### 1 **Attachment D** 

**Federal Food, Drug, and Cosmetic Act (FFDCA)**

Section 408

- Tolerances and Exemptions for Pesticide Chemical Residues

(21 U.S.C. 346a)

### 2 **Attachment D** 

**Federal Food, Drug, and Cosmetic Act (FFDCA)**

Section 408

- Tolerances and Exemptions for Pesticide Chemical Residues

(21 U.S.C. 346a)

From the U.S. Code Online via GPO Access

[wais.access.gpo.gov]

[Laws in effect as of January 3, 2005]

[Document not affected by Public Laws enacted between

January 3, 2005 and March 20, 2006]

[ **CITE** : **21USC 346a**  ]

TITLE 21

-- FOOD AND DRUGS

CHAPTER 9

-- FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV

-- FOOD

Sec. 346a. Tolerances and exemptions for pesticide chemical

residues

(a) Requirement for tolerance or exemption

(1) General rule

Except as provided in paragraph (2) or (3), any pesticide

chemical residue in or on a food shall be deemed unsafe for the

purpose of section 342(a )(2)(B) of this title unless

--

(A) a tolerance for such pesticide chemical residue in or on

such food is in effect under this section and the quantity of

the residue is within the limits of the tolerance; or

(B) an exemption from the requirement of a tolerance is in

effect under this section for the pesticide chemical residue.

For the purposes of this section, the term ``food'', when used as a

noun without modification, shall mean a raw agricultur al commodity

or processed food.

(2) Processed food

Notwithstanding paragraph (1)

--

(A) if a tolerance is in effect under this section for a

pesticide chemical residue in or on a raw agricultural

commodity, a pesticide chemical residue that is present in or on

a processed food because the food is made from that raw

agricultural commodity shall not be considered unsafe within the

meaning of section 342(a)(2)(B) of this title despite the lack

of a tolerance for the pesticide chemical residue in or on the

processed food if the pesticide chemical has been used in or on

the raw agricultural commodity in conformity with a tolerance

un der this section, such residue in or on the raw agricultural

commodity has been removed to the extent possible in good

### 3 manufacturing practice, and the concentration of the pesticide

chemical residue in the processed food is not g reater than the

tolerance prescribed for the pesticide chemical residue in the

raw agricultural commodity; or

(B) if an exemption for the requirement for a tolerance is

in effect under this section for a pesticide che mical residue in

or on a raw agricultural commodity, a pesticide chemical residue

that is present in or on a processed food because the food is

made from that raw agricultural commodity shall not be

considered unsafe wit hin the meaning of section 342(a)(2)(B) of

this title.

(3) Residues of degradation products

If a pesticide chemical residue is present in or on a food

because it is a metabolite or other degradation product of a

precursor substance that itself is a pesticide chemical or pesticide

chemical residue, such a residue shall not be considered to be

unsafe within the meaning of section 342(a)(2)(B) of this title

despite the lack of a tolerance or exemption from the need for a

tolerance for such residue in or on such food if

--

(A) the Administrator has not determined that the

degradation product is likely to pose any potential health risk

from dietary exposure that is of a different type than, or of a

greater significance than, any risk posed by dietary exposure to

the precursor substance;

(B) either

--

(i) a tolerance is in effect under this section for

residues of t he precursor substance in or on the food, and

the combined level of residues of the degradation product

and the precursor substance in or on the food is at or below

the stoichiometrically equivalent level that would b e

permitted by the tolerance if the residue consisted only of

the precursor substance rather than the degradation product;

or

(ii) an exemption from the need for a tolerance is in

effect u nder this section for residues of the precursor

substance in or on the food; and

(C) the tolerance or exemption for residues of the precursor

substance does not state that it applies only to particular

named subs tances and does not state that it does not apply to

residues of the degradation product.

(4) Effect of tolerance or exemption

While a tolerance or exemption from the requirement for a

tolerance is in effect under thi s section for a pesticide chemical

residue with respect to any food, the food shall not by reason of

bearing or containing any amount of such a residue be considered to

be adulterated within the meaning of section 342(a)(1) of this

titl e.

(b) Authority and standard for tolerance

(1) Authority

The Administrator may issue regulations establishing, modifying,

### 4

or revoking a tolerance for a pesticide chemical residue in or on a

food

-- (A) in response to a petition filed under subsection (d) of

this section; or

(B) on the Administrator's own initiative under subsection

(e) of this section.

As used in this section, the term ``modify'' shall not mean

expanding the tolerance to cover additional foods.

(2) Standard

(A) General rule

(i) Standard

The Administrator may establish or leave in effect a

tolerance for a pesticid e chemical residue in or on a food

only if the Administrator determines that the tolerance is

safe. The Administrator shall modify or revoke a tolerance

if the Administrator determines it is not safe.

(ii) Determination of safety

As used in this section, the term ``safe'', with respect

to a tolerance for a pesticide chemical residue, means that

the Administrator has determined that there is a reasonable

certainty that no harm will result from aggregate exposure

to the pesticide chemical residue, including all anticipated

dietary exposures and all other exposures for which there is

reliable information.

(iii) Rule of construction

With respect to a tolerance, a pesticide chemical

residue meeting the standard under clause (i) is not an

eligible pesticide chemical residue for purposes of

subparagraph (B ).

(B) Tolerances for eligible pesticide chemical residues

(i) Definition

As used in this subparagraph, the term ``eligible

pesticide chemical residue'' means a pesticide chemical

residue as to which

--

(I) the Administrator is not able to identify a

level of exposure to the residue at which the residue

will not cause or contribute to a known or anticipated

harm to human hea lth (referred to in this section as a

``nonthreshold effect'');

(II) the lifetime risk of experiencing the

nonthreshold effect is appropriately assessed by

quantitative risk assessment; and

(III) with regard to any known or anticipated harm

to human health for which the Administrator is able to

identify a level at which the residue will not cause

such harm (referred t o in this section as a ``threshold

effect''), the Administrator determines that the level

of aggregate exposure is safe.

### 5 (ii) Determination of tolerance

Notwithstanding subparagraph (A)(i), a t olerance for an

eligible pesticide chemical residue may be left in effect or

modified under this subparagraph if

--

(I) at least one of the conditions described in

clause (iii) is met; and

(II) both of the conditions described in clause (iv)

are met.

(iii) Conditions regarding use

For purposes of clause (ii), the conditions described in

this clause with respect to a to lerance for an eligible

pesticide chemical residue are the following:

(I) Use of the pesticide chemical that produces the

residue protects consumers from adverse effects on

health that woul d pose a greater risk than the dietary

risk from the residue.

