I

103D CONGRESS

2D SESSION H. R. 4091

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

under that Act to regulate pesticide chemical residues in food.

IN THE HOUSE OF REPRESENTATIVES

MARCH 18, 1994

Mr. WAXMAN (for himself, Mr. SYNAR, and Mr. TORRES) introduced the

following bill; which was referred to the Committee on Energy and Commerce

MAY 23, 1994

Additional sponsors: Mr. MILLER of California, Mr. YATES, Mrs. SCHROEDER,

Mr. FILNER, Mr. FORD of Tennessee, Mr. SABO, Mr. STARK, and Mr.

DELLUMS

A BILL

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

revise the authority under that Act to regulate pesticide

chemical residues in food.

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; REFERENCE; TABLE OF CON4 TENTS.

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

6 ‘‘Pesticide Food Safety Act of 1994’’.
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1 (b) REFERENCE.—Whenever in this Act an amend2 ment or repeal is expressed in terms of an amendment

3 to, or repeal of, a section or other provision, the reference

4 shall be considered to be made to a section or other provi5 sion of the Federal Food, Drug, and Cosmetic Act (21

6 U.S.C. 301 et seq.).

7 (c) TABLE OF CONTENTS.—The table of contents of

8 this Act is as follows:

Sec. 1. Short title; reference; table of contents.

Sec. 2. Definitions.

Sec. 3. Tolerances and exemptions for pesticide chemical residues.

Sec. 4. Evaluation of existing pesticide chemical residue tolerances and exemptions.

Sec. 5. Review of existing methods of analysis.

Sec. 6. Fees.

Sec. 7. General definitions.

9 SEC. 2. DEFINITIONS.

10 (a) PESTICIDE.—

11 (1) PESTICIDE CHEMICAL.—Section 201(q) (21

12 U.S.C. 321(q)) is amended to read as follows:

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

14 ‘‘(A) any substance that is a pesticide, as de15 fined in section 2(u) of the Federal Insecticide, Fun16 gicide, and Rodenticide Act (7 U.S.C. 136(u)); and

17 ‘‘(B) each active ingredient and inert ingredi18 ent, as defined in subsections (a) and (m), respec19 tively, of section 2 of the Federal Insecticide, Fun20 gicide, and Rodenticide Act, of the pesticide.
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1 ‘‘(2) The term ‘pesticide chemical residue’ means a

2 residue in or on food of—

3 ‘‘(A) any pesticide chemical; or

4 ‘‘(B) any other substance that is present in the

5 commodity or food as a result of the metabolism or

6 other degradation of a pesticide chemical,

7 regardless of whether the residue may be detected.’’.

8 (2) PERSON.—Section 201(s) (21 U.S.C.

9 321(s)) is amended—

10 (A) by striking paragraphs (1) and (2) and

11 inserting the following:

12 ‘‘(1) pesticide chemical residue; or’’; and

13 (B) by redesignating paragraphs (3), (4),

14 and (5) as paragraphs (2), (3), and (4), respec15 tively.

16 (b) CONFORMING AMENDMENTS.—

17 (1) Section 201 (21 U.S.C. 321) is amended by

18 adding at the end the following:

19 ‘‘(gg) The term ‘processed food’ means any food that

20 has been subject to processing from a raw agricultural

21 commodity.

22 ‘‘(hh) The term ‘Administrator’ means the Adminis23 trator of the Environmental Protection Agency.’’.

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

25 amended—
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1 (A) in clause (A)(i), to read as follows: ‘‘(i)

2 a pesticide chemical residue’’;

3 (B) in clause (B), to read as follows: ‘‘(B)

4 if it is, or it bears or contains, a pesticide chem5 ical residue unsafe within the meaning of sec6 tion 408(a);’’; and

7 (C) in clause (C)—

8 (i) by striking ‘‘: Provided, That

9 where a pesticide chemical’’ and inserting

10 ‘‘, except that if a pesticide chemical’’; and

11 (ii) by striking ‘‘sections 406 and

12 409’’ and inserting ‘‘section 406’’.

13 SEC. 3. TOLERANCES AND EXEMPTIONS FOR PESTICIDE

14 CHEMICAL RESIDUES.

15 (a) TOLERANCES AND EXEMPTIONS.—Section 408

16 (21 U.S.C. 346a) is amended to read as follows:

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

18 CHEMICAL RESIDUES.

19 ‘‘(a) REQUIREMENT FOR TOLERANCE OR EXEMP20 TION.—

21 ‘‘(1) GENERAL RULE.—Any pesticide chemical

22 residue shall be deemed unsafe for the purpose of

23 section 402(a)(2)(B) unless—
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1 ‘‘(A) a tolerance for such residue is in ef2 fect under this section and the quantity of such

3 residue is within the limits of such tolerance; or

4 ‘‘(B) an exemption for such residue is in

5 effect under this section and such residue com6 plies with such exemption.

7 ‘‘(2) EFFECT OF A TOLERANCE OR EXEMP8 TION.—While a tolerance or exemption from the re9 quirement for a tolerance is in effect under this sec10 tion for a pesticide chemical residue with respect to

11 any food, such food shall not by reason of bearing

12 or containing any amount of such residue be consid13 ered to be adulterated within the meaning of section

14 402(a)(1) if such residue on such food complies with

15 such tolerance or exemption.

16 ‘‘(b) TOLERANCES.—

17 ‘‘(1) AUTHORITY.—

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

19 may promulgate regulations establishing, modi20 fying, or revoking a tolerance for a pesticide

21 chemical residue—

22 ‘‘(i) in response to a petition filed

23 under subsection (k)(1); or

24 ‘‘(ii) on the initiative of the Adminis25 trator under subsection (k)(4).
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1 ‘‘(B) EXPIRATION DATE.—A regulation

2 under this paragraph may provide for an expi3 ration date for the tolerance.

4 ‘‘(C) SEPARATE TOLERANCES.—The Ad5 ministrator may establish a separate tolerance

6 under subparagraph (A) for a pesticide chemi7 cal residue with respect to food at each of the

8 following times:

9 ‘‘(i) At the time the food is harvested.

10 ‘‘(ii) At the time the food is purchased

11 at retail.

12 ‘‘(iii) After the food is processed.

13 ‘‘(2) STANDARD.—

14 ‘‘(A) GENERAL RULE.—Except as provided

15 in subparagraph (F)—

16 ‘‘(i) a tolerance may be established for

17 a pesticide chemical residue only if the risk

18 to human health from dietary exposure to

19 the pesticide chemical residue is negligible;

20 and

21 ‘‘(ii) the tolerance for a pesticide

22 chemical residue shall be revoked or modi23 fied unless the risk to human health from

24 dietary exposure to the pesticide chemical

25 residue is negligible.
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1 ‘‘(B) NEGLIGIBLE RISK.—

2 ‘‘(i) GENERAL RULE.—For purposes

3 of this paragraph, a risk to human health

4 from dietary exposure to a pesticide chemi5 cal residue is negligible only if dietary ex6 posure to the residue is reasonably certain

7 to cause no harm to human health and the

8 tolerance for such residue meets the re9 quirements of clause (ii) or (iii).

10 ‘‘(ii) THRESHOLD PESTICIDES.—

11 ‘‘(I) IN GENERAL.—If the Ad12 ministrator is able to identify a level

13 at which a pesticide chemical residue

14 will not cause or contribute to any

15 known or anticipated harm to human

16 health, the Administrator may estab17 lish or leave in effect a level for a tol18 erance for such residue only if the Ad19 ministrator finds that such tolerance

20 will provide an ample margin of safe21 ty, for each population group set out

22 in subparagraph (E).

