator for the detection and measure8 ment of the pesticide chemical residue with respect

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

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

11 needed. The notice shall include the summary re12 quired by paragraph (2)(A)(i).

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

14 Administrator shall, after giving due consideration

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

16 other information available to the Administrator—

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

18 vary from that sought by the petition) estab19 lishing, modifying, or revoking a tolerance for

20 the pesticide chemical residue or an exemption

21 of the pesticide chemical residue from the re22 quirement of a tolerance;

23 ‘‘(B) issue a proposed regulation under

24 subsection (e), and thereafter either issue a
53

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1 final regulation under subsection (e) or an

2 order denying the petition; or

3 ‘‘(C) issue an order denying the petition.

4 ‘‘(5) EFFECTIVE DATE.—A regulation issued

5 under paragraph (4) shall take effect upon publica6 tion.

7 ‘‘(6) FURTHER PROCEEDINGS.—

8 ‘‘(A) OBJECTIONS.—Not later than 60

9 days after a regulation or order is issued under

10 paragraph (4), subsection (e)(1), or subsection

11 (f)(1), any person may file objections thereto

12 with the Administrator, specifying with particu13 larity the provisions of the regulation or order

14 considered to be objectionable and stating rea15 sonable grounds therefor. If the regulation or

16 order was issued in response to a petition under

17 paragraph (d)(1), a copy of each objection filed

18 by a person other than the petitioner shall be

19 served by the Administrator on the petitioner.

20 ‘‘(B) PUBLIC EVIDENTIARY HEARING.—An

21 objection may include a request for a public evi22 dentiary hearing upon the objection. The Ad23 ministrator shall, upon the initiative of the Ad24 ministrator or upon the request of an interested

25 person and after due notice, hold a public evi-
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1 dentiary hearing if and to the extent the Ad2 ministrator determines that such a public hear3 ing is necessary to receive factual evidence rel4 evant to material issues of fact raised by the

5 objections. The presiding officer in such a hear6 ing may authorize a party to obtain discovery

7 from other persons and may upon a showing of

8 good cause made by a party issue a subpoena

9 to compel testimony or production of documents

10 from any person. The presiding officer shall

11 apply the Federal Rules of Civil Procedure in

12 making any order for the protection of the wit13 ness or the content of documents produced and

14 shall order the payment of reasonable fees and

15 expenses as a condition to requiring testimony

16 of the witness. On contest, such a subpoena

17 may be enforced by a Federal district court.

18 ‘‘(C) ISSUANCE OF AN ORDER.—After re19 ceiving the arguments of the parties, the Ad20 ministrator shall, as soon as practicable, issue

21 an order stating the action taken upon each

22 such objection and setting forth any revision to

23 the regulation or prior order that the Adminis24 trator has found to be warranted. If a hearing

25 was held under subparagraph (B), such order
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1 and any revision to the regulation or prior order

2 shall, with respect to questions of fact at issue

3 in the hearing, be based only on substantial evi4 dence of record at such hearing, and shall set

5 forth in detail the findings of facts and the con6 clusions of law or policy upon which the order

7 or regulation is based.

8 ‘‘(D) EFFECTIVE DATE OF AN ORDER.—

9 An order issued under this paragraph ruling on

10 an objection shall not take effect before the

11 90th day after its publication unless the Admin12 istrator finds that emergency conditions exist

13 necessitating an earlier effective date, in which

14 event the Administrator shall specify in the

15 order the Administrator’s findings as to such

16 conditions.

17 ‘‘(7) JUDICIAL REVIEW.—

18 ‘‘(A) FILING OF PETITION.—In a case of

19 actual controversy as to the validity of any

20 order issued under paragraph (6) or any regula21 tion that is the subject of such an order, any

22 person who will be adversely affected by such

23 order or regulation may obtain judicial review

24 by filing in the United States Court of Appeals

25 for the circuit wherein such person resides or
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1 has its principal place of business, or in the

2 United States Court of Appeals for the District

3 of Columbia Circuit, not later than 60 days

4 after publication of such order, a petition pray5 ing that the order or regulation be set aside in

6 whole or in part.