(II) Use of the pesticide chemical that produces the

residue is necessary to avoid a significant disruption

in domestic pro duction of an adequate, wholesome, and

economical food supply.

(iv) Conditions regarding risk

For purposes of clause (ii), the conditions described in

this clause with respect to a tolerance for an eligible

pesticide chemical residue are the following:

(I) The yearly risk associated with the nonthreshold

effect from aggregate exposure to the residue does not

exceed 10 times the yearl y risk that would be allowed

under subparagraph (A) for such effect.

(II) The tolerance is limited so as to ensure that

the risk over a lifetime associated with the

nonthreshold effect from aggregate exposure to the

residue is not greater than twice the lifetime risk that

would be allowed under subparagraph (A) for such effect.

(v) Review

Five years after the date on which th e Administrator

makes a determination to leave in effect or modify a

tolerance under this subparagraph, and thereafter as the

Administrator deems appropriate, the Administrator shall

determine, after noti ce and opportunity for comment, whether

it has been demonstrated to the Administrator that a

condition described in clause (iii)(I) or clause (iii)(II)

continues to exist with respect to the tolerance and that

the yearly and lifetime risks from aggregate exposure to

such residue continue to comply with the limits specified in

clause (iv). If the Administrator determines by such date

that such demonstration has not bee n made, the Administrator

shall, not later than 180 days after the date of such

determination, issue a regulation under subsection (e)(1) of

this section to modify or revoke the tolerance.

(vi) Infants and children

Any tolerance under this subparagraph shall meet the

requirements of subparagraph (C).

### 6 (C) Exposure of infants and children

In establishing, modifying, leaving in effect, or revoking a

tolerance or exemption for a pesticide chemical residue, the

Administrator

--

(i) shall assess the risk of the pesticide chemical

residue based on

--

(I) available information about consumption patter ns

among infants and children that are likely to result in

disproportionately high consumption of foods containing

or bearing such residue among infants and children in

comparison to the g eneral population;

(II) available information concerning the special

susceptibility of infants and children to the pesticide

chemical residues, including neurological differences

betwee n infants and children and adults, and effects of

in utero exposure to pesticide chemicals; and

(III) available information concerning the

cumulative effects on infants and children of such

residues and other substances that have a common

mechanism of toxicity; and

(ii) shall

-- (I) ensure that there is a reasonable certainty that

no harm will result to infants and chi ldren from

aggregate exposure to the pesticide chemical residue;

and

(II) publish a specific determination regarding the

safety of the pesticide chemical residue for infants and

children.

The Secretary of Health and Human Services and the Secretary of

Agriculture, in consultation with the Administrator, shall

conduct surveys to document dietary exposure to pesticides among

infants and children. In the case of threshold effects, for

purposes of clause (ii)(I) an additional tenfold margin of

safety for the pesticide chemical residue and other sources of

exposure shall be applied for infants and children to take into

account potential pre

- and post

- natal toxicity and completeness

of the data with respect to exposure and toxicity to infants and

children. Notwithstanding such requirement for an additional

margin of safety, the Adm inistrator may use a different margin

of safety for the pesticide chemical residue only if, on the

basis of reliable data, such margin will be safe for infants and

children.

(D) Factors

In establishing, modi fying, leaving in effect, or revoking a

tolerance or exemption for a pesticide chemical residue, the

Administrator shall consider, among other relevant factors

--

(i) the validity, completeness, and reliability of the

available data from studies of the pesticide chemical and

pesticide chemical residue;

(ii) the nature of any toxic effect shown to be caused

by the pesticide chemical or pesticide chemical residue in

such studies;

(iii) available information concerning the relationship

### 7 of the results of such studies to human risk;

(iv) available information concerning the dietary

consumption patterns of c onsumers (and major identifiable

subgroups of consumers);

(v) available information concerning the cumulative

effects of such residues and other substances that have a

common mechanism of toxicity;

(vi) available information concerning the aggregate

exposure levels of consumers (and major identifiable

subgroups of consumers) to the pesticide chemical residue

and to other related substances, includin g dietary exposure

under the tolerance and all other tolerances in effect for

the pesticide chemical residue, and exposure from other non

- occupational sources;

(vii) available information concerning th e variability

of the sensitivities of major identifiable subgroups of

consumers;

(viii) such information as the Administrator may require

on whether the pesticide chemical may have an effect in

humans that is similar to an effect produced by a naturally

occurring estrogen or other endocrine effects; and

(ix) safety factors which in the opinion of experts

qualified by scientific training and experien ce to evaluate

the safety of food additives are generally recognized as

appropriate for the use of animal experimentation data.

(E) Data and information regarding anticipated and actual

residue levels

(i) Authority

In establishing, modifying, leaving in effect, or

revoking a tolerance for a pesticide chemical residue, the

Administrator may consider available data and information on

the an ticipated residue levels of the pesticide chemical in

or on food and the actual residue levels of the pesticide

chemical that have been measured in food, including residue

data collected by the Food and Drug Administr ation.

(ii) Requirement

If the Administrator relies on anticipated or actual

residue levels in establishing, modifying, or leaving in

effect a tolerance, the Administrator shall pursuant to

subsection (f)(1) of this section require that data be

provided five years after the date on which the tolerance is

established, modified, or left in effect, and thereafter as

the Administrator deems appropriate, de monstrating that such

residue levels are not above the levels so relied on. If

such data are not so provided, or if the data do not

demonstrate that the residue levels are not above the levels

so relied o n, the Administrator shall, not later than 180

days after the date on which the data were required to be

provided, issue a regulation under subsection (e)(1) of this

section, or an order under subsection (f)(2) of thi s

section, as appropriate, to modify or revoke the tolerance.

(F) Percent of food actually treated

### 8 In establishing, modifying, leaving in effect, or revoking a

tolerance for a pesticide chemical residue, the Admi nistrator

may, when assessing chronic dietary risk, consider available

data and information on the percent of food actually treated

with the pesticide chemical (including aggregate pesticide use

data collected by the Dep artment of Agriculture) only if the

Administrator

--

(i) finds that the data are reliable and provide a valid

basis to show what percentage of the food derived from such

crop is likely to contain such pesti cide chemical residue;

(ii) finds that the exposure estimate does not

understate exposure for any significant subpopulation group;

(iii) finds that, if data are available on pesticide use

and consum ption of food in a particular area, the population

in such area is not dietarily exposed to residues above

those estimated by the Administrator; and

(iv) provides for the periodic reevaluation of the

e stimate of anticipated dietary exposure.