23 ‘‘(II) CONSIDERATIONS.—The

24 level described in subclause (I) shall

25 be based on consideration of—
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1 ‘‘(aa) the nature of the toxic

2 effects caused by such residue

3 and data regarding the preva4 lence of the same effects caused

5 by other chemicals;

6 ‘‘(bb) the validity, complete7 ness, and the reliability of the

8 data about the pesticide chemical

9 residue;

10 ‘‘(cc) the variability of indi11 vidual sensitivities and the sen12 sitivities of population subgroups

13 to the adverse effects from such

14 residue; and

15 ‘‘(dd) the possibility that

16 human susceptibility to such ad17 verse effects is significantly

18 greater than that of test animals.

19 ‘‘(III) MARGIN OF SAFETY.—For

20 purposes of this clause, a margin of

21 safety for a level of a pesticide chemi22 cal residue is not ample unless human

23 exposure per unit of body measure24 ment, to the pesticide chemical resi25 due and other chemicals that cause
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1 the same effect, is at least 100 times

2 less than the no observable effect level

3 in animals on which the pesticide

4 chemical residue was tested, and, if

5 human data are available, at least 10

6 times less than the no observable ef7 fect level in humans exposed to such

8 residue. The no observable effect level

9 is the level of exposure to a pesticide

10 chemical that reliable data, derived

11 from exposure of humans or animals

12 to the pesticide chemical, demonstrate

13 will cause no adverse effect. An addi14 tional 10-fold margin of safety shall

15 be added unless the Administrator de16 termines, on the basis of complete and

17 reliable exposure and toxicity data

18 with respect to infants and children,

19 that a different margin will fully pro20 tect the public health.

21 ‘‘(iii) NONTHRESHOLD PESTICIDES.—

22 If the Administrator is not able to identify

23 a level at which a pesticide chemical resi24 due will not cause or contribute to any

25 known or anticipated harm to human
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1 health or if the Administrator finds that a

2 pesticide chemical residue causes cancer in

3 animals or humans, the Administrator may

4 establish a level for a tolerance for such

5 residue or leave a level in effect for such

6 residue only if the Administrator finds that

7 such level—

8 ‘‘(I) will not cause or contribute

9 to, in individuals exposed to such pes10 ticide chemical residue, a lifetime risk

11 of an adverse human health effect

12 that occurs at a rate of one in a mil13 lion and will not cover a dispropor14 tionate accumulation of such risk dur15 ing the first 5 years of the life of an

16 exposed person, using conservative

17 risk assessment models;

18 ‘‘(II) is the lowest level reason19 ably required to allow the accomplish20 ment of the physical or other technical

21 effect for which the use of the pes22 ticide chemical involved is intended;

23 and

24 ‘‘(III) in the case of processed

25 food, is the lowest level that occurs if
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1 such pesticide chemical residue is re2 moved to the extent possible in ac3 cordance with good manufacturing

4 practice.

5 ‘‘(iv) INFANTS AND CHILDREN.—In

6 issuing or denying any tolerance or exemp7 tion from a tolerance, the Administrator

8 shall fully account for the susceptibility of

9 infants and children to harm from pes10 ticide chemicals, including physiological

11 and behavioral differences between infants

12 and the effect of in utero exposure to pes13 ticide chemicals.

14 ‘‘(C) EXPOSURE.—Except as provided in

15 subparagraph (D), in determining dietary expo16 sure to a pesticide chemical residue for pur17 poses of this paragraph, the Administrator

18 shall—

19 ‘‘(i)(I) use only reliable, statistically

20 significant data regarding the dietary expo21 sure to persons who have consumed the

22 food for which the tolerance for the residue

23 is proposed or is in effect;
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1 ‘‘(II) fully account for all other toler2 ances in effect for the same pesticide

3 chemical residue; and

4 ‘‘(III) fully account for the cumulative

5 exposure from all other sources including,

6 to the extent existing data permit, dietary,

7 drinking water, residential usage, and

8 other nondietary exposures; and

9 ‘‘(IV) fully account for the cumulative

10 effect of such residue and any other sub11 stances that are pharmacologically related,

12 have a common toxic mechanism, or have

13 a common toxic effect and that constitute

14 a part of the human diet or enter the

15 human body through other, nondietary

16 routes of exposure;

17 ‘‘(ii) consider the exposure to be the

18 level of exposure that would occur if—

19 ‘‘(I) all the food, for which the

20 tolerance for the pesticide chemical

21 residue is proposed or in effect, has

22 amounts of the pesticide chemical res23 idue equal to the tolerance proposed

24 or in effect;
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1 ‘‘(II) all other sources of dietary

2 exposure to such residue described in

3 clause (i)(III) occur; and

4 ‘‘(III) human exposure to the

5 pesticide chemical residue at the toler6 ance level occurs for a period equal to

7 a lifetime; and

8 ‘‘(iii) consider food consumption pat9 terns of significant subpopulations, includ10 ing categories of infants and children as

11 described in subparagraph (E), that are

12 likely to result in disproportionately high

13 consumption of foods containing or bearing

14 residues in comparison to the general pop15 ulation.

16 For purposes of clause (i)(IV), if the Adminis17 trator identifies pesticides that are pharma18 cologically related or have a common toxic

19 mechanism or effect, the Administrator shall

20 treat such pesticides as having an additive dele21 terious action in the absence of evidence to the

22 contrary.

23 ‘‘(D) SPECIAL EXPOSURE RULE.—

24 ‘‘(i) DATE.—The Administrator may

25 calculate dietary exposure to a food based
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1 on reliable data that provide the Adminis2 trator with a valid statistical basis to iden3 tify the percentage of the food in which the

4 pesticide chemical residue actually occurs.

5 ‘‘(ii) PERCENTAGE.—Such percentage

6 shall be not less than the percentage of the

7 food consumed in an appropriate locality,

8 identified by the Administrator, which per9 centage represents the highest level of ex10 posure to such residue in the United

11 States.

12 ‘‘(iii) REEVALUATION.—The Adminis13 trator shall reevaluate the determination

14 under this subparagraph every 2 years

15 after the date of the determination. If,

16 under such a reevaluation, the Adminis17 trator finds that the determination is not

18 justified, the Administrator shall promptly

19 issue a regulation requiring that the toler20 ance involved be set on the basis of the

21 new determination.

22 ‘‘(E) POPULATION COVERED.—In deter23 mining if the dietary exposure to a pesticide

24 chemical residue is negligible, the Administrator

25 shall evaluate the risk to—
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1 ‘‘(i) infants of the age 0 to 1;

2 ‘‘(ii) children of the age 1 to 2;

3 ‘‘(iii) children of the age 2 to 3;

4 ‘‘(iv) children of the age 3 to 4;

5 ‘‘(v) children of the age 4 to 5;

6 ‘‘(vi) children of the age 6 to 10;

7 ‘‘(vii) adolescents of the age 11 to 18;

8 ‘‘(viii) other population groups that

9 have been identified by the Administrator

10 to have special food consumption patterns

11 or for which data are sufficient to dem12 onstrate special food consumption patterns;

13 and

14 ‘‘(ix) the entire population,

15 who consume food with such pesticide chemical

16 residue.

17 ‘‘(F) UNAVOIDABLE PERSISTENCE.—If a

18 tolerance or an exemption from the requirement

19 for a tolerance for a pesticide chemical residue

20 is revoked and the Administrator finds the pes21 ticide chemical residue will unavoidably persist

22 in the environment and contaminate food, the

23 Administrator shall establish a new tolerance

24 under subsection (k)(4) for the pesticide chemi25 cal residue. The level permitted by the tolerance
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1 shall not be greater than the lowest level that

2 permits only such unavoidable levels to remain

3 in food. The Administrator shall evaluate any

4 such tolerance at least once a year to determine

5 whether modification of such tolerance is nec6 essary so that the tolerance provides only for

7 the level of the pesticide chemical residue that

8 is unavoidable.

