I

103D CONGRESS

2D SESSION H. R. 4362

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

MAY 5, 1994

Mr. WAXMAN (by request) 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 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,

17 whichever occurs 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 10-fold 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 5 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 multi-residue

25 method for detecting and measuring
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1 the levels of such pesticide chemical

2 residue in or on a food that will meas3 ure the residue at the level established

4 by 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 2 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 5 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 States 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 pesticide

3 chemical residue in or on the food, which meth4 ods meet the requirements of subsection

5 (b)(2)(E);

6 ‘‘(H) reports of investigations conducted

7 on the effects of processing methods used to

8 produce food on the level and identity of such

9 pesticide chemical residue;

10 ‘‘(I) if the petition is for a pesticide chemi11 cal residue that is described in subsection

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

13 physical or other technical effect the pesticide

14 chemical involved is intended to have and the

15 quantity of the pesticide chemical residue re16 quired to accomplish such effect;

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

18 defined in subsection (b)(2)(E)(iii)) for the pes19 ticide chemical residue;

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

21 the Administrator may require to support the

22 petition; and

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

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

25 ‘‘(3) ACTIONS ON PETITIONS.—
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1 ‘‘(A) FILING DETERMINATION.—

2 ‘‘(i) IN GENERAL.—Within 45 days of

3 the filing of a petition under paragraph (1)

4 for the establishment, modification, or rev5 ocation of a tolerance or an exemption, the

6 Administrator shall determine if the peti7 tion complies with the requirements of

8 paragraph (2) or applicable requirements

9 for petitions to modify or revoke tolerances

10 or exemptions from tolerances. If the Ad11 ministrator determines that the petition

12 complies with such requirements, the Ad13 ministrator shall publish a notice of the fil14 ing of the petition. If the Administrator

15 determines that the petition does not com16 ply with such requirements, the Adminis17 trator shall notify the petitioner of such

18 determination.

19 ‘‘(ii) CONTENTS OF NOTICE OF FIL20 ING.—A notice under clause (i) shall—

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

22 of a petition to establish a tolerance

23 or exemption, announce the availabil24 ity of a complete description of the

25 analytical methods available to the
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1 Administrator for the detection and

2 measurement of the pesticide chemical

3 residue with respect to which the peti4 tion is filed and include the summary

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

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

7 of a petition to modify or revoke a tol8 erance or exemption, contain the full

9 petition or a summary of the petition.

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

11 within one year of the publication of a notice

12 under subparagraph (A) with respect to a peti13 tion, and after giving due consideration to the

14 petition, any comments on the petition, and any

15 other information available to the Adminis16 trator—

17 ‘‘(i) issue a final regulation in accord18 ance with the petition establishing, modify19 ing, or revoking a tolerance or exemption

20 for the pesticide chemical residue;

21 ‘‘(ii) issue a proposed regulation es22 tablishing, modifying, or revoking a toler23 ance or exemption for the pesticide chemi24 cal residue, which tolerance or exemption
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1 is different from the tolerance or exemp2 tion requested in the petition; or

3 ‘‘(iii) issue an order denying the peti4 tion.

5 ‘‘(C) COMMENTS.—If the Administrator is6 sues a notice of the filing of a petition under

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

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

9 shall allow at least 30 days for comments on

10 such notice or proposed regulation.

11 ‘‘(D) FINAL REGULATION.—If the Admin12 istrator issues a proposed regulation under sub13 paragraph (B)(ii), the Administrator shall issue

14 a final regulation within 180 days of the date

15 of the publication of the proposed regulations.

16 ‘‘(E) PRIORITIES.—The Administrator

17 shall give priority to petitions for the establish18 ment or modification of a tolerance for a pes19 ticide chemical residue that appears to pose a

20 significantly lower risk to human health from

21 dietary exposure than pesticide chemical resi22 dues that have tolerances in effect for the same

23 or similar uses.

