II

103D CONGRESS

2D SESSION S. 2084

To amend the Federal Food, Drug, and Cosmetic Act, and for other purposes.

IN THE SENATE OF THE UNITED STATES

MAY 5 (legislative day, MAY 2), 1994

Mr. KENNEDY introduced the following bill; which was read twice and referred

to the Committee on Labor and Human Resources

A BILL

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

for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CON4 TENTS.

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

6 ‘‘Pesticide Reform Act of 1994’’.

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. 408. Tolerances and exemptions for pesticide chemical residues.

‘‘(a) Requirement for tolerance or exemption.

‘‘(b) Tolerances.

‘‘(c) Exemptions.

‘‘(d) Petitions and action on the initiative of the Administrator.

‘‘(e) Temporary tolerance or exemption.

‘‘(f) Confidentiality of data.

‘‘(g) Existing pesticide chemical residues.

‘‘(h) Food and Drug Administration monitoring of pesticide chemical

residues.

‘‘(i) Fees.

‘‘(j) Judicial review’’.

Sec. 4. Embargo authority.

Sec. 5. Civil Money Penalties.

Sec. 6. Recall.

Sec. 7. Evaluation of existing pesticide chemical residue tolerances and exemptions.

Sec. 8. Fees.

Sec. 9. 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 any sub10 stance that is a pesticide, as defined in section 2(u) of

11 the Federal Insecticide, Fungicide, and Rodenticide Act

12 (7 U.S.C. 136(u)), including each active ingredient and

13 inert ingredient, as defined in paragraphs (a) and (m) of

14 section 2 of such 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 a component of

4 such chemical; or

5 ‘‘(B) any other substance that is present in or

6 on the commodity or food as a result of the metabo7 lism or other degradation of a pesticide chemical.’’.

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 (3) RAW AGRICULTURAL COMMODITY.—Para17 graph (r) of section 201 (21 U.S.C. 321) is repealed.

18 (b) CONFORMING AMENDMENTS.—

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

20 adding at the end the following:

21 ‘‘(gg) The term ‘Administrator’ means the Adminis22 trator of the Environmental Protection Agency.’’.

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

24 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 bears or contains a pesticide chemical resi5 due that is unsafe within the meaning of sec6 tion 408(a);’’; and

7 (C) in clause (C), by striking ‘‘: Provided,

8 That where a pesticide chemical’’ through ‘‘sec9 tion 512’’.

10 (3) Section 403(l) (21 U.S.C. 343(l)) is amend11 ed by striking ‘‘raw agricultural commodity’’ and

12 ‘‘commodity’’ each time it occurs and inserting

13 ‘‘food’’.

14 SEC. 3. TOLERANCES AND EXEMPTIONS FOR PESTICIDE

15 CHEMICAL RESIDUES.

16 Section 408 (21 U.S.C. 346a) is amended to read as

17 follows:

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

19 CHEMICAL RESIDUES.

20 ‘‘(a) REQUIREMENT FOR TOLERANCE OR EXEMP21 TION.—

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

23 residue shall be deemed unsafe for the purpose of

24 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 such residue con3 forms with such tolerance; or

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

5 effect under this section and such residue con6 forms 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).

15 ‘‘(3) DERIVED FOOD.—A tolerance or exemp16 tion for a pesticide chemical residue established for

17 a food shall apply to all foods derived from such

18 food unless a tolerance specifies otherwise.

19 ‘‘(b) TOLERANCES.—

20 ‘‘(1) AUTHORITY.—

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

22 may promulgate regulations establishing, modi23 fying, or revoking a tolerance for a pesticide

24 chemical residue—
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1 ‘‘(i) in response to a petition filed

2 under subsection (d)(1); or

3 ‘‘(ii) on the initiative of the Adminis4 trator under subsection (d)(4).

5 ‘‘(B) EXPIRATION DATE.—A regulation

6 under this paragraph shall contain an expira7 tion date for a tolerance for a pesticide chemi8 cal established by the regulation. Such date

9 shall be not later than—

10 ‘‘(i) the expiration date (if any) for

11 such pesticide chemical established by the

12 Administrator under section 3 of the Fed13 eral Insecticide, Fungicide, and

14 Rodenticide Act, or

15 ‘‘(ii) 18 years after the date such tol16 erance is established, whichever occurs

17 first.

18 ‘‘(C) SEPARATE TOLERANCES.—Under

19 subparagraph (A), the Administrator may es20 tablish a separate tolerance, which more closely

21 reflects actual exposure or which is necessary

22 for more efficient enforcement, and which is

23 based on reliable data and information relating

24 to the appropriate sampling, for a pesticide

25 chemical residue with respect to food at any
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1 point in the chain of production or marketing,

2 including—

3 ‘‘(i) at the time the food is harvested,

4 ‘‘(ii) at the time the food is purchased

5 at retail, and

6 ‘‘(iii) after the food is processed.

7 ‘‘(2) STANDARD.—

8 ‘‘(A) ASSURANCE OF SAFETY.—

9 ‘‘(i) GENERAL RULE.—A tolerance for

10 a pesticide chemical residue in or on food

11 shall not be established or left in effect un12 less the residue permitted under the toler13 ance is safe.

14 ‘‘(ii) CANCER.—For pesticides found

15 to induce cancer when ingested by humans

16 or animals or determined on the basis of

17 reliable scientific evidence to pose a poten18 tial dietary risk of cancer in humans, a tol19 erance shall not be established or left in ef20 fect unless the Administrator finds on the

21 basis of conservative methods of risk as22 sessment that the risk is negligible for all

23 anticipated consumer exposures to such

24 residue, including all other anticipated

25 consumer exposures for which there is reli-
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1 able information, and taking into account

2 information concerning the special

3 vulnerabilities of children and sensitive

4 subpopulations.

5 ‘‘(iii) RISK OTHER THAN CANCER.—

6 For pesticide chemical residues that may

7 pose a potential dietary risk of adverse

8 health effects other than cancer in hu9 mans, a tolerance shall provide an ample

10 margin of safety.

11 ‘‘(iv) DEFINITIONS.—As used in this

12 section:

13 ‘‘(I) SAFE.—The term ‘safe’

14 means with respect to a tolerance for

15 a pesticide chemical residue that there

16 is a reasonable certainty that no harm

17 will result from all anticipated

18 consumer exposures to such residue,

19 including all anticipated dietary expo20 sures and all other anticipated expo21 sures for which there is reliable infor22 mation, and taking into account infor23 mation concerning the special

24 vulnerabilities of children and sen25 sitive subpopulations.
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1 ‘‘(II) MARGIN OF SAFETY.—A

2 margin of safety is considered ample

3 if the Administrator determines there

4 is a reasonable certainty of no harm

5 to significant subpopulations from ex6 posure to the pesticide chemical resi7 due in the diet and from exposure to

8 the pesticide chemical by other path9 ways. In making this determination,

10 the Administrator shall give due con11 sideration to the exposure level which

12 is determined not to cause adverse ef13 fects in animal studies or in observa14 tions of exposed humans and to the

15 application of appropriate factors.

16 These factors may include factors to

17 account for differences in sensitivity

18 between and within species, adequacy

19 of the study or studies, and complete20 ness of the available data to assess

21 potential for adverse effects.

22 ‘‘(III) RISK ASSESSMENT PROCE23 DURES.—The Administrator shall pe24 riodically review the risk assessment

25 procedures used to make safety deter-
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1 minations under this paragraph, in2 cluding methodologies with respect to

3 estimating exposure to pesticide

4 chemicals and evaluating risks to sig5 nificant subpopulations. The Adminis6 trator periodically shall revise the risk

7 assessment procedures accordingly to

8 incorporate advances in science and

9 risk assessment. The Administrator

10 may determine that a method of risk

11 assessment different from the method

12 required by subclause (II) is appro13 priate if the Administrator finds that

14 the alternative risk assessment meth15 od will fully protect the public health.