9 ‘‘(G) PRACTICAL METHODS OF ANALY10 SIS.—

11 ‘‘(i) GENERAL RULE.—A tolerance for

12 a pesticide chemical residue shall not be

13 established or allowed to remain in effect

14 unless the Administrator determines, after

15 consultation with the Secretary, that—

16 ‘‘(I) there is a method for detect17 ing and measuring the levels of such

18 pesticide chemical residue in or on a

19 food that will detect the residue at the

20 level established by the tolerance; and

21 ‘‘(II) except as provided in clause

22 (ii), such method is the best available,

23 practical method.

24 ‘‘(ii) SPECIAL RULE.—If the Adminis25 trator determines that a practical method
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1 of analysis for a pesticide chemical residue

2 is not available, the Administrator shall

3 identify the best available method that is

4 designed to identify the lowest detectable

5 amount of the pesticide chemical residue.

6 The Administrator shall, every 2 years

7 after the date of the determination under

8 this clause, reevaluate the determination.

9 ‘‘(iii) PRACTICAL METHOD.—A meth10 od shall be considered practical for pur11 poses of this subparagraph only if it is a

12 multiresidue method that can be performed

13 by the Secretary on a routine basis as part

14 of surveillance and compliance sampling of

15 foods for pesticide chemical residues with

16 the personnel, equipment, and other re17 sources available to the Secretary, or, if no

18 multiresidue method is available, only if it

19 can be so performed by the Secretary.

20 ‘‘(3) CONSISTENT APPLICATION.—The Adminis21 trator shall issue guidelines providing for the con22 sistent application of the requirements of paragraphs

23 (1) and (2).

24 ‘‘(c) PHASEOUT OF PESTICIDES THAT ARE KNOWN

25 OR PROBABLE HUMAN CARCINOGENS OR HAZARDOUS TO
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1 HUMAN HEALTH.—The Administrator may not issue a

2 tolerance for any pesticide that contains an active or inert

3 ingredient that is a known or probable human carcinogen

4 or highly hazardous to human health. Subject to the ex5 ceptions in subsection (k), each tolerance for any pesticide

6 containing an active or inert ingredient that is classified

7 by the Administrator as—

8 ‘‘(1) a known or probable human carcinogen

9 pursuant to the guidelines for carcinogen risk as10 sessment published at 51 Fed. Reg. 33992, 34000

11 (1986) or a comparable classification based on

12 equivalent criteria, or

13 ‘‘(2) highly hazardous to human health,

14 is terminated 5 years after the date the Administrator so

15 classifies such ingredient or the date of the enactment of

16 the Pesticide Food Safety Act of 1994, whichever is later.

17 ‘‘(d) EXTENSION OF PHASEOUT TIME.—In response

18 to a petition by any person, the Administrator may, by

19 regulation, extend the tolerance of a pesticide to allow the

20 identification and implementation of alternatives to such

21 pesticide for a period not to exceed 3 years after the date

22 specified in subsection (c). Such an extension may be

23 granted only if the petitioner demonstrates, in a petition

24 filed no later than 3 years after the date of enactment

25 of the Pesticide Food Safety Act of 1994, or 3 years after
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1 a pesticide is determined to meet the standard in sub2 section (c), whichever occurs later, by clear and convincing

3 evidence, for each use of the pesticide for which an exten4 sion is sought, that revocation of the tolerance will cause

5 a severe disruption of the availability of foods on the na6 tional market, and that—

7 ‘‘(1) there is no alternative effective pest man8 agement practice for the pesticide for which the tol9 erance is scheduled to be revoked;

10 ‘‘(2) the tolerance otherwise meets the require11 ments of this section; and

12 ‘‘(3) the proponent of the extension submits a

13 plan to assure that the quantity of the pesticide used

14 will be reduced by at least an average of 20 percent

15 per year over the 3-year period following the grant16 ing of the extension.

17 ‘‘(e) LISTS.—

18 ‘‘(1) KNOWN OR PROBABLE HUMAN CARCINO19 GENS.—No later than 60 days from the date of en20 actment of the Pesticide Food Safety Act of 1994,

21 the Administrator shall publish a list of active and

22 inert ingredients of pesticide chemicals that were

23 classified as known or probable human carcinogens

24 on the date of enactment of the Pesticide Food Safe25 ty Act of 1994. Such list shall be revised every 2
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1 years to reflect new information, including data gen2 erated under subsection (m).

3 ‘‘(2) OTHER HUMAN HEALTH EFFECTS.—No

4 later than 6 months after the date of enactment of

5 the Pesticide Food Safety Act of 1994, the Adminis6 trator shall publish lists of active and inert ingredi7 ents—

8 ‘‘(A) of pesticide chemicals for which there

9 is limited evidence of carcinogenicity in animals,

10 and

11 ‘‘(B) of pesticide chemicals which are high12 ly hazardous to human health as determined by

13 the Administrator on the basis of the classifica14 tion that the pesticide chemicals are persistent,

15 (as defined in the Sixth Biennial Report on

16 Great Lakes Water Quality of the International

17 Joint Commission (1992)), bioaccumulative (as

18 defined by the Administrator in 58 Fed. Reg.

19 20858–63 (1993)), an endocrine disruptor, a

20 potent reproductive or developmental toxin (as

21 defined by the Administrator in 53 Fed. Reg.

22 24834–69 (1988) and 56 Fed. Reg. 63798–826

23 (1991)), or a potent neurotoxin (including tox24 ins identified in 40 C.F.R. 156.10(i)(A)

25 (1993)).
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1 Within 1 year of the publication of the lists under

2 this subsection, the Administrator shall take appro3 priate measures to inform the public of its exposure

4 to pesticides in such lists.

5 ‘‘(3) ADDITIONAL HEALTH EFFECTS.—No later

6 than 3 years after the date of enactment of the Pes7 ticide Food Safety Act of 1994, the Administrator

8 shall publish a list of active and inert ingredients of

9 pesticide chemicals that are hazardous to human

10 health as determined by the Administrator on the

11 basis of data developed under protocols required

12 under subsections (n) and (o)

13 ‘‘(f) MODERN BEST SCIENCE PERIODIC REVIEW.—

14 The Administrator shall, within 4 years of the date of en15 actment of the Pesticide Food Safety Act of 1994, conduct

16 a review of the best available cancer data with respect to

17 all possible human carcinogens to determine whether they

18 are known or probable human carcinogens. Any person

19 may, prior to 2 years after the date of enactment of the

20 Pesticide Food Safety Act of 1994, petition the Adminis21 trator for a determination that a pesticide which is a po22 tential carcinogen is not a known or probable human car23 cinogen. For a pesticide identified as a potential carcino24 gen subsequent to the date of enactment of the Pesticide

25 Food Safety Act of 1994, any person may petition the Ad-
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1 ministrator for a determination that the pesticide is not

2 a known or probable human carcinogen 1 year after that

3 identification. Upon the filing of any such petition, the Ad4 ministrator shall determine within 2 years, in accordance

5 with the standards of this Act and based upon adequate

6 scientific data, whether the petitioner has demonstrated

7 that the pesticide is not a known or probable human car8 cinogen. If the Administrator does not adopt the regula9 tion granting a petition filed pursuant to this section, or

10 if no petition has been filed regarding a potential carcino11 gen, the pesticide shall be a known or probable human

12 carcinogen within the meaning of this Act and shall be

13 subject to subsection (l)(1).

14 ‘‘(g) PROTOCOLS FOR ENDOCRINE DISRUPTORS,

15 NEUROTOXIC, REPRODUCTIVELY AND DEVELOPMEN16 TALLY TOXIC SUBSTANCES.—The Administrator shall, no

17 later than 1 year of the date of enactment of the Pesticide

18 Food Safety Act of 1994, establish testing protocols ade19 quate to determine whether a pesticide disrupts the endo20 crine systems, is neurotoxic, or reproductively or devel21 opmentally toxic and shall require the submission of data

22 meeting such protocol as necessary to determine whether

23 a pesticide meets the requirements of this section. Prior

24 to promulgation of such protocols, the Administrator shall
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1 make any classifications of pesticide chemicals as meeting

2 such criteria based upon the best available scientific data.

