II

106TH CONGRESS

1ST SESSION S. 1464

To amend the Federal Food, Drug, and Cosmetic Act to establish certain

requirements regarding the Food Quality Protection Act of 1996, and

for other purposes.

IN THE SENATE OF THE UNITED STATES

JULY 29, 1999

Mr. HAGEL (for himself, Mrs. LINCOLN, Mr. ROBERTS, Ms. LANDRIEU, Mr.

HUTCHINSON, Mr. COCHRAN, Mr. GRAMS, Mr. ABRAHAM, Mr. SMITH of

Oregon, Mr. HOLLINGS, Mr. CRAIG, Mr. GORTON, Mr. GRASSLEY, Mr.

CRAPO, Mr. BURNS, Mr. FRIST, Mr. BREAUX, Mr. ASHCROFT, Mr.

COVERDELL, Mr. HELMS, and Mr. LOTT) introduced the following bill;

which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to

establish certain requirements regarding the Food Quality Protection Act of 1996, 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; TABLE OF CONTENTS.

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

5 ‘‘Regulatory Openness and Fairness Act of 1999’’.

6 (b) TABLE OF CONTENTS.—The table of contents of

7 this Act is as follows:
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Sec. 1. Short title; table of contents.

Sec. 2. Findings.

TITLE I—ISSUANCE AND CONTINUATION OF TOLERANCES

Sec. 101. Transition analysis and description of basis for decisions relating to

tolerance reviews.

Sec. 102. Interim procedures for reviews of tolerances.

Sec. 103. Implementation rules and guidance.

Sec. 104. Data in support of tolerances and registrations.

Sec. 105. Expedited action.

TITLE II—STUDIES AND REPORTS

Sec. 201. Definitions.

Sec. 202. Priorities and resources.

Sec. 203. International trade effects.

Sec. 204. Advisory committee.

1 SEC. 2. FINDINGS.

2 Congress finds the following:

3 (1) The Food Quality Protection Act of 1996

4 (Public Law 104–170; 110 Stat. 1489), enacted on

5 August 3, 1996, made many major modifications to

6 section 408 of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 346a) that require the Admin8 istrator of the Environmental Protection Agency to

9 consider new kinds of information and use additional

10 criteria in regulating pesticide chemical residues and

11 in reviewing tolerances for pesticide chemical resi12 dues that had previously been found to be adequate

13 to protect the public health.

14 (2)(A) Amendments made by the Food Quality

15 Protection Act of 1996 prescribe the use of a num16 ber of new risk assessment criteria that require the

17 development of major modifications to regulatory
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1 policies and procedures used by the Administrator to

2 regulate pesticide chemical residues.

3 (B) Since the enactment of the Food Quality

4 Protection Act of 1996, it has become clear that sev5 eral of the new concepts embodied in that Act in6 volve a high degree of complexity.

7 (C) Practical implementation of the concepts

8 demands new scientific tools in addition to the tools

9 that were available when the Food Quality Protec10 tion Act of 1996 was enacted.

11 (3)(A) To reach sound, suitably protective deci12 sions on tolerance reviews under the new criteria,

13 the Administrator also will need a great deal of new

14 data, not only on the newly considered nondietary

15 routes of exposure, but also, in some cases, on die16 tary exposure and toxicity, so that the Administrator

17 can determine whether pesticide chemicals residues

18 that were found safe under the former criteria sat19 isfy the new criteria as well.

20 (B) Some data collection efforts are underway

21 to obtain new data for tolerance reviews, but will not

22 yield results for 1 or more years.

23 (C) In some areas, the need for new data de24 pends on decisions not yet made by the Adminis25 trator about what kinds of tests should be conducted
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1 and which compounds should be tested, for tolerance

2 reviews.

3 (4)(A) The Administrator has instituted public

4 proceedings, relating to the regulations and toler5 ance reviews, on such topics as what new interpreta6 tions and policies are needed, what new kinds of

7 data are needed, how the new data would be used,

8 and how the needed regulatory transition can be

9 achieved.

10 (B) These proceedings are not yet finished, and

11 on some issues public notice and comment pro12 ceedings have been scheduled but have not yet

13 begun.

14 (5)(A) The Food Quality Protection Act of

15 1996 amended the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 301 et seq.) by adding several

17 provisions that provide flexibility to the Adminis18 trator in making the transition to the new approach

19 to regulating pesticide chemical residues.

