I

106TH CONGRESS

1ST SESSION H. R. 1592

To establish certain requirements regarding the Food Quality Protection

Act of 1996, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

APRIL 28, 1999

Mr. POMBO (for himself, Mr. TOWNS, Mr. CONDIT, Mr. BOYD, Mr. KOLBE,

Mr. JOHN, Mr. ISTOOK, Mr. STRICKLAND, Mr. SHOWS, Mrs. BONO, Mr.

BOUCHER, Mr. ETHERIDGE, Mr. DOOLITTLE, Mr. SANDLIN, Mr. GOODE,

Mr. HUNTER, Mr. SALMON, Mr. HILL of Montana, Mr. RADANOVICH,

Mr. CANADY of Florida, Mr. NETHERCUTT, and Mr. BISHOP) introduced

the following bill; which was referred to the Committee on Commerce,

and in addition to the Committee on Agriculture, for a period to be subsequently determined by the Speaker, in each case for consideration of

such provisions as fall within the jurisdiction of the committee concerned

A BILL

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.

4 This Act may be cited as the ‘‘Regulatory Fairness

5 and Openness Act of 1999’’.

6 SEC. 2. DEFINITIONS.

7 As used in this Act:
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1 (1) ADMINISTRATOR.—The term ‘‘Adminis2 trator’’ means the Administrator of the Environ3 mental Protection Agency.

4 (2) AGENCY.—The term ‘‘Agency’’ means the

5 Environmental Protection Agency.

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

7 the Secretary of Agriculture.

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

9 a regulation establishing a tolerance, including an

10 exemption from the requirement for a tolerance,

11 under section 408 of the Federal Food, Drug, and

12 Cosmetic Act.

13 SEC. 3. FINDINGS.

14 The Congress finds as follows:

15 (1) The Food Quality Protection Act of 1996

16 (Public Law 104–170), enacted on August 3, 1996,

17 made many major modifications to section 408 of

18 the Federal Food, Drug, and Cosmetic Act

19 (‘‘FFDCA’’), requiring the Administrator to con20 sider new kinds of information and use additional

21 criteria in regulating pesticide residues and in re22 viewing existing tolerances that had previously been

23 found to be adequate to protect the public health.

24 (2) The Food Quality Protection Act of 1996

25 (‘‘FQPA’’) prescribes the use of a number of new
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1 risk assessment criteria that require the development

2 of major modifications to existing regulatory policies

3 and procedures used by the Administrator to regu4 late pesticide tolerances. Since the enactment of the

5 FQPA it has become clear that several of the new

6 concepts embodied in it involve a high degree of

7 complexity. Practical implementation of them de8 mands new scientific tools in addition to those that

9 were available when the FQPA was enacted.

10 (3) To reach sound, suitably protective deci11 sions on tolerance reviews under the new criteria,

12 the Administrator also will need a great deal of new

13 data, not only on the newly considered non-food

14 routes of exposure, but also, in some cases, on die15 tary exposure and toxicity, so that it can be deter16 mined whether pesticides that were found safe under

17 the former criteria satisfy the new criteria as well.

18 Some data collection efforts are underway, but will

19 not yield results for one or more years. In some

20 areas, the need for new data depends on decisions

21 not yet made by the Administrator about what kinds

22 of tests should be conducted and which compounds

23 should be tested.

24 (4) The Administrator has instituted public

25 proceedings on such topics as what new interpreta-
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1 tions and policies are needed, what new kinds of

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

3 and how the needed regulatory transition can be

4 achieved. These proceedings are not yet finished,

5 and on some issues public notice-and-comment pro6 ceedings have been scheduled but have not yet

7 begun.

8 (5) The FQPA added to the FFDCA several

9 provisions that provide flexibility to the Adminis10 trator in making the transition to the new approach.

