I

103D CONGRESS

1ST SESSION H. R. 872

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

FEBRUARY 4, 1993

Mr. WAXMAN introduced the following bill; which was referred to the

Committee on Energy and Commerce

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 1993’’.

7 (b) REFERENCE.—Whenever in this Act an amend8 ment or repeal is expressed in terms of an amendment

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

10 shall be considered to be made to a section or other provi-
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1 sion of the Federal Food, Drug, and Cosmetic Act (21

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

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

4 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.

5 SEC. 2. DEFINITIONS.

6 (a) PESTICIDE.—

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

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

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

10 ‘‘(A) any substance that is a pesticide, as de11 fined in section 2(u) of the Federal Insecticide, Fun12 gicide, and Rodenticide Act (7 U.S.C. 136(u)); and

13 ‘‘(B) each active ingredient and inert ingredi14 ent, as defined in subsections (a) and (m), respec15 tively, of section 2 of the Federal Insecticide, Fun16 gicide, and Rodenticide Act, of the pesticide.

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

18 residue in or on food of—

19 ‘‘(A) any pesticide chemical; or
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1 ‘‘(B) any other substance that is present in the

2 commodity or food as a result of the metabolism or

3 other degradation of a pesticide chemical,

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

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

6 321(s)) is amended—

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

8 inserting the following:

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

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

11 and (5) as paragraphs (2), (3), and (4), respec12 tively.

13 (b) CONFORMING AMENDMENTS.—

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

15 adding at the end the following:

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

17 has been subject to processing from a raw agricultural

18 commodity.

19 ‘‘(hh) The term ‘Administrator’ means the Adminis20 trator of the Environmental Protection Agency.’’.

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

22 amended—

23 (A) in clause (A)(i), to read as follows: ‘‘(i)

24 a pesticide chemical residue’’;
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1 (B) in clause (B), to read as follows: ‘‘(B)

2 if it is, or it bears or contains, a pesticide chem3 ical residue unsafe within the meaning of sec4 tion 408(a);’’; and

5 (C) in clause (C)—

6 (i) by striking ‘‘: Provided, That

7 where a pesticide chemical’’ and inserting

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

9 (ii) by striking ‘‘sections 406 and

10 409’’ and inserting ‘‘section 406’’.

11 SEC. 3. TOLERANCES AND EXEMPTIONS FOR PESTICIDE

12 CHEMICAL RESIDUES.

13 (a) TOLERANCES AND EXEMPTIONS.—Section 408

14 (21 U.S.C. 346a) is amended to read as follows:

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

16 CHEMICAL RESIDUES.

17 ‘‘(a) REQUIREMENT FOR TOLERANCE OR EXEMP18 TION.—

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

20 residue shall be deemed unsafe for the purpose of

21 section 402(a)(2)(B) unless—

22 ‘‘(A) a tolerance for such residue is in ef23 fect under this section and the quantity of such

24 residue is within the limits of such tolerance; or
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1 ‘‘(B) an exemption for such residue is in

2 effect under this section and such residue com3 plies with such exemption.

4 ‘‘(2) EFFECT OF A TOLERANCE OR EXEMP5 TION.—While a tolerance or exemption from the re6 quirement for a tolerance is in effect under this sec7 tion for a pesticide chemical residue with respect to

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

9 or containing any amount of such residue be consid10 ered to be adulterated within the meaning of section

11 402(a)(1).

12 ‘‘(b) TOLERANCES.—

13 ‘‘(1) AUTHORITY.—

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

15 may promulgate regulations establishing, modi16 fying, or revoking a tolerance for a pesticide

17 chemical residue—

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

19 under subsection (d)(1); or

20 ‘‘(ii) on the initiative of the Adminis21 trator under subsection (d)(4).

22 ‘‘(B) EXPIRATION DATE.—A regulation

23 under this paragraph may provide for an expi24 ration date for the tolerance.
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1 ‘‘(C) SEPARATE TOLERANCES.—The Ad2 ministrator may establish a separate tolerance

3 under subparagraph (A) for a pesticide chemi4 cal residue with respect to food at each of the

5 following times:

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

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

8 at retail.

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

10 ‘‘(2) STANDARD.—

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

12 in subparagraph (F)—

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

14 a pesticide chemical residue only if the risk

15 to human health from dietary exposure to

16 the pesticide chemical residue is negligible;

17 and

18 ‘‘(ii) the tolerance for a pesticide

19 chemical residue shall be revoked or modi20 fied unless the risk to human health from

21 dietary exposure to the pesticide chemical

22 residue is negligible.

23 ‘‘(B) NEGLIGIBLE RISK.—

24 ‘‘(i) GENERAL RULE.—For purposes

25 of this paragraph, a risk to human health
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1 from dietary exposure to a pesticide chemi2 cal residue is negligible only if dietary ex3 posure to the residue is reasonably certain

4 to cause no harm to human health and the

5 tolerance for such residue meets the re6 quirements of clause (ii) or (iii).

7 ‘‘(ii) THRESHOLD PESTICIDES.—

8 ‘‘(I) IN GENERAL.—If the Ad9 ministrator is able to identify a level

10 at which a pesticide chemical residue

11 will not cause or contribute to any

12 known or anticipated harm to human

13 health, the Administrator may estab14 lish or leave in effect a level for a tol15 erance for such residue only if the Ad16 ministrator finds that such tolerance

17 will provide an ample margin of safe18 ty, for each population group set out

19 in subparagraph (E).