16 ‘‘(B) FACTORS.—In determining whether

17 to establish, modify, or revoke a tolerance under

18 subparagraph (A) for a pesticide chemical resi19 due on a food, the Administrator—

20 ‘‘(i) except as provided in clause (ii),

21 shall in estimating the anticipated dietary

22 exposure to such residue assume that all

23 food for which the pesticide chemical resi24 due has or will have a tolerance bears or

25 contains residues of the pesticide chemical
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1 equal to the levels established by their re2 spective tolerances and where separate tol3 erances for a pesticide chemical residue in

4 the same food are established for different

5 points in the chain of production or mar6 keting pursuant to subsection (b)(1)(C),

7 the Administrator shall assume that the

8 food bears or contains residues of the pes9 ticide chemical equal to the level estab10 lished by the tolerance set at the point

11 closest to the time the food is purchased at

12 retail;

13 ‘‘(ii) may use data regarding the per14 cent of a crop treated by a pesticide chemi15 cal to estimate dietary exposure to such

16 residue only if the Administrator—

17 ‘‘(I) finds that the data are reli18 able and provide a valid basis to show

19 what percentage of the food derived

20 from such crop is likely to contain

21 such pesticide chemical residue;

22 ‘‘(II) finds that the exposure esti23 mate does not understate exposure for

24 any significant subpopulation group;
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1 ‘‘(III) if data are available on

2 pesticide use and consumption of food

3 in a particular area, finds that the

4 population in such area is not

5 dietarily exposed to residues above

6 those estimated by the Administrator;

7 and

8 ‘‘(IV) provides for the periodic

9 reevaluation of the estimate of antici10 pated dietary exposure;

11 ‘‘(iii) shall fully account for available

12 information on the probable consumption

13 of foods for which there is or will be a tol14 erance for residues of the pesticide chemi15 cal, including, to the extent possible, con16 sumption by significant subpopulations

17 with differing food consumption patterns,

18 including infants, children, and other sub19 populations with disproportionately high

20 consumption of particular foods;

21 ‘‘(iv) shall fully account for available

22 information on the cumulative effect of

23 such residue and any chemically or phar24 macologically related substances in the

25 human diet, and other ways in which the
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1 consumer may be exposed to such residue

2 and substances, including, to the extent

3 representative data permit, through drink4 ing water;

5 ‘‘(v) shall fully account for valid sci6 entific information regarding any estro7 genic or other hormonal effects associated

8 with the residue; and

9 ‘‘(vi) shall apply safety factors which

10 after consultation with experts qualified by

11 scientific training and experience to evalu12 ate the safety of pesticide chemical resi13 dues determine are appropriate for use in

14 connection with animal experimentation or

15 other relevant data.

16 ‘‘(C) EXPOSURE OF INFANTS AND CHIL17 DREN.—In determining whether to establish,

18 modify, or revoke a tolerance for a pesticide

19 chemical residue, the Administrator, in addition

20 to the requirements of subparagraph (B)—

21 ‘‘(i) shall assess the risk of the pes22 ticide chemical residue based on the follow23 ing:

24 ‘‘(I) Available information about

25 consumption patterns among infants
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1 and children that are likely to result

2 in disproportionately high consump3 tion of foods containing or bearing

4 such residue among infants and chil5 dren in comparison to the general

6 population.

7 ‘‘(II) Available information con8 cerning the special susceptibility of in9 fants and children to the pesticide

10 chemical residues, including neuro11 logical differences between infants and

12 children and adults, and effects of in

13 utero exposure to pesticide chemicals.

14 ‘‘(III) Available information con15 cerning the cumulative effects on in16 fants and children of such residues

17 and other substances that have a com18 mon mechanism of toxicity;

19 ‘‘(ii) shall—

20 ‘‘(I) ensure that there is an

21 ample margin of safety for infants

22 and children and impose other re23 quirements necessary to ensure that

24 exposure to the pesticide chemical res25 idue will be safe; and
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1 ‘‘(II) publish a specific deter2 mination regarding the safety of the

3 pesticide chemical residue for infants

4 and children.

5 The Secretary of Health and Human Services

6 and the Secretary of Agriculture, in consulta7 tion with the Administrator, shall conduct sur8 veys to document dietary exposure to pesticides

9 among infants and children. For the purpose of

10 subclause (I), an additional tenfold margin of

11 safety for the pesticide chemical residue and

12 other sources of exposure shall be applied for

13 children and infants to take into account poten14 tial pre- and post-natal toxicity and complete15 ness of the data with respect to exposure to in16 fants and children. Notwithstanding this re17 quirement for an additional factor, the Admin18 istrator may determine that a margin of safety

19 for a pesticide chemical residue is considered

20 ample for children and infants if, on the basis

21 of reliable data, such margin will fully protect

22 the public health.

23 ‘‘(D) UNAVOIDABLE PERSISTENCE.—If a

24 tolerance or an exemption from the requirement

25 for a tolerance for a pesticide chemical residue
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1 is revoked and the Administrator finds the pes2 ticide chemical residue will unavoidably persist

3 in the environment and be found in food, the

4 Administrator shall establish a new tolerance

5 under subsection (d)(4) for the pesticide chemi6 cal residue. The level permitted by the tolerance

7 shall not be greater than and may be less than

8 the lowest level that permits only such unavoid9 able levels to remain in food. The Administrator

10 shall evaluate any such tolerance at least every

11 five years to determine whether modification of

12 such tolerance is necessary so that the tolerance

13 provides only for no greater than the level of

14 the pesticide chemical residue that is unavoid15 able.

16 ‘‘(E) PRACTICAL METHODS OF ANALY17 SIS.—

18 ‘‘(i) GENERAL RULE.—Except as pro19 vided in clause (ii), a tolerance for a pes20 ticide chemical residue shall not be estab21 lished or left in effect unless the Adminis22 trator determines, after consultation with

23 the Secretary, that—

24 ‘‘(I) there is a multiresidue meth25 od for detecting and measuring the
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1 levels of such pesticide chemical resi2 due in or on a food that will measure

3 the residue at the level established by

4 the tolerance; and

5 ‘‘(II) such method can be per6 formed by the Secretary on a routine

7 basis as part of surveillance and com8 pliance sampling of foods for pesticide

9 chemical residues with the personnel,

10 equipment, and other resources avail11 able to the Secretary.

12 ‘‘(ii) EXCEPTION.—If the Adminis13 trator is not able to make the determina14 tion described in clause (i), the Adminis15 trator shall identify, after consultation

16 with the Secretary, the method for detect17 ing and measuring levels of such pesticide

18 chemical residue in or on a food that will

19 measure the residue at the level established

20 by the tolerance. The Administrator shall,

21 every two years after the date of the deter22 mination under this clause, reevaluate the

23 determination.

24 ‘‘(iii) PESTICIDE REFERENCE STAND25 ARD.—
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1 ‘‘(I) PROVISION TO THE ADMIN2 ISTRATOR.—A registrant of a pes3 ticide chemical for which a tolerance

4 has been established shall provide the

5 Administrator, upon request, with an

6 appropriate pesticide reference stand7 ard for such pesticide chemical, in8 cluding standards for all residues of

9 toxicological significance. Each pes10 ticide reference standard provided to

11 the Administrator shall be certified by

12 a competent laboratory for both iden13 tity and purity.

14 ‘‘(II) ADMINISTRATOR AC15 TIONS.—The Administrator shall

16 maintain a repository of pesticide ref17 erence standards, audit the certifi18 cation of such standards, and make

19 such standards available to any pri20 vate, public, domestic, or foreign lab21 oratory requesting the standard. The

22 Administrator may also request pes23 ticide reference standards for pesticide

24 chemical manufactured or used in for25 eign countries. To the extent that the
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1 Administrator obtains standards for

2 pesticide chemicals manufactured or

3 used in foreign countries, the Admin4 istrator shall certify such standards

5 for identity and purity and make

6 them available to any private, public,

7 domestic, or foreign laboratory re8 questing such standard.