7 ‘‘(B) FILING OF RECORD OF PROCEED8 INGS.—A copy of the petition shall be forthwith

9 transmitted by the clerk of the court to the Ad10 ministrator, or any officer designated by the

11 Administrator for that purpose, and thereupon

12 the Administrator shall file in the court the

13 record of the proceedings on which the Admin14 istrator based the order or regulation, as pro15 vided in section 2112 of title 28, United States

16 Code. Upon the filing of such a petition, the

17 court shall have exclusive jurisdiction to affirm

18 or set aside the order or regulation complained

19 of in whole or in part. The findings of the Ad20 ministrator with respect to questions of fact

21 shall be sustained only if supported by substan22 tial evidence when considered on the record as

23 a whole.

24 ‘‘(C) ADDITIONAL EVIDENCE.—If a party

25 applies to the court for leave to adduce addi-
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1 tional evidence, and shows to the satisfaction of

2 the court that the additional evidence is mate3 rial and that there were reasonable grounds for

4 the failure to adduce the evidence in the pro5 ceeding before the Administrator, the court may

6 order that the additional evidence (and evidence

7 in rebuttal thereof) shall be taken before the

8 Administrator in the manner and upon the

9 terms and conditions the court deems proper.

10 The Administrator may modify prior findings

11 as to the facts by reason of the additional evi12 dence so taken and may modify the order or

13 regulation accordingly. The Administrator shall

14 file with the court any such modified finding,

15 order, or regulation.

16 ‘‘(D) FINAL JUDGMENT.—The judgment of

17 the court affirming or setting aside, in whole or

18 in part, any order under paragraph (6) and any

19 regulation that is the subject of such an order

20 shall be final, subject to review by the Supreme

21 Court of the United States as provided in sec22 tion 1254 of title 28 of the United States Code.

23 The commencement of proceedings under this

24 paragraph shall not, unless specifically ordered
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1 by the court to the contrary, operate as a stay

2 of a regulation or order.

3 ‘‘(E) LIMITATIONS ON JUDICIAL RE4 VIEW.—Any issue as to which review is or was

5 obtainable under paragraph (6) and this para6 graph shall not be the subject of judicial review

7 under any other provision of law.

8 ‘‘(e) ACTION ON ADMINISTRATOR’S OWN INITIA9 TIVE.—

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

11 issue a regulation—

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

13 tolerance for a pesticide chemical or a pesticide

14 chemical residue;

15 ‘‘(B) establishing or revoking an exemption

16 of a pesticide chemical residue from the require17 ment of a tolerance; or

18 ‘‘(C) establishing general procedures and

19 requirements to implement this section.

20 A regulation issued under this paragraph shall be21 come effective upon its publication.

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

23 under paragraph (1), the Administrator shall issue

24 a notice of proposed rulemaking and provide a pe25 riod of not less than 60 days for public comment on
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1 the proposed regulation, except that a shorter period

2 for comment may be provided if the Administrator

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

4 public interest to do so and states the reasons for

5 the finding in the notice of proposed rulemaking.

6 The Administrator shall provide an opportunity for

7 a public hearing during the rulemaking under proce8 dures provided in subsection (d)(6)(B).

9 ‘‘(f) SPECIAL DATA REQUIREMENTS.—

10 ‘‘(1) REQUIRING SUBMISSION OF ADDITIONAL

11 DATA.—If the Administrator determines that addi12 tional data or information are reasonably required to

13 support the continuation of a tolerance or exemption

14 that is in effect under this section for a pesticide

15 chemical residue on a food, the Administrator

16 shall—

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

18 holding the pesticide registrations associated

19 with such tolerance or exemption to submit the

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

21 the Federal Insecticide, Fungicide, and

22 Rodenticide Act (7 U.S.C. 136a(c)(2)(B));

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

24 conducted on a substance or mixture under sec-
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1 tion 4 of the Toxic Substances Control Act (15

2 U.S.C. 2603); or

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

4 first providing notice and an opportunity for

5 comment of not less than 90 days duration, an

6 order—

7 ‘‘(i) requiring the submission to the

8 Administrator by one or more interested

9 persons of a notice identifying the person

10 or persons who will submit the required

11 data and information;

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

13 information required to be submitted to

14 the Administrator and stating why the

15 data and information could not be obtained

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

17 of the Federal Insecticide, Fungicide, and

18 Rodenticide Act (7 U.S.C. 136a(c)(2)(B))

19 or section 4 of the Toxic Substances Con20 trol Act (15 U.S.C. 2603);

21 ‘‘(iii) describing the reports to the Ad22 ministrator required to be prepared during

23 and after the collection of the data and in24 formation;
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1 ‘‘(iv) requiring the submission to the

2 Administrator of the data, information,

3 and reports referred to in clauses (ii) and

4 (iii); and

5 ‘‘(v) establishing dates by which the

6 submissions described in clauses (i) and

7 (iv) must be made.