20 ‘‘(II) CONSIDERATIONS.—The

21 level described in subclause (I) shall

22 be based on consideration of—

23 ‘‘(aa) the nature of the toxic

24 effects caused by such residue

25 and data regarding the preva-
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1 lence of the same effects caused

2 by other chemicals;

3 ‘‘(bb) the validity, complete4 ness, and the reliability of the

5 data about the pesticide chemical

6 residue;

7 ‘‘(cc) the variability of indi8 vidual sensitivities and the sen9 sitivities of population subgroups

10 to the adverse effects from such

11 residue; and

12 ‘‘(dd) the possibility that

13 human susceptibility to such ad14 verse effects is significantly

15 greater than that of test animals.

16 ‘‘(III) MARGIN OF SAFETY.—For

17 purposes of this clause, a margin of

18 safety for a level of a pesticide chemi19 cal residue is not ample unless human

20 exposure per unit of body measure21 ment, to the pesticide chemical resi22 due and other chemicals that cause

23 the same effect, is at least 100 times

24 less than the no observable effect level

25 in animals on which the pesticide
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1 chemical residue was tested, and, if

2 human data are available, at least 10

3 times less than the no observable ef4 fect level in humans exposed to such

5 residue. The no observable effect level

6 is the level of exposure to a pesticide

7 chemical that reliable data, derived

8 from exposure of humans or animals

9 to the pesticide chemical, demonstrate

10 will cause no adverse effect.

11 ‘‘(iii) NONTHRESHOLD PESTICIDES.—

12 If the Administrator is not able to identify

13 a level at which a pesticide chemical resi14 due will not cause or contribute to any

15 known or anticipated harm to human

16 health or if the Administrator finds that a

17 pesticide chemical residue causes cancer in

18 animals or humans, the Administrator may

19 establish a level for a tolerance for such

20 residue or leave a level in effect for such

21 residue only if the Administrator finds that

22 such level—

23 ‘‘(I) will not cause or contribute

24 to, in individuals exposed to such pes25 ticide chemical residue, a lifetime risk
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1 of an adverse human health effect

2 that occurs at a rate of one in a mil3 lion or a risk of an adverse human

4 health effect that occurs at a rate of

5 one in a million, divided by 70, for

6 any single year of exposure during the

7 first 5 years of the life of an exposed

8 person, using conservative risk assess9 ment models;

10 ‘‘(II) is the lowest level reason11 ably required to allow the accomplish12 ment of the physical or other technical

13 effect for which the use of the pes14 ticide chemical involved is intended;

15 and

16 ‘‘(III) in the case of processed

17 food, is the lowest level that occurs if

18 such pesticide chemical residue is re19 moved to the extent possible in ac20 cordance with good manufacturing

21 practice.

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

23 subparagraph (D), in determining dietary expo24 sure to a pesticide chemical residue for pur-
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1 poses of this paragraph, the Administrator

2 shall—

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

4 significant data regarding the dietary expo5 sure to persons who have consumed the

6 food for which the tolerance for the residue

7 is proposed or is in effect;

8 ‘‘(II) take into account all other toler9 ances in effect for the same pesticide

10 chemical residue; and

11 ‘‘(III) take into account all other

12 sources (including drinking water if data

13 demonstrating widespread or significant

14 regional contamination in drinking water

15 are available) of dietary exposure to the

16 same pesticide chemical residue; and

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.

8 ‘‘(D) SPECIAL EXPOSURE RULE.—

9 ‘‘(i) DATE.—The Administrator may

10 calculate dietary exposure to a food based

11 on reliable data that provide the Adminis12 trator with a valid statistical basis to iden13 tify the percentage of the food in which the

14 pesticide chemical residue actually occurs.

15 ‘‘(ii) PERCENTAGE.—Such percentage

16 shall be not less than the percentage of the

17 food consumed in an appropriate locality,

18 identified by the Administrator, which per19 centage represents the highest level of ex20 posure to such residue in the United

21 States.

22 ‘‘(iii) REEVALUATION.—The Adminis23 trator shall reevaluate the determination

24 under this subparagraph every 2 years

25 after the date of the determination. If,
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1 under such a reevaluation, the Adminis2 trator finds that the determination is not

3 justified, the Administrator shall promptly

4 issue a regulation requiring that the toler5 ance involved be set on the basis of the

6 new determination.

7 ‘‘(E) POPULATION COVERED.—In deter8 mining if the dietary exposure to a pesticide

9 chemical residue is negligible, the Administrator

10 shall evaluate the risk to—

11 ‘‘(i) infants of the age 0 to 1;

12 ‘‘(ii) children of the age 1 to 2;

13 ‘‘(iii) children of the age 2 to 3;

14 ‘‘(iv) children of the age 3 to 4;

15 ‘‘(v) children of the age 4 to 5;

16 ‘‘(vi) children of the age 6 to 10;

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

18 ‘‘(viii) other population groups that

19 have been identified by the Administrator

20 to have special food consumption patterns

21 or for which data are sufficient to dem22 onstrate special food consumption patterns;

23 and

24 ‘‘(ix) the entire population,
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1 who consume food with such pesticide chemical

2 residue.

3 ‘‘(F) UNAVOIDABLE PERSISTENCE.—If a

4 tolerance or an exemption from the requirement

5 for a tolerance for a pesticide chemical residue

6 is revoked and the Administrator finds the pes7 ticide chemical residue will unavoidably persist

8 in the environment and contaminate food, the

9 Administrator shall establish a new tolerance

10 under subsection (d)(4) for the pesticide chemi11 cal residue. The level permitted by the tolerance

12 shall not be greater than the lowest level that

13 permits only such unavoidable levels to remain

14 in food. The Administrator shall evaluate any

15 such tolerance at least once a year to determine

16 whether modification of such tolerance is nec17 essary so that the tolerance provides only for

18 the level of the pesticide chemical residue that

19 is unavoidable.