11 The FFDCA anticipates a continuing process of re12 finement and improvement in tolerance decision13 making, as additional information is collected and as

14 new policies and methods are developed and adopted

15 for the practical implementation of the new require16 ments. The FFDCA provides that the data require17 ments for tolerances must be set out clearly in regu18 lations and guidelines, so that the regulated commu19 nity will know what types of information the Agency

20 requires and what testing procedures should be used

21 to develop the information. The FQPA only allows

22 the use of ‘‘reliable’’ information on the non-dietary

23 exposure routes that were not previously considered

24 in risk assessments affecting tolerances. The Con25 gress did not anticipate that a tolerance would be
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1 revoked because of Agency reliance on estimates or

2 assumptions stemming from absence of such data,

3 without first providing notice of what data are need4 ed and a reasonable opportunity to collect the data.

5 Thus, when an existing tolerance is under review

6 and the Administrator determines that additional in7 formation is needed to support the continuation of

8 the tolerance, the FFDCA now authorizes the Ad9 ministrator to postpone the effective date of any tol10 erance rule resulting from a review, and this author11 ity can be utilized as appropriate where additional

12 information is pertinent to a tolerance review. Fi13 nally, the current FFDCA permits the Agency to

14 conduct a review in stages, as allowed by the avail15 able, reliable information.

16 (6) Although these authorities already are pro17 vided by law, it appears that further congressional

18 guidance is needed to ensure that Agency decisions

19 are reasonable, well supported, and balanced, and to

20 avoid disruptions in agriculture, other sectors of the

21 economy, and international trade. During the transi22 tion to revised standards, procedures, and require23 ments, the Administrator must ensure that decisions

24 are balanced, reasonable, understandable, and based

25 on and supported by sound information, in order to
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1 avoid unnecessary disruptions in agriculture, the

2 economy, and world trade, and to maintain the pub3 lic trust in the food supply.

4 (7) Unless the Administrator implements sec5 tion 408 of the FFDCA carefully and wisely, deci6 sions made under it could cause great harm to the

7 presently safe and affordable food supply, to Amer8 ican agriculture (including food, fiber, nursery, and

9 forestry production, and food storage and transpor10 tation), to related industries, and to other private

11 and public sector activities such as public health pro12 tection against bacteria and other microorganisms,

13 control of insects and other disease vectors, and resi14 dential and business pest control.

15 SEC. 4. REQUIREMENTS FOR TRANSITION ANALYSIS AND

16 DESCRIPTION OF BASIS FOR DECISIONS.

17 (a) IN GENERAL.—This section applies to any pro18 posed or final rule, order, notice, report, guidance docu19 ment, or risk assessment issued by the Administrator that

20 is based on or results from a review or reassessment of

21 an existing tolerance or of the uses of a pesticide having

22 an existing tolerance. However, this section does not apply

23 to any document that concludes or recommends that no

24 revocation or denial of a tolerance, or other adverse action

25 against a tolerance, is required.
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1 (b) PERIOD OF APPLICABILITY.—This section applies

2 to any document described by subsection (a) that the Ad3 ministrator issues or otherwise discloses to any member

4 of the public during the period beginning on January 1,

5 1999, and ending on the date of completion of the process

6 of tolerance review under section 408(q) of the Federal

7 Food, Drug, and Cosmetic Act.

8 (c) REQUIREMENT FOR TRANSITION ANALYSIS RE9 PORT.—Before issuing any document to which this section

10 applies, the Administrator shall conduct a transition anal11 ysis of the findings and regulatory steps recommended by

12 or set forth in the document. The document shall include

13 a report describing the results of the analysis and the ex14 tent to which the conclusions in the document are ten15 tative, preliminary, or subject to possible modification be16 cause of policy reevaluation, correction of data defi17 ciencies, or use of new data to replace assumptions. A

18 transition analysis statement under this section shall de19 scribe the extent to which any finding or regulatory step

20 recommended by or set forth in the analyzed document

21 is based in whole or in part on—

22 (1) any assumption, if the Administrator is in

23 possession of data that would make use of the as24 sumption unnecessary;
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1 (2) any information about possible exposure

2 from drinking water or other non-occupational, non3 dietary exposure routes that is derived from use of—

4 (A) worst-case assumptions;

5 (B) computations or modeling results that

6 are based on high-end or upper-bound inputs or

7 are designed to be worst-case, high-end, or

8 bounding estimates; or

9 (C) information that otherwise is not rea10 sonably representative of risks to consumers or