20 (B) The Federal Food, Drug, and Cosmetic Act

21 allows a continuing process of refinement and im22 provement in tolerance decisionmaking, as additional

23 information is collected and as new policies and

24 methods are developed and adopted for the practical

25 implementation of the new requirements in that Act.
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1 (C) The Federal Food, Drug, and Cosmetic Act

2 provides that the data requirements for tolerances

3 must be set out clearly in regulations and guidelines,

4 so that the regulated community will know what

5 types of information the Administrator requires and

6 what testing procedures should be used to develop

7 the information.

8 (D) Amendments made by the Food Quality

9 Protection Act of 1996 relating to risk assessments

10 affecting tolerances allow only the use of reliable in11 formation regarding nondietary exposure routes,

12 which were not previously considered in risk assess13 ments affecting tolerances.

14 (E) Congress did not anticipate that a tolerance

15 would be revoked because of reliance by the Admin16 istrator on estimates or assumptions stemming from

17 absence of that information, without first providing

18 notice of what information is needed and a reason19 able opportunity to collect the information.

20 (F) When a tolerance is under review and the

21 Administrator determines that additional informa22 tion is needed to support the continuation of the tol23 erance, the Federal Food, Drug, and Cosmetic Act

24 authorizes the Administrator to postpone the effec25 tive date of any tolerance rule resulting from the re-
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1 view, and this authority can be utilized as appro2 priate in cases in which additional information is

3 pertinent to a tolerance review.

4 (G) The Federal Food, Drug, and Cosmetic Act

5 permits the Administrator to conduct a tolerance re6 view in stages, as allowed by the available, reliable

7 information.

8 (6)(A) Although the authorities described in

9 subparagraphs (F) and (G) of paragraph (5) already

10 are provided by law, it appears that further congres11 sional guidance is needed to ensure that decisions of

12 the Administrator relating to tolerance reviews are

13 reasonable, well supported, and balanced, and to

14 avoid disruptions in agriculture, other sectors of the

15 economy, and international trade.

16 (B) During the transition to revised standards,

17 procedures, and requirements for the regulation of

18 pesticide chemical residues, the Administrator must

19 ensure that decisions are balanced, reasonable, and

20 understandable, and are based on and supported by

21 sound information, in order to avoid unnecessary

22 disruptions in agriculture, the economy, and inter23 national trade, and to maintain the public trust in

24 the food supply.
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1 (7) Unless the Administrator implements sec2 tion 408 of the Federal Food, Drug, and Cosmetic

3 Act (21 U.S.C. 346a) carefully and wisely, decisions

4 made under that section could cause great harm

5 to—

6 (A) the safe and affordable food supply of

7 the United States;

8 (B) the agricultural system of the United

9 States (including food, fiber, nursery, and for10 estry production, food storage, and transpor11 tation);

12 (C) related industries; and

13 (D) other private and public sector activi14 ties, such as—

15 (i) public health protection against

16 bacteria and other microorganisms;

17 (ii) control of insects and diseases;

18 and

19 (iii) residential and business pest con20 trol.
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1 TITLE I—ISSUANCE AND CON2 TINUATION OF TOLERANCES

3 SEC. 101. TRANSITION ANALYSIS AND DESCRIPTION OF

4 BASIS FOR DECISIONS RELATING TO TOLER5 ANCE REVIEWS.

6 Section 408 of the Federal Food, Drug, and Cosmetic

7 Act (21 U.S.C. 346a) is amended by adding at the end

8 the following:

9 ‘‘(t) TRANSITION ANALYSIS AND DESCRIPTIONS OF

10 BASIS FOR DECISIONS RELATING TO TOLERANCE RE11 VIEWS.—

12 ‘‘(1) APPLICATION OF REQUIREMENTS TO CER13 TAIN DOCUMENTS.—

14 ‘‘(A) IN GENERAL.—Except as provided in

15 subparagraph (B), this subsection applies to

16 any proposed or final rule, order, notice, report,

17 guidance document, or risk assessment (re18 ferred to in this subsection as a ‘document’)

19 that is—

20 ‘‘(i) based on, or results from, any re21 view (including a reassessment) by the Ad22 ministrator of a tolerance or of the uses of

23 a pesticide chemical for which a tolerance

24 is in effect; and
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1 ‘‘(ii) issued or disclosed as described

2 in paragraph (2).

3 ‘‘(B) EXCEPTION.—This subsection does

4 not apply to any document in which the Admin5 istrator determines or recommends that no rev6 ocation or denial of a tolerance, or other ad7 verse action regarding a tolerance, is required.