24 ‘‘(4) ACTION ON THE ADMINISTRATOR’S INITIA25 TIVE.—
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1 ‘‘(A) GENERAL RULE.—The Administrator

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 30

10 days for public comment on the proposed regu11 lation unless the Administrator finds that such

12 notice and comment would be contrary to the

13 public interest and states the reasons for the

14 finding in the notice of the final regulation. If

15 the Administrator makes such a finding and is16 sues such a regulation, the Administrator shall

17 provide at least 30 days for comment on the

18 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
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1 deadline for a period no longer than such

2 times 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,

14 as will enable the Administrator to evaluate the safety of

15 such article in the event of the filing of an application

16 pursuant to this section. Such regulations, among other

17 things, shall set forth the conditions (if any) upon which

18 food treated with such pesticide chemicals may be mar19 keted 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 are 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), 30 days

16 before disclosing data or information claimed as

17 privileged or confidential under subparagraph

18 (A), the Administrator shall notify the person

19 who submitted or cited the data or information

20 of the intent to disclose the data or information

21 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
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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-
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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 an order may

10 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 with13 in 60 days of the issuance of such order or regulation.

14 Judicial review shall be in accordance with sections 701

15 through 706 of title 5, United States Code, and the chal16 lenged order or regulation shall be sustained unless it is

17 found to be arbitrary, capricious, and an abuse of discre18 tion or not in accordance with law. Orders and regulations

19 of the Administrator with respect to which review could

20 have been obtained under this subsection shall not be sub21 ject to judicial review in civil or criminal proceedings for

22 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-
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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 Department has

4 reason to believe that any article of food is adulterated

5 within the meaning of section 402(a)(2)(B), the officer or

6 employee may order the food detained (in accordance with

7 regulations prescribed by the Secretary) for a reasonable

8 period which may not exceed 20 days (or 10 days, in the

9 case of a perishable food) unless the Secretary determines

10 that a longer period of detention is required to institute

11 an action under subsection (a) or section 302, in which

12 case the Secretary may authorize a detention period of not

13 more than 30 days (or not more than 15 days, in the case

14 of a perishable food). Regulations of the Secretary shall

15 require that before a food may be detained, the Secretary

16 or an officer or employee designated by the Secretary shall

17 approve the detention order. Such an order may require

18 the labeling or marking of a food during the period of its

19 detention for the purpose of identifying the food as de20 tained.’’.

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

22 section 304(g) (21 U.S.C. 334(g)), as redesignated by sub23 section (a), is amended—

24 (1) in subparagraph (A), by striking ‘‘a device

25 subject to a detention order issued under paragraph
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1 (1)’’ and inserting ‘‘an article subject to a detention

2 order under paragraph (1) or (2)’’,

3 (2) in the matter preceding clause (i) of sub4 paragraph (B), by striking ‘‘a device subject to a de5 tention order under paragraph (1)’’ and inserting

6 ‘‘an article subject to a detention order under para7 graph (1) or (2)’’, and

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

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

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

11 331(r)) is amended by inserting ‘‘or a food’’ after ‘‘device’’

12 each time it appears.

13 SEC. 5. CIVIL MONEY PENALTIES.

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

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

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

17 (2) by inserting after paragraph (1) the follow18 ing:

19 ‘‘(2) Any person who introduces into interstate com20 merce or delivers for introduction into interstate com21 merce an article of food that is adulterated within the

22 meaning of section 402(a)(2)(B) shall be subject, in addi23 tion to any other penalties that may be prescribed by law,

24 to a civil money penalty of not more than $50,000 in the
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1 case of an individual and $250,000 in the case of any

2 other person for such introduction or delivery.’’,

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

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

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

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

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

8 ‘‘(4)’’.

9 SEC. 6. RECALL.

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

11 (1) by redesignating sections 309 and 310 as

12 section 310 and 311, respectively, and

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

14 ‘‘RECALL

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

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

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

18 may require the manufacturer, processor, or distributor

19 of such article to take immediately all action necessary to

20 recall such article from all wholesale and retail establish21 ments. A recall order of the Secretary under this sub22 section shall be a final agency action subject to review by

23 the United States district court for the judicial district

24 in which the manufacturer, processor, or distributor re25 sides or transacts business or in which is located the arti26 cle of food that is the subject of such order.
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1 ‘‘(b) REPORT.—Manufacturers, processors, and dis2 tributors shall report promptly to the Secretary any recall

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

4 distributor, including any recall required under subsection

5 (a) or section 302 and any recall conducted at the initia6 tive of the manufacturer, processor, or distributor on the

7 grounds that the food may be adulterated within the

8 meaning of section 402(a)(2)(B).