11 to major identifiable subgroups of consumers,

12 on a national or regional basis;

13 (3) any assumption about exposure from drink14 ing water or other non-occupational, non-dietary ex15 posure routes, if data that would make use of the

16 assumption unnecessary, and would likely dem17 onstrate a lower level of exposure than that used in

18 the assumption or model—

19 (A) are being developed and will be sub20 mitted within a reasonable period, in accord21 ance with a request by the Administrator under

22 section 408(f) of the Federal Food, Drug, and

23 Cosmetic Act or any of the authorities referred

24 to in such section or at the initiative of an in25 terested person; or
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1 (B) could be obtained by the Administrator

2 by an action taken in accordance with section

3 408(f) of such Act;

4 (4) any assumption regarding the method for

5 determining the aggregate exposure to a pesticide

6 chemical or the cumulative effect of exposure to two

7 or more pesticides having a common mechanism of

8 toxicity, if the use of such assumption is based in

9 whole or in part on the absence of data that could

10 be obtained by the Administrator by an action taken

11 in accordance with section 408(f) of the Federal

12 Food, Drug, and Cosmetic Act, unless the data that

13 would eliminate the need for use of the assumption

14 have been identified and made known by the Admin15 istrator to interested persons and sufficient time has

16 been provided to allow the data to be developed, sub17 mitted, and subsequently evaluated by the Agency;

18 (5) any calculation developed by use of the ad19 ditional safety factor described by section

20 408(b)(2)(C) of the Federal Food, Drug, and Cos21 metic Act, if the use of such additional safety factor

22 is based in whole or in part on the absence of data

23 that could be obtained by the Administrator by an

24 action taken in accordance with section 408(f) of

25 such Act, unless the data that would eliminate the
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1 need for use of the assumption have been identified

2 and made known by the Administrator to interested

3 persons and sufficient time has been provided to

4 allow the data to be developed, submitted, and sub5 sequently evaluated by the Agency; or

6 (6) any information about an alleged adverse

7 effect if the information is anecdotal, unverified, or

8 scientifically implausible, or comes from any study

9 whose design and conduct has not been found by the

10 Administrator to be scientifically sound with regard

11 to design, conduct, reporting, and data availability.

12 (d) ADDITIONAL CONTENTS OF REPORT.—A transi13 tion analysis report under this section shall:

14 (1) Summarize and respond briefly to com15 ments received by the Administrator from any other

16 persons regarding the applicability of any provision

17 of subsection (c) to the document analyzed under

18 this section.

19 (2) Discuss briefly the availability and suit20 ability of pesticidal and nonpesticidal alternatives to

21 the pesticide uses being reviewed or reassessed. At

22 a minimum, the Administrator, in consultation with

23 the Secretary of Agriculture, shall include in the

24 analysis a determination on the extent to which an

25 effective and economical alternative to the pesticidal
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1 tolerance under review has been approved and

2 whether revocation or modification of the tolerance

3 will result in—

4 (A) a significant regional shift of produc5 tion within the United States;

6 (B) an increase in imports of cor7 responding commodities;

8 (C) an increase in pest control costs;

9 (D) pest crop damage and yield loss, in10 cluding quality degradation, due to the lack of

11 an effective alternative; or

12 (E) a disruption of domestic production of

13 an adequate, wholesome and economical food

14 supply.

15 (3) Identify the data that, if available, would

16 make unnecessary any reliance on any information,

17 calculation, or assumption described in paragraph

18 (2), (3), (4), or (5) of subsection (c) that is identi19 fied in the report.