(3) Detection methods

(A) General rule

A tolerance for a pesticide chemical residue in or on a food

shall not be established or modified by the Administrator u nless

the Administrator determines, after consultation with the

Secretary, that there is a practical method for detecting and

measuring the levels of the pesticide chemical residue in or on

the food.

(B) Detecti on limit

A tolerance for a pesticide chemical residue in or on a food

shall not be established at or modified to a level lower than

the limit of detection of the method for detecting and measuring

the pesticide chemi cal residue specified by the Administrator

under subparagraph (A).

(4) International standards

In establishing a tolerance for a pesticide chemical residue in

or on a food, the Administrator shall determine whet her a maximum

residue level for the pesticide chemical has been established by the

Codex Alimentarius Commission. If a Codex maximum residue level has

been established for the pesticide chemical and the Administrator

does not propose to adopt the Codex level, the Administrator shall

publish for public comment a notice explaining the reasons for

departing from the Codex level.

(c) Authority and standard for exemptions

(1) Authority

The Admi nistrator may issue a regulation establishing,

modifying, or revoking an exemption from the requirement for a

tolerance for a pesticide chemical residue in or on food

--

(A) in response to a petition filed under subsection (d) of

this section; or

### 9 (B) on the Administrator's initiative under subsection (e)

of this section.

(2) Standard

(A) General rule

(i) Standard

The Administrator may estab lish or leave in effect an

exemption from the requirement for a tolerance for a

pesticide chemical residue in or on food only if the

Administrator determines that the exemption is safe. The

Administrator shall modify or revoke an exemption if the

Administrator determines it is not safe.

(ii) Determination of safety

The term ``safe'', with respect to an exemption for a

pesticide chemical residue, means that the Administrator has

determined that there is a reasonable certainty that no harm

will result from aggregate exposure to the pesticide

chemical residue, including all anticipated dietary

exposures a nd all other exposures for which there is

reliable information.

(B) Factors

In making a determination under this paragraph, the

Administrator shall take into account, among other relevant

considerations, the considerations set forth in subparagraphs

(C) and (D) of subsection (b)(2) of this section.

(3) Limitation

An exemption from the requirement for a tolerance for a

pesticide chemical residue in or on f ood shall not be established or

modified by the Administrator unless the Administrator determines,

after consultation with the Secretary

--

(A) that there is a practical method for detecting and

measuring the levels of such pe sticide chemical residue in or on

food; or

(B) that there is no need for such a method, and states the

reasons for such determination in issuing the regulation

establishing or modifying the exemption.

(d) Petition fo r tolerance or exemption

(1) Petitions and petitioners

Any person may file with the Administrator a petition proposing

the issuance of a regulation

--

(A) establishing, modifying, or revoking a tolerance for a

pesticide chemical residue in or on a food; or

(B) establishing, modifying, or revoking an exemption from

the requirement of a tolerance for such a residue.

(2) Petition contents

### 10 (A) Establish ment

A petition under paragraph (1) to establish a tolerance or

exemption for a pesticide chemical residue shall be supported by

such data and information as are specified in regulations issued

by the Administrator, including

--

(i)(I) an informative summary of the petition and of the

data, information, and arguments submitted or cited in

support of the petition; and

(II) a statement that the petitioner agrees t hat such

summary or any information it contains may be published as a

part of the notice of filing of the petition to be published

under this subsection and as part of a proposed or final

regulation issue d under this section;

(ii) the name, chemical identity, and composition of the

pesticide chemical residue and of the pesticide chemical

that produces the residue;

(iii) data showing the recommended amount, frequency,

method, and time of application of that pesticide chemical;

(iv) full reports of tests and investigations made with

respect to the safety of the pesticide chemical, including

full in formation as to the methods and controls used in

conducting those tests and investigations;

(v) full reports of tests and investigations made with

respect to the nature and amount of the pesticide chemical

residue that is likely to remain in or on the food,

including a description of the analytical methods used;

(vi) a practical method for detecting and measuring the

levels of the pesticide chemical residue in o r on the food,

or for exemptions, a statement why such a method is not

needed;

(vii) a proposed tolerance for the pesticide chemical

residue, if a tolerance is proposed;

(viii) if the p etition relates to a tolerance for a

processed food, reports of investigations conducted using

the processing method(s) used to produce that food;

(ix) such information as the Administrator may require

to make the determination under subsection (b)(2)(C) of this

section;

(x) such information as the Administrator may require on

whether the pesticide chemical may have an effect in humans

that is simil ar to an effect produced by a naturally

occurring estrogen or other endocrine effects;

(xi) information regarding exposure to the pesticide

chemical residue due to any tolerance or exemption already

gr anted for such residue;

(xii) practical methods for removing any amount of the

residue that would exceed any proposed tolerance; and

(xiii) such other data and information as the

Administrator requi res by regulation to support the

petition.

If information or data required by this subparagraph is

available to the Administrator, the person submitting the

petition may **cite** the availability of the information or da ta in

lieu of submitting it. The Administrator may require a petition

to be accompanied by samples of the pesticide chemical with

respect to which the petition is filed.

### 11 (B) Modification or revocation

The Ad ministrator may by regulation establish the

requirements for information and data to support a petition to

modify or revoke a tolerance or to modify or revoke an exemption

from the requirement for a tolerance.

(3) Notice

A notice of the filing of a petition that the Administrator

determines has met the requirements of paragraph (2) shall be

published by the Administrator within 30 days after such

determination. The notice shall announce the availability of a

description of the analytical methods available to the Administrator

for the detection and measurement of the pesticide chemical residue

with respect to which the petition is filed or shall set forth the

petitioner's statement of why such a method is not needed. The

notice shall include the summary required by paragraph (2)(A)(i)(I).

(4) Actions by the Administrator

(A) In general

The Administrator shall, after giving due consideration to a

petition filed under paragraph (1) and any other information

available to the Administrator

--

(i) issue a final regulation (which may vary from that

sought by the petition) estab lishing, modifying, or revoking

a tolerance for the pesticide chemical residue or an

exemption of the pesticide chemical residue from the

requirement of a tolerance (which final regulation shall be

issued without further notice and without further period for

public comment);

(ii) issue a proposed regulation under subsection (e) of

this section, and thereafter issue a final regulation under

such subsect ion; or

(iii) issue an order denying the petition.

(B) Priorities

The Administrator shall give priority to petitions for the

establishment or modification of a tolerance or exemption for a

pesticide c hemical residue that appears to pose a significantly

lower risk to human health from dietary exposure than pesticide

chemical residues that have tolerances in effect for the same or

similar uses.