9 ‘‘(c) SCOPE OF ORDER.—For purposes of this sec10 tion, an order under subsection (a) with respect to an arti11 cle of food shall include an order to retrieve or replace

12 such article.’’.

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

14 is amended by adding at the end the following:

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

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

17 section 309(b).’’.

18 SEC. 7. EVALUATION OF EXISTING PESTICIDE CHEMICAL

19 RESIDUE TOLERANCES AND EXEMPTIONS.

20 (a) CLASSIFICATION.—

21 (1) IDENTIFICATION.—Within 180 days of the

22 date of enactment of this Act, the Administrator of

23 the Environmental Protection Agency shall, for each

24 pesticide chemical residue that has a tolerance or ex25 emption in effect on such date, identify each toler-
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1 ance or exemption which does not appear to meet

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

3 of the Federal Food, Drug, and Cosmetic Act and

4 publish a notice summarizing the data and analysis

5 upon which such determination is made. The notice

6 published pursuant to this paragraph shall include

7 all tolerances for a pesticide chemical, if the cumu8 lative risk from exposure for any pesticide chemical

9 residue, calculated by the methodology in paragraph

10 (2), appears not to meet the requirements of section

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

12 Act.

13 (2) FACTORS.—In making the determination

14 under paragraph (1) with respect to tolerances for

15 a pesticide chemical residue, the Administrator

16 shall—

17 (A) use the toxicological conclusions, in18 cluding appropriate factors where applicable,

19 used in the most current risk assessment for

20 the pesticide chemical residue performed by the

21 Administrator on or before the date of enact22 ment; and

23 (B) assume that all food for which the pes24 ticide chemical residue has a tolerance bears or

25 contains residues of the pesticide chemical equal
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1 to the levels established by their respective tol2 erances.

3 (3) OBJECTIONS.—Any person adversely af4 fected by the Administrator’s action under para5 graph (1) may file objections to the action with the

6 Administrator. Such objections must be filed within

7 30 days of publication of the notice required in para8 graph (1). The Administrator shall act on such ob9 jections within 60 days of the receipt of the objec10 tions.

11 (4) SUBSEQUENT IDENTIFICATIONS.—On a

12 yearly basis in the 4 year period after the date of

13 enactment of this Act, if the Administrator con14 cludes that any additional tolerances or exemptions

15 do not appear to meet the requirements of section

16 408(b)(2) and 408(c)(2) of the Federal Food, Drug,

17 and Cosmetic Act, the Administrator shall identify

18 such tolerances and exemptions and publish a notice

19 summarizing the data and analysis upon which such

20 identification is made. Prior to identifying any addi21 tional tolerances or exemptions under this para22 graph, the Administrator shall publish the identifica23 tion as a proposal and seek public comment.

24 (b) DATA SUBMISSION.—
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1 (1) DEADLINE FOR SUBMISSION OF DATA ON

2 APPARENTLY UNACCEPTABLE PESTICIDE CHEMICAL

3 RESIDUES.—For any pesticide chemical residue for

4 which the Administrator makes the identification de5 scribed in subsection (a)(1) or (a)(4), any person

6 wanting to maintain the tolerance or exemption for

7 such pesticide chemical shall have 2 years from the

8 publication of the notices in subsection (a) to submit

9 data or information on such chemical relative to the

10 safety standard in section 408(b)(2) or 408(c)(2) of

11 the Federal Food, Drug, and Cosmetic Act.