8 ‘‘(2) PERIOD OF APPLICABILITY.—This sub9 section applies to a document that the Administrator

10 issues or otherwise discloses to any member of the

11 public during the period beginning on January 1,

12 1999, and ending on the date of completion of the

13 process of reviewing tolerances under subsection (q).

14 ‘‘(3) TRANSITION ANALYSIS REPORT.—

15 ‘‘(A) TRANSITION ANALYSIS.—Before

16 issuing any document to which this subsection

17 applies, the Administrator shall conduct a tran18 sition analysis of the findings and regulatory

19 steps recommended by or set forth in the docu20 ment.

21 ‘‘(B) REPORT.—The Administrator shall

22 prepare a report, to be issued with the docu23 ment, that—

24 ‘‘(i) describes the results of the anal25 ysis;
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1 ‘‘(ii) describes the extent to which the

2 conclusions in the document are tentative,

3 preliminary, or subject to possible modi4 fication because of policy reevaluation, cor5 rection of data deficiencies, or use of new

6 data to replace assumptions; and

7 ‘‘(iii) contains the information de8 scribed in subparagraphs (C) and (D).

9 ‘‘(C) CONTENTS OF REPORT RELATING TO

10 BASIS FOR FINDINGS AND REGULATORY

11 STEPS.—A transition analysis report prepared

12 under this paragraph shall describe the extent

13 to which any finding or regulatory step rec14 ommended by or set forth in the analyzed docu15 ment is based in whole or in part on—

16 ‘‘(i) any assumption, if the Adminis17 trator is in possession of data that would

18 make use of the assumption unnecessary;

19 ‘‘(ii) any information about possible

20 exposure from drinking water, or another

21 nonoccupational, nondietary exposure

22 route, that is derived from use of—

23 ‘‘(I) a worst-case assumption;

24 ‘‘(II) a computation or modeling

25 result that is—
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1 ‘‘(aa) based on a high-end or

2 upper-bound input; or

3 ‘‘(bb) designed to be a

4 worst-case, high-end, or upper5 bound estimate; or

6 ‘‘(III) information that otherwise

7 is not reasonably representative of

8 risks to consumers or to major identi9 fiable subgroups of consumers, on a

10 national or regional basis;

11 ‘‘(iii) any assumption about exposure

12 from drinking water, or another non13 occupational, nondietary exposure route, if

14 data that would make use of the assump15 tion unnecessary, and would likely dem16 onstrate a lower level of exposure than that

17 used in the assumption—

18 ‘‘(I) are being developed and will

19 be submitted to the Administrator

20 within a reasonable period—

21 ‘‘(aa) in accordance with a

22 request by the Administrator

23 under subsection (f) or any of the

24 authorities referred to in that

25 subsection; or
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1 ‘‘(bb) at the initiative of an

2 interested person; or

3 ‘‘(II) could be obtained by the

4 Administrator by an action taken in

5 accordance with subsection (f);

6 ‘‘(iv) any assumption regarding the

7 method for determining the aggregate ex8 posure to a pesticide chemical or the cu9 mulative effect of exposure to 2 or more

10 pesticide chemicals having a common

11 mechanism of toxicity, if the use of the as12 sumption is based in whole or in part on

13 the absence of data that could be obtained

14 by the Administrator by an action taken in

15 accordance with subsection (f), unless the

16 data that would eliminate the need for use

17 of the assumption have been identified and

18 made known by the Administrator to inter19 ested persons and sufficient time has been

20 provided to allow the data to be developed,

21 submitted, and subsequently evaluated by

22 the Administrator;

23 ‘‘(v) any calculation developed by use

24 of the margin of safety described in sub25 section (b)(2)(C), if the use of the margin
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1 of safety is based in whole or in part on

2 the absence of data that could be obtained

3 by the Administrator by an action taken in

4 accordance with subsection (f), unless the

5 data that would eliminate the need for use

6 of the margin of safety have been identi7 fied and made known by the Administrator

8 to interested persons and sufficient time

9 has been provided to allow the data to be

10 developed, submitted, and subsequently

11 evaluated by the Administrator; or

12 ‘‘(vi) any information about an alleged

13 adverse effect relating to a pesticide chem14 ical, if the information is anecdotal,

15 unverified, or scientifically implausible, or

16 comes from any study whose design and

17 conduct has not been found by the Admin18 istrator to be scientifically sound with re19 gard to design, conduct, reporting, and

20 data availability.