9 ‘‘(III) DEFINITION.—For pur10 poses of this clause, the term ‘pes11 ticide reference standard’ means a

12 pesticide chemical of known identity,

13 purity, and composition that is re14 quired for comparison purposes in lab15 oratory analysis to measure the

16 amount and confirm the identity of a

17 pesticide chemical residue in food.

18 ‘‘(3) CONSISTENT APPLICATION.—The Adminis19 trator shall issue guidelines providing for the con20 sistent application of the requirements of paragraphs

21 (1) and (2). The lack of guidelines does not affect

22 the authority of the Administrator to implement

23 such paragraphs.

24 ‘‘(4) REEVALUATION PERIOD.—Each tolerance

25 for a pesticide chemical residue established under
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1 this subsection shall prescribe the period (at least

2 every five years) for reevaluating the estimate of the

3 amount of dietary exposure to such residue made

4 under paragraph (2)(B)(ii).

5 ‘‘(5) TOLERANCES IN EFFECT ON DATE OF EN6 ACTMENT.—For pesticide chemical residue toler7 ances in effect on the date of enactment of the Pes8 ticide Reform Act of 1994 this subsection shall

9 apply as prescribed by section 7 of such Act.

10 ‘‘(c) EXEMPTIONS.—

11 ‘‘(1) AUTHORITY.—

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

13 may promulgate regulations establishing or re14 voking an exemption from the requirement for

15 a tolerance for a pesticide chemical residue—

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

17 under subsection (d)(1); or

18 ‘‘(ii) on the initiative of the Adminis19 trator under subsection (d)(4).

20 ‘‘(B) EXPIRATION DATE.—Such a regula21 tion may provide for an expiration date for the

22 exemption.

23 ‘‘(2) STANDARD.—

24 ‘‘(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 presents no risk to

5 human health at any level that is reason6 ably likely to occur under extreme condi7 tions of use, including the health of the

8 subpopulations identified in subsection

9 (b)(2)(B)(iii), from dietary exposure to

10 such residue.

11 ‘‘(ii) REVOCATION.—An exemption

12 shall be revoked unless the residue is not

13 a human or an animal carcinogen and oth14 erwise presents no risk to human health at

15 any level that is reasonably likely to occur

16 under extreme conditions of use, including

17 the health of subpopulations identified in

18 subsection (b)(2)(B)(iii), from dietary ex19 posure to such residue.

20 ‘‘(B) EXPOSURE.—For purposes of sub21 paragraph (A), in determining dietary exposure

22 to a pesticide chemical residue, the Adminis23 trator shall—

24 ‘‘(i) use only reliable information re25 garding the dietary exposure resulting
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1 from the consumption of the food for

2 which the exemption for such residue is

3 proposed or is in effect;

4 ‘‘(ii) fully account for all other exemp5 tions in effect for such residue;

6 ‘‘(iii) fully account for all other

7 sources of dietary exposure to the pesticide

8 chemical and to chemically or pharma9 cologically related chemicals if there is ade10 quate information about such sources of

11 exposure; and

12 ‘‘(iv) consider the exposure to be the

13 level of exposure that would occur if

14 human exposure to the pesticide chemical

15 residue at the level that is reasonably likely

16 to occur under extreme conditions of use

17 occurs for a period equal to a lifetime.

18 ‘‘(3) CONSISTENT APPLICATION.—The Adminis19 trator shall issue guidelines providing for the con20 sistent application of the requirements of paragraphs

21 (1) and (2). The lack of guidelines does not affect

22 the authority of the Administrator to implement

23 such paragraphs.

24 ‘‘(4) EXEMPTIONS IN EFFECT ON DATE OF EN25 ACTMENT.—For pesticide chemical residue exemp-
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1 tions in effect on the date of enactment of the Pes2 ticide Reform Act of 1994 this subsection shall

3 apply as prescribed by section 7 of such Act.

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

5 THE ADMINISTRATOR.—

6 ‘‘(1) GENERAL RULE.—Any person may file

7 with the Administrator a petition proposing the issu8 ance of a regulation establishing, modifying, or re9 voking a tolerance or exemption for a pesticide

10 chemical residue. Sections 553 and 554 of title 5,

11 United State Code, shall not apply with respect to

12 procedures concerning such petitions.

13 ‘‘(2) REQUIREMENTS FOR PETITIONS.—A peti14 tion under paragraph (1) to establish a tolerance or

15 exemption for a pesticide chemical residue shall con16 tain—

17 ‘‘(A) an informative summary of the peti18 tion and of the data, information, and argu19 ments submitted or cited in support of the peti20 tion, including—

21 ‘‘(i) a summary of the reports re22 quired under subparagraph (D); and

23 ‘‘(ii) a characterization of—

24 ‘‘(I) the exposure to the pesticide

25 chemical residue due to any tolerance
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1 or exemption already granted for such

2 residue; and

3 ‘‘(II) the additional exposure to

4 such residue that would result if the

5 requested tolerance or exemption were

6 granted;

7 ‘‘(B) a proposed tolerance for such residue,

8 if a tolerance is proposed;

9 ‘‘(C) the name, chemical identity, and com10 position of the pesticide chemical that produces

11 such residue;

12 ‘‘(D) reports of tests and investigations

13 made with respect to the safety of such pes14 ticide chemical residue, including complete in15 formation as to the methods and controls used

16 in conducting such tests and investigations;

17 ‘‘(E) data showing the amount, frequency,

18 method, and time of application of such pes19 ticide chemical;

20 ‘‘(F) reports of tests and investigations

21 made with respect to the nature and amount of

22 the pesticide chemical residue that is likely to

23 remain in or on food when ready for sale to

24 consumers, including a description of the ana25 lytical methods used;
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1 ‘‘(G) a description of methods for detecting

2 and measuring the levels of such chemical resi3 due in or on the food, which methods meet the

4 requirements of subsection (b)(2)(E);

5 ‘‘(H) reports of investigations conducted

6 on the effects of processing methods used to

7 produce food on the level and identity of such

8 pesticide chemical residue;

9 ‘‘(I) if the petition is for a pesticide chemi10 cal residue that is described in subsection

11 (b)(2)(A)(ii), all relevant data bearing on the

12 physical or other technical effect the pesticide

13 chemical involved is intended to have and the

14 quantity of the pesticide chemical residue re15 quired to accomplish such effect;

16 ‘‘(J) the pesticide reference standard (as

17 defined in subsection (b)(2)(E)(iii)) for the pes18 ticide chemical residue;

19 ‘‘(K) such other data and information as

20 the Administrator may require to support the

21 petition; and

22 ‘‘(L) the data referred to in subsection

23 (b)(2)(B)(ii)(III) if available.

24 ‘‘(3) ACTIONS ON PETITIONS.—

25 ‘‘(A) FILING DETERMINATION.—
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1 ‘‘(i) IN GENERAL.—Within 45 days of

2 the filing of a petition under paragraph (1)

3 for the establishment, modification, or rev4 ocation of a tolerance or an exemption, the

5 Administrator shall determine if the peti6 tion complies with the requirements of

7 paragraph (2) or applicable requirements

8 for petitions to modify or revoke tolerances

9 or exemptions from tolerances. If the Ad10 ministrator determines that the petition

11 complies with such requirements, the Ad12 ministrator shall publish a notice of the fil13 ing of the petition. If the Administrator

14 determines that the petition does not com15 ply with such requirements, the Adminis16 trator shall notify the petitioner of such

17 determination.