3 ‘‘(h) PROTOCOLS FOR DETERMINING FETAL, IN4 FANT, AND CHILD SENSITIVITY TO PESTICIDE CHEMI5 CALS.—No later than 1 year after the date of enactment

6 of the Pesticide Food Safety Act of 1994, the Adminis7 trator shall establish testing protocols adequate to deter8 mine whether a pesticide chemical has the potential to

9 cause chronic multigenerational, developmental, reproduc10 tive, neurotoxic, endocrine, carcinogenic, or other adverse

11 health effects that may result from exposure to pesticide

12 chemicals during fetal development, infancy, or early

13 childhood. The Administrator shall require the submission

14 of data meeting such protocols as necessary to determine

15 whether a pesticide chemical meets the requirements of

16 this section.

17 ‘‘(i) INERT INGREDIENTS.—No tolerance or exemp18 tion from a tolerance for a pesticide containing an inert

19 ingredient that is a known, probable, or possible human

20 carcinogen, which presents significant hazards to children

21 or which is highly hazardous to human health, may be es22 tablished for a new use on food. Existing tolerances or

23 exemptions from tolerances for a pesticide containing an

24 inert ingredient known to meet such criteria shall be ter25 minated no later than 2 years after the effective date of
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1 the Pesticide Food Safety Act of 1994. Tolerances or ex2 emptions from tolerances for pesticides found to contain

3 an inert ingredient found subsequent to the date of the

4 enactment of the Pesticide Food Safety Act of 1994 to

5 meet such criteria shall terminate 2 years after such sub6 sequent determination unless terminated prior to that date

7 by the Administrator.’’.

8 ‘‘(j) EXEMPTIONS.—

9 ‘‘(1) AUTHORITY.—

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

11 may promulgate regulations establishing or re12 voking an exemption from the requirement for

13 a tolerance for a pesticide chemical residue—

14 ‘‘(i) in response to a petition filed

15 under subsection (k)(1); or

16 ‘‘(ii) on the initiative of the Adminis17 trator under subsection (k)(4).

18 ‘‘(B) EXPIRATION DATE.—Such a regula19 tion may provide for an expiration date for the

20 exemption.

21 ‘‘(2) STANDARD.—

22 ‘‘(A) AUTHORITY AND RISK STANDARD.—

23 ‘‘(i) ESTABLISHMENT.—An exemption

24 may be established for a pesticide chemical

25 residue if such residue is not a human or
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1 animal carcinogen and otherwise presents

2 no risk to human health, including the

3 health of individuals in the population

4 groups set out in subsection (b)(2)(E),

5 from dietary exposure to such residue.

6 ‘‘(ii) REVOCATION.—An exemption

7 shall be revoked unless the residue is not

8 a human or animal carcinogen and the res9 idue does not present any risk to human

10 health, including the health of individuals

11 in the population groups set out in sub12 section (b)(2)(E), from dietary exposure to

13 such residue.

14 ‘‘(iii) TOLERANCE.—No exemption

15 may be established or allowed to remain in

16 effect for a pesticide chemical residue for

17 which there is in effect a tolerance.

18 ‘‘(B) EXPOSURE.—For purposes of sub19 paragraph (A), in determining dietary exposure

20 to a pesticide chemical residue, the Adminis21 trator shall—

22 ‘‘(i) use only reliable, statistically sig23 nificant data regarding the dietary expo24 sure resulting from the consumption of the
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1 food for which the exemption for such resi2 due is proposed or is in effect;

3 ‘‘(ii) take into account all other ex4 emptions in effect for such residue and all

5 other sources (including drinking water if

6 data demonstrating widespread or signifi7 cant regional contamination in drinking

8 water are available) of dietary exposure to

9 such residue; and

10 ‘‘(iii) consider the exposure to be the

11 level of exposure that would occur if—

12 ‘‘(I) all the food, for which the

13 tolerance for such residue is proposed

14 or in effect, has amounts of such resi15 due equal to the tolerance proposed or

16 in effect, respectively;

17 ‘‘(II) all other sources of dietary

18 exposure to such residue described in

19 clause (ii) occur; and

20 ‘‘(III) human exposure to the

21 pesticide chemical residue at the toler22 ance level occurs for a period equal to

23 a lifetime.

24 ‘‘(C) PRACTICAL METHODS OF ANALY25 SIS.—An exemption for a pesticide chemical
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1 residue shall not be established or allowed to re2 main in effect unless the Administrator deter3 mines, after consultation with the Secretary,

4 that there is a method for detecting and meas5 uring the levels of such pesticide chemical resi6 due on a food and that such method is the best

7 available, practical method, as defined in sub8 section (b)(2)(G).

9 ‘‘(3) CONSISTENT APPLICATION.—The Adminis10 trator shall issue guidelines providing for the con11 sistent application of the requirements of paragraphs

12 (1) and (2).

13 ‘‘(k) PETITIONS AND ACTION ON THE INITIATIVE OF

14 THE ADMINISTRATOR.—

15 ‘‘(1) GENERAL RULE FOR PETITIONS.—Any

16 person may file with the Administrator a petition

17 proposing the issuance of a regulation establishing,

18 modifying, or revoking a tolerance or exemption for

19 a pesticide chemical residue.

20 ‘‘(2) REQUIREMENTS FOR PETITIONS TO ES21 TABLISH A TOLERANCE OR EXEMPTION.—

22 ‘‘(A) CONTENTS.—A petition under para23 graph (1) to establish a tolerance or exemption

24 for a pesticide chemical residue shall contain—
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1 ‘‘(i) an informative summary of the

2 petition and of the data, information, and

3 arguments submitted or cited in support of

4 the petition, including—

5 ‘‘(I) a summary of the reports re6 quired under clause (iv) respecting the

7 safety of the pesticide chemical resi8 due; and

9 ‘‘(II) a characterization of—

10 ‘‘(aa) the exposure to the

11 pesticide chemical residue due to

12 any tolerance or exemption al13 ready granted for such residue;

14 and

15 ‘‘(bb) the additional expo16 sure to such residue that would

17 result if the requested tolerance

18 or exemption were granted;

19 ‘‘(ii) a proposed tolerance for such

20 residue, if a tolerance is proposed;

21 ‘‘(iii) the name, chemical identity, and

22 composition of the pesticide chemical that

23 produces such residue;

24 ‘‘(iv) reports of tests and investiga25 tions made with respect to the safety of
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•HR 4091 SC

1 such pesticide chemical, including complete

2 information as to the methods and controls

3 used in conducting such tests and inves4 tigations;

5 ‘‘(v) data showing the amount, fre6 quency, method, and time of application of

7 such pesticide chemical;

8 ‘‘(vi) reports of tests and investiga9 tions made with respect to the nature and

10 amount of the pesticide chemical residue

11 that is likely to remain in or on food when

12 ready for sale to consumers, including a

13 description of the analytical methods used;

14 ‘‘(vii) a description of methods for de15 tecting and measuring the levels of such

16 pesticide chemical residue in or on the

17 food, which methods meet the require18 ments of subsection (b)(2)(G) or (j)(2)(C);

19 ‘‘(viii) reports of investigations con20 ducted on the effects of processing meth21 ods used to produce food on the level and

22 identity of such pesticide chemical residue;

23 ‘‘(ix) if the petition is for a pesticide

24 chemical residue that is described in sub25 section (b)(2)(B)(iii), all relevant data
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1 bearing on the physical or other technical

2 effect the pesticide chemical involved is in3 tended to have and the quantity of the pes4 ticide chemical residue required to accom5 plish such effect; and

6 ‘‘(x) such other data and information

7 (including a sample of the pesticide chemi8 cal from which the pesticide chemical resi9 due is derived) as the Administrator may

10 require to support the petition.