21 ‘‘(D) ADDITIONAL CONTENTS OF RE22 PORT.—A transition analysis report prepared

23 under this paragraph shall contain

24 information—
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1 ‘‘(i) summarizing and responding

2 briefly to comments received by the Admin3 istrator from any other person regarding

4 the applicability of any provision of sub5 paragraph (C) to the document analyzed

6 under this subsection;

7 ‘‘(ii) describing briefly the availability

8 and suitability of pesticidal and nonpes9 ticidal alternatives to the pesticide chem10 ical uses being reviewed, including a de11 scription of—

12 ‘‘(I) the extent to which (as de13 termined by the Administrator, in

14 consultation with the Secretary of Ag15 riculture) an alternative to the use for

16 which the tolerance under review has

17 been approved that is effective and ec18 onomical; and

19 ‘‘(II) whether revocation or modi20 fication of the tolerance will result

21 in—

22 ‘‘(aa) a significant regional

23 shift of production of food within

24 the United States;
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1 ‘‘(bb) an increase in imports

2 of corresponding commodities;

3 ‘‘(cc) an increase in pest

4 control costs;

5 ‘‘(dd) an increase in pest

6 crop damage and yield loss, in7 cluding quality degradation, due

8 to the lack of an effective alter9 native; or

10 ‘‘(ee) a disruption of domes11 tic production of an adequate,

12 wholesome, and economical food

13 supply;

14 ‘‘(iii) identifying the data that, if

15 available, would make unnecessary any re16 liance on any information, assumption, or

17 calculation that is described in clause (ii),

18 (iii), (iv), or (v) of subparagraph (C) and

19 identified in the report;

20 ‘‘(iv) describing the extent to which

21 any finding or regulatory step rec22 ommended by or set forth in the document

23 is based in whole or in part on any as24 sumption about toxicity, dietary exposure,

25 or risk from dietary exposure, if data that
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1 would make use of the assumption

2 unnecessary—

3 ‘‘(I) are being developed and will

4 be submitted to the Administrator

5 within a reasonable period—

6 ‘‘(aa) in accordance with a

7 request by the Administrator

8 under subsection (f) or any of the

9 authorities referred to in that

10 subsection; or

11 ‘‘(bb) at the initiative of an

12 interested person; or

13 ‘‘(II) could be obtained by the

14 Administrator by an action taken in

15 accordance with subsection (f); and

16 ‘‘(v) describing the extent to which

17 any finding or regulatory step rec18 ommended by or set forth in the document

19 is based in whole or in part on—

20 ‘‘(I) any use of data on the pres21 ence or absence of nonadverse effects,

22 rather than data on the presence or

23 absence of adverse effects, as the

24 basis for calculation of allowable expo25 sure levels; or
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1 ‘‘(II) any policy that the Admin2 istrator may revise after completion of

3 any reevaluation of that policy that is

4 being conducted or is scheduled to be

5 conducted.

6 ‘‘(4) DEFINITION.—In this subsection and sub7 section (u), the term ‘tolerance’ has the meaning

8 given the term in section 201 of the Regulatory

9 Openness and Fairness Act of 1999.’’.

10 SEC. 102. INTERIM PROCEDURES FOR REVIEWS OF TOLER11 ANCES.

12 Section 408 of the Federal Food, Drug, and Cosmetic

13 Act, as amended by section 101, is further amended by

14 adding at the end the following:

15 ‘‘(u) INTERIM PROCEDURES FOR REVIEWS OF TOL16 ERANCES.—

17 ‘‘(1) APPLICATION OF REQUIREMENTS TO CER18 TAIN ACTIONS.—This subsection applies to—

19 ‘‘(A) any review (including a reassessment)

20 by the Administrator of a tolerance, whether

21 initiated by the Administrator or by petition by

22 another person; and

23 ‘‘(B) any review (including a reassessment)

24 by the Administrator of any registration of a

25 pesticide chemical under the Federal Insecti-
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1 cide, Fungicide, and Rodenticide Act (7 U.S.C.

2 136 et seq.) that is associated with or results

3 from such a tolerance review;

4 that the Administrator issues during the period de5 scribed in paragraph (2).

6 ‘‘(2) PERIOD OF APPLICABILITY.—The period

7 referred to in paragraph (1) is the period beginning

8 on January 1, 1999, and ending on the date of com9 pletion of the process of reviewing tolerances under

10 subsection (q).