8 The Administrator may revise any such order to cor9 rect an error.

10 ‘‘(2) NONCOMPLIANCE.—If a submission re11 quired by a notice issued in accordance with para12 graph (1)(A) or an order issued under paragraph

13 (1)(B) is not made by the time specified in such no14 tice or order, the Administrator may by order pub15 lished in the Federal Register modify or revoke the

16 tolerance or exemption in question.

17 ‘‘(3) REVIEW.—An order issued under this sub18 section shall be effective upon publication and shall

19 be subject to review in accordance with paragraphs

20 (6) and (7) of subsection (d).

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

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

23 that are submitted to the Administrator under this

24 section in support of a tolerance shall be entitled to

25 confidential treatment for reasons of business con-
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1 fidentiality and to exclusive use and data compensa2 tion, to the same extent provided by sections 3 and

3 10 of the Federal Insecticide, Fungicide, and

4 Rodenticide Act (7 U.S.C. 136a and 136h).

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

6 confidential treatment under paragraph (1) may be

7 disclosed to the Congress, and may be disclosed,

8 under such security requirements as the Adminis9 trator may provide by regulation, to—

10 ‘‘(A) employees of the United States who

11 are authorized by the Administrator to examine

12 such data in the carrying out of their official

13 duties under this Act or other Federal laws in14 tended to protect the public health; or

15 ‘‘(B) contractors with the United States

16 authorized by the Administrator to examine

17 such data in the carrying out of contracts under

18 such statutes.

19 ‘‘(3) SUMMARIES.—Notwithstanding any provi20 sion of this subsection or other law, the Adminis21 trator may publish the informative summary re22 quired by subsection (d)(2)(A)(i) and may, in issu23 ing a proposed or final regulation or order under

24 this section, publish an informative summary of the

25 data relating to the regulation or order.
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1 ‘‘(h) STATUS OF PREVIOUSLY ISSUED REGULA2 TIONS.—

3 ‘‘(1) REGULATIONS UNDER SECTION 406.—Reg4 ulations affecting pesticide chemical residues in or

5 on raw agricultural commodities promulgated, in ac6 cordance with section 701(e), under the authority of

7 section 406(a) upon the basis of public hearings in8 stituted before January 1, 1953, shall be deemed to

9 be regulations issued under this section and shall be

10 subject to modification or revocation under sub11 sections (d) and (e).

12 ‘‘(2) REGULATIONS UNDER SECTION 409.—Reg13 ulations that established tolerances for substances

14 that are pesticide chemical residues on or in proc15 essed food, or that otherwise stated the conditions

16 under which such pesticide chemicals could be safely

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

18 before the date of the enactment of this paragraph,

19 shall be deemed to be regulations issued under this

20 section and shall be subject to modification or rev21 ocation under subsection (d) or (e).

22 ‘‘(3) REGULATIONS UNDER SECTION 408.—Reg23 ulations that established tolerances or exemptions

24 under this section that were issued on or before the

25 date of the enactment of this paragraph shall remain
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1 in effect unless modified or revoked under subsection

2 (d) or (e).

3 ‘‘(i) TRANSITIONAL PROVISION.—If, on the day be4 fore the date of the enactment of this subsection, a sub5 stance that is a pesticide chemical was, with respect to

6 a particular pesticidal use of the substance and any result7 ing pesticide chemical residue in or on a particular food—

8 ‘‘(1) regarded by the Administrator or the Sec9 retary as generally recognized as safe for use within

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

11 201(s) as then in effect; or

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

13 described by section 201(s)(4),

14 such a pesticide chemical residue shall be regarded as ex15 empt from the requirement for a tolerance, as of the date

16 of enactment of this subsection. The Administrator shall

17 by regulation indicate which substances are described by

18 this subsection. An exemption under this subsection may

19 be revoked or modified as if it had been issued under sub20 section (c).

