I

106TH CONGRESS

1ST SESSION H. R. 1334

To provide for the enhanced implementation of the amendments made to

the Federal Food, Drug, and Cosmetic Act by the Food Quality Protection Act of 1996, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

MARCH 25, 1999

Mr. LAHOOD (for himself, Mr. BLUNT, and Mr. HASTINGS of Washington)

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 provide for the enhanced implementation of the amendments made to the Federal Food, Drug, and Cosmetic

Act by 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 ‘‘FQPA Implementation

5 Act of 1999’’.
2

•HR 1334 IH

1 SEC. 2. FINDINGS.

2 The Congress finds as follows:

3 (1) The Food Quality Protection Act of 1996,

4 enacted on August 3, 1996, made a number of sig5 nificant modifications to section 408 of the Federal

6 Food, Drug, and Cosmetic Act (‘‘the Act’’). Section

7 408 as amended sets forth new criteria and proce8 dures for use by the Administrator of the Environ9 mental Protection Agency in assessing and reas10 sessing the acceptability of tolerances that govern

11 the level of pesticide chemical residues that may be

12 present in or on any food that enters or is present

13 in interstate commerce or is imported into the

14 United States.

15 (2) Under section 408 of the Act as amended,

16 the Administrator must use these new criteria and

17 procedures in deciding whether new tolerances may

18 be issued, and thus whether new pesticides or new

19 pesticide uses may be approved for use under the

20 Federal Insecticide, Fungicide, and Rodenticide Act.

21 Such section also requires that all tolerances in ef22 fect on the date of the enactment of the 1996

23 amendment be reassessed under the new criteria and

24 procedures.

25 (3) The Food Quality Protection Act of 1996

26 requires the use of a number of important new risk
3

•HR 1334 IH

1 assessment criteria and concepts that had never pre2 viously been used by the Administrator and that re3 quire the development of major modifications to ex4 isting Agency practices. New regulatory concepts in5 troduced by such Act include, but are not limited to,

6 those associated with new statutory terms such as

7 ‘‘exposures for which there is reliable information’’,

8 ‘‘aggregate exposure’’, ‘‘reasonable certainty that no

9 harm will result’’, ‘‘common mechanism of toxicity’’,

10 ‘‘cumulative effects’’, ‘‘potential pre- and post-natal

11 toxicity’’, ‘‘completeness of the data with respect to

12 exposure and toxicity’’, ‘‘significant subpopulation

13 group’’, ‘‘additional data or information [that] are

14 reasonably required to support the continuation of a

15 tolerance’’, and ‘‘pose the greatest risk to human

16 health’’. How these terms are defined and used by

17 the Administrator, singly and in combination, will

18 greatly affect the outcome of the assessments and

19 reassessments required to be conducted under the

20 Act as amended.

21 (4) The Act as amended requires the Environ22 mental Protection Agency to revoke tolerances now

23 in effect if the Administrator finds that the sum of

24 the exposure from all the tolerances exceeds safe lev25 els. However, the Act as amended does not provide
4

•HR 1334 IH

1 any criteria for determining which of the tolerances

2 should be revoked in such situations in order to re3 duce the exposure sufficiently. Nor does the Act as

4 amended establish procedures for providing pesticide

5 producers, agricultural producers, food processors

6 and distributors, and non-food pesticide users the

7 opportunity to participate in such decision making

8 before proposed rules are issued by the Adminis9 trator.

10 (5) Under the revised criteria of the Act as

11 amended, entirely new categories of data regarding

12 toxicity, metabolism, cumulative effects, and dietary,

13 drinking water, and other nonoccupational exposure

14 levels are required to allow the Administrator to

15 reach sound, accurate, valid, and understandable de16 cisions on tolerance assessments and reassessments.

17 In some areas, massive data collection efforts are

18 underway but will not yield results for another year

19 or more. In other areas, the need for new data de20 pends on decisions not yet made by the Adminis21 trator about what kinds of tests should be conducted

22 and which compounds should be the subjects of

23 these new test requirements.