20 ‘‘(G) PRACTICAL METHODS OF ANALY21 SIS.—

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

23 a pesticide chemical residue shall not be

24 established or allowed to remain in effect
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1 unless the Administrator determines, after

2 consultation with the Secretary, that—

3 ‘‘(I) there is a method for detect4 ing and measuring the levels of such

5 pesticide chemical residue in or on a

6 food that will detect the residue at the

7 level established by the tolerance; and

8 ‘‘(II) except as provided in clause

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

10 practical method.

11 ‘‘(ii) SPECIAL RULE.—If the Adminis12 trator determines that a practical method

13 of analysis for a pesticide chemical residue

14 is not available, the Administrator shall

15 identify the best available method that is

16 designed to identify the lowest detectable

17 amount of the pesticide chemical residue.

18 The Administrator shall, every 2 years

19 after the date of the determination under

20 this clause, reevaluate the determination.

21 ‘‘(iii) PRACTICAL METHOD.—A meth22 od shall be considered practical for pur23 poses of this subparagraph only if it is a

24 multiresidue method that can be performed

25 by the Secretary on a routine basis as part
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1 of surveillance and compliance sampling of

2 foods for pesticide chemical residues with

3 the personnel, equipment, and other re4 sources available to the Secretary, or, if no

5 multiresidue method is available, only if it

6 can be so performed by the Secretary.

7 ‘‘(3) CONSISTENT APPLICATION.—The Adminis8 trator shall issue guidelines providing for the con9 sistent application of the requirements of paragraphs

10 (1) and (2).

11 ‘‘(c) EXEMPTIONS.—

12 ‘‘(1) AUTHORITY.—

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

14 may promulgate regulations establishing or re15 voking an exemption from the requirement for

16 a tolerance for a pesticide chemical residue—

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

18 under subsection (d)(1); or

19 ‘‘(ii) on the initiative of the Adminis20 trator under subsection (d)(4).

21 ‘‘(B) EXPIRATION DATE.—Such a regula22 tion may provide for an expiration date for the

23 exemption.

24 ‘‘(2) STANDARD.—

25 ‘‘(A) AUTHORITY AND RISK STANDARD.—
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1 ‘‘(i) ESTABLISHMENT.—An exemption

2 may be established for a pesticide chemical

3 residue if such residue is not a human or

4 animal carcinogen and otherwise presents

5 no risk to human health, including the

6 health of individuals in the population

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

8 from dietary exposure to such residue.

9 ‘‘(ii) REVOCATION.—An exemption

10 shall be revoked unless the residue is not

11 a human or animal carcinogen and the res12 idue does not present any risk to human

13 health, including the health of individuals

14 in the population groups set out in sub15 section (b)(2)(E), from dietary exposure to

16 such residue.

17 ‘‘(iii) TOLERANCE.—No exemption

18 may be established or allowed to remain in

19 effect for a pesticide chemical residue for

20 which there is in effect a tolerance.

21 ‘‘(B) EXPOSURE.—For purposes of sub22 paragraph (A), in determining dietary exposure

23 to a pesticide chemical residue, the Adminis24 trator shall—
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1 ‘‘(i) use only reliable, statistically sig2 nificant data regarding the dietary expo3 sure resulting from the consumption of the

4 food for which the exemption for such resi5 due is proposed or is in effect;

6 ‘‘(ii) take into account all other ex7 emptions in effect for such residue and all

8 other sources (including drinking water if

9 data demonstrating widespread or signifi10 cant regional contamination in drinking

11 water are available) of dietary exposure to

12 such residue; and

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

14 level of exposure that would occur if—

15 ‘‘(I) all the food, for which the

16 tolerance for such residue is proposed

17 or in effect, has amounts of such resi18 due equal to the tolerance proposed or

19 in effect, respectively;

20 ‘‘(II) all other sources of dietary

21 exposure to such residue described in

22 clause (ii) occur; and

23 ‘‘(III) human exposure to the

24 pesticide chemical residue at the toler-
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1 ance level occurs for a period equal to

2 a lifetime.

3 ‘‘(C) PRACTICAL METHODS OF ANALY4 SIS.—An exemption for a pesticide chemical

5 residue shall not be established or allowed to re6 main in effect unless the Administrator deter7 mines, after consultation with the Secretary,

8 that there is a method for detecting and meas9 uring the levels of such pesticide chemical resi10 due on a food and that such method is the best

11 available, practical method, as defined in sub12 section (b)(2)(G).

13 ‘‘(3) CONSISTENT APPLICATION.—The Adminis14 trator shall issue guidelines providing for the con15 sistent application of the requirements of paragraphs

16 (1) and (2).

17 ‘‘(d) PETITIONS AND ACTION ON THE INITIATIVE OF

18 THE ADMINISTRATOR.—

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

20 person may file with the Administrator a petition

21 proposing the issuance of a regulation establishing,

22 modifying, or revoking a tolerance or exemption for

23 a pesticide chemical residue.