18 ‘‘(ii) CONTENTS OF NOTICE OF FIL19 ING.—A notice under clause (i) shall—

20 ‘‘(I) if it is a notice of the filing

21 of a petition to establish a tolerance

22 or exemption, announce the availabil23 ity of a complete description of the

24 analytical methods available to the

25 Administrator for the detection and
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1 measurement of the pesticide chemical

2 residue with respect to which the peti3 tion is filed and include the summary

4 required by paragraph (2)(A); and

5 ‘‘(II) if it is a notice of the filing

6 of a petition to modify or revoke a tol7 erance or exemption, contain the full

8 petition or a summary of the petition.

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

10 within one year of the publication of a notice

11 under subparagraph (A) with respect to a peti12 tion, and after giving due consideration to the

13 petition, any comments on the petition, and any

14 other information available to the Adminis15 trator—

16 ‘‘(i) issue a final regulation in accord17 ance with the petition establishing, modify18 ing, or revoking a tolerance or exemption

19 for the pesticide chemical residue;

20 ‘‘(ii) issue a proposed regulation es21 tablishing, modifying, or revoking a toler22 ance or exemption for the pesticide chemi23 cal residue, which tolerance or exemption

24 is different from the tolerance or exemp25 tion requested in the petition; or
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1 ‘‘(iii) issue an order denying the peti2 tion.

3 ‘‘(C) COMMENTS.—If the Administrator is4 sues a notice of the filing of a petition under

5 subparagraph (A)(i) or a proposed regulation

6 under subparagraph (B)(ii), the Administrator

7 shall allow at least thirty days for comments on

8 such notice or proposed regulation.

9 ‘‘(D) FINAL REGULATION.—If the Admin10 istrator issues a proposed regulation under sub11 paragraph (B)(ii), the Administrator shall issue

12 a final regulation within one hundred and

13 eighty days of the date of the publication of the

14 proposed regulations.

15 ‘‘(E) PRIORITIES.—The Administrator

16 shall give priority to petitions for the establish17 ment or modification of a tolerance for a pes18 ticide chemical residue that appears to pose a

19 significantly lower risk to human health from

20 dietary exposure than pesticide chemical resi21 dues that have tolerances in effect for the same

22 or similar uses.

23 ‘‘(4) ACTION ON THE ADMINISTRATOR’S INITIA24 TIVE.—
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1 ‘‘(A) GENERAL RULE.—The Administrtor

2 may, on the initiative of the Administrator,

3 issue a final regulation establishing, modifying,

4 or revoking a tolerance or exemption for a pes5 ticide chemical residue.

6 ‘‘(B) NOTICE.—Before issuing a final reg7 ulation under subparagraph (A), the Adminis8 trator shall issue a notice of proposed rule9 making and provide a period of not less than

10 thirty days for public comment on the proposed

11 regulation unless the Administrator finds that

12 such notice and comment would be contrary to

13 the public interest and states the reasons for

14 the finding in the notice of the final regulation.

15 If the Administrator makes such a finding and

16 issues such a regulation, the Administrator

17 shall provide at least thirty days for comment

18 on the regulation after it is issued.

19 ‘‘(5) EFFECTIVE DATE.—

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

21 in subparagraph (B), a final regulation issued

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

23 upon publication.

24 ‘‘(B) DELAY.—
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1 ‘‘(i) GENERAL RULE.—If a regulation

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

3 or modifies a tolerance for a pesticide

4 chemical residue or revokes an exemption

5 for a pesticide chemical residue, the Ad6 ministrator may, in accordance with clause

7 (ii), delay the effective date of the regula8 tion to permit the tolerance or exemption

9 to remain in effect at a level not to exceed

10 the level in effect immediately before such

11 regulation is issued only—

12 ‘‘(I) for foods that contain such

13 pesticide chemical residue in an

14 amount that is not more than the

15 amount that would remain if the pes16 ticide chemical had been legally ap17 plied on the date the Administrator

18 acted under paragraph (3) or (4); and

19 ‘‘(II) if dietary exposure to the

20 pesticide chemical residue in or on the

21 foods described in subclause (I) is safe

22 during the period of delay of the effec23 tive date.

24 ‘‘(ii) PERIOD OF DELAY.—If the Ad25 ministrator finds that delay of the effective
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1 date of such a revocation or modification is

2 consistent with the public health, the Ad3 ministrator may delay such date under

4 clause (i), for each type of food that con5 tains such pesticide chemical residue, for

6 the period that is required for such food to

7 be sold to consumers in the course of the

8 usual practice for persons engaged in the

9 production, processing, transportation,

10 storage, and distribution of the food.

11 ‘‘(6) REQUIRED SUBMISSION OF DATA.—

12 ‘‘(A) GENERAL RULE.—If the Adminis13 trator finds that additional data are required to

14 determine whether an existing tolerance or ex15 emption from a tolerance meets the safety

16 standard in subsection (b)(2) or (c)(2), the Ad17 ministrator shall publish an order—

18 ‘‘(i) requiring one or more interested

19 persons to notify the Administrator that

20 such person will submit the required data;

21 ‘‘(ii) describing the type of data re22 quired to be submitted;

23 ‘‘(iii) describing the reports required

24 to be made during and after the collection

25 of the data; and
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1 ‘‘(iv) establishing deadlines for the ac2 tions described in clauses (i), (ii), and (iii).

3 ‘‘(B) DEADLINES.—If an order is issued

4 under subparagraph (A) with respect to a toler5 ance or an exemption and the Administrator

6 finds that a deadline or other condition in the

7 order is not met, the Administrator may revoke,

8 pursuant to the procedures in paragraph (4),

9 the tolerance or exemption for failure to comply

10 with such order.

11 ‘‘(C) EXTENSIONS.—

12 ‘‘(i) EXTENSION REQUEST.—Any per13 son may request the Administrator to issue

14 an order to extend the schedule established

15 under subparagraph (A) before the expira16 tion of a deadline in the schedule.

17 ‘‘(ii) GRANT OF REQUEST.—The Ad18 ministrator may grant a request under

19 clause (i) only if the Administrator finds

20 that extraordinary circumstances beyond

21 the control of such person prevented such

22 person from submitting the required data.

23 ‘‘(iii) EXTENSION.—If the Adminis24 trator issues an order extending a sched25 ule, the Administrator may extend the
33

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1 deadline for a period no longer than such

2 time as is necessary for such person to

3 submit the data.

4 ‘‘(7) TOLERANCE FOR USE OF PESTICIDES

5 UNDER AN EMERGENCY EXEMPTION.—If the Admin6 istrator grants an exemption under section 18 of the

7 Federal Insecticide, Fungicide, and Rodenticide Act

8 (7 U.S.C. 136p) for a pesticide chemical, the Admin9 istrator shall establish a tolerance or exemption from

10 a tolerance for the residue of the pesticide chemical.

11 Such a tolerance or exemption from a tolerance shall

12 have an expiration date. The Administrator may es13 tablish such a tolerance or exemption without pro14 viding notice or a period for comment on the toler15 ance or exemption. The Administrator shall promul16 gate regulations within 365 days after the date of

17 the enactment of this paragraph governing the es18 tablishment of tolerances and exemptions under this

19 paragraph. Such regulations shall be consistent with

20 the safety standard under subsection (b)(2) and with

21 section 18 of the Federal Insecticide, Fungicide, and

22 Rodenticide Act.

23 ‘‘(e) EXPERIMENTAL PERMITS.—To the extent con24 sistent with the public health, the Administrator shall pro25 mulgate regulations for exempting from the operation of
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1 this section new pesticide chemicals intended solely for in2 vestigational use by experts qualified by scientific training

3 and experience to investigate the safety of pesticide chemi4 cals. Such regulations may, in the discretion of the Admin5 istrator, among other conditions relating to the protection

6 of the public health, provide for—

7 ‘‘(1) conditioning such exemption upon the es8 tablishment and maintenance of such records, and

9 ‘‘(2) the making of such reports to the Sec10 retary, by the manufacturer or the sponsor of the in11 vestigation of such article, of data (including analyt12 ical reports by investigators) obtained as a result of

13 such investigational use of such article, as well as

14 enable the Administrator to evaluate the safety of

15 such article in the event of the filing of an applica16 tion pursuant to this section. Such regulations,

17 among other things, shall set forth the conditions (if

18 any) upon which food treated with such pesticide

19 chemicals may be marketed for food use.