12 (2) DEADLINE FOR SUBMISSION OF DATA ON

13 ALL OTHER PESTICIDE CHEMICAL RESIDUES.—For

14 any other pesticide chemical residue that had a tol15 erance or exemption from a tolerance on the date of

16 enactment of this Act, any person wanting to main17 tain the tolerance or exemption for such pesticide

18 chemical residue shall have not more than 5 years

19 from such date of enactment, subject to any sched20 ule imposed under paragraph (3), to submit data or

21 information relative to the safety standards in such

22 section 408(b)(2) or 408(c)(2) of the Federal Food,

23 Drug, and Cosmetic Act.

24 (3) SCHEDULE.—For any pesticide chemical

25 residue for which the Administrator does not make
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1 the identification described in subsection (a), the

2 Administrator may establish a schedule for the sub3 mission of data for the tolerance or exemption for

4 such pesticide chemical residue which data shall be

5 the basis for a determination by the Administrator

6 as to whether the tolerance or exemption meets the

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

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

9 (4) EXTENSIONS.—

10 (A) REQUEST.—Any person may request

11 the Administrator to issue an order to extend a

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

13 or (3) before expiration of the deadline.

14 (B) GRANT OF REQUEST.—The Adminis15 trator may grant such a request only if the Ad16 ministrator finds that extraordinary cir17 cumstances beyond the control of such person

18 prevented such person from submitting the re19 quired data.

20 (C) EXTENSION.—If the Administrator is21 sues an order extending a deadline—

22 (i) the Administrator may extend the

23 deadline for a period no longer than such

24 time as is necessary for such person to

25 submit the data; and
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1 (ii) the Administrator may extend the

2 deadline in paragraph (1) for no more than

3 1 year and any deadline established under

4 paragraph (2) or (3) so long as such exten5 sion does not extend the deadline beyond 6

6 years from the date of enactment of the

7 Act.

8 (c) DEADLINES FOR ACTION.—

9 (1) 3-YEAR DEADLINE.—Within 3 years of the

10 date of enactment of this Act, the Administrator

11 shall issue a final decision for 75 percent of the tol12 erances and exemptions of the pesticide chemical

13 residues identified in subsection (a)(1) by classifying

14 such tolerances and exemptions as meeting or not

15 meeting the requirements of section 408(b)(2) or

16 408(c)(2) of the Federal Food, Drug, and Cosmetic

17 Act. Such decisions shall be based only on data re18 ceived by the Administrator before the deadline in

19 subsection (b)(1) or before the expiration of an ex20 tension granted under subsection (b)(4), whichever

21 is later.

22 (2) 4-YEAR DEADLINE.—Within 4 years of the

23 date of enactment of the Act, the Administrator

24 shall issue a final decision for 100 percent of the tol25 erances and exemptions of the pesticide chemical
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1 residues identified in subsection (a)(1) by classifying

2 such tolerances and exemptions as meeting or not

3 meeting the requirements of section 408(b)(2) or

4 408(c)(2) of the Federal Food, Drug, and Cosmetic

5 Act. Such decision shall be based only on data re6 ceived by the Administrator before the deadline in

7 subsection (b)(1) or before the expiration of an ex8 tension granted under subsection (b)(4), whichever

9 is later.

10 (3) DEADLINE FOR SUBSEQUENTLY IDENTI11 FIED TOLERANCES AND EXEMPTIONS.—Within 4

12 years of the date of identification of a tolerance or

13 exemption under subsection (a)(4) or 7 years from

14 the date of enactment, whichever is sooner, the Ad15 ministrator shall issue a final decision classifying

16 such tolerance or exemption as meeting or not meet17 ing the requirements of section 408(b)(2) or

18 408(c)(2) of the Federal Food, Drug, and Cosmetic

19 Act. Such decision shall be based only on data re20 ceived by the Administrator before the deadline in

21 subsection (b)(1) or before the expiration of an ex22 tension granted under subsection (b)(4), whichever

23 is later.

24 (4) 7-YEAR DEADLINE.—Within 7 years of the

25 date of the enactment of this Act, the Administrator
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1 shall determine if each tolerance or exemption in ex2 istence on the date of enactment of this Act and not

3 identified in subsection (a) meets the requirements

4 of section 408(b)(2) or 408(c)(2) of the Federal

5 Food, Drug, and Cosmetic Act. Such determination

6 shall be based only on data received by the Adminis7 trator before the deadline in subsection (b)(2) or the

8 deadline in a schedule established by the Adminis9 trator for the pesticide chemical residue under sub10 section (b)(3) or the expiration of an extension

11 granted under subsection (b)(4), whichever is later.