11 ‘‘(3) LIMITATION.—Notwithstanding any other

12 provision of law—

13 ‘‘(A) in any tolerance review (including a

14 reassessment) to which this subsection applies,

15 the Administrator may not base the revocation

16 or denial of, or other adverse action regarding,

17 a tolerance on any information, calculation, or

18 assumption described in subsection (t)(3)(C);

19 and

20 ‘‘(B) in any review (including a reassess21 ment) to which this subsection applies of the

22 registration of a pesticide chemical under the

23 Federal Insecticide, Fungicide, and Rodenticide

24 Act (7 U.S.C. 136 et seq.), the Administrator

25 may not base any adverse action regarding a
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1 registration on any such information, calcula2 tion, or assumption.’’.

3 SEC. 103. IMPLEMENTATION RULES AND GUIDANCE.

4 Section 408(e) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 346a(e)) is amended by adding at

6 the end the following:

7 ‘‘(3) IMPLEMENTATION RULES AND GUID8 ANCE.—

9 ‘‘(A) IN GENERAL.—In establishing gen10 eral procedures and requirements to implement

11 this section in accordance with paragraph

12 (1)(C), the Administrator shall issue rules and

13 guidance, including guidance regarding the pro14 visions of this Act regarding aggregate exposure

15 to pesticide chemicals and cumulative effects of

16 exposure to 2 or more pesticide chemicals hav17 ing a common mechanism of toxicity. The Ad18 ministrator shall include in such rules and guid19 ance general procedures and requirements to

20 implement the provisions of this Act that were

21 added by amendments made by the Regulatory

22 Openness and Fairness Act of 1999.

23 ‘‘(B) ISSUANCE.—The Administrator shall

24 issue—
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1 ‘‘(i) proposed rules and guidance de2 scribed in subparagraph (A) not later than

3 180 days after the date of enactment of

4 the Regulatory Openness and Fairness Act

5 of 1999;

6 ‘‘(ii) final rules and guidance de7 scribed in subparagraph (A) not later than

8 1 year after the date of enactment of the

9 Regulatory Openness and Fairness Act of

10 1999; and

11 ‘‘(iii) such revisions to the rules and

12 guidance as the Administrator determines

13 to be necessary and appropriate.’’.

14 SEC. 104. DATA IN SUPPORT OF TOLERANCES AND REG15 ISTRATIONS.

16 (a) FEDERAL FOOD, DRUG, AND COSMETIC ACT.—

17 Section 408(f) of the Federal Food, Drug, and Cosmetic

18 Act (21 U.S.C. 346a(f)) is amended by adding at the end

19 the following:

20 ‘‘(3) ISSUANCE OF GUIDELINES.—

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

22 shall issue guidelines specifying the kinds of in23 formation that will be required to support the

24 issuance or continuation of a tolerance for a

25 pesticide chemical residue or the exemption
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1 from the requirement of such a tolerance, es2 tablished under this section. The Administrator

3 shall revise the guidelines from time to time.

4 The guidelines shall specify the conditions

5 under which data requirements will apply to

6 particular types of pesticide chemical residues.

7 ‘‘(B) PROCEDURES.—In issuing the guide8 lines described in subparagraph (A), the Ad9 ministrator shall provide notice and an oppor10 tunity for comment, except for those guidelines

11 that already have been issued after notice and

12 an opportunity for comment under section

13 3(c)(2)(A) of the Federal Insecticide, Fun14 gicide, and Rodenticide Act (7 U.S.C.

15 136a(c)(2)(A)).’’.

16 (b) FEDERAL INSECTICIDE, FUNGICIDE, AND

17 RODENTICIDE ACT.—The first sentence of section

18 3(c)(2)(A) of the Federal Insecticide, Fungicide, and

19 Rodenticide Act (7 U.S.C. 136a(c)(2)(A)) is amended by

20 striking the period and inserting ‘‘, after providing notice

21 and an opportunity for comment on the guidelines or revi22 sions by interested parties.’’.

23 SEC. 105. EXPEDITED ACTION.

24 (a) EXPEDITED ACTION TO PROVIDE EFFECTIVE,

25 ECONOMIC ALTERNATIVES.—Section 3(c)(3) of the Fed-
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1 eral Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.

2 136a(c)(3)) is amended by adding at the end the following:

3 ‘‘(E) EXPEDITED ACTION TO PROVIDE EF4 FECTIVE, ECONOMIC ALTERNATIVES.—The Ad5 ministrator shall expedite the review of any

6 complete application for registration or amend7 ed registration of a pesticide under this section,

8 for an experimental use permit under section 5,

9 or for an emergency exemption under section

10 18, if the application seeks approval for the reg11 istration or use of a pesticide—

12 ‘‘(i) that, in the opinion of the Admin13 istrator, is likely to provide an effective

14 and economic alternative to the use of a

15 pesticide that has been or is likely to be re16 moved from the market as a result of a re17 view conducted under section 408 of the

18 Federal Food, Drug, and Cosmetic Act (21

19 U.S.C. 346a); and

20 ‘‘(ii) for which—

21 ‘‘(I) there is no registered effec22 tive and economical alternative (as of

23 the date of submission of the applica24 tion); or
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1 ‘‘(II) the number of the alter2 natives is insufficient to avoid prob3 lems such as pest resistance.’’.