20 ‘‘(f) CONFIDENTIALITY OF DATA.—

21 ‘‘(1) ACCESS TO DATA AND INFORMATION.—

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

23 in paragraphs (2) and (3), the Administrator

24 shall not make public data or information sub25 mitted to the Administrator or cited to the Ad-
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1 ministrator in a petition under subsection

2 (d)(1) and data and information otherwise con3 sidered by the Administrator in issuing a pro4 posed or final regulation or order under this

5 section which contains or relates to trade se6 crets or commercial or financial information ob7 tained from a person and is privileged or con8 fidential. The person submitting information

9 which they believe is privileged or confidential

10 information shall notify the Administrator of

11 such information. If a notice is not made to the

12 Administrator, the Administrator may make

13 such information public.

14 ‘‘(B) NOTICE.—Except as to data or infor15 mation disclosed under paragraph (2), thirty

16 days before disclosing data or information

17 claimed as privileged or confidential under sub18 paragraph (A), the Administrator shall notify

19 the person who submitted or cited the data or

20 information of the intent to disclose the data or

21 information to the public.

22 ‘‘(2) AUTHORIZED DISCLOSURE FOR GOVERN23 MENTAL PURPOSES.—Data and information that are

24 entitled to confidential treatment under paragraph

25 (1)—
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1 ‘‘(A) shall be disclosed to either House of

2 Congress, to the extent of matter within its ju3 risdiction, to any committee or subcommittee of

4 the Congress, and to any joint committee of the

5 Congress or subcommittee of such a joint com6 mittee and to the Comptroller General of the

7 United States;

8 ‘‘(B) shall be disclosed to any officer or

9 employee of the United States or of any

10 State—

11 ‘‘(i) in connection with the official du12 ties of such officer or employee under any

13 law for the protection of health or the envi14 ronment, or

15 ‘‘(ii) for specific law enforcement pur16 poses;

17 ‘‘(C) shall be disclosed, under such security

18 requirements as the Administrator may provide,

19 to contractors with the United States and em20 ployees of such contractors, if such disclosure is

21 necessary for the satisfactory performance by

22 the contractor of a contract with the United

23 States or for work in connection with this sec24 tion or other statutes administered by the Ad25 ministrator;
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1 ‘‘(D) shall be disclosed to the extent the

2 Administrator determines disclosure is nec3 essary to protect the public health; and

4 ‘‘(E) may be disclosed when relevant in

5 any proceeding under this section, except that

6 disclosure in such a proceeding shall be made in

7 such manner as to preserve confidentiality to

8 the extent practicable.

9 ‘‘(3) DISCLOSURE OF HEALTH EFFECTS DATA

10 AND RESIDUE DATA.—

11 ‘‘(A) GENERAL RULE.—All data and infor12 mation concerning any test of a pesticide chem13 ical residue or a pesticide chemical to determine

14 the potential effects of such residue or chemical

15 on human health or concerning the levels of

16 such residue in or on food shall be available for

17 disclosure to the public except to the extent

18 such data or information include—

19 ‘‘(i) manufacturing or quality control

20 processes,

21 ‘‘(ii) methods for detecting the quan22 tity of any deliberately added inert ingredi23 ent of a pesticide chemical other than

24 methods for detecting residues of the inert

25 ingredient in or on food, or
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1 ‘‘(iii) the identity or quantity of any

2 deliberately added inert ingredient of a

3 pesticide chemical other than an inert in4 gredient which is the subject of a petition

5 under subsection (d)(1) or an action of the

6 Administrator under subsection (d)(4).

7 ‘‘(B) DATA AND INFORMATION ALSO SUB8 MITTED UNDER FIFRA.—Data and information

9 described in subparagraph (A) which were also

10 submitted to the Administrator under the Fed11 eral Insecticide, Fungicide, and Rodenticide Act

12 shall be available for disclosure to the public in

13 accordance with section 10(g) of such Act (7

14 U.S.C. 136h(g)).

15 ‘‘(g) EXISTING PESTICIDE CHEMICAL RESIDUES.—

16 ‘‘(1) PESTICIDE CHEMICAL RESIDUES UNDER

17 REGULATIONS UNDER SECTION 406.—Regulations af18 fecting pesticide chemical residues promulgated, in

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

20 basis of public hearings instituted before January 1,

21 1953, shall be deemed to be tolerances issued under

22 this section and shall be subject to modification or

23 revocation under subsection (d).

24 ‘‘(2) PESTICIDE CHEMICAL RESIDUES UNDER

25 REGULATIONS.—Regulations establishing, modifying,
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1 or revoking tolerances for pesticide chemical residues

2 under this section and section 409 or exemptions for

3 pesticide chemical residues under this section on or

4 before the date of the enactment of this section shall

5 be deemed to be tolerances or exemptions issued

6 under this section and shall be subject to modifica7 tion or revocation under subsection (d).

8 ‘‘(3) GENERALLY RECOGNIZED AS SAFE PES9 TICIDE CHEMICAL RESIDUES.—

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

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

12 enactment of the Pesticide Reform Act of 1994,

13 do not have tolerances or exemptions from tol14 erances under this section because the residues

15 are generally recognized as safe under this sec16 tion or section 201(s) shall, until the expiration

17 of the period prescribed by subparagraph (C),

18 not be considered unsafe under section

19 402(a)(2)(B) solely because the residues do not

20 have such a tolerance or exemption.

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

22 ‘‘(i) not later than 180 days after the

23 date of the enactment of such Act, publish

24 a list of all pesticide chemical residues that

25 the Administrator has determined are gen-
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1 erally recognized, on the day before the

2 date of the enactment of such Act, as safe

3 under this section or section 201(s); and

4 ‘‘(ii) require that any person who, be5 fore the date of the enactment of such Act,

6 distributed in commerce as a pesticide

7 chemical, a pesticide chemical that pro8 duces a pesticide chemical residue that is

9 not on the list described in clause (i), and

10 that such person determined such pesticide

11 chemical is generally recognized as safe

12 under this section or section 201(s), shall

13 within 6 months of the date of the publica14 tion of the list under clause (i), report to

15 the Administrator the data that supports

16 the claim that the pesticide chemical resi17 due is generally recognized as safe.

18 ‘‘(C) DETERMINATION OF THE ADMINISTRATOR.—Not later than 21 19 ⁄2 years after the

20 date of the enactment of the Pesticide Reform

21 Act of 1994, the Administrator shall determine

22 if each pesticide chemical reported to the Ad23 ministrator in accordance with subparagraph

24 (B)(ii) is generally recognized as safe. If the

25 Administrator determines, by order, that such
41

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1 pesticide chemical residue is generally recog2 nized as safe, the residue of such pesticide

3 chemical shall be considered a pesticide chemi4 cal residue subject to an exemption under this

5 section, which exemption shall be subject to

6 modification or revocation under subsection (d).

7 ‘‘(h) MONITORING OF PESTICIDE CHEMICAL RESI8 DUES.—

9 ‘‘(1) SAMPLING.—The Secretary shall conduct a

10 comprehensive surveillance and compliance enforce11 ment monitoring program for domestic and imported

12 food for pesticide chemical residues to determine if

13 the pesticide chemical residues are in compliance

14 with this section. In carrying out this paragraph, the

15 Secretary shall give priority to—

16 ‘‘(A) sampling foods for pesticide chemical

17 residues included in a notice under paragraph

18 (2);

19 ‘‘(B) sampling foods that are high con20 sumption items for infants and children;

21 ‘‘(C) analyzing pesticides most likely to re22 sult in violation of this section;

23 ‘‘(D) conducting incidence and level mon24 itoring; and
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1 ‘‘(E) collecting data on dietary intake of

2 pesticide residues on food as it is consumed.