24 (6) The Administrator has instituted public

25 proceedings to discuss how the new criteria of the
5

•HR 1334 IH

1 Act as amended should be interpreted and amended,

2 what new kinds of data are needed and how the new

3 data would be used once available, how criteria can

4 be made more transparent, equitable, and under5 standable, how the Administrator should use avail6 able authority to be flexible, how to decide which tol7 erances should be revoked when some action is de8 cided to be necessary, and how to provide needed

9 transition periods in case some existing products or

10 product uses should be removed from the market.

11 These proceedings are not yet finished and in some

12 cases planned public proceedings have been sched13 uled but have not yet begun.

14 (7) Unless the Administrator implements sec15 tion 408 of the Act as amended carefully and wisely,

16 decisions made under it could cause great harm to

17 American agriculture, to food production, food stor18 age and transportation, and related industries, and

19 to other business. Such decisions could reduce avail20 ability of fruits and vegetables, and other foods

21 known to aid human health, and could also have

22 highly disruptive and problematic effects on a vari23 ety of other important public and private areas such

24 as public health protection against insects and other

25 disease vectors and residential and business pest
6

•HR 1334 IH

1 control. A major concern is that some products will

2 be removed from the market that are essential in

3 integrated pest management programs or pesticide

4 resistance management programs, and that pest spe5 cies will more easily develop resistance to the fewer

6 remaining products that remain available.

7 (8) The regulatory requirements under the

8 Food Quality Protection Act of 1996 could have

9 both short and long term deleterious effects on U.S.

10 agricultural products as these producers move to a

11 free market system as envisioned by the Freedom to

12 Farm Act.

13 (9) These disruptive and harmful effects could

14 occur without necessarily bringing about any signifi15 cant health benefits or risk reductions. The Adminis16 trator is now engaged in making decisions on toler17 ance assessments and reassessments at the same

18 time that the Administrator is conducting a massive

19 program of policy development and reevaluation, and

20 while the Administrator is determining what data

21 would be needed under the new criteria and policies

22 to answer some of the new questions. If these deci23 sions on individual pesticides are issued and put into

24 effect before the new policies are in place or before

25 the needed data are available, they may be based on
7

•HR 1334 IH

1 outdated and overly stringent policies, worst-case as2 sumptions, or both. These actions may be accom3 panied by adverse publicity that could lead to un4 warranted concern and could effectively destroy the

5 marketability of products that in fact are safe.

6 (10) The Act as amended has caused a major

7 slowing of the process for approval of new pesticide

8 chemicals, new uses of pesticides already registered

9 for other uses, and applications for emergency ex10 emptions from the need for registration. This is

11 traceable to—

12 (A) the Agency’s need to develop new cri13 teria and procedures;

14 (B) the diversion of resources to developing

15 such criteria and procedures and to the reas16 sessment of existing tolerances and registra17 tions;

18 (C) the requirement that no new tolerance

19 can be issued until the Administrator deter20 mines that all existing tolerances for the pes21 ticide have been reassessed and found safe; and

22 (D) the priority choices and resource allo23 cation decisions that are either dictated by the

24 Act as amended or chosen by the Administrator

25 as a matter of discretion.
8

•HR 1334 IH

1 (11) Congressional guidance for the Adminis2 trator is needed to ensure that decisions are reason3 able, well supported, and balanced; to avoid disrup4 tions in agriculture, other sectors of the economy,

5 and international trade caused by prematurely im6 plemented decisions or by public misunderstanding

7 or unwarranted speculation about tentative deci8 sions. Much of the potential problem can be avoided

9 if the Administrator uses available authority to re10 solve policy issues, announce data needs, avoid

11 unneeded use of assumptions in lieu of data, make

12 clear the tentative and preliminary nature of find13 ings made in the short term, and provide extended

14 implementation periods for adverse decisions when

15 appropriate.