11 ‘‘(B) INFORMATION AVAILABLE TO ADMIN12 ISTRATOR.—If information or data required by

13 this paragraph are available to the Adminis14 trator, the person submitting the petition may,

15 in lieu of submitting the information or data,

16 cite the availability of the information or data.

17 ‘‘(3) ACTIONS ON PETITIONS.—

18 ‘‘(A) NOTICE.—

19 ‘‘(i) IN GENERAL.—Within 45 days of

20 the filing of a petition under paragraph (1)

21 for the establishment of a tolerance or an

22 exemption, the Administrator shall deter23 mine if the petition complies with the re24 quirements of paragraph (2). If the Ad25 ministrator determines that the petition
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•HR 4091 SC

1 complies with such requirements, the Ad2 ministrator shall publish a notice of the fil3 ing of the petition. If the Administrator

4 determines that the petition does not com5 ply with such requirements, the Adminis6 trator shall notify the petitioner of such

7 determination.

8 ‘‘(ii) CONTENTS.—A notice published

9 under this subparagraph shall—

10 ‘‘(I) announce the availability of

11 a complete description of the analyt12 ical methods available to the Adminis13 trator for the detection and measure14 ment of the pesticide chemical residue

15 with respect to which the petition is

16 filed;

17 ‘‘(II) include the summary re18 quired by paragraph (2)(A)(i); and

19 ‘‘(III) provide at least 30 days

20 for comments on the petition.

21 ‘‘(B) ACTION.—The Administrator shall,

22 within 270 days of the publication of a notice

23 under subparagraph (A) with respect to a peti24 tion, and after giving due consideration to the

25 petition, any comments on the petition, and any
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•HR 4091 SC

1 other information available to the Adminis2 trator—

3 ‘‘(i) issue a final regulation in accord4 ance with the petition establishing a toler5 ance or exemption for the pesticide chemi6 cal residue;

7 ‘‘(ii) issue a proposed regulation es8 tablishing a tolerance or exemption for the

9 pesticide chemical residue, which tolerance

10 or exemption is different from the toler11 ance or exemption requested in the peti12 tion; or

13 ‘‘(iii) issue an order denying the peti14 tion.

15 ‘‘(C) MODIFICATION OR REVOCATION.—

16 ‘‘(i) NOTICE.—Within 45 days of the

17 filing of a petition under paragraph (1) for

18 the modification or revocation of a toler19 ance or exemption, the Administrator shall

20 publish a notice of the filing of the peti21 tion. Such notice shall contain the full peti22 tion or a summary of the petition and shall

23 provide at least 30 days for comments on

24 the petition.
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1 ‘‘(ii) ACTION.—The Administrator

2 shall, within 270 days of the publication of

3 the notice under subparagraph (A) and

4 after giving due consideration to the peti5 tion, any comments on the petition, and

6 any other information available to the Ad7 ministrator—

8 ‘‘(I) issue a final regulation in

9 accordance with the petition modify10 ing or revoking a tolerance or exemp11 tion for the pesticide chemical residue;

12 ‘‘(II) issue a proposed regulation

13 modifying or revoking a tolerance or

14 exemption for the pesticide chemical

15 residue, which tolerance or exemption

16 is different from the modification or

17 revocation requested in the petition;

18 or

19 ‘‘(III) issue an order denying the

20 petition.

21 ‘‘(D) COMMENTS AND FINAL REGULA22 TIONS.—If the Administrator issues a proposed

23 regulation under subparagraph (B)(ii) or

24 (C)(ii)(II), the Administrator shall allow at

25 least 30 days for comments on such proposed
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1 regulations. The Administrator shall issue a

2 final decision within 180 days of the date of the

3 publication of the proposed regulations.

4 ‘‘(E) PRIORITIES.—The Administrator

5 shall give priority to petitions for the establish6 ment of a tolerance for a pesticide chemical res7 idue that appears to pose a significantly lower

8 risk to human health from dietary exposure

9 than pesticide chemical residues that have toler10 ances in effect for the same or similar uses.

11 ‘‘(4) ACTION ON THE INITIATIVE BY THE AD12 MINISTRATOR.—

13 ‘‘(A) GENERAL RULE.—The Administrator

14 may, on the initiative of the Administrator,

15 issue a final regulation establishing, modifying,

16 or revoking a tolerance or exemption for a pes17 ticide chemical residue.

18 ‘‘(B) NOTICE.—Before issuing a final reg19 ulation under subparagraph (A), the Adminis20 trator shall issue a notice of proposed rule21 making and provide a period of not less than 30

22 days for public comment on the proposed regu23 lation unless the Administrator finds that it

24 would be contrary to the public interest to issue

25 the notice and provide the period and states the
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1 reasons for the finding in the notice of the final

2 regulation.

3 ‘‘(5) EFFECTIVE DATE.—

4 ‘‘(A) GENERAL RULE.—Except as provided

5 in subparagraph (B), a final regulation issued

6 under paragraph (3) or (4) shall take effect

7 upon publication.

8 ‘‘(B) DELAY.—

9 ‘‘(i) GENERAL RULE.—If a regulation

10 issued under paragraph (3) or (4) revokes

11 or modifies a tolerance for a pesticide

12 chemical residue or revokes an exemption

13 for a pesticide chemical residue, the Ad14 ministrator may, in accordance with clause

15 (ii), delay the effective date of the regula16 tion to permit the tolerance or exemption

17 to remain in effect at the level in effect im18 mediately before such regulation is issued

19 only—

20 ‘‘(I) for foods that, on the date of

21 the publication of the regulation, con22 tain such pesticide chemical residue in

23 an amount that is not more than the

24 amount that could legally be applied
36

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1 on the date the Administrator acted

2 under paragraph (3) or (4); and

3 ‘‘(II) if dietary exposure to the

4 pesticide chemical residue in or on the

5 foods described in subclause (I) meets

6 the negligible risk standard prescribed

7 by subsection (b)(2) during the period

8 of delay of the effective date.

9 ‘‘(ii) PERIOD OF DELAY.—If the Ad10 ministrator finds that delay of the effective

11 date of such a revocation or modification is

12 consistent with the public health, the Ad13 ministrator may delay such date under

14 clause (i), for each type of food that con15 tains such pesticide chemical residue, for

16 the period that is required for such food to

17 be sold to consumers in the course of the

18 usual practice for persons engaged in the

19 production, processing, transportation,

20 storage, and distribution of the type of

21 food.

22 ‘‘(l) SPECIAL DATA REQUIREMENTS.—

23 ‘‘(1) DETERMINATION OF INADEQUATE DATA.—

24 The Administrator shall take the action described in

25 paragraph (2) if a tolerance or exemption is in effect
37

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1 for a pesticide chemical residue and the Adminis2 trator determines that data contained in the peti3 tion, which had been submitted, under subsection

4 (k)(1) for establishment of the tolerance or exemp5 tion, or under this section, before the date of the en6 actment of the Pesticide Food Safety Act of 1994,

7 are not adequate to support the continuation of such

8 tolerance or exemption because—

9 ‘‘(A) based on the data contained in the

10 petition and other data available to the Admin11 istrator, the Administrator determines that die12 tary exposure to such pesticide chemical residue

13 may present a risk to human health that is

14 greater than the standard prescribed by sub15 section (b)(2) or (j)(2); or

16 ‘‘(B) the data contained in the petition are

17 insufficient to determine if the tolerance or ex18 emption meets the requirements of subsection

19 (b)(2) or (j)(2) or the requirements of sub20 section (k)(2).