4 (b) COORDINATION.—Section 408(d)(4)(B) of the

5 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

6 346a(d)(4)(B)) is amended—

7 (1) by striking ‘‘tolerance or exemption for’’

8 and inserting ‘‘tolerance or exemption—

9 ‘‘(i) for’’;

10 (2) by striking the period at the end and insert11 ing ‘‘; or’’; and

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

13 ‘‘(ii) that is needed in connection with

14 an application under section 3(c)(3)(E) of

15 the Federal Insecticide, Fungicide, and

16 Rodenticide Act (7 U.S.C. 136a(c)(3)(E))

17 for approval of an effective and economic

18 alternative.’’.

19 (c) TOLERANCES FOR EMERGENCY USES.—Section

20 408(l)(6) of the Federal Food, Drug, and Cosmetic Act

21 (21 U.S.C. 346a(l)(6)) is amended—

22 (1) by inserting before the first sentence the

23 following:

24 ‘‘(A) IN GENERAL.—’’;
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1 (2) by inserting before the third sentence the

2 following:

3 ‘‘(B) PROCEDURE.—’’;

4 (3) by inserting before the fifth sentence the

5 following:

6 ‘‘(C) SAFETY STANDARD.—’’;

7 (4) in the fifth sentence, by striking the period

8 and inserting ‘‘, except as described in subparagraph

9 (D).’’; and

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

11 ‘‘(D) EMERGENCY EXEMPTIONS.—The Ad12 ministrator may establish a tolerance for a pes13 ticide chemical residue associated with an emer14 gency exemption without regard to other toler15 ances for a pesticide chemical residue and be16 fore reviewing those other tolerances, if the Ad17 ministrator determines that any incremental ex18 posure that may result from the tolerance asso19 ciated with the emergency exemption will not

20 pose any significant risk to food consumers.’’.

21 TITLE II—STUDIES AND

22 REPORTS

23 SEC. 201. DEFINITIONS.

24 In this title:
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1 (1) ADMINISTRATOR.—The term ‘‘Adminis2 trator’’ means the Administrator of the Environ3 mental Protection Agency.

4 (2) PESTICIDE CHEMICAL; PESTICIDE CHEM5 ICAL RESIDUE.—The terms ‘‘pesticide chemical’’ and

6 ‘‘pesticide chemical residue’’ have the meanings

7 given the terms in section 201 of the Federal Food,

8 Drug, and Cosmetic Act (21 U.S.C. 321).

9 (3) SECRETARY.—The term ‘‘Secretary’’ means

10 the Secretary of Agriculture.

11 (4) TOLERANCE.—The term ‘‘tolerance’’ means

12 a tolerance for a pesticide chemical residue or an ex13 emption from the requirement of such a tolerance,

14 established under section 408 of the Federal Food,

15 Drug, and Cosmetic Act (21 U.S.C. 346a).

16 SEC. 202. PRIORITIES AND RESOURCES.

17 (a) ENVIRONMENTAL PROTECTION AGENCY PRO18 POSAL.—The Administrator shall prepare a proposal for

19 revising the priorities of and resources available to the Ad20 ministrator that will allow the Administrator—

21 (1) to process promptly all—

22 (A) applications for registration of pes23 ticide chemicals under the Federal Insecticide,

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

25 et seq.);
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1 (B) petitions for tolerances (including ex2 emptions) under section 408 of the Federal

3 Food, Drug, and Cosmetic Act (21 U.S.C.

4 346a);

5 (C) requests for experimental use permits,

6 for approval of new inert ingredients, and for

7 emergency exemptions, relating to pesticide

8 chemicals under an Act described in subpara9 graph (A) or (B); and

10 (D) requests for decisions on the merits of

11 the applications, petitions, and requests de12 scribed in subparagraphs (A) through (C); and

13 (2) to perform tolerance reviews (including re14 assessments) and other duties relating to pesticide

15 chemicals, as required by the Federal Food, Drug,

16 and Cosmetic Act or the Federal Insecticide, Fun17 gicide, and Rodenticide Act.