16 SEC. 3. SPECIAL DATA REQUIREMENTS; REQUIREMENT

17 FOR CALLING IN ADDITIONAL DATA.

18 (a) IN GENERAL.—Section 408(f) of the Federal

19 Food, Drug, and Cosmetic Act (21 U.S.C. 346a(f)) is

20 amended—

21 (1) by redesignating paragraph (2) as para22 graph (3); and

23 (2) by striking ‘‘(1) REQUIRING SUBMISSION’’

24 and all that follows through ‘‘(A) issue a notice re25 quiring the person’’ and inserting the following:
9

•HR 1334 IH

1 ‘‘(1) REQUIRING SUBMISSION OF ADDITIONAL

2 DATA.—

3 ‘‘(A) CONTINUATION OF TOLERANCE OR

4 EXEMPTION.—If the Administrator determines

5 that additional data or information are reason6 ably required to support the continuation of a

7 tolerance or exemption that is in effect under

8 this section for a pesticide chemical residue on

9 a food, the Administrator shall obtain addi10 tional data or information through any of the

11 methods described in paragraph (2).

12 ‘‘(B) MODIFYING, SUSPENDING, OR RE13 VOKING TOLERANCE OR EXEMPTION.—If the

14 Administrator makes a determination that there

15 may be grounds for modifying, suspending, or

16 revoking a tolerance or exemption in effect

17 under this section for a pesticide chemical res18 idue in or on food, the Administrator may not

19 modify, suspend, or revoke the tolerance or ex20 emption until the Administrator has considered

21 additional data or information obtained by the

22 Administrator (after making such determina23 tion). The Administrator shall obtain the re24 quired additional data or information through

25 any of the methods described in paragraph (2).
10

•HR 1334 IH

1 ‘‘(2) METHODS OF OBTAINING ADDITIONAL

2 DATA.—For purposes of obtaining additional data or

3 information under subparagraph (A) or (B) of para4 graph (1), the Administrator shall—

5 ‘‘(A) issue a notice requiring the person’’.

6 (b) CONFORMING AMENDMENTS.—Section 408 of the

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a)

8 is amended—

9 (1) in subsection (b)(2)(E)(ii), by striking

10 ‘‘(f)(2)’’ and inserting ‘‘(f)(3)’’; and

11 (2) in subsection (g), in each of paragraphs (1)

12 and (2)(A), by striking ‘‘(f)(2)’’ and inserting

13 ‘‘(f)(3)’’.

14 SEC. 4. REVIEW.

15 (a) AGENCY AUTHORITY FOR CERTAIN PUBLIC-IN16 TEREST DETERMINATIONS.—Section 408 of the Federal

17 Food, Drug, and Cosmetic Act (21 U.S.C. 346a) is

18 amended in subparagraph (C) of subsection (q)(1) by

19 striking the period at the end and inserting a comma, and

20 in the matter immediately after and below such subpara21 graph by inserting before the sentence the following: ‘‘ex22 cept that such requirements relating to periods of time

23 apply only to the extent determined by the Administrator

24 to be in the public interest. Any such determination shall
11

•HR 1334 IH

1 be published in the Federal Register, together with a

2 statement of the reasons underlying the determination.’’.

3 (b) PUBLIC INPUT.—Section 408(q)(1) of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C.

5 346a(q)(1)) is amended in the matter after and below sub6 paragraph (C) by inserting before the period at the end

7 the following: ‘‘, except that before issuing a final rule

8 under subsection (d)(4) the Administrator shall issue a

9 proposed rule with a period of 60 days for public comment,

10 and before issuing a proposed rule under subsection (e)

11 the Administrator shall issue an advance notice of pro12 posed rulemaking in order to provide for a preliminary ex13 change of information and comments between the Admin14 istrator and the public’’.

15 SEC. 5. TOLERANCES FOR EMERGENCY USES.

16 Section 408(l)(6) of the Federal Food, Drug, and

17 Cosmetic Act is amended in the last sentence by inserting

18 before the period the following: ‘‘, except that the Adminis19 trator may issue such a tolerance or exemption associated

20 with an emergency exemption without regard to other tol21 erances or exemptions for the pesticide chemical residue

22 and before reassessing such tolerances or exemptions, if

23 the Administrator determines that any incremental expo24 sure that may result from the tolerance or exemption asso-
12

•HR 1334 IH

1 ciated with the emergency exemption alone will not pose

2 any significant dietary risk’’.