24 ‘‘(2) REQUIREMENTS FOR PETITIONS TO ES25 TABLISH A TOLERANCE OR EXEMPTION.—
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1 ‘‘(A) CONTENTS.—A petition under para2 graph (1) to establish a tolerance or exemption

3 for a pesticide chemical residue shall contain—

4 ‘‘(i) an informative summary of the

5 petition and of the data, information, and

6 arguments submitted or cited in support of

7 the petition, including—

8 ‘‘(I) a summary of the reports re9 quired under clause (iv) respecting the

10 safety of the pesticide chemical resi11 due; and

12 ‘‘(II) a characterization of—

13 ‘‘(aa) the exposure to the

14 pesticide chemical residue due to

15 any tolerance or exemption al16 ready granted for such residue;

17 and

18 ‘‘(bb) the additional expo19 sure to such residue that would

20 result if the requested tolerance

21 or exemption were granted;

22 ‘‘(ii) a proposed tolerance for such

23 residue, if a tolerance is proposed;
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1 ‘‘(iii) the name, chemical identity, and

2 composition of the pesticide chemical that

3 produces such residue;

4 ‘‘(iv) reports of tests and investiga5 tions made with respect to the safety of

6 such pesticide chemical, including complete

7 information as to the methods and controls

8 used in conducting such tests and inves9 tigations;

10 ‘‘(v) data showing the amount, fre11 quency, method, and time of application of

12 such pesticide chemical;

13 ‘‘(vi) reports of tests and investiga14 tions made with respect to the nature and

15 amount of the pesticide chemical residue

16 that is likely to remain in or on food when

17 ready for sale to consumers, including a

18 description of the analytical methods used;

19 ‘‘(vii) a description of methods for de20 tecting and measuring the levels of such

21 pesticide chemical residue in or on the

22 food, which methods meet the require23 ments of subsection (b)(2)(G) or (c)(2)(C);

24 ‘‘(viii) reports of investigations con25 ducted on the effects of processing meth-
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1 ods used to produce food on the level and

2 identity of such pesticide chemical residue;

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

4 chemical residue that is described in sub5 section (b)(2)(B)(iii), all relevant data

6 bearing on the physical or other technical

7 effect the pesticide chemical involved is in8 tended to have and the quantity of the pes9 ticide chemical residue required to accom10 plish such effect; and

11 ‘‘(x) such other data and information

12 (including a sample of the pesticide chemi13 cal from which the pesticide chemical resi14 due is derived) as the Administrator may

15 require to support the petition.

16 ‘‘(B) INFORMATION AVAILABLE TO ADMIN17 ISTRATOR.—If information or data required by

18 this paragraph are available to the Adminis19 trator, the person submitting the petition may,

20 in lieu of submitting the information or data,

21 cite the availability of the information or data.

22 ‘‘(3) ACTIONS ON PETITIONS.—

23 ‘‘(A) NOTICE.—

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

25 the filing of a petition under paragraph (1)
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1 for the establishment of a tolerance or an

2 exemption, the Administrator shall deter3 mine if the petition complies with the re4 quirements of paragraph (2). If the Ad5 ministrator determines that the petition

6 complies with such requirements, the Ad7 ministrator shall publish a notice of the fil8 ing of the petition. If the Administrator

9 determines that the petition does not com10 ply with such requirements, the Adminis11 trator shall notify the petitioner of such

12 determination.

13 ‘‘(ii) CONTENTS.—A notice published

14 under this subparagraph shall—

15 ‘‘(I) announce the availability of

16 a complete description of the analyt17 ical methods available to the Adminis18 trator for the detection and measure19 ment of the pesticide chemical residue

20 with respect to which the petition is

21 filed;

22 ‘‘(II) include the summary re23 quired by paragraph (2)(A)(i); and

24 ‘‘(III) provide at least 30 days

25 for comments on the petition.
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1 ‘‘(B) ACTION.—The Administrator shall,

2 within 270 days of the publication of a notice

3 under subparagraph (A) with respect to a peti4 tion, and after giving due consideration to the

5 petition, any comments on the petition, and any

6 other information available to the Adminis7 trator—

8 ‘‘(i) issue a final regulation in accord9 ance with the petition establishing a toler10 ance or exemption for the pesticide chemi11 cal residue;

12 ‘‘(ii) issue a proposed regulation es13 tablishing a tolerance or exemption for the

14 pesticide chemical residue, which tolerance

15 or exemption is different from the toler16 ance or exemption requested in the peti17 tion; or

18 ‘‘(iii) issue an order denying the peti19 tion.

20 ‘‘(C) MODIFICATION OR REVOCATION.—

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

22 filing of a petition under paragraph (1) for

23 the modification or revocation of a toler24 ance or exemption, the Administrator shall

25 publish a notice of the filing of the peti-
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1 tion. Such notice shall contain the full peti2 tion or a summary of the petition and shall

3 provide at least 30 days for comments on

4 the petition.

5 ‘‘(ii) ACTION.—The Administrator

6 shall, within 270 days of the publication of

7 the notice under subparagraph (A) and

8 after giving due consideration to the peti9 tion, any comments on the petition, and

10 any other information available to the Ad11 ministrator—

12 ‘‘(I) issue a final regulation in

13 accordance with the petition modify14 ing or revoking a tolerance or exemp15 tion for the pesticide chemical residue;

16 ‘‘(II) issue a proposed regulation

17 modifying or revoking a tolerance or

18 exemption for the pesticide chemical

19 residue, which tolerance or exemption

20 is different from the modification or

21 revocation requested in the petition;

22 or

23 ‘‘(III) issue an order denying the

24 petition.
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1 ‘‘(D) COMMENTS AND FINAL REGULA2 TIONS.—If the Administrator issues a proposed

3 regulation under subparagraph (B)(ii) or

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

5 least 30 days for comments on such proposed

6 regulations. The Administrator shall issue a

7 final decision within 180 days of the date of the

8 publication of the proposed regulations.

9 ‘‘(E) PRIORITIES.—The Administrator

10 shall give priority to petitions for the establish11 ment of a tolerance for a pesticide chemical res12 idue that appears to pose a significantly lower

13 risk to human health from dietary exposure

14 than pesticide chemical residues that have toler15 ances in effect for the same or similar uses.

16 ‘‘(4) ACTION ON THE INITIATIVE BY THE AD17 MINISTRATOR.—

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

19 may, on the initiative of the Administrator,

20 issue a final regulation establishing, modifying,

21 or revoking a tolerance or exemption for a pes22 ticide chemical residue.