21 ‘‘(2) ACTION BY ADMINISTRATOR.—When the

22 Administrator makes the determination described in

23 paragraph (1) with respect to a tolerance or exemp24 tion for a pesticide chemical residue, the Adminis25 trator shall—
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1 ‘‘(A) within 30 days of a determination

2 under paragraph (1)(A), initiate an action

3 under subsection (k)(4) to modify or revoke the

4 tolerance or exemption so that the tolerance or

5 exemption meets the standard prescribed by

6 subsection (b)(2) or (j)(2), and within 1 year of

7 such determination issue a final regulation to

8 complete such action; and

9 ‘‘(B) within 30 days of the date of a deter10 mination under paragraph (1)(B), require the

11 submission of data to support—

12 ‘‘(i) the existing tolerance or exemp13 tion; or

14 ‘‘(ii) a new tolerance or exemption for

15 such residue,

16 that meets the standard prescribed by sub17 section (b)(2) or (k)(2).

18 ‘‘(3) SUBMISSION OF REQUIRED DATA.—When

19 the Administrator requires the submission of data

20 under paragraph (2)(B), the Administrator shall

21 publish an order—

22 ‘‘(A) requiring one or more interested per23 sons to notify the Administrator that such per24 son will submit the required data;
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1 ‘‘(B) describing the type of data required

2 to be submitted;

3 ‘‘(C) describing the reports required to be

4 made during and after the collection of the

5 data; and

6 ‘‘(D) establishing deadlines for the actions

7 described in subparagraphs (A) and (C).

8 ‘‘(4) DEADLINES.—

9 ‘‘(A) GENERAL RULE.—Except as provided

10 in subparagraphs (B) and (C), if an order is is11 sued under paragraph (3) with respect to a tol12 erance or exemption and a deadline in the order

13 is not met, the tolerance or exemption is re14 voked, effective 45 days after the date the dead15 line is not met. Immediately after such deadline

16 is not met, the Administrator shall publish a

17 notice of the revocation.

18 ‘‘(B) EXTENSION REQUEST.—

19 ‘‘(i) REQUEST.—Any person may re20 quest the Administrator to issue an order

21 to extend the deadline established under

22 paragraph (3)(D) before expiration of the

23 deadline.
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1 ‘‘(ii) GRANT OF REQUEST.—The Ad2 ministrator may grant such a request only

3 if—

4 ‘‘(I) the person submitting the

5 request notified the Administrator

6 pursuant to paragraph (3)(A) in com7 pliance with the deadline established

8 under paragraph (3)(C); and

9 ‘‘(II) the Administrator finds

10 that extraordinary circumstances be11 yond the control of such person pre12 vented such person from submitting

13 the required data.

14 ‘‘(iii) EXTENSION.—If the Adminis15 trator issues an order extending a dead16 line—

17 ‘‘(I) the Administrator may ex18 tend the deadline for a period no

19 longer than such time as is necessary

20 for such person to submit the data;

21 and

22 ‘‘(II) the Administrator shall es23 tablish a new deadline in accordance

24 with paragraph (3)(D).
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1 ‘‘(C) DELAY.—If a tolerance or exemption

2 is revoked under subparagraph (A), the Admin3 istrator may delay the effective date of the rev4 ocation in accordance with subsection (k)(5)(B).

5 ‘‘(5) EVALUATION OF DATA.—Within 90 days

6 of the date of the receipt of data under paragraph

7 (3), the Administrator shall evaluate such data and

8 determine whether action is required under sub9 section (k)(4) with respect to the tolerance or ex10 emption for the pesticide chemical residue for which

11 the data were submitted so that such tolerance

12 meets the negligible risk standard prescribed under

13 subsection (b)(2) or (j)(2). If the Administrator de14 termines that action under subsection (k)(4) is re15 quired, the Administrator shall complete such action

16 within 1 year of the date of such determination.

17 ‘‘(m) CONFIDENTIALITY OF DATA.—

18 ‘‘(1) GENERAL RULE.—Data submitted to the

19 Administrator in support of a petition under sub20 section (k)(1), which data have not previously been

21 made available to the public without restriction,

22 shall, upon request of the petitioner, be considered

23 as entitled to confidential treatment by the Adminis24 trator until publication of a regulation or order

25 under subsection (k)(3) in response to the petition
42

•HR 4091 SC

1 unless disclosure of such data is required by sub2 section (k)(3)(A)(ii)(II) or (n) or is allowed by para3 graph (2).

4 ‘‘(2) DISCLOSURE.—Data that are entitled to

5 confidential treatment under paragraph (1) until

6 publication of a regulation or order under subsection

7 (k)(3) may be revealed to—

8 ‘‘(A) either House of Congress or any com9 mittee or subcommittee of such House to the

10 extent of matter within the jurisdiction of the

11 committee or subcommittee;

12 ‘‘(B) any officer or employee of the United

13 States in connection with the official duties of

14 such officer or employee under any law for the

15 protection of health or the environment or for

16 specific law enforcement purposes;

17 ‘‘(C) any officer or employee of a State in

18 connection with the official duties of such offi19 cer or employee under any law of the State for

20 the protection of health or the environment or

21 for specific law enforcement purposes; or

22 ‘‘(D) contractors with the United States

23 authorized by the Administrator to examine

24 such data in the carrying out of contracts under
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1 such statutes under such security requirements

2 as the Administrator may provide.

3 ‘‘(n) ACCESS TO DATA IN SUPPORT OF PETITION.—

4 ‘‘(1) GENERAL RULE.—

5 ‘‘(A) PUBLIC ACCESS.—If data in support

6 of a petition are submitted to the Adminis7 trator, the Administrator, before acting on such

8 petition, shall provide, in accordance with this

9 subsection, public access to health and safety

10 data that are submitted or cited in support of

11 such petition.

12 ‘‘(B) REQUEST.—To obtain access to such

13 data, a person shall, not later than 30 days

14 after the publication under subsection (k)(3)(A)

15 of a notice of the filing of a petition, send by

16 certified mail to the Administrator and to the

17 petitioner a request for such access and the af18 firmation required by paragraph (2).

19 ‘‘(C) GRANT OF REQUEST.—The Adminis20 trator shall grant such request unless, within

21 15 days after the receipt by the Administrator

22 of such request and affirmation, the petitioner

23 submits to the Administrator an objection to

24 the request asserting that the affirmation is in25 accurate and other reasons for the objection.
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1 ‘‘(D) OBJECTION.—If an objection to a re2 quest is submitted to the Administrator within

3 such 15-day period, the Administrator shall de4 termine whether to grant the request within 5

5 days after the receipt of the objection. If the

6 Administrator determines to grant the request,

7 access shall not be permitted until 5 days after

8 the petitioner making the objection has been

9 notified that access has been granted.

10 ‘‘(E) DENIAL OF REQUEST.—If access to

11 data is denied, comments on the petition for

12 which such data were submitted or cited shall

13 be filed within 30 days after the decision of the

14 Administrator denying access.

15 ‘‘(2) RESTRICTION.—

16 ‘‘(A) AFFIRMATION.—Data referred to in

17 paragraph (1) may be made available only to a

18 person who provides an affirmation (and such

19 supporting evidence as the Administrator may

20 require) that—

21 ‘‘(i) states that the person is not en22 gaged in, and is neither employed by, nor

23 acting (directly or indirectly) on behalf of,

24 any other person, or affiliate of a person,
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1 engaged in, the production, sale, or dis2 tribution of a pesticide chemical;

3 ‘‘(ii) identifies any business, employer,

4 or other person, if any, on whose behalf

5 the person is requesting access to the data;

6 and

7 ‘‘(iii) states that the person will not

8 intentionally or recklessly violate this sub9 section.

10 ‘‘(B) AFFILIATE.—For purposes of this

11 paragraph, an affiliate of a person is a person

12 who directly or indirectly, through one or more

13 intermediates, controls or is controlled by or is

14 under common control with the other person.

15 ‘‘(C) FRAUD.—Section 1001 of title 18,

16 United States Code, shall apply to an affirma17 tion made under this paragraph.

18 ‘‘(3) COMMENTS.—

19 ‘‘(A) GENERAL RULE.—Data supporting a

20 petition may be made available under para21 graph (1) to a person only for the purpose of

22 permitting the person to comment to the Ad23 ministrator on such petition. Such comments

24 may reasonably quote data submitted to the

25 Administrator. No person, including the Admin-
46

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1 istrator, may make such comments public be2 fore the decision of the Administrator on the

3 petition for which such data were submitted or

4 after such decision if the petition is denied.