3 SEC. 6. REPORTS ON RESOURCES AND PRIORITIES.

4 (a) ENVIRONMENTAL PROTECTION AGENCY.—

5 (1) IN GENERAL.—Not later than January 15,

6 2000, the Administrator of the Environmental Pro7 tection Agency (in this subsection referred to as the

8 ‘‘Administrator’’) shall submit to the Congress a re9 port specifying the financial resources needed by the

10 Administrator for the fiscal years 2001 through

11 2005 in order to carry out the amendments made by

12 the Food Quality Protection Act of 1996 to the Fed13 eral Food, Drug, and Cosmetic Act and the Federal

14 Insecticide, Fungicide, and Rodenticide Act, includ15 ing providing for the prompt processing of all reg16 istration applications and petitions for tolerances,

17 requests for experimental use permits, and requests

18 for emergency exemptions and for decisions on the

19 merits of such applications, petitions, and requests,

20 in addition to performing tolerance reassessments

21 and other duties required by such amendments.

22 (2) DETERMINATION OF EFFECTS OF NOT RE23 CEIVING INCREASED AMOUNT OF APPROPRIATIONS;

24 REALLOCATION OF RESOURCES.—The report under

25 paragraph (1) shall, in addition to provisions re-
13

•HR 1334 IH

1 quired in such paragraph, contain a determination of

2 the effects with respect to carrying out the amend3 ments referred to in such paragraph that would

4 occur if relative to fiscal year 2000 an increased

5 amount of appropriations is not made available to

6 the Administrator for carrying out the amendments,

7 including a description of the reallocations of exist8 ing resources of the Environmental Protection Agen9 cy that would be required in order to carry out the

10 amendments.

11 (b) DEPARTMENT OF AGRICULTURE.—

12 (1) IN GENERAL.—Not later than January 15,

13 2000, the Secretary of Agriculture (in this section

14 referred to as the ‘‘Secretary’’) shall submit to the

15 Congress a report specifying the financial resources

16 needed by the Secretary for the fiscal years 2001

17 through 2005 in order to carry out the responsibil18 ities of the Secretary under the Food Quality Pro19 tection Act of 1996.

20 (2) DETERMINATION OF EFFECTS OF NOT RE21 CEIVING INCREASED AMOUNT OF APPROPRIATIONS;

22 REALLOCATION OF RESOURCES.—The report under

23 paragraph (1) shall, in addition to provisions re24 quired in such paragraph, contain a determination of

25 the effects with respect to carrying out the respon-
14

•HR 1334 IH

1 sibilities referred to in such paragraph that would

2 occur if relative to fiscal year 2000 an increased

3 amount of appropriations is not made available to

4 the Secretary for carrying out the responsibilities,

5 including a description of the reallocations of exist6 ing resources of the Department of Agriculture that

7 would be required in order to carry out the respon8 sibilities.

9 SEC. 7. INTERNATIONAL TRADE EFFECTS.

10 (a) STUDY.—

11 (1) IN GENERAL.—The Secretary of Agriculture

12 (in this section referred to as the ‘‘Secretary’’), after

13 consultation with the Administrator of the Environ14 mental Protection Agency and the United States

15 Trade Representative, shall establish and administer

16 a program to continuously monitor the competitive

17 strength of major United States agricultural com18 modity sectors in the international marketplace.

19 Such commodity sectors include but are not limited

20 to fruits and vegetables, corn, wheat, cotton, rice,

21 soybeans, and nursery crops.

22 (2) CERTAIN FACTORS.—In carrying out the re23 quirements of paragraph (1), the Secretary shall ex24 amine factors pertinent to assessing, by sector, the

25 sustainability and competitive strength in the inter-
15

•HR 1334 IH

1 national marketplace and the relationship of such

2 factors to regulatory decisions issued under the

3 amendments made by the Food Quality Protection

4 Act of 1996. Such factors include but are not lim5 ited to sector changes, regional changes, price, qual6 ity, and ratio of imports to exports.

7 (b) REPORTS.—The Secretary shall prepare periodic

8 reports addressing the requirements and factors of para9 graphs (1) and (2) of subsection (a). Each such report

10 shall be submitted to the Congress, with referrals to the

11 committees of jurisdiction in the House of Representatives

12 and the Senate. The first report shall be submitted not

13 later than October 1, 2000, and subsequent reports shall

14 be submitted biennially thereafter.

Æ