(C) Expedited review of certain petitions

(i) Date certain for review

If a person files a complete petition with the

Administrator proposing the issuance of a regulation

establishing a tolerance or exemption for a pesticide

chemical residue that presents a lower risk to human health

than a pesticide chemical residue for which a tolerance has

been left in effect or modified under subsection (b)(2)(B)

### 12 of this section, the Admi nistrator shall complete action on

such petition under this paragraph within 1 year.

(ii) Required determinations

If the Administrator issues a final regulation

establishing a tolerance or exemption fo r a safer pesticide

chemical residue under clause (i), the Administrator shall,

not later than 180 days after the date on which the

regulation is issued, determine whether a condition

described in subclau se (I) or (II) of subsection

(b)(2)(B)(iii) of this section continues to exist with

respect to a tolerance that has been left in effect or

modified under subsection (b)(2)(B) of this section. If such

cond ition does not continue to exist, the Administrator

shall, not later than 180 days after the date on which the

determination under the preceding sentence is made, issue a

regulation under subsection (e)(1) of this sec tion to modify

or revoke the tolerance.

(e) Action on Administrator's own initiative

(1) General rule

The Administrator may issue a regulation

-- (A) establishing, modifying, suspending under sub section

(l)(3) of this section, or revoking a tolerance for a pesticide

chemical or a pesticide chemical residue;

(B) establishing, modifying, suspending under subsection

(l)(3) of this section, or revoking an exempti on of a pesticide

chemical residue from the requirement of a tolerance; or

(C) establishing general procedures and requirements to

implement this section.

(2) Notice

Before issuing a fina l regulation under paragraph (1), the

Administrator shall issue a notice of proposed rulemaking and

provide a period of not less than 60 days for public comment on the

proposed regulation, except that a shorter period for comment may be

provided if the Administrator for good cause finds that it would be

in the public interest to do so and states the reasons for the

finding in the notice of proposed rulemaking.

(f) Special data requirements

(1) Requiring submissio n of additional data

If the Administrator determines that additional data or

information are reasonably required to support the continuation of a

tolerance or exemption that is in effect under this section for a

pesticide chemical r esidue on a food, the Administrator shall

--

(A) issue a notice requiring the person holding the

pesticide registrations associated with such tolerance or

exemption to submit the data or information under section

3(c)( 2)(B) of the Federal Insecticide, Fungicide, and

Rodenticide Act [7 U.S.C. 136a(c)(2)(B)];

(B) issue a rule requiring that testing be conducted on a

substance or mixture under section 4 of the Toxic Substances

### 13 Control Act [15 U.S.C. 2603]; or

(C) publish in the Federal Register, after first providing

notice and an opportunity for comment of not less than 60 days'

duration, an order

--

(i) requiring the submission to the Admi nistrator by one

or more interested persons of a notice identifying the

person or persons who will submit the required data and

information;

(ii) describing the type of data and information

required to be submitted to the Administrator and stating

why the data and information could not be obtained under the

authority of section 3(c)(2)(B) of the Federal Insecticide,

Fungicide, and Rodenticide Act [7 U. S.C. 136a(c)(2)(B)] or

section 4 of the Toxic Substances Control Act [15 U.S.C.

2603];

(iii) describing the reports of the Administrator

required to be prepared during and after the collection of

the data and information;

(iv) requiring the submission to the Administrator of

the data, information, and reports referred to in clauses

(ii) and (iii); and

(v) establishing dates by which the submissions

described in clauses (i) and (iv) must be made.

The Administrator may under subparagraph (C) revise any such

order to correct an error. The Administrator may under this

paragraph require data or infor mation pertaining to whether the

pesticide chemical may have an effect in humans that is similar

to an effect produced by a naturally occurring estrogen or other

endocrine effects.

(2) Noncompliance

If a submission required by a notice issued in accordance with

paragraph (1)(A), a rule issued under paragraph (1)(B), or an order

issued under paragraph (1)(C) is not made by the time specified in

such notice, rule, or order, the Admi nistrator may by order

published in the Federal Register modify or revoke the tolerance or

exemption in question. In any review of such an order under

subsection (g)(2) of this section, the only material issue shall be

whether a submiss ion required under paragraph (1) was not made by

the time specified.

(g) Effective date, objections, hearings, and administrative review

(1) Effective date

A regulation or order issued under subsection (d)(4), (e)(1 ), or

(f)(2) of this section shall take effect upon publication unless the

regulation or order specifies otherwise. The Administrator may stay

the effectiveness of the regulation or order if, after issuance of

such regulation or order, objections are filed with respect to such

regulation or order pursuant to paragraph (2).

(2) Further proceedings

(A) Objections

### 14 Within 60 days after a regulation or order is issued under

subsectio n (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or

(n)(5)(C) of this section, any person may file objections

thereto with the Administrator, specifying with particularity

the provisions of the regulation or order deemed objection able

and stating reasonable grounds therefor. If the regulation or

order was issued in response to a petition under subsection

(d)(1) of this section, a copy of each objection filed by a

person other than the petitioner shall be served by the

Administrator on the petitioner.

(B) Hearing

An objection may include a request for a public evidentiary

hearing upon the objection. The Administrator shall, upon the

initiative of the Administrator or upon the request of an

interested person and after due notice, hold a public

evidentiary hearing if and to the extent the Administrator

determines that such a public hearing is necessary to receive

fact ual evidence relevant to material issues of fact raised by

the objections. The presiding officer in such a hearing may

authorize a party to obtain discovery from other persons and may

upon a showing of good cause made by a party issue a subpoena to

compel testimony or production of documents from any person. The

presiding officer shall be governed by the Federal Rules of

Civil Procedure in making any order for the protection of the

witness or th e content of documents produced and shall order the

payment of reasonable fees and expenses as a condition to

requiring testimony of the witness. On contest, such a subpoena

may be enforced by a Federal district court.

( C) Final decision

As soon as practicable after receiving the arguments of the

parties, the Administrator shall issue an order stating the

action taken upon each such objection and setting forth any

revision to the re gulation or prior order that the Administrator

has found to be warranted. If a hearing was held under

subparagraph (B), such order and any revision to the regulation

or prior order shall, with respect to questions of fact at issu e

in the hearing, be based only on substantial evidence of record

at such hearing, and shall set forth in detail the findings of

facts and the conclusions of law or policy upon which the order

or regulation is based.