12 (5) REVOCATION PROCEEDINGS.—If the Admin13 istrator determines under this subsection that any

14 tolerance or exemption does not meet the require15 ments of section 408(b)(2) or 408(c)(2) of the Fed16 eral Food, Drug, and Cosmetic Act, the Adminis17 trator shall promptly initiate revocation proceedings

18 for such tolerance or exemption under section

19 408(d) of such Act.

20 (d) EXPIRATION OF A TOLERANCE OR EXEMP21 TION.—

(1) GENERAL RULE.—No later than 6 and 1 22 ⁄2

23 years but not before 6 years after the date of the en24 actment of this Act, the Administrator shall publish

25 a list of tolerances and exemptions for pesticide
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1 chemical residues which shall expire 7 years after

2 such date of enactment, unless the Administrator—

3 (A) has issued a decision finding that such

4 pesticide chemical residue meets the require5 ments of section 408(b)(2) or 408(c)(2) of the

6 Federal Food, Drug, and Cosmetic Act, or

7 (B) has granted an extension under para8 graph (2).

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

10 the Administrator may grant an extension beyond

11 the 7-year period in section (d)(1), of not more than

12 1 year for the term of a tolerance or exemption for

13 a pesticide chemical residue if the Administrator

14 finds that a person seeking to support such toler15 ance or exemption has met all applicable require16 ments for the submission of information or data re17 quired by subsection (b), the Administrator has not

18 completed review of the data submitted pursuant to

19 subsection (b), and the extension would not ad20 versely affect public health. Any tolerance granted

21 an extension under this paragraph shall expire when

22 the extension expires, unless prior to expiration of

23 the extension the Administrator makes the finding

24 in subparagraph (A).
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1 (3) LIST.—The Administrator shall include on

2 the list established under paragraph (1) each toler3 ance and exemption which was identified under sub4 section (a)(1) or (a)(4) for which the Administrator

5 has not issued a decision classifying it as meeting or

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

7 408(c)(2) of the Federal Food, Drug, and Cosmetic

8 Act and which the Administrator now determines do

9 not appear to meet such requirements. The Adminis10 trator shall develop such list using the methodology

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

12 to consider data submitted on or before the expira13 tion of the deadlines for data submission in sub14 section (b).

15 (4) OBJECTIONS.—Any person adversely af16 fected by the Administrator’s action under para17 graph (1) may file objections to the action with the

18 Administrator. The person filing the objection must

19 file it within 30 days of the publication of the list

20 under paragraph (1) and must demonstrate, using

21 the methodology specified in subsection (a)(2)(B)

22 and considering only data submitted on or before the

23 expiration of the deadlines for data submission in

24 subsection (b), that the tolerance or exemption

25 which was identified under subsection (a)(1) or
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1 (a)(4) should not be included on the list under para2 graph (1). The Administrator shall act on such ob3 jections within 60 days of the receipt of the

4 objections.

5 (e) TRANSITIONAL REVOCATION RULE.—

6 (1) GENERAL RULE.—If the Administrator de7 termines under section 408 of the Federal Food,

8 Drug, and Cosmetic Act that a tolerance for a pes9 ticide chemical residue should be revoked or if a tol10 erance will expire within 1 year based on operation

11 of subsection (d), the Administrator may, upon a pe12 tition from any person, extend the tolerance for a

13 period not longer than 5 years after such determina14 tion if the Administrator finds—

15 (A) the risk to health presented by expo16 sure to such residue is equal to or less than 10

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

18 of such Act, and

19 (B)(i) that the health benefits to the per20 son exposed to such residue are greater than

21 the dietary risks to health presented to such

22 person by such exposure, or

23 (ii) that such extension is necessary to

24 avoid a significant disruption in domestic food

25 production.
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1 The Administrator may not extend a tolerance under

2 this paragraph for a period which extends beyond 10

3 years after the date of enactment of this Act.