18 (b) DEPARTMENT OF AGRICULTURE PROPOSAL.—

19 The Secretary shall prepare a proposal for revising the

20 priorities of and resources available to the Secretary that

21 will allow the Secretary—

22 (1) to obtain and provide to the Administrator

23 adequate and timely information on food consump24 tion, pesticide chemical residues in or on food and

25 drinking water, and pesticide chemical use;
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1 (2) to review actions proposed by the Adminis2 trator under section 408 of the Federal Food, Drug,

3 and Cosmetic Act and the Federal Insecticide, Fun4 gicide, and Rodenticide Act; and

5 (3) to perform other duties related to the regu6 lation of pesticide chemicals (including pesticide

7 chemical residues).

8 (c) REPORT.—The Administrator and the Secretary

9 shall prepare and submit to Congress a report containing

10 the proposals described in subsections (a) and (b) not later

11 than 180 days after the date of enactment of this Act.

12 SEC. 203. INTERNATIONAL TRADE EFFECTS.

13 (a) ASSESSMENT.—

14 (1) ASSESSMENT PROGRAM.—The Secretary

15 shall establish and administer a program to continu16 ously assess the strength of major United States ag17 ricultural commodities and products in the inter18 national marketplace. The commodities and products

19 assessed shall include fruits and vegetables, corn,

20 wheat, cotton, rice, soybeans, and nursery and forest

21 products.

22 (2) FACTORS.—In carrying out paragraph (1),

23 the Secretary shall examine factors pertinent to as24 sessing the sustainability and competitive strength of

25 each commodity and product in the international
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1 marketplace and the relationship of the factors to

2 regulatory actions taken under the Federal Food,

3 Drug, and Cosmetic Act and the Federal Insecticide,

4 Fungicide, and Rodenticide Act. The factors exam5 ined for each commodity and product shall include

6 commodity changes, regional changes, prices, qual7 ity, input costs and availability, and the ratio of im8 ports to exports.

9 (b) REPORT.—The Secretary shall prepare periodic

10 reports describing the results obtained from the assess11 ment program conducted under subsection (a). The Sec12 retary shall submit the reports to the Committee on Agri13 culture of the House of Representatives and the Com14 mittee on Agriculture, Nutrition, and Forestry of the Sen15 ate. The Secretary shall submit the reports not later than

16 October 1, 2000, and October 1 of every second year

17 thereafter through 2010.

18 SEC. 204. ADVISORY COMMITTEE.

19 (a) ESTABLISHMENT.—There is established an advi20 sory committee to be known as the Pesticide Advisory

21 Committee (referred to in this section as the ‘‘Advisory

22 Committee’’).

23 (b) MEMBERSHIP.—

24 (1) COMPOSITION.—The Advisory Committee

25 shall be composed of 20 members, appointed by the
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1 Administrator and the Secretary. The members of

2 the Advisory Committee shall represent a wide vari3 ety of interests and viewpoints and shall be ap4 pointed from among individuals who are representa5 tives of organizations who are interested in the regu6 lation of pesticide chemicals, including representa7 tives of—

8 (A) organizations that represent—

9 (i) food consumers;

10 (ii) persons with a special interest in

11 environmental protection;

12 (iii) farmworkers;

13 (iv) agricultural producers (including

14 persons engaged in crop production, live15 stock and poultry production, or nursery

16 and forestry production);

17 (v) nonagricultural pesticide chemical

18 users;

19 (vi) food manufacturers and proc20 essors;

21 (vii) food distributors and marketers;

22 and

23 (viii) manufacturers of agricultural

24 and nonagricultural pesticide chemicals;

25 and
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1 (B) Federal and State agencies.

2 (2) PUBLICATION.—The Administrator shall

3 publish in the Federal Register the name, address,

4 and professional affiliation of each member of the

5 Advisory Committee.

6 (3) TERMS OF APPOINTMENT.—Each member

7 of the Advisory Committee shall serve for a term of

8 years determined by the Administrator and the Sec9 retary, except that—

10 (A) the terms of service of the members

11 initially appointed shall be (as specified by the

12 Administrator and the Secretary) for such

13 fewer number of years as will provide for the

14 expiration of terms on a staggered basis;

15 (B) a member appointed to fill a vacancy

16 occurring prior to the expiration of the term for

17 which a predecessor was appointed, shall be ap18 pointed for the remainder of the term; and

19 (C) the Secretary and the Administrator

20 may extend the term of a member of the Advi21 sory Committee until a new member is ap22 pointed to fill the vacancy.