5 ‘‘(B) RESTRICTIONS.—A person who ob6 tains data (directly or indirectly) under para7 graph (1) may not publish, copy, or transfer the

8 data to any other person to obtain approval to

9 sell, manufacture, or distribute a pesticide

10 chemical anywhere in the world.

11 ‘‘(4) PROCEDURE.—

12 ‘‘(A) IN GENERAL.—Data made available

13 under paragraph (1) may be examined at an of14 fice of the Environmental Protection Agency or

15 an appropriate State agency under the condi16 tions prescribed by this subsection and may not

17 be removed from such office.

18 ‘‘(B) RECORD.—The Administrator shall

19 maintain a record of the persons who inspect

20 data. A copy of such record shall be sent on re21 quest to the person who submitted the data.

22 ‘‘(C) BASIS FOR COMMENTS.—Once access

23 to data supporting a petition is granted, the

24 data may be examined and notes may be taken

25 for use in developing comments on the petition.
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1 Such comments on the petition shall be filed

2 within 60 days after the decision of the Admin3 istrator granting access, unless the comment

4 period is extended by the Administrator for an

5 additional 30 days for good cause.

6 ‘‘(o) ACCESS TO DATA AFTER DECISION.—When the

7 Administrator takes final action on a petition submitted

8 under subsection (k)(1) or on the initiative of the Adminis9 trator under subsection (k)(4), the Administrator shall

10 make available to the public the administrative record of

11 the decision, including the data relied upon for the deci12 sion.

13 ‘‘(p) EXISTING PESTICIDE CHEMICAL RESIDUES.—

14 ‘‘(1) PESTICIDE CHEMICAL RESIDUES UNDER

15 REGULATIONS UNDER SECTION 406.—Regulations af16 fecting pesticide chemical residues promulgated, in

17 accordance with sections 701(e) and 406, upon the

18 basis of public hearings instituted before January 1,

19 1953, shall be deemed to be tolerances issued under

20 this section and shall be subject to modification or

21 revocation under subsection (k) or (l).

22 ‘‘(2) PESTICIDE CHEMICAL RESIDUES UNDER

23 REGULATIONS.—Regulations establishing tolerances

24 for pesticide chemical residues under this section

25 and section 409 or exemptions for pesticide chemical
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1 residues under this section on or before the date of

2 the enactment of this section shall be deemed to be

3 tolerances or exemptions issued under this section

4 and shall be subject to modification or revocation

5 under subsection (k) or (l).

6 ‘‘(3) GENERALLY RECOGNIZED AS SAFE PES7 TICIDE CHEMICAL RESIDUES.—

8 ‘‘(A) GENERAL RULE.—Pesticide chemical

9 residues that, on the day before the date of the

10 enactment of the Pesticide Food Safety Act of

11 1994, do not have tolerances or exemptions

12 from tolerances under this section because the

13 residues are generally recognized as safe under

14 this section or section 409 shall, until the expi15 ration of the period prescribed by subparagraph

16 (C), not be considered unsafe under section

17 402(a)(2)(B) solely because the chemicals do

18 not have such a tolerance or exemption.

19 ‘‘(B) LIST.—Not later than 90 days after

20 the date of the enactment of such Act, the Ad21 ministrator shall—

22 ‘‘(i) publish a list of all pesticide

23 chemical residues that the Administrator

24 has determined are generally recognized,

25 on the day before the date of the enact-
49

•HR 4091 SC

1 ment of such Act, as safe under this sec2 tion or section 409; and

3 ‘‘(ii) require, by regulation, that any

4 person who, before the date of the enact5 ment of such Act, distributed in commerce

6 as a pesticide chemical, a pesticide chemi7 cal that is not on the list described in

8 clause (i), and that such person deter9 mined is generally recognized as safe under

10 this section or section 409, shall—

11 ‘‘(I) report to the Administrator

12 the identity of such pesticide chemical;

13 and

14 ‘‘(II) report to the Administrator

15 the data that supports the claim that

16 the pesticide chemical is so safe.

17 ‘‘(C) DETERMINATION OF THE ADMINIS18 TRATOR.—Not later than 270 days after such

19 date, the Administrator shall determine if each

20 pesticide chemical reported to the Adminis21 trator in accordance with subparagraph (B)(ii)

22 is generally recognized as safe. If the Adminis23 trator determines, by order, that such pesticide

24 chemical is generally recognized as safe, the

25 residue of such pesticide chemical shall be con-
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1 sidered a pesticide chemical residue subject to

2 an exemption under this section, which exemp3 tion shall be subject to modification or revoca4 tion under subsection (k) or (l).

5 ‘‘(q) FOOD AND DRUG ADMINISTRATION MONITOR6 ING OF PESTICIDE CHEMICAL RESIDUES.—

7 ‘‘(1) SAMPLING.—The Secretary shall conduct

8 surveillance and compliance sampling of food for

9 pesticide chemical residues to determine if the pes10 ticide chemical residues are in compliance with this

11 section. In carrying out this paragraph, the Sec12 retary shall give priority to foods that contain pes13 ticide chemical residues included in a notice under

14 paragraph (2).

15 ‘‘(2) NOTIFICATION.—The Administrator shall

16 notify the Secretary of the pesticide chemical resi17 dues that the Administrator determines, in the ad18 ministration of this section—

19 ‘‘(A) are above the standard prescribed by

20 subsection (b)(2); or

21 ‘‘(B) are not above such standard but that

22 may under certain circumstances reach or ex23 ceed such standard.

24 ‘‘(r) FEES.—The Administrator shall by regulation

25 require the payment of such fees as will in the aggregate,
51

•HR 4091 SC

1 in the judgment of the Administrator, be sufficient over

2 a reasonable term to provide, equip, and maintain an ade3 quate service for the performance of the functions of the

4 Administrator under this section. Under such regulations,

5 the performance of the services or other functions of the

6 Administrator under this section may be conditioned upon

7 the payment of such fees. Such regulations may further

8 provide that the continuation in effect of a tolerance or

9 exemption shall be conditioned upon the payment of an

10 annual fee and for waiver or refund of fees in whole or

11 in part when, in the judgment of the Administrator, such

12 waiver or refund is equitable and not contrary to the pur13 poses of this subsection.

14 ‘‘(s) JUDICIAL REVIEW.—

15 ‘‘(1) REVIEW.—Any person (including a person

16 without an economic interest) who may be adversely

17 affected by a final regulation or order issued under

18 subsection (k)(3), (k)(4), (l)(4), or (i)(3) may obtain

19 judicial review of such regulation or order by filing

20 a petition requesting that the regulation or order be

21 set aside in whole or in part in the United States

22 Court of Appeals for the circuit in which such per23 son resides or has its principal place of business, or

24 in the United States Court of Appeals for the Dis25 trict of Columbia Circuit, within 60 days after publi-
52

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1 cation of the regulation or order under such sub2 section.

3 ‘‘(2) REVIEW OF DATA.—

4 ‘‘(A) IN GENERAL.—Any person (including

5 a person without an economic interest) may ob6 tain judicial review, of the adequacy of the data

7 made available by the Administrator under sub8 section (o) to support the issuance of a toler9 ance or exemption for a pesticide chemical resi10 due, by filing a petition for the review of the

11 data in the United States Court of Appeals for

12 the circuit in which such person resides or has

13 its principal place of business, or in the United

14 States Court of Appeals for the District of Co15 lumbia Circuit.

16 ‘‘(B) SCOPE OF REVIEW.—Review in a pro17 ceeding initiated under this paragraph shall be

18 limited to whether the data under review are

19 adequate to demonstrate that the tolerance or

20 exemption supported by such data meets the

21 standards required by subsection (b)(2) or

22 (j)(2) and interpreted by the guidelines issued

23 under subsection (b)(3) or (j)(3). Unless the

24 court determines that such data are adequate,
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1 the court shall revoke the tolerance or exemp2 tion supported by such data.