(h ) Judicial review

(1) Petition

In a case of actual controversy as to the validity of any

regulation issued under subsection (e)(1)(C) of this section, or any

order issued under subsection (f)(1)(C) or (g)(2)( C) of this

section, or any regulation that is the subject of such an order, any

person who will be adversely affected by such order or regulation

may obtain judicial review by filing in the United States Court of

Appeals for the circuit wherein that person resides or has its

principal place of business, or in the United States Court of

Appeals for the District of Columbia Circuit, within 60 days after

### 15

publication of such order or regulation, a petition praying that the

order or regulation be set aside in whole or in part.

(2) Record and jurisdiction

A copy of the petition under paragraph (1) shall be forthwith

transmitted by the clerk of the court to the Administrator, or any

of ficer designated by the Administrator for that purpose, and

thereupon the Administrator shall file in the court the record of

the proceedings on which the Administrator based the order or

regulation, as provided in section 2112 of title 28. Upon the filing

of such a petition, the court shall have exclusive jurisdiction to

affirm or set aside the order or regulation complained of in whole

or in part. As to orders issued following a public evidentiary

hearing, the findings o f the Administrator with respect to questions

of fact shall be sustained only if supported by substantial evidence

when considered on the record as a whole.

(3) Additional evidence

If a party applies to the court for leave to adduce additional

evidence and shows to the satisfaction of the court that the

additional evidence is material and that there were reasonable

grounds for the failure to adduce the evidence in the proceeding

before the Admin istrator, the court may order that the additional

evidence (and evidence in rebuttal thereof) shall be taken before

the Administrator in the manner and upon the terms and conditions

the court deems proper. The Administrator may modify prior findings

as to the facts by reason of the additional evidence so taken and

may modify the order or regulation accordingly. The Administrator

shall file with the court any such modified finding, order, or

regulation.

(4) F inal judgment; Supreme Court review

The judgment of the court affirming or setting aside, in whole

or in part, any regulation or any order and any regulation which is

the subject of such an order shall be final, subject to review by

the Supreme Court of the United States as provided in section 1254

of title 28. The commencement of proceedings under this subsection

shall not, unless specifically ordered by the court to the contrary,

operate as a stay of a regulation or order.

(5) Application

Any issue as to which review is or was obtainable under this

subsection shall not be the subject of judicial review under any

other provision of law.

(i) Confidentiality and use of data

(1) General rule

Data and information that are or have been submitted to the

Administrator under this section or section 348 of this title in

support of a tolerance or an exemption from a tolerance shall be

entitled to confidential treatment for reasons of business

confidentiality and to exclusive use and data compensation to the

### 16

same extent provided by sections 3 and 10 of the Federal

Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 13 6a, 136h].

(2) Exceptions

(A) In general

Data and information that are entitled to confidential

treatment under paragraph (1) may be disclosed, under such

security requirements as the Admi nistrator may provide by

regulation, to

--

(i) employees of the United States authorized by the

Administrator to examine such data and information in the

carrying out of their official duties under this cha pter or

other Federal statutes intended to protect the public

health; or

(ii) contractors with the United States authorized by

the Administrator to examine such data and information in

the carrying out of contracts under this chapter or such

statutes.

(B) Congress

This subsection does not authorize the withholding of data

or information from either House of Congress or from, to the

extent of matter within its jurisdiction, any committee or

subcommittee of such committee or any joint committee of

Congress or any subcommittee of such joint committee.

(3) Summaries

Notwithstanding any pr ovision of this subsection or other law,

the Administrator may publish the informative summary required by

subsection (d)(2)(A)(i) of this section and may, in issuing a

proposed or final regulation or order under this section, publish an

informative summary of the data relating to the regulation or order.

(j) Status of previously issued regulations

(1) Regulations under section 346

Regulations affecting pesticide chemical residues in or on raw

agricultur al commodities promulgated, in accordance with section

371(e) of this title, under the authority of section 346(a) \ 1 \ of

this title upon the basis of public hearings instituted before

January 1, 1953, shall be deemed to be regulations issue d under this

section and shall be subject to modification or revocation under

subsections (d) and (e) of this section, and shall be subject to

review under subsection (q) of this section.

----------------------------------------------------- ----------------------

\ 1 \ See References in Text note below.

---------------------------------------------------------------------------

(2) Regulations under section 348

Regulations that established tolerances for substanc es that are

pesticide chemical residues in or on processed food, or that

otherwise stated the conditions under which such pesticide chemicals

### 17

could be safely used, and that were issued under section 348 of this

title on or before August 3, 1996, shall be deemed to be regulations

issued under this section and shall be subject to modification or

revocation under subsection (d) or (e) of this section, and shall be

subject to review under subsection (q) of this section.

(3) Regulations under section 346a

Regulations that established tolerances or exemptions under this

section that were issued on or before August 3, 1996, shall remain

in effect unless modified or revoked under subsection (d) or (e) of

this section, and shall be subject to review under subsection (q) of

this section.

(4) Certain substances

With respect to a substance that is not included in the

definition of the term ``pesticide c hemical'' under section

321(q)(1) of this title but was so included on the day before

October 30, 1998, the following applies as of October 30, 1998:

(A) Notwithstanding paragraph (2), any regulation applying

to the use of th e substance that was in effect on the day before

October 30, 1998, and was on such day deemed in such paragraph

to have been issued under this section, shall be considered to

have been issued under section 348 of this title.

(B) Notwithstanding paragraph (3), any regulation applying

to the use of the substance that was in effect on such day and

was issued under this section (including any such regulation

issued before August 3, 1996) is deeme d to have been issued

under section 348 of this title.

(k) Transitional provision

If, on the day before August 3, 1996, a substance that is a

pesticide chemical was, with respect to a particular pesticidal use of

the substance and any resu lting pesticide chemical residue in or on a

particular food

--

(1) regarded by the Administrator or the Secretary as generally

recognized as safe for use within the meaning of the provisions of

subsection (a) of this section or section 32 1(s) of this title as

then in effect; or

(2) regarded by the Secretary as a substance described by

section 321(s)(4) of this title;

such a pesticide chemical residue shall be regarded as exempt from the

requirement for a tolerance, as o f August 3, 1996. The Administrator

shall by regulation indicate which substances are described by this

subsection. Any exemption under this subsection may be modified or

revoked as if it had been issued under subsection (c) of this section.

(l) Harmon ization with action under other laws

(1) Coordination with FIFRA

To the extent practicable and consistent with the review

deadlines in subsection (q) of this section, in issuing a final rule

under this subsection th at suspends or revokes a tolerance or

exemption for a pesticide chemical residue in or on food, the

### 18

Administrator shall coordinate such action with any related

necessary action under the Federal Insecticide, Fungicide, and

Rodenticide A ct [7 U.S.C. 136 et seq.].