20 (4) Describe the extent to which any finding or

21 regulatory step recommended by or set forth in the

22 analyzed document is based in whole or in part on—

23 (A) any assumption about toxicity, dietary

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

2 unnecessary—

3 (i) are being developed and will be

4 submitted within a reasonable period, in

5 accordance with a request by the Adminis6 trator under section 408(f) of the Federal

7 Food, Drug, and Cosmetic Act or any of

8 the authorities referred to in that section

9 or at the initiative of an interested person;

10 or

11 (ii) could be obtained by the Adminis12 trator by an action taken in accordance

13 with section 408(f) of such Act;

14 (B) any use of data on the presence or ab15 sence of non-adverse effects, rather than data

16 on the presence or absence of adverse effects, as

17 the basis for calculation of allowable exposure

18 levels; or

19 (C) any policy that the Administrator may

20 revise after completion of any reevaluation of

21 such policy that is being conducted or is sched22 uled to be conducted.
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1 SEC. 5. INTERIM PROCEDURES FOR REVIEWS OR REAS2 SESSMENTS.

3 (a) DOCUMENTS AND ACTIONS TO WHICH THIS SEC4 TION APPLIES.—To the extent provided by subsection (b),

5 this section applies to—

6 (1) any review or reassessment by the Adminis7 trator of any existing tolerance for a pesticide chem8 ical, whether initiated by the Administrator or by

9 petition by another person; and

10 (2) any review or reassessment by the Adminis11 trator of any pesticide registration under the Fed12 eral Insecticide, Fungicide, and Rodenticide Act that

13 is associated with or results from such a tolerance

14 review or reassessment.

15 (b) PERIOD OF APPLICABILITY.—This section applies

16 to any review or reassessment described by subsection (a)

17 that the Administrator issues during the period beginning

18 on January 1, 1999, and ending on the date of completion

19 of the process of tolerance review under section 408(q) of

20 the Federal Food, Drug, and Cosmetic Act.

21 (c) LIMITATION.—Notwithstanding any provision of

22 section 408 of the Federal Food, Drug, and Cosmetic Act:

23 (1) In any tolerance review or reassessment to

24 which this section applies, the Administrator may

25 not base the revocation of or other adverse action
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1 against an existing tolerance on any information,

2 calculation, or assumption described in section 4(c).

3 (2) In any review or reassessment of the reg4 istration of a pesticide product to which this section

5 applies, the Administrator may not base any adverse

6 action against the registration under the Federal In7 secticide, Fungicide, and Rodenticide Act on any in8 formation, calculation, or assumption described in

9 section 4(c).

10 SEC. 6. IMPLEMENTATION RULES.

11 (a) IN GENERAL.—The Administrator shall issue

12 rules in accordance with section 408(e) of the Federal

13 Food, Drug, and Cosmetic Act establishing general proce14 dures and requirements to implement section 408 of such

15 Act, including guidance regarding the provisions of such

16 Act regarding aggregate exposure to residues of a single

17 pesticide and cumulative effects of exposure to pesticides

18 having a common mechanism of toxicity. The Adminis19 trator shall include in such rules general procedures and

20 requirements to implement this Act.

21 (b) RULES.—The rules described by subsection (a)

22 shall be issued in proposed form not later than 6 months

23 after the date of enactment of this Act and in final form

24 not later than one year after the date of enactment of this
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1 Act, and shall be revised thereafter as necessary and ap2 propriate.

3 SEC. 7. DATA IN SUPPORT OF TOLERANCES AND REGISTRA4 TIONS.

5 (a) GUIDELINES.—Section 408(f) of the Federal

6 Food, Drug, and Cosmetic Act is amended by adding at

7 the end the following:

8 ‘‘(3) ISSUANCE OF GUIDELINES.—The Adminis9 trator shall issue guidelines specifying the kinds of

10 information that will be required to support the

11 issuance or continuation of a tolerance or exemption

12 from the requirement for a tolerance and shall revise

13 such guidelines from time to time. Such guidelines

14 shall specify the conditions under which data re15 quirements will apply to particular types of pesticide

16 chemicals. Notice and comment procedures shall be

17 used in the issuance of such guidelines, except for

18 those guidelines that already have been issued after

19 notice and comment under section 3(c)(2)(A) of the

20 Federal Insecticide, Fungicide, and Rodenticide

21 Act.’’.

22 (b) FIFRA.—Section 3(c)(2)(A) of the Federal In23 secticide, Fungicide, and Rodenticide Act is amended by

24 striking the period at the end and inserting ‘‘, after first
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1 providing notice and opportunity for comment by inter2 ested parties.’’.