21 ‘‘(j) HARMONIZATION WITH ACTION UNDER OTHER

22 LAWS.—

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

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

25 that revokes, modifies, or suspends a tolerance or
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1 exemption for a pesticide chemical residue in or on

2 a food may be issued only if the Administrator has

3 first taken any necessary action under the Federal

4 Insecticide, Fungicide, and Rodenticide Act (7

5 U.S.C. 136 et seq.), with respect to the registration

6 of the pesticide whose use results in such residue to

7 ensure that any authorized use of the pesticide in

8 producing, storing, processing, or transporting food

9 that occurs after the issuance of such final rule

10 under this section will not result in pesticide chemi11 cal residues on such food that are unsafe within the

12 meaning of subsection (a).

13 ‘‘(2) REVOCATION OF TOLERANCE OR EXEMP14 TION FOLLOWING CANCELLATION OF ASSOCIATED

15 REGISTRATIONS.—If the Administrator, acting under

16 the Federal Insecticide, Fungicide, and Rodenticide

17 Act (7 U.S.C. 136 et seq.), cancels the registration

18 of each pesticide that contains a particular pesticide

19 chemical and that is labeled for use on a particular

20 food, or requires that the registration of each such

21 pesticide be modified to prohibit its use in connec22 tion with the production, storage, or transportation

23 of such food, due in whole or in part to dietary risks

24 to humans posed by residues of such pesticide chem25 ical on such food, the Administrator shall revoke any
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1 tolerance or exemption that allows the presence of

2 such pesticide chemical, or any pesticide chemical

3 residue that results from its use, in or on such food.

4 The Administrator shall use the procedures set forth

5 in subsection (e) in taking action under this para6 graph. A revocation under this paragraph shall be7 come effective not later than 180 days after—

8 ‘‘(A) the date by which each such cancella9 tion of a registration has become effective; or

10 ‘‘(B) the date on which the use of the can11 celed pesticide becomes unlawful under the

12 terms of the cancellation,

13 whichever is later.

14 ‘‘(3) SUSPENSION OF TOLERANCE OR EXEMP15 TION FOLLOWING SUSPENSION OF ASSOCIATED REG16 ISTRATIONS.—

17 ‘‘(A) SUSPENSION.—If the Administrator,

18 acting under the Federal Insecticide, Fungicide,

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

20 suspends the use of each registered pesticide

21 that contains a particular pesticide chemical

22 and that is labeled for use on a particular food,

23 due in whole or in part to dietary risks to hu24 mans posed by residues of such pesticide chemi25 cal on such food, the Administrator shall sus-
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1 pend any tolerance or exemption that allows the

2 presence of such pesticide chemical, or any pes3 ticide chemical residue that results from its use,

4 in or on such food. The Administrator shall use

5 the procedures set forth in subsection (e) in

6 taking action under this paragraph. A suspen7 sion under this paragraph shall become effective

8 not later than 60 days after the date by which

9 each such suspension of use has become effec10 tive.

11 ‘‘(B) EFFECT OF SUSPENSION.—The sus12 pension of a tolerance or exemption under sub13 paragraph (A) shall be effective as long as the

14 use of each associated registration of a pesticide

15 is suspended under the Federal Insecticide,

16 Fungicide, and Rodenticide Act (7 U.S.C. 136

17 et seq.). While a suspension of a tolerance or

18 exemption is effective the tolerance or exemp19 tion shall not be considered to be in effect. If

20 the suspension of use of the pesticide under

21 such Act is terminated, leaving the registration

22 of the pesticide for such use in effect under

23 such Act, the Administrator shall rescind any

24 associated suspension of a tolerance or exemp25 tion.
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1 ‘‘(4) TOLERANCES FOR UNAVOIDABLE RESI2 DUES.—In connection with action taken under para3 graph (2) or (3), or with respect to pesticides whose

4 registrations were canceled prior to the effective date

5 of this paragraph, if the Administrator determines

6 that a residue of the canceled or suspended pesticide

7 chemical will unavoidably persist in the environment

8 and thereby be present in or on a food, the Adminis9 trator may establish a tolerance for the pesticide

10 chemical residue at a level that permits such un11 avoidable residue to remain in such food. In estab12 lishing such a tolerance, the Administrator shall

13 take into account the factors set forth in subsection

14 (b)(2)(F)(iii) and shall use the procedures set forth

15 in subsection (e). The Administrator shall review

16 any such tolerance periodically and modify it as nec17 essary so that it allows only that level of the pes18 ticide chemical residue that is unavoidable.