23 ‘‘(B) NOTICE.—Before issuing a final reg24 ulation under subparagraph (A), the Adminis25 trator shall issue a notice of proposed rule-
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1 making and provide a period of not less than 30

2 days for public comment on the proposed regu3 lation unless the Administrator finds that it

4 would be contrary to the public interest to issue

5 the notice and provide the period and states the

6 reasons for the finding in the notice of the final

7 regulation.

8 ‘‘(5) EFFECTIVE DATE.—

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

10 in subparagraph (B), a final regulation issued

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

12 upon publication.

13 ‘‘(B) DELAY.—

14 ‘‘(i) GENERAL RULE.—If a regulation

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

16 or modifies a tolerance for a pesticide

17 chemical residue or revokes an exemption

18 for a pesticide chemical residue, the Ad19 ministrator may, in accordance with clause

20 (ii), delay the effective date of the regula21 tion to permit the tolerance or exemption

22 to remain in effect at the level in effect im23 mediately before such regulation is issued

24 only—
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1 ‘‘(I) for foods that, on the date of

2 the publication of the regulation, con3 tain such pesticide chemical residue in

4 an amount that is not more than the

5 amount that could legally be applied

6 on the date the Administrator acted

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

8 ‘‘(II) if dietary exposure to the

9 pesticide chemical residue in or on the

10 foods described in subclause (I) meets

11 the negligible risk standard prescribed

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

13 of delay of the effective date.

14 ‘‘(ii) PERIOD OF DELAY.—If the Ad15 ministrator finds that delay of the effective

16 date of such a revocation or modification is

17 consistent with the public health, the Ad18 ministrator may delay such date under

19 clause (i), for each type of food that con20 tains such pesticide chemical residue, for

21 the period that is required for such food to

22 be sold to consumers in the course of the

23 usual practice for persons engaged in the

24 production, processing, transportation,
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1 storage, and distribution of the type of

2 food.

3 ‘‘(e) SPECIAL DATA REQUIREMENTS.—

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

5 The Administrator shall take the action described in

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

7 for a pesticide chemical residue and the Adminis8 trator determines that data contained in the peti9 tion, which had been submitted, under subsection

10 (d)(1) for establishment of the tolerance or exemp11 tion, or under this section, before the date of the en12 actment of the Pesticide Food Safety Act of 1993,

13 are not adequate to support the continuation of such

14 tolerance or exemption because—

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

16 petition and other data available to the Admin17 istrator, the Administrator determines that die18 tary exposure to such pesticide chemical residue

19 may present a risk to human health that is

20 greater than the standard prescribed by sub21 section (b)(2) or (c)(2); or

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

23 insufficient to determine if the tolerance or ex24 emption meets the requirements of subsection
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1 (b)(2) or (c)(2) or the requirements of sub2 section (d)(2).

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

4 Administrator makes the determination described in

5 paragraph (1) with respect to a tolerance or exemp6 tion for a pesticide chemical residue, the Adminis7 trator shall—

8 ‘‘(A) within 30 days of a determination

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

10 under subsection (d)(4) to modify or revoke the

11 tolerance or exemption so that the tolerance or

12 exemption meets the standard prescribed by

13 subsection (b)(2) or (c)(2), and within 1 year of

14 such determination issue a final regulation to

15 complete such action; and

16 ‘‘(B) within 30 days of the date of a deter17 mination under paragraph (1)(B), require the

18 submission of data to support—

19 ‘‘(i) the existing tolerance or exemp20 tion; or

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

22 such residue,

23 that meets the standard prescribed by sub24 section (b)(2) or (c)(2).
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1 ‘‘(3) SUBMISSION OF REQUIRED DATA.—When

2 the Administrator requires the submission of data

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

4 publish an order—

5 ‘‘(A) requiring one or more interested per6 sons to notify the Administrator that such per7 son will submit the required data;

8 ‘‘(B) describing the type of data required

9 to be submitted;

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

11 made during and after the collection of the

12 data; and

13 ‘‘(D) establishing deadlines for the actions

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

15 ‘‘(4) DEADLINES.—

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

17 in subparagraphs (B) and (C), if an order is is18 sued under paragraph (3) with respect to a tol19 erance or exemption and a deadline in the order

20 is not met, the tolerance or exemption is re21 voked, effective 45 days after the date the dead22 line is not met. Immediately after such deadline

23 is not met, the Administrator shall publish a

24 notice of the revocation.

25 ‘‘(B) EXTENSION REQUEST.—
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1 ‘‘(i) REQUEST.—Any person may re2 quest the Administrator to issue an order

3 to extend the deadline established under

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

5 deadline.

6 ‘‘(ii) GRANT OF REQUEST.—The Ad7 ministrator may grant such a request only

8 if—

9 ‘‘(I) the person submitting the

10 request notified the Administrator

11 pursuant to paragraph (3)(A) in com12 pliance with the deadline established

13 under paragraph (3)(C); and

14 ‘‘(II) the Administrator finds

15 that extraordinary circumstances be16 yond the control of such person pre17 vented such person from submitting

18 the required data.

19 ‘‘(iii) EXTENSION.—If the Adminis20 trator issues an order extending a dead21 line—

22 ‘‘(I) the Administrator may ex23 tend the deadline for a period no

24 longer than such time as is necessary
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1 for such person to submit the data;

2 and

3 ‘‘(II) the Administrator shall es4 tablish a new deadline in accordance

5 with paragraph (3)(D).

6 ‘‘(C) DELAY.—If a tolerance or exemption

7 is revoked under subparagraph (A), the Admin8 istrator may delay the effective date of the rev9 ocation in accordance with subsection (d)(5)(B).