3 SEC. 8. EXPEDITING CERTAIN MATTERS.

4 (a) IN GENERAL.—

5 (1) FIFRA.—Section 3(c)(3) of the Federal In6 secticide, Fungicide, and Rodenticide Act is amend7 ed by adding at the end the following:

8 ‘‘(E) EXPEDITED ACTION TO PROVIDE EF9 FECTIVE, ECONOMIC ALTERNATIVES.—The Ad10 ministrator shall expedite the review of any

11 complete application for registration or amend12 ed registration of a product under section 3, for

13 an experimental use permit under section 5, or

14 for an emergency exemption under section 18,

15 if such application seeks approval for the reg16 istration or use of a product that, in the opin17 ion of the Administrator, is likely to provide an

18 effective, economic alternative to the use of a

19 pesticide that has been or is likely to be re20 moved from the market as a result of a review

21 conducted under section 408 of the Federal

22 Food, Drug, and Cosmetic Act and for which

23 there is no currently registered effective and ec24 onomical alternative or for which the number of
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1 such alternatives is insufficient to avoid prob2 lems such as pest resistance.’’.

3 (2) COORDINATION WITH PRIORITIES UNDER

4 FFDCA.—Section 408(d)(4)(B) of the Federal Food,

5 Drug, and Cosmetic Act is amended—

6 (A) by striking ‘‘for a pesticide chemical

7 residue that appears to pose’’ and inserting the

8 following: ‘‘for a pesticide chemical residue

9 that—

10 ‘‘(i) appears to pose’’;

11 (B) by striking ‘‘same or similar uses.’’

12 and inserting ‘‘same or similar uses; or’’; and

13 (C) by adding at the end the following:

14 ‘‘(ii) is needed in connection with a

15 request under section 3(c)(3)(E) of the

16 Federal Insecticide, Fungicide, and

17 Rodenticide Act for approval of an effec18 tive, economic alternative.’’.

19 (b) AMENDMENT.—Section 408(l)(6) of the Federal

20 Food, Drug, and Cosmetic Act is amended by striking the

21 period at the end and inserting ‘‘, except that the Adminis22 trator may issue a tolerance associated with an emergency

23 exemption without regard to other tolerances for the pes24 ticide and before reassessing those other tolerances, if the

25 Administrator determines that any incremental exposure
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1 that may result from the tolerance associated with the

2 emergency exemption will not pose any significant risk to

3 food consumers.’’.

4 SEC. 9. PRIORITIES AND RESOURCES.

5 The Administrator and the Secretary shall prepare

6 a report that shall be delivered to the Congress not later

7 than 6 months after the date of enactment of this Act.

8 The report shall include a proposal for revising the prior9 ities of and resources available to the Administrator that

10 will allow the Administrator to process promptly all reg11 istration applications and petitions for tolerances or ex12 emptions, requests for experimental use permits, requests

13 for approval of new inert ingredients, and requests for

14 emergency exemptions and for decisions on the merits of

15 such applications, petitions, and requests, in addition to

16 performing tolerance reviews and reassessments and other

17 duties required by the Federal Food, Drug, and Cosmetic

18 Act and the Federal Insecticide, Fungicide, and

19 Rodenticide Act. The report shall also include a proposal

20 for revising the priorities of and resources available to the

21 Secretary that will allow the Secretary to obtain and pro22 vide to the Administrator adequate and timely information

23 on food consumption, pesticide residues in or on food and

24 drinking water, and pesticide use and usage, to review ac25 tions proposed by the Administrator under the Federal
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1 Food, Drug, and Cosmetic Act and the Federal Insecti2 cide, Fungicide, and Rodenticide Act, and to perform

3 other duties related to the regulation of pesticides and pes4 ticide chemical residues.

5 SEC. 10. INTERNATIONAL TRADE EFFECTS.

6 (a) STUDY.—

7 (1) PROGRAM.—The Secretary shall establish

8 and administer a program to continuously monitor

9 the competitive strength of major United States ag10 ricultural commodity sectors in the international

11 marketplace. Such commodity sectors include fruits

12 and vegetables, corn, wheat, cotton, rice, soybeans,

13 and nursery and forest products.