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

4 notify the Secretary of the pesticide chemical resi5 dues that the Administrator determines, in the ad6 ministration of this section—

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

8 subsection (b)(2); or

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

10 may under certain circumstances reach or ex11 ceed such standard.

12 ‘‘(i) FEES.—The Administrator shall by regulation

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

14 in the judgment of the Administrator, be sufficient over

15 a reasonable term to provide, equip, and maintain an ade16 quate service for the performance of the functions of the

17 Administrator under this section. Under such regulations,

18 the performance of the services or other functions of the

19 Administrator under this section may be conditioned upon

20 the payment of such fees. Such regulations may further

21 provide that the continuation in effect of a tolerance or

22 exemption shall be conditioned upon the payment of an

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

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

25 waiver or refund is equitable and not contrary to the pur-
43

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1 poses of this subsection. Such fees shall be deposited in

2 the Treasury and shall be credited to the appropriation

3 account of the Administrator for salaries and expenses

4 and shall be available for costs incurred in carrying out

5 this section in accordance with appropriation Acts until

6 expended without fiscal year limitation.

7 ‘‘(j) JUDICIAL REVIEW.—A petition for review of any

8 final order of the Administrator issued under subsection

9 (d) or any regulation that is the subject of such an order

10 may be filed by any adversely affected person only in the

11 United States Court of Appeals for the District of Colum12 bia Circuit. Any such petition for review must be filed

13 within sixty days of the issuance of such order or regula14 tion. Judicial review shall be in accordance with sections

15 701 through 706 of title 5 of the United States Code, and

16 the challenged order or regulation shall be sustained un17 less it is found to be arbitrary, capricious, and abuse of

18 discretion, or not in accordance with law. Orders and regu19 lations of the Administrator with respect to which review

20 could have been obtained under this subsection shall not

21 be subject to judicial review in civil or criminal proceedings

22 for enforcement or other judicial proceedings.’’.

23 SEC. 4. EMBARGO AUTHORITY.

24 (a) ADMINISTRATIVE EMBARGO AUTHORITY.—Sec25 tion 304(g) (21 U.S.C. 334(g)) is amended by redesignat-
44

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1 ing paragraph (2) as paragraph (3) and adding after para2 graph (1) the following new paragraph:

3 ‘‘(2) If an officer or employee of the Depart4 ment has reason to believe that any article of food

5 is adulterated within the meaning of section

6 402(a)(2)(B), the officer or employee may order the

7 food detained (in accordance with regulations pre8 scribed by the Secretary) for a reasonable period

9 which may not exceed twenty days (or ten days, in

10 the case of a perishable food) unless the Secretary

11 determines that a longer period of detention is re12 quired to institute an action under subsection (a) or

13 section 302, in which case the Secretary may au14 thorize a detention period of not more than thirty

15 days (or not more than fifteen days, in the case of

16 a perishable food). Regulations of the Secretary shall

17 require that before a food may be detained, the Sec18 retary or an officer or employee designated by the

19 Secretary shall approve the detention order. Such an

20 order may require the labeling or marking of a food

21 during the period of its detention for the purpose of

22 identifying the food as detained.’’.

23 (b) PROHIBITION ON REMOVAL.—Paragraph (3) of

24 section 304(g) (21 U.S.C. 334(g)), as redesignated by sub25 section (a), is amended—
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1 (1) in subparagraph (A), by striking ‘‘a device

2 subject to a detention order issued under paragraph

3 (1)’’ and inserting ‘‘an article subject to a detention

4 order under paragraph (1) or (2)’’,

5 (2) in the matter preceding clause (i) of sub6 paragraph (B), by striking ‘‘a device subject to a de7 tention order under paragraph (1)’’ and inserting

8 ‘‘an article subject to a detention order under para9 graph (1) or (2)’’, and

10 (3) in subparagraph (B)(ii), by striking ‘‘if’’

11 and inserting ‘‘in the case of a device’’.

12 (c) PROHIBITED ACT.—Section 301(r) (21 U.S.C.

13 331(r)) is amended by inserting ‘‘or a food’’ after ‘‘device’’

14 each time it appears.

15 SEC. 5. CIVIL MONEY PENALTIES.

16 Section 303(f) (21 U.S.C. 333(f)) is amended—

17 (1) by redesignating paragraphs (2), (3), and

18 (4) as paragraphs (3), (4), and (5), respectively,

19 (2) by inserting after paragraph (1) the follow20 ing:

21 ‘‘(2) Any person who introduces into interstate

22 commerce or delivers for introduction into interstate

23 commerce an article of food that is adulterated with24 in the meaning of section 402(a)(2)(B) shall be sub25 ject, in addition to any other penalties that may be
46

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1 prescribed by law, to a civil money penalty of not

2 more than $50,000 in the case of an individual and

3 $250,000 in the case of any other person for such

4 introduction or delivery.’’,

5 (3) in paragraph (3), as so redesignated, by

6 striking ‘‘paragraph (1)’’ each place it occurs and

7 inserting ‘‘paragraph (1) or (2)’’, and

8 (4) in paragraph (5), as so redesignated, by

9 striking ‘‘(3)’’ each place it occurs and inserting

10 ‘‘(4)’’.

11 SEC. 6. RECALL.

12 (a) AUTHORITY.—Chapter III is amended—

13 (1) by redesignating sections 309 and 310 as

14 section 310 and 311, respectively, and

15 (2) by adding after section 308 the following:

16 ‘‘RECALL

17 ‘‘SEC. 309. (a) GENERAL RULE.—If the Secretary

18 has reason to believe that an article of food is adulterated

19 within the meaning of section 402(a)(2)(B), the Secretary

20 may require the manufacturer, processor, or distributor

21 of such article to take immediately all action necessary to

22 recall such article from all wholesale and retail establish23 ments. A recall order of the Secretary under this sub24 section shall be a final agency action subject to review by

25 the United States district court for the judicial district

26 in which the manufacturer, processor, or distributor re-
47

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1 sides or transacts business or in which is located the arti2 cle of food that is the subject of such order.

3 ‘‘(b) REPORT.—Manufacturers, processors, and dis4 tributors shall report promptly to the Secretary any recall

5 of a food undertaken by the manufacturer, processor, or

6 distributor, including any recall required under subsection

7 (a) or section 302 and any recall conducted at the initia8 tive of the manufacturer, processor, or distributor on the

9 grounds that the food may be adulterated within the

10 meaning of section 403(a)(2)(B).

11 ‘‘(c) SCOPE OF ORDER.—For purposes of this sec12 tion, an order under subsection (a) with respect to an arti13 cle of food shall include an order to retrieve or replace

14 such article.’’.

15 (b) PROHIBITED ACT.—Section 301 (21 U.S.C. 331)

16 is amended by adding at the end the following:

17 ‘‘(w) The failure to comply with a recall order under

18 section 309(a) or a requirement to report a recall under

19 section 309(b).’’.