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

11 of the date of the receipt of data under paragraph

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

13 determine whether action is required under sub14 section (d)(4) with respect to the tolerance or ex15 emption for the pesticide chemical residue for which

16 the data were submitted so that such tolerance

17 meets the negligible risk standard prescribed under

18 subsection (b)(2) or (c)(2). If the Administrator de19 termines that action under subsection (d)(4) is re20 quired, the Administrator shall complete such action

21 within 1 year of the date of such determination.

22 ‘‘(f) CONFIDENTIALITY OF DATA.—

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

24 Administrator in support of a petition under sub25 section (d)(1), which data have not previously been
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1 made available to the public without restriction,

2 shall, upon request of the petitioner, be considered

3 as entitled to confidential treatment by the Adminis4 trator until publication of a regulation or order

5 under subsection (d)(3) in response to the petition

6 unless disclosure of such data is required by sub7 section (d)(3)(A)(ii)(II) or (g) or is allowed by para8 graph (2).

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

10 confidential treatment under paragraph (1) until

11 publication of a regulation or order under subsection

12 (d)(3) may be revealed to—

13 ‘‘(A) either House of Congress or any com14 mittee or subcommittee of such House to the

15 extent of matter within the jurisdiction of the

16 committee or subcommittee;

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

18 States in connection with the official duties of

19 such officer or employee under any law for the

20 protection of health or the environment or for

21 specific law enforcement purposes;

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

23 connection with the official duties of such offi24 cer or employee under any law of the State for
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1 the protection of health or the environment or

2 for specific law enforcement purposes; or

3 ‘‘(D) contractors with the United States

4 authorized by the Administrator to examine

5 such data in the carrying out of contracts under

6 such statutes under such security requirements

7 as the Administrator may provide.

8 ‘‘(g) ACCESS TO DATA IN SUPPORT OF PETITION.—

9 ‘‘(1) GENERAL RULE.—

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

11 of a petition are submitted to the Adminis12 trator, the Administrator, before acting on such

13 petition, shall provide, in accordance with this

14 subsection, public access to health and safety

15 data that are submitted or cited in support of

16 such petition.

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

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

19 after the publication under subsection (d)(3)(A)

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

21 certified mail to the Administrator and to the

22 petitioner a request for such access and the af23 firmation required by paragraph (2).

24 ‘‘(C) GRANT OF REQUEST.—The Adminis25 trator shall grant such request unless, within
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1 15 days after the receipt by the Administrator

2 of such request and affirmation, the petitioner

3 submits to the Administrator an objection to

4 the request asserting that the affirmation is in5 accurate and other reasons for the objection.

6 ‘‘(D) OBJECTION.—If an objection to a re7 quest is submitted to the Administrator within

8 such 15-day period, the Administrator shall de9 termine whether to grant the request within 5

10 days after the receipt of the objection. If the

11 Administrator determines to grant the request,

12 access shall not be permitted until 5 days after

13 the petitioner making the objection has been

14 notified that access has been granted.

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

16 data is denied, comments on the petition for

17 which such data were submitted or cited shall

18 be filed within 30 days after the decision of the

19 Administrator denying access.

20 ‘‘(2) RESTRICTION.—

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

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

23 person who provides an affirmation (and such

24 supporting evidence as the Administrator may

25 require) that—
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1 ‘‘(i) states that the person is not en2 gaged in, and is neither employed by, nor

3 acting (directly or indirectly) on behalf of,

4 any other person, or affiliate of a person,

5 engaged in, the production, sale, or dis6 tribution of a pesticide chemical;

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

8 or other person, if any, on whose behalf

9 the person is requesting access to the data;

10 and

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

12 intentionally or recklessly violate this sub13 section.

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

15 paragraph, an affiliate of a person is a person

16 who directly or indirectly, through one or more

17 intermediates, controls or is controlled by or is

18 under common control with the other person.

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

20 United States Code, shall apply to an affirma21 tion made under this paragraph.

22 ‘‘(3) COMMENTS.—

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

24 petition may be made available under para25 graph (1) to a person only for the purpose of
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1 permitting the person to comment to the Ad2 ministrator on such petition. Such comments

3 may reasonably quote data submitted to the

4 Administrator. No person, including the Admin5 istrator, may make such comments public be6 fore the decision of the Administrator on the

7 petition for which such data were submitted or

8 after such decision if the petition is denied.

9 ‘‘(B) RESTRICTIONS.—A person who ob10 tains data (directly or indirectly) under para11 graph (1) may not publish, copy, or transfer the

12 data to any other person to obtain approval to

13 sell, manufacture, or distribute a pesticide

14 chemical anywhere in the world.

15 ‘‘(4) PROCEDURE.—

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

17 under paragraph (1) may be examined at an of18 fice of the Environmental Protection Agency or

19 an appropriate State agency under the condi20 tions prescribed by this subsection and may not

21 be removed from such office.

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

23 maintain a record of the persons who inspect

24 data. A copy of such record shall be sent on re25 quest to the person who submitted the data.
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1 ‘‘(C) BASIS FOR COMMENTS.—Once access

2 to data supporting a petition is granted, the

3 data may be examined and notes may be taken

4 for use in developing comments on the petition.

5 Such comments on the petition shall be filed

6 within 60 days after the decision of the Admin7 istrator granting access, unless the comment

8 period is extended by the Administrator for an

9 additional 30 days for good cause.

10 ‘‘(h) ACCESS TO DATA AFTER DECISION.—When the

11 Administrator takes final action on a petition submitted

12 under subsection (d)(1) or on the initiative of the Adminis13 trator under subsection (d)(4), the Administrator shall

14 make available to the public the administrative record of

15 the decision, including the data relied upon for the deci16 sion.