14 (2) EXAMINATION.—In carrying out the re15 quirements of paragraph (1) of this section, the Sec16 retary shall examine factors pertinent to assessing,

17 by sector, the sustainability and competitive strength

18 in the international marketplace and the relationship

19 of such factors to regulatory decisions issued under

20 the Federal Food, Drug, and Cosmetic Act and the

21 Federal Insecticide, Fungicide, and Rodenticide Act.

22 Such factors include sector changes, regional

23 changes, prices, quality, input costs and availability,

24 and ratio of imports to exports.
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1 (b) REPORT.—The Secretary shall prepare periodic

2 reports describing the findings from the program con3 ducted under subsection (a). The first such report shall

4 be submitted to the House Committee on Agriculture and

5 the Senate Committee on Agriculture, Nutrition, and For6 estry not later than October 1, 2000, with subsequent re7 ports submitted by October 1 of every second year there8 after until 2010.

9 SEC. 11. ADVISORY COMMITTEE.

10 (a) ESTABLISHMENT AND PURPOSE.—There is es11 tablished a Federal advisory committee to be known as

12 the Pesticide Advisory Committee (in this section referred

13 to as the ‘‘Advisory Commitee’’). The purpose of the Advi14 sory Committee shall be to provide advice to the Adminis15 trator and the Secretary on matters related to implemen16 tation of section 408 of the Federal Food, Drug, and Cos17 metic Act and this Act, including proposed and final rules,

18 policies, procedures, and testing guidelines used to regu19 late pesticide tolerances and registrations, and to foster

20 communication between the Administrator, the Secretary,

21 and the various stakeholder organizations who represent

22 persons having particular interest in the regulation of pes23 ticides under Federal Food, Drug, and Cosmetic Act. The

24 Advisory Committee shall be permanent, and shall among

25 other things assume the functions formerly performed by
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1 the Tolerance Reassessment Advisory Committee. The

2 Secretary shall provide staff to serve as a secretariat for

3 the Advisory Committee.

4 (b) MEMBERSHIP.—The Advisory Committee shall be

5 composed of representatives of organizations interested in

6 the regulation of pesticides, and shall consist of 20 mem7 bers appointed by the Administrator and Secretary uti8 lizing a system of staggered terms of appointment. The

9 membership of the Advisory Committee shall be chosen to

10 represent a wide variety of interests and viewpoints, and

11 shall include representatives of organizations that rep12 resent the following groups: Food consumers, persons with

13 a special interest in environmental protection, farm work14 ers, agricultural producers (including crop production,

15 livestock and poultry production, and nursery and for16 estry), non-agricultural pesticide users, food manufactur17 ers and processors, food distributors and marketers, man18 ufacturers of agricultural and nonagricultural pesticides,

19 and Federal and State agencies. The Administrator may

20 extend the term of a member of the Advisory Committee

21 until the new member is appointed to fill the vacancy. The

22 Administrator shall publish in the Federal Register the

23 name, address, and professional affiliations of each nomi24 nee. Each member of the Advisory Committee shall be en25 titled to be reimbursed by the Administrator for reason-
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1 able costs of lodging, meals, and travel associated with at2 tendance at meetings of the advisory committee, as deter3 mined by the Administrator.

4 (c) MEETINGS.—The Advisory Committee shall con5 duct its principal business in meetings that are open to

6 the public in facilities that can accommodate the reason7 ably foreseeable number of attendees, or by telecon8 ferences with open access. Written communications be9 tween the Secretary or Administrator and the Committee

10 shall be docketed and available to any person upon re11 quest. The Secretary shall be responsible for providing or

12 making arrangements for the meeting facilities. Meetings

13 of the full committee shall be held at least two times per

14 year at times determined jointly by the Administrator and

15 the Secretary. All meetings of the Advisory Committee

16 shall be the subject of notices published in the Federal

17 Register by the Administrator not less than two weeks be18 fore the date of the meeting.

Æ