20 SEC. 7. EVALUATION OF EXISTING PESTICIDE CHEMICAL

21 RESIDUE TOLERANCES AND EXEMPTIONS.

22 (a) CLASSIFICATION.—

23 (1) IDENTIFICATION.—Within one hundred and

24 eighty days of the date of enactment of this Act, the

25 Administrator of the Environmental Protection
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1 Agency shall, for each pesticide chemical residue

2 that has a tolerance or exemption in effect on such

3 date, identify each tolerance or exemption which

4 does not appear to meet the requirements of section

5 408(b)(2) or 408(c)(2) of the Federal Food, Drug,

6 and Cosmetic Act and publish a notice summarizing

7 the data and analysis upon which such determina8 tion is made. The notice published pursuant to this

9 paragraph shall include all tolerances for a pesticide

10 chemical, if the cumulative risk from exposure for

11 any pesticide chemical residue, calculated by the

12 methodology in paragraph (2), appears not to meet

13 the requirements of section 408(b)(2) of the Federal

14 Food, Drug, and Cosmetic Act.

15 (2) FACTORS.—In making the determination

16 under paragraph (1) with respect to tolerances for

17 a pesticide chemical residue, the Administrator

18 shall—

19 (A) use the toxicological conclusions, in20 cluding appropriate factors where applicable,

21 used in the most current risk assessment for

22 the pesticide chemical residue performed by the

23 Administrator on or before the date of enact24 ment;
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1 (B) assume that all food for which the pes2 ticide chemical residue has a tolerance bears or

3 contains residues of the pesticide chemical equal

4 to the levels established by their respective tol5 erances.

6 (3) OBJECTIONS.—Any person adversely af7 fected by the Administrator’s action under para8 graph (1) may file objections to the action with the

9 Administrator. Such objections must be filed within

10 thirty days of publication of the notice required in

11 paragraph (1). The Administrator shall act on such

12 objections within sixty days of the receipt of the ob13 jections.

14 (4) SUBSEQUENT IDENTIFICATIONS.—On a

15 yearly basis in the four-year period after the date of

16 enactment of this Act, if the Administrator con17 cludes that any additional tolerances or exemptions

18 do not appear to meet the requirements of section

19 408(b)(2) and 408(c)(2) of the Federal Food, Drug,

20 and Cosmetic Act, the Administrator shall identify

21 such tolerances and exemptions and publish a notice

22 summarizing the data and analysis upon which such

23 identification is made. Prior to identifying any addi24 tional tolerances or exemptions under this para-
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1 graph, the Administrator shall publish the identifica2 tion as a proposal and seek public comment.

3 (b) DATA SUBMISSION.—

4 (1) DEADLINE FOR SUBMISSION OF DATA ON

5 APPARENTLY UNACCEPTABLE PESTICIDE CHEMICAL

6 RESIDUES.—For any pesticide chemical residue for

7 which the Administrator makes the identification de8 scribed in subsection (a)(1) or (a)(4), any person

9 wanting to maintain the tolerance or exemption for

10 such pesticide chemical shall have two years from

11 the publication of the notices in subsection (a) to

12 submit data or information on such chemical relative

13 to the safety standard in section 408(b)(2) or

14 408(c)(2) of the Federal Food, Drug, and Cosmetic

15 Act.

16 (2) DEADLINE FOR SUBMISSION OF DATA ON

17 ALL OTHER PESTICIDE CHEMICAL RESIDUES.—For

18 any other pesticide chemical residue that had a tol19 erance or exemption from a tolerance on the date of

20 enactment of this Act, any person wanting to main21 tain the tolerance or exemption for such pesticide

22 chemical residue shall have not more than five years

23 from such date of enactment, subject to any sched24 ule imposed under paragraph (3), to submit data or

25 information relative to the safety standards in such
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1 section 408(b)(2) or 408(c)(2) of the Federal Food,

2 Drug, and Cosmetic Act.

3 (3) SCHEDULE.—For any pesticide chemical

4 residue for which the Administrator does not make

5 the identification described in subsection (a), the

6 Administrator may establish a schedule for the sub7 mission of data for the tolerance or exemption for

8 such pesticide chemical residue which data shall be

9 the basis for a determination by the Administrator

10 as to whether the tolerance or exemption meets the

11 requirements of such section 408(b)(2) or 408(c)(2)

12 of the Federal Food, Drug, and Cosmetic Act.

13 (4) EXTENSIONS.—

14 (A) REQUEST.—Any person may request

15 the Administrator to issue an order to extend a

16 deadline established under paragraph (1), (2),

17 or (3) before expiration of the deadline.

18 (B) GRANT OF REQUEST.—The Adminis19 trator may grant such a request only if the Ad20 ministrator finds that extraordinary cir21 cumstances beyond the control of such person

22 prevented such person from submitting the re23 quired data.

24 (C) EXTENSION.—If the Administrator is25 sues an order extending a deadline—
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1 (i) the Administrator may extend the

2 deadline for a period no longer than such

3 time as is necessary for such person to

4 submit the data; and

5 (ii) the Administrator may extend the

6 deadline in paragraph (1) for no more than

7 one year and any deadline established

8 under paragraph (2) or (3) so long as such

9 extension does not extend the deadline be10 yond six years from the date of enactment

11 of the Act.

12 (c) DEADLINES FOR ACTION.—

13 (1) THREE-YEAR DEADLINE.—Within three

14 years of the date of enactment of this Act, the Ad15 ministrator shall issue a final decision for 75 percent

16 of the tolerances and exemptions of the pesticide

17 chemical residues identified in subsection (a)(1) by

18 classifying such tolerances and exemptions as meet19 ing or not meeting the requirements of section

20 408(b)(2) or 408(c)(2) of the Federal Food, Drug,

21 and Cosmetic Act. Such decisions shall be based only

22 on data received by the Administrator before the

23 deadline in subsection (b)(1) or before the expiration

24 of an extension granted under subsection (b)(4),

25 whichever is later.
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1 (2) FOUR-YEAR DEADLINE.—Within four years

2 of the date of enactment of the Act, the Adminis3 trator shall issue a final decision for 100 percent of

4 the tolerances and exemptions of the pesticide chem5 ical residues identified in subsection (a)(1) by

6 classifying such tolerances and exemptions as meet7 ing or not meeting the requirements of section

8 408(b)(2) or 408(c)(2) of the Federal Food, Drug,

9 and Cosmetic Act. Such decision shall be based only

10 on data received by the Administrator before the

11 deadline in subsection (b)(1) or before the expiration

12 of an extension granted under subsection (b)(4),

13 whichever is later.

14 (3) DEADLINE FOR SUBSEQUENTLY IDENTI15 FIED TOLERANCES AND EXEMPTIONS.—Within four

16 years of the date of identification of a tolerance or

17 exemption under subsection (a)(4) or seven years

18 from the date of enactment, whichever is sooner, the

19 Administrator shall issue a final decision classifying

20 such tolerance or exemption as meeting or not meet21 ing the requirements of section 408(b)(2) or

22 408(c)(2) of the Federal Food, Drug, and Cosmetic

23 Act. Such decision shall be based only on data re24 ceived by the Administrator before the deadline in

25 subsection (b)(1) or before the expiration of an ex-
54

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1 tension granted under subsection (b)(4), whichever

2 is later.

3 (4) SEVEN-YEAR DEADLINE.—Within seven

4 years of the date of the enactment of this Act, the

5 Administrator shall determine if each tolerance or

6 exemption in existence on the date of enactment of

7 this Act and not identified in subsection (a) meets

8 the requirements of section 408(b)(2) or 408(c)(2)

9 of the Federal Food, Drug, and Cosmetic Act. Such

10 determination shall be based only on data received

11 by the Administrator before the deadline in sub12 section (b)(2) or the deadline in a schedule estab13 lished by the Administrator for the pesticide chemi14 cal residue under subsection (b)(3) or the expiration

15 of an extension granted under subsection (b)(4),

16 whichever is later.

17 (5) REVOCATION PROCEEDINGS.—If the Admin18 istrator determines under this subsection that any

19 tolerance or exemption does not meet the require20 ments of section 408(b)(2) or 408(c)(2) of the Fed21 eral Food, Drug, and Cosmetic Act, the Adminis22 trator shall promptly initiate revocation proceedings

23 for such tolerance or exemption under section

24 408(d) of such Act.
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1 (d) EXPIRATION OF A TOLERANCE OR EXEMP2 TION.—

3 (1) GENERAL RULE.—No later than six and

4 one-half years but not before six years from the date

5 of the enactment of this Act, the Administrator shall

6 publish a list of tolerances and exemptions for pes7 ticides chemical residues which shall expire seven

8 years after such date of enactment, unless the Ad9 ministrator—

10 (A) has issued a decision finding that such

11 pesticide chemical residue meets the require12 ments of section 408(b)(2) or 408(c)(2) of the

13 Federal Food, Drug, and Cosmetic Act, or

14 (B) has granted an extension under para15 graph (2).