17 ‘‘(i) EXISTING PESTICIDE CHEMICAL RESIDUES.—

18 ‘‘(1) PESTICIDE CHEMICAL RESIDUES UNDER

19 REGULATIONS UNDER SECTION 406.—Regulations af20 fecting pesticide chemical residues promulgated, in

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

22 basis of public hearings instituted before January 1,

23 1953, shall be deemed to be tolerances issued under

24 this section and shall be subject to modification or

25 revocation under subsection (d) or (e).
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1 ‘‘(2) PESTICIDE CHEMICAL RESIDUES UNDER

2 REGULATIONS.—Regulations establishing tolerances

3 for pesticide chemical residues under this section

4 and section 409 or exemptions for pesticide chemical

5 residues under this section on or before the date of

6 the enactment of this section shall be deemed to be

7 tolerances or exemptions issued under this section

8 and shall be subject to modification or revocation

9 under subsection (d) or (e).

10 ‘‘(3) GENERALLY RECOGNIZED AS SAFE PES11 TICIDE CHEMICAL RESIDUES.—

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

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

14 enactment of the Pesticide Food Safety Act of

15 1993, do not have tolerances or exemptions

16 from tolerances under this section because the

17 residues are generally recognized as safe under

18 this section or section 409 shall, until the expi19 ration of the period prescribed by subparagraph

20 (C), not be considered unsafe under section

21 402(a)(2)(B) solely because the chemicals do

22 not have such a tolerance or exemption.

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

24 the date of the enactment of such Act, the Ad25 ministrator shall—
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1 ‘‘(i) publish a list of all pesticide

2 chemical residues that the Administrator

3 has determined are generally recognized,

4 on the day before the date of the enact5 ment of such Act, as safe under this sec6 tion or section 409; and

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

8 person who, before the date of the enact9 ment of such Act, distributed in commerce

10 as a pesticide chemical, a pesticide chemi11 cal that is not on the list described in

12 clause (i), and that such person deter13 mined is generally recognized as safe under

14 this section or section 409, shall—

15 ‘‘(I) report to the Administrator

16 the identity of such pesticide chemical;

17 and

18 ‘‘(II) report to the Administrator

19 the data that supports the claim that

20 the pesticide chemical is so safe.

21 ‘‘(C) DETERMINATION OF THE ADMINIS22 TRATOR.—Not later than 270 days after such

23 date, the Administrator shall determine if each

24 pesticide chemical reported to the Adminis25 trator in accordance with subparagraph (B)(ii)
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1 is generally recognized as safe. If the Adminis2 trator determines, by order, that such pesticide

3 chemical is generally recognized as safe, the

4 residue of such pesticide chemical shall be con5 sidered a pesticide chemical residue subject to

6 an exemption under this section, which exemp7 tion shall be subject to modification or revoca8 tion under subsection (d) or (e).

9 ‘‘(j) FOOD AND DRUG ADMINISTRATION MONITOR10 ING OF PESTICIDE CHEMICAL RESIDUES.—

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

12 surveillance and compliance sampling of food for

13 pesticide chemical residues to determine if the pes14 ticide chemical residues are in compliance with this

15 section. In carrying out this paragraph, the Sec16 retary shall give priority to foods that contain pes17 ticide chemical residues included in a notice under

18 paragraph (2).

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

20 notify the Secretary of the pesticide chemical resi21 dues that the Administrator determines, in the ad22 ministration of this section—

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

24 subsection (b)(2); or
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1 ‘‘(B) are not above such standard but that

2 may under certain circumstances reach or ex3 ceed such standard.

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

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

6 in the judgment of the Administrator, be sufficient over

7 a reasonable term to provide, equip, and maintain an ade8 quate service for the performance of the functions of the

9 Administrator under this section. Under such regulations,

10 the performance of the services or other functions of the

11 Administrator under this section may be conditioned upon

12 the payment of such fees. Such regulations may further

13 provide that the continuation in effect of a tolerance or

14 exemption shall be conditioned upon the payment of an

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

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

17 waiver or refund is equitable and not contrary to the pur18 poses of this subsection.

19 ‘‘(l) JUDICIAL REVIEW.—

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

21 without an economic interest) who may be adversely

22 affected by a final regulation or order issued under

23 subsection (d)(3), (d)(4), (e)(4), or (i)(3) may obtain

24 judicial review of such regulation or order by filing

25 a petition requesting that the regulation or order be
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1 set aside in whole or in part in the United States

2 Court of Appeals for the circuit in which such per3 son resides or has its principal place of business, or

4 in the United States Court of Appeals for the Dis5 trict of Columbia Circuit, within 60 days after publi6 cation of the regulation or order under such sub7 section.

8 ‘‘(2) REVIEW OF DATA.—

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

10 a person without an economic interest) may ob11 tain judicial review, of the adequacy of the data

12 made available by the Administrator under sub13 section (h) to support the issuance of a toler14 ance or exemption for a pesticide chemical resi15 due, by filing a petition for the review of the

16 data in the United States Court of Appeals for

17 the circuit in which such person resides or has

18 its principal place of business, or in the United

19 States Court of Appeals for the District of Co20 lumbia Circuit.

21 ‘‘(B) SCOPE OF REVIEW.—Review in a pro22 ceeding initiated under this paragraph shall be

23 limited to whether the data under review are

24 adequate to demonstrate that the tolerance or

25 exemption supported by such data meets the
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1 standards required by subsection (b)(2) or

2 (c)(2) and interpreted by the guidelines issued

3 under subsection (b)(3) or (c)(3). Unless the

4 court determines that such data are adequate,

5 the court shall revoke the tolerance or exemp6 tion supported by such data.

7 ‘‘(C) BURDEN OF PROOF.—In any such

8 proceeding the Administrator shall have the

9 burden of proof on all issues.