19 ‘‘(5) PESTICIDE RESIDUES RESULTING FROM

20 LAWFUL APPLICATION OF PESTICIDE.—Notwith21 standing any other provision of this Act, if a toler22 ance or exemption for a pesticide chemical residue in

23 or on a food has been revoked, suspended, or modi24 fied under this section, an article of that food shall

25 not be considered unsafe solely because of the pres-
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1 ence of such pesticide chemical residue in or on such

2 food if it is shown to the satisfaction of the Sec3 retary that—

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

5 an application or use of a pesticide at a time

6 and in a manner that was lawful under the

7 Federal Insecticide, Fungicide, and Rodenticide

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

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

10 that was authorized at the time of that applica11 tion or use to be present on the food under a

12 tolerance, exemption, food additive regulation,

13 or other sanction then in effect under this Act,

14 unless, in the case of any tolerance or exemption re15 voked, suspended, or modified under this subsection

16 or subsection (d) or (e), the Administrator has is17 sued a determination that consumption of the legally

18 treated food during the period of its likely availabil19 ity in commerce will pose an unreasonable dietary

20 risk.

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

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

23 in the judgment of the Administrator, be sufficient over

24 a reasonable term to provide, equip, and maintain an ade25 quate service for the performance of the Administrator’s
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1 functions under this section. Under the regulations, the

2 performance of the Administrator’s services or other func3 tions under this section, including—

4 ‘‘(1) the acceptance for filing of a petition sub5 mitted under subsection (d);

6 ‘‘(2) the promulgation of a regulation establish7 ing, modifying, or revoking a tolerance or establish8 ing or revoking an exemption from the requirement

9 of a tolerance under this section;

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

11 under subsection (d)(6); or

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

13 transcript of the proceedings and the record under

14 subsection (d)(7),

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

16 regulations may further provide for waiver or refund of

17 fees in whole or in part when in the judgment of the Ad18 ministrator such a waiver or refund is equitable and not

19 contrary to the purposes of this subsection.

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

21 ‘‘(1) QUALIFYING PESTICIDE CHEMICAL RESI22 DUE.—For purposes of this subsection, the term

23 ‘qualifying pesticide chemical residue’ means a pes24 ticide chemical residue resulting from the use, in

25 production, processing, or storage of a food, of a
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1 pesticide chemical that is an active ingredient and

2 that—

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

4 registration of a pesticide issued under section

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

6 Rodenticide Act (7 U.S.C. 136a(c)(5)) on or

7 after April 25, 1985, on the basis of data deter8 mined by the Administrator to meet all applica9 ble requirements for data prescribed by regula10 tions in effect under such Act on April 25,

11 1985; or

12 ‘‘(B) was approved for such use in a rereg13 istration eligibility determination issued under

14 section 4(g) of the Federal Insecticide, Fun15 gicide, and Rodenticide Act (7 U.S.C. 136a–

16 1(g)) on or after the date of enactment of the

17 Food Quality Protection Act of 1993.

18 ‘‘(2) QUALIFYING FEDERAL DETERMINATION.—

19 For purposes of this subsection, the term ‘qualifying

20 Federal determination’ means—

21 ‘‘(A) a tolerance or exemption from the re22 quirement for a tolerance for a qualifying pes23 ticide chemical residue that was—
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1 ‘‘(i) issued under this section after the

2 date of enactment of the Food Quality

3 Protection Act of 1993; and

4 ‘‘(ii) issued (or, pursuant to sub5 section (h) or (i), deemed to have been is6 sued) under this section, and determined

7 by the Administrator to meet the standard

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

9 tolerance) or (c)(2) (in the case of an ex10 emption); and

11 ‘‘(B) any statement, issued by the Sec12 retary, of the residue level below which enforce13 ment action will not be taken under this Act

14 with respect to any qualifying pesticide chemi15 cal residue, if the Secretary finds that such pes16 ticide chemical residue level permitted by such

17 statement during the period to which such

18 statement applies protects human health.