(2) Revocation of tolerance or exemption following

cancellation of associated registrations

If the Administrator, acting under the Federal Insecticide,

Fungicide, and Rodenticide Act, ca ncels the registration of each

pesticide that contains a particular pesticide chemical and that is

labeled for use on a particular food, or requires that the

registration of each such pesticide be modified to prohibit its use

in connect ion with the production, storage, or transportation of

such food, due in whole or in part to dietary risks to humans posed

by residues of that pesticide chemical on that food, the

Administrator shall revoke any tolerance or exemption that al lows

the presence of the pesticide chemical, or any pesticide chemical

residue that results from its use, in or on that food. Subsection

(e) of this section shall apply to actions taken under this

paragraph. A revocation under this para graph shall become effective

not later than 180 days after

--

(A) the date by which each such cancellation of a

registration has become effective; or

(B) the date on which the use of the canceled pesticide

beco mes unlawful under the terms of the cancellation, whichever

is later.

(3) Suspension of tolerance or exemption following

suspension of associated registrations

(A) Suspension

If the Administrator , acting under the Federal Insecticide,

Fungicide, and Rodenticide Act, suspends the use of each

registered pesticide that contains a particular pesticide

chemical and that is labeled for use on a particular food, due

in whole or in part to dietary risks to humans posed by residues

of that pesticide chemical on that food, the Administrator shall

suspend any tolerance or exemption that allows the presence of

the pesticide chemical, or any pestici de chemical residue that

results from its use, in or on that food. Subsection (e) of this

section shall apply to actions taken under this paragraph. A

suspension under this paragraph shall become effective not later

than 60 days after the date by which each such suspension of use

has become effective.

(B) Effect of suspension

The suspension of a tolerance or exemption under

subparagraph (A) shall be effective as long as the use of e ach

associated registration of a pesticide is suspended under the

Federal Insecticide, Fungicide, and Rodenticide Act. While a

suspension of a tolerance or exemption is effective the

tolerance or exemption shall not be c onsidered to be in effect.

If the suspension of use of the pesticide under that Act is

terminated, leaving the registration of the pesticide for such

use in effect under that Act, the Administrator shall rescind

any asso ciated suspension of tolerance or exemption.

### 19 (4) Tolerances for unavoidable residues

In connection with action taken under paragraph (2) or (3), or

with respect to pesticides whose registrations were suspended or

canceled prior to August 3, 1996, under the Federal Insecticide,

Fungicide, and Rodenticide Act, if the Administrator determines that

a residue of the canceled or suspended pesticide chemical will

unavoidably persist in the environment and thereby b e present in or

on a food, the Administrator may establish a tolerance for the

pesticide chemical residue. In establishing such a tolerance, the

Administrator shall take into account both the factors set forth in

subsection (b)(2) of th is section and the unavoidability of the

residue. Subsection (e) of this section shall apply to the

establishment of such tolerance. The Administrator shall review any

such tolerance periodically and modify it as necessary so that it

al lows no greater level of the pesticide chemical residue than is

unavoidable.

(5) Pesticide residues resulting from lawful application of

pesticide

Notwithstanding any other provision of this chapter, if a

tolerance or exemption for a pesticide chemical residue in or on a

food has been revoked, suspended, or modified under this section, an

article of that food shall not be deemed unsafe solely because of

the presence of such pesticide chemical residue in or on such food

if it is shown to the satisfaction of the Secretary that

--

(A) the residue is present as the result of an application

or use of a pesticide at a time and in a manner that was lawful

und er the Federal Insecticide, Fungicide, and Rodenticide Act;

and

(B) the residue does not exceed a level that was authorized

at the time of that application or use to be present on the food

under a tolerance, exemption , food additive regulation, or other

sanction then in effect under this chapter;

unless, in the case of any tolerance or exemption revoked,

suspended, or modified under this subsection or subsection (d) or

(e) of this section, the A dministrator has issued a determination

that consumption of the legally treated food during the period of

its likely availability in commerce will pose an unreasonable

dietary risk.

(6) Tolerance for use of pesticides under an emerge ncy

exemption

If the Administrator grants an exemption under section 18 of the

Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136p)

for a pesticide chemical, the Administrator shall estab lish a

tolerance or exemption from the requirement for a tolerance for the

pesticide chemical residue. Such a tolerance or exemption from a

tolerance shall have an expiration date. The Administrator may

establish such a tolerance or exe mption without providing notice or

a period for comment on the tolerance or exemption. The

Administrator shall promulgate regulations within 365 days after

August 3, 1996, governing the establishment of tolerances and

exemptions under t his paragraph. Such regulations shall be

### 20

consistent with the safety standard under subsections (b)(2) and

(c)(2) of this section and with section 18 of the Federal

Insecticide, Fungicide, and Rodenticide Act.

(m) Fees

(1) Amount

The Administrator shall by regulation require the payment of

such fees as will in the aggregate, in the judgment of the

Administrator, be sufficient over a reasonable term to provide,

equip, and maintain an adequa te service for the performance of the

Administrator's functions under this section. Under the regulations,

the performance of the Administrator's services or other functions

under this section, including

--

(A) the acceptance for filing of a petition submitted under

subsection (d) of this section;

(B) establishing, modifying, leaving in effect, or revoking

a tolerance or establishing, modifying, leaving in effect, or

revoking an exemption from the requirement for a tolerance under

this section;

(C) the acceptance for filing of objections under subsection

(g) of this section; or

(D) the certification and filing in court of a transcript of

the pr oceedings and the record under subsection (h) of this

section;

may be conditioned upon the payment of such fees. The regulations

may further provide for waiver or refund of fees in whole or in part

when in the judgment of the Admini strator such a waiver or refund is

equitable and not contrary to the purposes of this subsection.

(2) Deposit

All fees collected under paragraph (1) shall be deposited in the

Reregistration and Expedited Pro cessing Fund created by section 4(k)

of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.

136a

- 1(k)]. Such fees shall be available to the Administrator,

without fiscal year limitation, for the performance of the

Administ rator's services or functions as specified in paragraph (1).

(n) National uniformity of tolerances

(1) ``Qualifying pesticide chemical residue'' defined

For purposes of this subsection, the term ``qualifying pesticide

chemical resid ue'' means a pesticide chemical residue resulting from

the use, in production, processing, or storage of a food, of a

pesticide chemical that is an active ingredient and that

--

(A) was first approved for such use in a registration of a

pesticide issued under section 3(c)(5) of the Federal

Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.