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

11 seeking judicial review of actions under this section,

12 the court shall have the principal responsibility for

13 deciding issues of law.

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

15 prevails in a proceeding brought under this section

16 shall be entitled to recover reasonable attorney fees

17 and expenses (including expert witness fees).

18 ‘‘(m) DEFINITIONS.—For purposes of this section,

19 the terms ‘modify’ and ‘modification’ mean the lowering

20 of a tolerance for a pesticide chemical residue.’’.

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

22 U.S.C. 333) is amended by adding at the end the follow23 ing:

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

25 under section 408(b)(2) for a food at the time the food
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1 is purchased at retail shall not be subject to any penalty

2 under this section.’’.

3 SEC. 4. EVALUATION OF EXISTING PESTICIDE CHEMICAL

4 RESIDUE TOLERANCES AND EXEMPTIONS.

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

6 enactment of this Act, the Administrator of the Environ7 mental Protection Agency shall, for each pesticide chemi8 cal residue that has a tolerance or exemption in effect

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

10 all available data with respect to the safety of such pes11 ticide chemical residue and the nature and amount of such

12 residue remaining in or on foods and determine if—

13 (1) the tolerance or exemption meets the re14 quirements of subsection (b)(2) or (c)(2) of section

15 408 of such Act;

16 (2) the tolerance or exemption does not meet

17 such requirements; or

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

19 tolerance or exemption meets such requirements.

20 (b) SUFFICIENT DATA.—

21 (1) ACCEPTABLE RISK DATA.—If, with respect

22 to any pesticide chemical residue that is evaluated

23 under subsection (a), the Administrator finds that

24 data for the pesticide chemical residue are sufficient

25 to determine that the tolerance or exemption for the
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1 pesticide chemical residue meets the standard under

2 section 408(b)(2) or 408(c)(2) of such Act, the Ad3 ministrator shall publish such finding.

4 (2) UNACCEPTABLE RISK DATA.—If, with re5 spect to any pesticide chemical residue that is evalu6 ated under subsection (a), the Administrator finds

7 that data for the pesticide chemical residue are suffi8 cient to determine that the tolerance or exemption

9 for the pesticide chemical residue does not meet the

10 standard under section 408(b)(2) or 408(c)(2) of

11 such Act, the Administrator shall, within 1 year of

12 the date of such finding, modify or revoke the toler13 ance.

14 (3) INSUFFICIENT DATA.—

15 (A) GENERAL RULE.—

16 (i) SUBMISSION OF DATA.—If, with

17 respect to any pesticide chemical residue

18 that is evaluated under subsection (a), the

19 Administrator determines that the data are

20 insufficient to determine whether the toler21 ance or exemption meets the requirements

22 of section 408(b)(2) or 408(c)(2) of such

23 Act, the Administrator shall establish a

24 schedule for the submission of data in ac25 cordance with the requirements of sections
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1 408(e)(2)(B) and 408(e)(3) of such Act,

2 which data shall be the basis for a deter3 mination by the Administrator as to

4 whether the tolerance or exemption meets

5 the standard prescribed by section

6 408(b)(2) or 408(c)(2) of such Act.

7 (ii) DETERMINATIONS.—The Adminis8 trator shall—

9 (I) within 2 years of the date of

10 the enactment of this Act, make such

11 a determination respecting a tolerance

12 or exemption meeting a standard

13 under section 408 of such Act for at

14 least 30 percent of the tolerances or

15 exemptions in effect for pesticide

16 chemical residues in existence on such

17 date;

18 (II) within 4 years of the date of

19 the enactment of this Act, make such

20 a determination for at least 60 per21 cent of the tolerances or exemptions

22 in effect for pesticide chemical resi23 dues in existence on such date;

24 (III) within 6 years of the date of

25 the enactment of this Act, make such
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1 a determination for at least 90 per2 cent of the tolerances or exemptions

3 in effect for pesticide chemical resi4 dues in existence on such date; and

5 (IV) within 7 years of the date of

6 the enactment of this Act, make such

7 a determination for 100 percent of the

8 tolerances or exemptions in effect for

9 pesticide chemical residues in exist10 ence on such date.

11 (iii) DEADLINES.—Section 408(e)(4)

12 of such Act shall apply to the deadlines es13 tablished by such schedule.

14 (B) PRIORITIES.—In establishing such

15 schedule, the Administrator shall give priority

16 to the consideration of any pesticide chemical

17 residue for which there is reason to believe that

18 the tolerance or exemption in effect for such

19 residue may present a risk greater than the

20 negligible risk standard prescribed by section

21 408(b)(2) or 408(c)(2) of such Act.

22 (C) ACTION BY THE ADMINISTRATOR.—If

23 the Administrator determines under subpara24 graph (A) that a tolerance or exemption does

25 not meet the standard under section 408(b)(2)
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1 or 408(c)(2) of such Act after the submission of

2 data in accordance with the schedule prescribed

3 by such subparagraph, the Administrator shall

4 take the action described in section

5 408(e)(2)(A) of such Act with respect to such

6 tolerance or exemption.

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

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

9 of the enactment of this Act, the Administrator of the En10 vironmental Protection Agency shall determine, for each

11 method of detecting and measuring levels of pesticide

12 chemical residues, whether the requirements of section

13 408(b)(2)(G) of the Federal Food, Drug, and Cosmetic

14 Act have been met.

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

16 identifying each pesticide chemical for which there is such

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

18 method that does not meet such requirements shall be re19 vised so that the method meets such requirements within

20 3 years of the date of the issuance of the notice.

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

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

23 then any tolerance or exemption in effect for the pesticide

24 chemical residue subject to such method shall be consid25 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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