3 ‘‘(C) BURDEN OF PROOF.—In any such

4 proceeding the Administrator shall have the

5 burden of proof on all issues.

6 ‘‘(3) COURT RESPONSIBILITY.—In any action

7 seeking judicial review of actions under this section,

8 the court shall have the principal responsibility for

9 deciding issues of law.

10 ‘‘(4) ATTORNEY FEES.—Any petitioner who

11 prevails in a proceeding brought under this section

12 shall be entitled to recover reasonable attorney fees

13 and expenses (including expert witness fees).

14 ‘‘(t) DEFINITIONS.—For purposes of this section, the

15 terms ‘modify’ and ‘modification’ mean the lowering of a

16 tolerance for a pesticide chemical residue.’’.

17 (b) CONFORMING AMENDMENT.—Section 303 (21

18 U.S.C. 333) is amended by adding at the end the follow19 ing:

20 ‘‘(g) A person who violates a tolerance established

21 under section 408(b)(2) for a food at the time the food

22 is purchased at retail shall not be subject to any penalty

23 under this section.’’.
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1 SEC. 4. EVALUATION OF EXISTING PESTICIDE CHEMICAL

2 RESIDUE TOLERANCES AND EXEMPTIONS.

3 (a) EVALUATION.—Within 1 year of the date of the

4 enactment of this Act, the Administrator of the Environ5 mental Protection Agency shall, for each pesticide chemi6 cal residue that has a tolerance or exemption in effect

7 under the Federal Food, Drug, and Cosmetic Act, evaluate

8 all available data with respect to the safety of such pes9 ticide chemical residue and the nature and amount of such

10 residue remaining in or on foods and determine if—

11 (1) the tolerance or exemption meets the re12 quirements of subsection (b)(2) or (j)(2) of section

13 408 of such Act;

14 (2) the tolerance or exemption does not meet

15 such requirements; or

16 (3) the data are insufficient to determine if the

17 tolerance or exemption meets such requirements.

18 (b) SUFFICIENT DATA.—

19 (1) ACCEPTABLE RISK.—If, with respect to any

20 pesticide chemical residue that is evaluated under

21 subsection (a), the Administrator finds that data for

22 the pesticide chemical residue are sufficient to deter23 mine that the tolerance or exemption for the pes24 ticide chemical residue meets the standard under

25 section 408(b)(2) or 408(j)(2) of such Act, the Ad26 ministrator shall publish such finding.
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•HR 4091 SC

1 (2) UNACCEPTABLE RISK.—If, with respect to

2 any pesticide chemical residue that is evaluated

3 under subsection (a), the Administrator finds that

4 data for the pesticide chemical residue are sufficient

5 to determine that the tolerance or exemption for the

6 pesticide chemical residue does not meet the stand7 ard under section 408(b)(2) or 408(j)(2) of such

8 Act, the Administrator shall, within 1 year of the

9 date of such finding, modify or revoke the tolerance.

10 (3) INSUFFICIENT DATA.—

11 (A) GENERAL RULE.—

12 (i) SUBMISSION OF DATA.—If, with

13 respect to any pesticide chemical residue

14 that is evaluated under subsection (a), the

15 Administrator determines that the data are

16 insufficient to determine whether the toler17 ance or exemption meets the requirements

18 of section 408(b)(2) or 408(j)(2) of such

19 Act, the Administrator shall establish a

20 schedule for the submission of data in ac21 cordance with the requirements of sections

22 408(g), 408(h), 408(l)(2)(B), and

23 408(l)(3) of such Act, which data shall be

24 the basis for a determination by the Ad25 ministrator as to whether the tolerance or
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1 exemption meets the standard prescribed

2 by section 408(b)(2) or 408(j)(2) of such

3 Act.

4 (ii) DETERMINATIONS.—The Adminis5 trator shall—

6 (I) within 2 years of the date of

7 the enactment of this Act, make such

8 a determination respecting a tolerance

9 or exemption meeting a standard

10 under section 408 of such Act for at

11 least 30 percent of the tolerances or

12 exemptions in effect for pesticide

13 chemical residues in existence on such

14 date;

15 (II) within 4 years of the date of

16 the enactment of this Act, make such

17 a determination for at least 60 per18 cent of the tolerances or exemptions

19 in effect for pesticide chemical resi20 dues in existence on such date;

21 (III) within 6 years of the date of

22 the enactment of this Act, make such

23 a determination for at least 90 per24 cent of the tolerances or exemptions
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1 in effect for pesticide chemical resi2 dues in existence on such date; and

3 (IV) within 7 years of the date of

4 the enactment of this Act, make such

5 a determination for 100 percent of the

6 tolerances or exemptions in effect for

7 pesticide chemical residues in exist8 ence on such date.

9 (iii) DEADLINES.—Section 408(l)(4)

10 of such Act shall apply to the deadlines es11 tablished by such schedule.

12 (B) PRIORITIES.—In establishing such

13 schedule, the Administrator shall give priority

14 to the consideration of any pesticide chemical

15 residue for which there is reason to believe that

16 the tolerance or exemption in effect for such

17 residue may present a risk greater than the

18 negligible risk standard prescribed by section

19 408(b)(2) or 408(j)(2) of such Act.

20 (C) ACTION BY THE ADMINISTRATOR.—If

21 the Administrator determines under subpara22 graph (A) that a tolerance or exemption does

23 not meet the standard under section 408(b)(2)

24 or 408(j)(2) of such Act after the submission of

25 data in accordance with the schedule prescribed
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1 by such subparagraph, the Administrator shall

2 take the action described in section

3 408(l)(2)(A) of such Act with respect to such

4 tolerance or exemption.

5 SEC. 5. REVIEW OF EXISTING METHODS OF ANALYSIS.

6 (a) DETERMINATION.—Within 180 days of the date

7 of the enactment of this Act, the Administrator of the En8 vironmental Protection Agency shall determine, for each

9 method of detecting and measuring levels of pesticide

10 chemical residues, whether the requirements of section

11 408(b)(2)(G) of the Federal Food, Drug, and Cosmetic

12 Act have been met.

13 (b) NOTICE.—The Administrator shall issue a notice

14 identifying each pesticide chemical for which there is such

15 a method that does not meet such requirements. Any such

16 method that does not meet such requirements shall be re17 vised so that the method meets such requirements within

18 3 years of the date of the issuance of the notice.

19 (c) REVOCATION.—If upon the expiration of such 3-

20 year period, a method does not meet such requirements,

21 then any tolerance or exemption in effect for the pesticide

22 chemical residue subject to such method shall be consid23 ered revoked.
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1 SEC. 6. FEES.

2 The Administrator of the Environmental Protection

3 Agency shall by regulation require the payment of such

4 fees as will in the aggregate, in the judgment of the Ad5 ministrator, be sufficient over a reasonable term to pro6 vide, equip, and maintain an adequate service for the per7 formance of the functions of the Administrator under this

8 section and sections 4 and 5 of this Act.

9 SEC. 7. GENERAL DEFINITIONS.

10 As used in sections 4 and 5 of this Act:

11 (1) IN GENERAL.—The terms that are also used

12 in section 408 of the Federal Food, Drug, and Cos13 metic Act shall have the meanings given the terms

14 by sections 201 and 408 of such Act.

15 (2) DIETARY EXPOSURE.—The term ‘‘dietary

16 exposure’’ means dietary exposure as determined

17 under section 408(b)(2)(C) of the Federal Food,

18 Drug, and Cosmetic Act.

19 (3) EXEMPTION.—The term ‘‘exemption’’

20 means an exemption from the requirement for a tol21 erance under section 408 of the Federal Food, Drug,

22 and Cosmetic Act.

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