136a(c)(5)] on or after April 25, 1985, on the basis of data

determined by the Administrator to meet all appli cable

requirements for data prescribed by regulations in effect under

that Act [7 U.S.C. 136 et seq.] on April 25, 1985; or

(B) was approved for such use in a reregistration

eligibility determination issued under sect ion 4(g) of that Act

### 21 [7 U.S.C. 136a

- 1(g)] on or after August 3, 1996.

(2) ``Qualifying Federal determination'' defined

For purposes of this subsection, the term ``qualifying Federal

determination'' means a tolerance or exe mption from the requirement

for a tolerance for a qualifying pesticide chemical residue that

--

(A) is issued under this section after August 3, 1996, and

determined by the Administrator to meet the standard under

subsecti on (b)(2)(A) (in the case of a tolerance) or (c)(2) (in

the case of an exemption) of this section; or

(B)(i) pursuant to subsection (j) of this section is

remaining in effect or is deemed to have been issued under this

section, or is regarded under subsection (k) of this section as

exempt from the requirement for a tolerance; and

(ii) is determined by the Administrator to meet the standard

under subsection (b)(2)(A) (in the case of a toler ance) or

(c)(2) (in the case of an exemption) of this section.

(3) Limitation

The Administrator may make the determination described in

paragraph (2)(B)(ii) only by issuing a rule in accordance with the

procedure set forth in subsection (d) or (e) of this section and

only if the Administrator issues a proposed rule and allows a period

of not less than 30 days for comment on the proposed rule. Any such

rule shall be reviewable in accordan ce with subsections (g) and (h)

of this section.

(4) State authority

Except as provided in paragraphs (5), (6), and (8) no State or

political subdivision may establish or enforce any regulatory limit

on a q ualifying pesticide chemical residue in or on any food if a

qualifying Federal determination applies to the presence of such

pesticide chemical residue in or on such food, unless such State

regulatory limit is identical to such qualifying Fe deral

determination. A State or political subdivision shall be deemed to

establish or enforce a regulatory limit on a pesticide chemical

residue in or on a food if it purports to prohibit or penalize the

production, processing, shipping , or other handling of a food

because it contains a pesticide residue (in excess of a prescribed

limit).

(5) Petition procedure

(A) In general

Any State may petition the Administrator for authorizatio n

to establish in such State a regulatory limit on a qualifying

pesticide chemical residue in or on any food that is not

identical to the qualifying Federal determination applicable to

such qualifying pesticide chemical residue.

(B) Petition requirements

Any petition under subparagraph (A) shall

-- (i) satisfy any requirements prescribed, by rule, by the

### 22 Administrator; and

(ii) be supported by scientific da ta about the pesticide

chemical residue that is the subject of the petition or

about chemically related pesticide chemical residues, data

on the consumption within such State of food bearing the

pesticide chemical residue, and data on exposure of humans

within such State to the pesticide chemical residue.

(C) Authorization

The Administrator may, by order, grant the authorization

described in subparagraph (A) if t he Administrator determines

that the proposed State regulatory limit

--

(i) is justified by compelling local conditions; and

(ii) would not cause any food to be a violation of

Federal law.

(D) T reatment

In lieu of any action authorized under subparagraph (C), the

Administrator may treat a petition under this paragraph as a

petition under subsection (d) of this section to modify or

revoke a tolerance or an e xemption. If the Administrator

determines to treat a petition under this paragraph as a

petition under subsection (d) of this section, the Administrator

shall thereafter act on the petition pursuant to subsection (d)

of this section.

(E) Review

Any order of the Administrator granting or denying the

authorization described in subparagraph (A) shall be subject to

review in the manner described in subsections (g) and (h) of

th is section.

(6) Urgent petition procedure

Any State petition to the Administrator pursuant to paragraph

(5) that demonstrates that consumption of a food containing such

pesticide residue level during the period of th e food's likely

availability in the State will pose a significant public health

threat from acute exposure shall be considered an urgent petition.

If an order by the Administrator to grant or deny the requested

authorization in an urgen t petition is not made within 30 days of

receipt of the petition, the petitioning State may establish and

enforce a temporary regulatory limit on a qualifying pesticide

chemical residue in or on the food. The temporary regulatory limit

shall be validated or terminated by the Administrator's final order

on the petition.

(7) Residues from lawful application

No State or political subdivision may enforce any regulatory

limit on the level of a pesticide che mical residue that may appear

in or on any food if, at the time of the application of the

pesticide that resulted in such residue, the sale of such food with

such residue level was lawful under this section and under the law

of such Sta te, unless the State demonstrates that consumption of the

### 23

food containing such pesticide residue level during the period of

the food's likely availability in the State will pose an

unreasonable dietary risk to the health of persons within su ch

State.

(8) Savings

Nothing in this chapter preempts the authority of any State or

political subdivision to require that a food containing a pesticide

chemical residue bear or be the subject of a warn ing or other

statement relating to the presence of the pesticide chemical residue

in or on such food.

(o) Consumer right to know

Not later than 2 years after August 3, 1996, and annually

thereafter, the Administrator shall, in consultation with the Secretary

of Agriculture and the Secretary of Health and Human Services, publish

in a format understandable to a lay person, and distribute to large

retail grocers for public display (in a manner determined by the

grocer), the following infor mation, at a minimum:

(1) A discussion of the risks and benefits of pesticide chemical

residues in or on food purchased by consumers.

(2) A listing of actions taken under subparagraph (B) of

subsection (b)(2) of this section that may result in pesticide

chemical residues in or on food that present a yearly or lifetime

risk above the risk allowed under subparagraph (A) of such

subsection, and the food on which the pesticide chemicals producing

the residues are us ed.

(3) Recommendations to consumers for reducing dietary exposure

to pesticide chemical residues in a manner consistent with

maintaining a healthy diet, including a list of food that may

reasonably substitute for food listed under p aragraph (2).

Nothing in this subsection shall prevent retail grocers from

providing additional information.

(p) Estrogenic substances screening program

(1) Development

Not later than 2 years after August 3, 1996 , the Administrator

shall in consultation with the Secretary of Health and Human

Services develop a screening program, using appropriate validated

test systems and other scientifically relevant information, to

determine whether certain substances may have an effect in humans

that is similar to an effect produced by a naturally occurring

estrogen, or such other endocrine effect as the Administrator may

designate.

(2) Implementation

Not lat er than 3 years after August 3, 1996, after obtaining

public comment and review of the screening program described in

paragraph (1) by the scientific advisory panel established under

section 25(d) of the Federal Insecticide, Fungicide, and R odenticide

Act [7 U.S.C. 136w(d)] or the science advisory board established by

section 4365 \ 2 \ of title 42, the Administrator shall implement the

### 24

program.