19 ‘‘(3) LIMITATION.—The Administrator may

20 make the determination described in paragraph

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

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

23 only if the Administrator issues a proposed rule and

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

25 on the proposed rule. Any such rule shall be
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1 reviewable in accordance with paragraphs (6) and

2 (7) of subsection (d).

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

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

5 may establish or enforce any regulatory limit on a

6 qualifying pesticide chemical residue in or on any

7 food if a qualifying Federal determination applies to

8 the presence of such pesticide chemical residue in or

9 on such food, unless such State regulatory limit is

10 identical to such qualifying Federal determination. A

11 State or political subdivision shall be considered to

12 establish or enforce a regulatory limit on a pesticide

13 chemical residue in or on food if it purports to pro14 hibit or penalize the production, processing, ship15 ping, or other handling of a food because it contains

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

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

18 pesticide residue be the subject of a warning or

19 other statement relating to the presence of the pes20 ticide residue in the food.

21 ‘‘(5) PETITION PROCEDURE.—

22 ‘‘(A) IN GENERAL.—Any State may peti23 tion the Administrator for authorization to es24 tablish in such State a regulatory limit on a

25 qualifying pesticide chemical residue in or on
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1 any food that is not identical to the qualifying

2 Federal determination applicable to such quali3 fying pesticide chemical residue.

4 ‘‘(B) PETITION REQUIREMENTS.—Any pe5 tition under subparagraph (A) shall—

6 ‘‘(i) satisfy any requirements pre7 scribed, by rule, by the Administrator; and

8 ‘‘(ii) be supported by scientific data

9 about the pesticide chemical residue that is

10 the subject of the petition or about chemi11 cally related pesticide chemical residues,

12 data on the consumption within such State

13 of food bearing the pesticide chemical resi14 due, and data on exposure of humans with15 in such State to the pesticide chemical res16 idue.

17 ‘‘(C) ORDER.—Subject to paragraph (6),

18 the Administrator may, by order, grant the au19 thorization described in subparagraph (A) if the

20 Administrator determines that the proposed

21 State regulatory limit—

22 ‘‘(i) is justified by compelling local

23 conditions;

24 ‘‘(ii) would not unduly burden inter25 state commerce; and
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1 ‘‘(iii) would not cause any food to be

2 in violation of Federal law.

3 ‘‘(D) CONSIDERATION OF PETITION AS PE4 TITION FOR TOLERANCE OR EXEMPTIONS.—In

5 lieu of any action authorized under subpara6 graph (C), the Administrator may treat a peti7 tion under this paragraph as a petition under

8 subsection (d) to revoke or modify a tolerance

9 or to revoke an exemption. If the Administrator

10 determines to treat a petition under this para11 graph as a petition under subsection (d), the

12 Administrator shall thereafter act on the peti13 tion pursuant to subsection (d).

14 ‘‘(E) REVIEW OF ORDER.—Any order of

15 the Administrator granting or denying the au16 thorization described in subparagraph (A) shall

17 be subject to review in the manner described in

18 subsections (d)(6) and (d)(7).

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

20 No State or political subdivision may enforce any

21 regulatory limit on the level of a pesticide chemical

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

23 time of the application of the pesticide that resulted

24 in such residue, the sale of such food with such resi25 due level was lawful under this Act and under the
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1 law of such State, unless the State demonstrates

2 that consumption of the food containing such pes3 ticide residue level during the period of the food’s

4 likely availability in the State will pose an unreason5 able dietary risk to the health of persons within such

6 State.’’.

7 SEC. 305. CONFORMING AMENDMENT.

8 Section 512(a)(1) (21 U.S.C. 360b(a)(1)) is amended

9 by striking ‘‘section 402(a)(2)(D)’’ and inserting ‘‘section

10 402(a)(2)(C)(ii)’’.

11 SEC. 306. AUTHORIZATION FOR INCREASE MONITORING.

12 There is authorized to be appropriated $12,000,000

13 in addition to other amounts appropriated for increased

14 monitoring by the Secretary of Health and Human Serv15 ices of pesticide residues in imported and domestic food.

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