23 (4) VACANCIES.—Any vacancy occurring in the

24 membership of the Advisory Committee shall be

25 filled in the same manner as the original appoint-
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1 ment. The vacancy shall not affect the power of the

2 remaining members to execute the duties of the Ad3 visory Committee.

4 (c) DUTIES.—The Advisory Committee shall—

5 (1) provide advice to the Administrator and the

6 Secretary on matters related to implementation of

7 section 408 of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 346a) and the Federal Insecti9 cide, Fungicide, and Rodenticide Act (7 U.S.C. 136

10 et seq.), including proposed and final rules, policies,

11 procedures, and testing guidelines used to regulate

12 tolerances and pesticide chemical registrations;

13 (2) foster communication between the Adminis14 trator, the Secretary, and the various organizations

15 who represent persons having particular interest in

16 the regulation of pesticide chemicals under the Fed17 eral Food, Drug, and Cosmetic Act and the Federal

18 Insecticide, Fungicide, and Rodenticide Act; and

19 (3) carry out the functions performed by the

20 Tolerance Reassessment Advisory Committee.

21 (d) MEETINGS.—

22 (1) FREQUENCY.—The Advisory Committee

23 shall meet at least 2 times per year, at times deter24 mined jointly by the Administrator and the Sec25 retary. Not later than 14 days before the date of
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1 each meeting, the Administrator shall publish a no2 tice regarding the meeting in the Federal Register.

3 (2) OPEN MEETINGS.—The Advisory Com4 mittee shall conduct its principal business—

5 (A) in meetings that are—

6 (i) open to the public; and

7 (ii) in facilities that can accommodate

8 the reasonably foreseeable number of per9 sons attending; or

10 (B) by teleconference, with open access.

11 (3) FACILITIES.—The Secretary shall be re12 sponsible for providing or making arrangements for

13 the meeting facilities or teleconferences.

14 (e) COMMUNICATIONS.—The Administrator or the

15 Secretary shall ensure that written communications be16 tween the Administrator or Secretary, respectively, and

17 the Advisory Committee, are recorded and made available

18 to any person upon request.

19 (f) CHAIRPERSON.—The Advisory Committee shall

20 select a Chairperson from among its members.

21 (g) POWERS OF THE ADVISORY COMMITTEE.—

22 (1) HEARINGS.—The Advisory Committee may

23 hold such hearings, sit and act at such times and

24 places, take such testimony, and receive such evi-
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1 dence as the Advisory Committee considers advisable

2 to carry out this section.

3 (2) INFORMATION FROM FEDERAL AGENCIES.—

4 Except as otherwise provided in Federal law, the Ad5 visory Committee may secure directly from any Fed6 eral department or agency such information as the

7 Advisory Committee considers necessary to carry out

8 this section. Upon request of the Chairperson of the

9 Advisory Committee, the head of the department or

10 agency shall furnish the information to the Advisory

11 Committee.

12 (3) POSTAL SERVICES.—The Advisory Com13 mittee may use the United States mails in the same

14 manner and under the same conditions as other de15 partments and agencies of the Federal Government.

16 (4) GIFTS.—The Advisory Committee may ac17 cept, use, and dispose of gifts or donations of serv18 ices or property.

19 (h) ADVISORY COMMITTEE PERSONNEL MATTERS.—

20 (1) TRAVEL EXPENSES.—

21 (A) IN GENERAL.—The members of the

22 Advisory Committee shall not receive compensa23 tion for the performance of services for the Ad24 visory Committee, but shall be allowed travel

25 expenses, including per diem in lieu of subsist-
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1 ence, at rates authorized for employees of agen2 cies under subchapter I of chapter 57 of title 5,

3 United States Code, while away from their

4 homes or regular places of business in the per5 formance of services for the Advisory Com6 mittee.

7 (B) FUNDS.—Funds used to provide travel

8 expenses under subparagraph (A) shall be paid

9 by the Administrator from appropriations avail10 able for those purposes.

11 (2) DETAIL OF GOVERNMENT EMPLOYEES.—

12 Any employee of the Department of Agriculture (and

13 no other Federal employee) may be detailed to the

14 Advisory Committee without reimbursement, and the

15 detail shall be without interruption or loss of civil

16 service status or privilege.

17 (i) PERMANENT COMMITTEE.—Section 14 of the

18 Federal Advisory Committee Act (5 U.S.C. App.) shall not

19 apply to the Advisory Committee.

Æ