4 (2) MODIFICATION.—The Administrator may

5 modify or revoke a tolerance or exemption extended

6 under paragraph (1), if the Administrator deter7 mines that circumstances no longer justify the con8 tinuation of such tolerance or exemption as ex9 tended.

10 (3) DEFINITIONS.—For purposes of this sub11 section, the term ‘‘health benefits’’ means the bene12 fits which occur when the application of a pesticide

13 chemical residue to a food directly reduces the inci14 dence of illness or disease but such term does not in15 clude benefits from an adequate, wholesome, or eco16 nomical food supply.

17 (f) DEADLINE SUITS, JUDICIAL REVIEW.—

18 (1) DEADLINE SUITS.—Any person may com19 mence a civil action on such person’s own behalf

20 against the Administrator in the United States Dis21 trict Court for the District of Columbia where there

22 is alleged a failure of the Administrator to perform

23 any of the nondiscretionary acts required by sub24 sections (c)(2), (c)(3), or (c)(4). The court shall

25 have jurisdiction in actions brought under this para-
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1 graph to order the Administrator to perform such

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

3 if the court finds that the Administrator has failed

4 to perform a nondiscretionary act, the court shall

5 have jurisdiction to order the Administrator to per6 form such act within a specified period of time, but

7 that period may not exceed 8 years after the date of

8 enactment of this Act. Suits involving subsections

9 (c)(2) or (c)(3) must be brought within 6 years of

10 the date of the enactment of this Act. No action may

11 be commenced prior to 60 days after the plaintiff

12 has given notice of such action to the Administrator.

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

14 a final action of the Administrator under subsection

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

16 by any adversely affected person only in the United

17 States Court of Appeals for the District of Columbia

18 Circuit. Any such petition for review must be filed

19 within 60 days of the issuance of the final action.

20 Judicial review shall be in accordance with sections

21 701 through 706 of title 5 of the United States

22 Code, and the challenged action shall be sustained

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

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

25 Any determinations made by the Administrator
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1 under subsections (b) or (c), shall be subject to judi2 cial review only in a petition for review of a final ac3 tion of the Administrator under section 408(d) of

4 the Federal Food, Drug, and Cosmetic Act pursuant

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

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

7 the court may not extend the deadline for data sub8 mission in subsection (b)(1). Actions of the Adminis9 trator with respect to which review could have been

10 obtained under this subsection shall not be subject

11 to judicial review in civil or criminal proceedings for

12 enforcement or other judicial proceedings.

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

14 annually submit a report to Congress that lists the toler15 ances which have been revoked pursuant to Tolerance Re16 view. The report shall also provide an analysis of the im17 pacts of tolerance revocation.

18 (h) CONSTRUCTION.—Any reference under this sec19 tion to any provision of section 408 of the Federal Food,

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

21 as amended by this Act.

22 SEC. 8. FEES.

23 (a) GENERAL RULE.—The Administrator of the En24 vironmental Protection Agency shall by regulation require

25 the payment of such fees as will in the aggregate, in the
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1 judgment of the Administrator, be sufficient over a rea2 sonable term to provide, equip, and maintain an adequate

3 service for the performance of the functions of the Admin4 istrator under this Act. The fee requirement of this sub5 section shall not apply to any agency of the Federal Gov6 ernment.

7 (b) DEPOSIT, ETC.—Such fees shall be deposited in

8 the Treasury and shall be credited to the appropriation

9 account of the Administrator for salaries and expenses

10 and shall be available for costs incurred in carrying out

11 this section in accordance with appropriation Acts until

12 expended without fiscal year limitation.

13 SEC. 9. GENERAL DEFINITIONS.

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

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

16 in section 408 of the Federal Food, Drug, and Cos17 metic Act shall have the meanings given the terms

18 by sections 201 and 408 of such Act.

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

20 exposure’’ means dietary exposure as determined

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

22 Drug, and Cosmetic Act.

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

24 means an exemption from the requirement for a tol-
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1 erance under section 408 of the Federal Food, Drug,

2 and Cosmetic Act.

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