16 (2) EXTENSION.—Upon petition of any person,

17 the Administrator may grant an extension beyond

18 the seven-year period in section (d)(1), of not more

19 than one year for the term of a tolerance or exemp20 tion for a pesticide chemical residue if the Adminis21 trator finds that a person seeking to support such

22 tolerance or exemption has met all applicable re23 quirements for the submission of information or

24 data required by subsection (b), the Administrator

25 has not completed review of the data submitted pur-
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1 suant to subsection (b), and the extension would not

2 adversely affect public health. Any tolerance granted

3 an extension under this paragraph shall expire when

4 the extension expires, unless prior to expiration of

5 the extension the Administrator makes the finding

6 in subparagraph (A).

7 (3) LIST.—The Administrator shall include on

8 the list established under paragraph (1) each toler9 ance and exemption which was identified under sub10 section (a)(1) or (a)(4) for which the Administrator

11 has not issued a decision classifying it as meeting or

12 not meeting the requirements of section 408(b)(2) or

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

14 Act, and which the Administrator now determines do

15 not appear to meet such requirements. The Adminis16 trator shall develop such list using the methodology

17 specified in subsection (a)(2)(B) and is only required

18 to consider data submitted on or before the expira19 tion of the deadlines for data submission in sub20 section (b).

21 (4) OBJECTIONS.—Any person adversely af22 fected by the Administrator’s action under para23 graph (1) may file objections to the action with the

24 Administrator. The person filing the objection must

25 file it within thirty days of the publication of the list
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1 specified in paragraph (1), and must demonstrate,

2 using the methodology specified in subsection

3 (a)(2)(B) and considering only data submitted on or

4 before the expiration of the deadlines for data sub5 mission in subsection (b), that the tolerance or ex6 emption which was identified under subsection (a)(1)

7 or (a)(4) should not be included on the list under

8 paragraph (1). The Administrator shall act on such

9 objections within sixty days of the receipt of the ob10 jections.

11 (e) TRANSITIONAL REVOCATION RULE.—

12 (1) GENERAL RULE.—If the Administrator de13 termines under section 408 of the Federal Food,

14 Drug, and Cosmetic Act that a tolerance for a pes15 ticide chemical residue should be revoked or if a tol16 erance will expire within one year based on operation

17 of subsection (d), the Administrator may, upon a pe18 tition from any person, extend the tolerance for a

19 period not longer than five years after such deter20 mination if the Administrator finds—

21 (A) the risk to health presented by expo22 sure to such residue is equal to or less than ten

23 times the risk allowed under section 408(b)(2)

24 of such Act, and
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1 (B)(i) that the health benefits to the per2 son exposed to such residue are greater than

3 the dietary risks to health presented to such

4 person by such exposure, or

5 (ii) that such extension is necessary to

6 avoid a significant disruption in domestic food

7 production.

8 The Administrator may not extend a tolerance under

9 this paragraph for a period which extends beyond

10 ten years after the date of enactment of this Act.

11 (2) MODIFICATION.—The Administrator may

12 modify or revoke a tolerance or exemption extended

13 under paragraph (1), if the Administrator deter14 mines that circumstances no longer justify the con15 tinuation of such tolerance or exemption as ex16 tended.

17 (3) DEFINITIONS.—For the purposes of this

18 subsection, the term ‘‘health benefits’’ means the

19 benefits which occur when the application of a pes20 ticide chemical residue to a food directly reduces the

21 incidence of illness or disease but such term does not

22 include benefits from an adequate, wholesome, or ec23 onomical food supply.

24 (f) DEADLINE SUITS, JUDICIAL REVIEW.—
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1 (1) DEADLINE SUITS.—Any person may com2 mence a civil action on such person’s own behalf

3 against the Administrator in the United States Dis4 trict Court for the District of Columbia where there

5 is alleged a failure of the Administrator to perform

6 any of the nondiscretionary acts required by sub7 sections (c)(2), (c)(3), or (c)(4). The court shall

8 have jurisdiction in actions brought under this para9 graph to order the Administrator to perform such

10 act. For suits involving subsections (c)(2) or (c)(3),

11 if the court finds that the Administrator has failed

12 to perform a nondiscretionary act, the court shall

13 have jurisdiction to order the Administrator to per14 form such act within a specified period of time, but

15 that period may not exceed eight years after the

16 date of enactment of this Act. Suits involving sub17 sections (c)(2) or (c)(3) must be brought within six

18 years of the date of the enactment of this Act. No

19 action may be commenced prior to sixty days after

20 the plaintiff has given notice of such action to the

21 Administrator.

22 (2) JUDICIAL REVIEW.—A petition for review of

23 a final action of the Administrator under subsection

24 (a)(3), (a)(4), (d)(2), (d)(3) or (e)(1) may be filed

25 by any adversely affected person only in the United
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1 States Court of Appeals for the District of Columbia

2 Circuit. Any such petition for review must be filed

3 within sixty days of the issuance of the final action.

4 Judicial review shall be in accordance with sections

5 701 through 706 of title 5 of the United States

6 Code, and the challenged action shall be sustained

7 unless it is found to be arbitrary, capricious, an

8 abuse of discretion, or not in accordance with law.

9 Any determinations made by the Administrator

10 under subsections (b) or (c), shall be subject to judi11 cial review only in a petition for review of a final ac12 tion of the Administrator under section 408(d) of

13 the Federal Food, Drug, and Cosmetic Act pursuant

14 to section 408(j) of such Act. In reviewing a final

15 action of the Administrator under subsection (a)(3),

16 the court may not extend the deadline for data sub17 mission in subsection (b)(1). Actions of the Adminis18 trator with respect to which review could have been

19 obtained under this subsection shall not be subject

20 to judicial review in civil or criminal proceedings for

21 enforcement or other judicial proceedings.

22 (g) REPORT TO CONGRESS.—The Administrator shall

23 annually submit a report to Congress that lists the toler24 ances which have been revoked pursuant to tolerance re-
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1 view. The report shall also provide an analysis of the im2 pacts of tolerance revocation.

3 (h) CONSTRUCTION.—Any reference under this sec4 tion to any provision of section 408 of the Federal Food,

5 Drug, and Cosmetic Act is a reference to such provision

6 as amended by this Act.

7 SEC. 8. FEES.

8 (a) GENERAL RULE.—The Administrator of the En9 vironmental Protection Agency shall by regulation require

10 the payment of such fees as will in the aggregate, in the

11 judgment of the Administrator, be sufficient over a rea12 sonable term to provide, equip, and maintain an adequate

13 service for the performance of the functions of the Admin14 istrator under this Act. The fee requirement of this sub15 section shall not apply to any agency of the Federal Gov16 ernment.

17 (b) DEPOSIT, AND SO FORTH.—Such fees shall be de18 posited in the Treasury and shall be credited to the appro19 priation account of the Administrator for salaries and ex20 penses and shall be available for costs incurred in carrying

21 out this section in accordance with appropriation Acts

22 until expended without fiscal year limitation.

23 SEC. 9. GENERAL DEFINITIONS.

24 As used in sections 4 and 5 of this Act:
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1 (1) IN GENERAL.—The terms that are also used

2 in section 408 of the Federal Food, Drug, and Cos3 metic Act shall have the meanings given the terms

4 by sections 201 and 408 of such Act.

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

6 exposure’’ means dietary exposure as determined

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

8 Drug, and Cosmetic Act.

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

10 means an exemption from the requirement for a tol11 erance under section 408 of the Federal Food, Drug,

12 and Cosmetic Act.

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