--------------------------------------------------------------------------- \ 2 \ S ee References in Text note below.

---------------------------------------------------------------------------

(3) Substances

In carrying out the screening program described in paragraph

(1), the Administrator

--

(A) shall provide for the testing of all pesticide

chemicals; and

(B) may provide for the testing of any other substance that

may have an effect that is cumulative to an effect of a

pesticide chemical if the Administrator determines that a

substantial population may be exposed to such substance.

(4) Exemption

Notwithstanding paragraph (3), the Administrator may, by order,

exempt from the requirements of this section a biologic substance or

other substance if the Administrator determines that the substance

is anticipated not to produce any effect in humans similar to an

effect produced by a naturally occurring estrogen.

(5) C ollection of information

(A) In general

The Administrator shall issue an order to a registrant of a

substance for which testing is required under this subsection,

or to a person who manufactures or imports a substanc e for which

testing is required under this subsection, to conduct testing in

accordance with the screening program described in paragraph

(1), and submit information obtained from the testing to the

Administrator, within a reasonable time period that the

Administrator determines is sufficient for the generation of the

information.

(B) Procedures

To the extent practicable the Administrator shall minimize

duplicative testing of the same substance for the same endocrine

effect, develop, as appropriate, procedures for fair and

equitable sharing of test costs, and develop, as necessary,

procedures for handling of confidential business information.

(C) Failure of registrants to submit information

(i) Suspension

If a registrant of a substance referred to in paragraph

(3)(A) fails to comply with an order under subparagraph (A)

of this paragrap h, the Administrator shall issue a notice of

intent to suspend the sale or distribution of the substance

by the registrant. Any suspension proposed under this

paragraph shall become final at the end of the 30

- day peri od

beginning on the date that the registrant receives the

notice of intent to suspend, unless during that period a

### 25 person adversely affected by the notice requests a hearing

or the Administrator determine s that the registrant has

complied fully with this paragraph.

(ii) Hearing

If a person requests a hearing under clause (i), the

hearing shall be conducted in accordance with section 554 of

title 5. The only matter for resolution at the hearing shall

be whether the registrant has failed to comply with an order

under subparagraph (A) of this paragraph. A decision by the

Administrator after completion of a hearing shall be

considered to be a final agency action.

(iii) Termination of suspensions

The Administrator shall terminate a suspension under

this subparagraph issued with respect to a registrant if the

Administrator determines that the registrant has complied

fully with this paragraph.

(D) Noncompliance by other persons

Any person (other than a registrant) who fails to comply

with an order und er subparagraph (A) shall be liable for the

same penalties and sanctions as are provided under section 16 of

the Toxic Substances Control Act [15 U.S.C. 2615] in the case of

a violation referred to in that section. Such penalties and

sanctions shall be assessed and imposed in the same manner as

provided in such section 16.

(6) Agency action

In the case of any substance that is found, as a result of

testing and evaluation u nder this section, to have an endocrine

effect on humans, the Administrator shall, as appropriate, take

action under such statutory authority as is available to the

Administrator, including consideration under other sections of this

cha pter, as is necessary to ensure the protection of public health.

(7) Report to Congress

Not later than 4 years after August 3, 1996, the Administrator

shall prepare and submit to Congress a report containing

--

(A) the findings of the Administrator resulting from the

screening program described in paragraph (1);

(B) recommendations for further testing needed to evaluate

the impact on human health of the substances tested under th e

screening program; and

(C) recommendations for any further actions (including any

action described in paragraph (6)) that the Administrator

determines are appropriate based on the findings.

(q) Schedule for review

(1) In general

The Administrator shall review tolerances and exemptions for

pesticide chemical residues in effect on the day before August 3,

1996, as expeditiously as practicable, assuring that

--

### 26 (A) 33 percent of such tolerances and exemptions are

reviewed within 3 years of August 3, 1996;

(B) 66 percent of such tolerances and exemptions are

reviewed within 6 years of August 3, 1996; and

(C) 100 percent of such tolerances and exemptions are

reviewed within 10 years of August 3, 1996.

In conducting a review of a tolerance or exemption, the

Administrator shall determine whether the tolerance or exemption

meets the requirements of subse ctions \ 3 \ (b)(2) or (c)(2) of this

section and shall, by the deadline for the review of the tolerance

or exemption, issue a regulation under subsection (d)(4) or (e)(1)

of this section to modify or revoke the tolerance or exemption if

the tolerance or exemption does not meet such requirements.

---------------------------------------------------------------------------

\ 3 \ So in original. Probably should be ``subsection''.

------------------------------------------------------------- --------------

(2) Priorities

In determining priorities for reviewing tolerances and

exemptions under paragraph (1), the Administrator shall give

priority to the review of the tolerances or exemptions that app ear

to pose the greatest risk to public health.

(3) Publication of schedule

Not later than 12 months after August 3, 1996, the Administrator

shall publish a schedule for review of tolerances and exemptions

esta blished prior to August 3, 1996. The determination of priorities

for the review of tolerances and exemptions pursuant to this

subsection is not a rulemaking and shall not be subject to judicial

review, except that failure to take final actio n pursuant to the

schedule established by this paragraph shall be subject to judicial

review.

(r) Temporary tolerance or exemption

The Administrator may, upon the request of any person who has

obtained an experimental permit for a pesticid e chemical under the

Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et

seq.] or upon the Administrator's own initiative, establish a temporary

tolerance or exemption for the pesticide chemical residue for the uses

covered by the perm it. Subsections (b)(2), (c)(2), (d), and (e) of this

section shall apply to actions taken under this subsection.

(s) Savings clause

Nothing in this section shall be construed to amend or modify the

provisions of the Toxic Substances Control Act [15 U.S.C. 2601 et seq.]

or the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136

et seq.].

(June 25, 1938, ch. 675, Sec. 408, as added July 22, 1954, ch. 559,

Sec. 3, 68 Stat. 511; amended Pub. L. 85

- 791, Sec. 20, Aug. 28, 1958, 72

Stat. 947; Pub. L. 91

- 515, title VI, Sec. 601(d)(1), Oct. 30, 1970, 84

Stat. 1311; Pub. L. 92

- 157, title III, Sec. 303(a), Nov. 18, 1971, 85

Stat. 464; Pub. L. 92

- 516, Sec. 3(3), Oct. 21, 1972, 86 Stat. 998; Pub.

### 27

L. 98

- 620, title IV, Sec. 402(25)(A), Nov. 8, 1984, 98 Stat. 3359; Pub.

L. 102

- 300, Sec. 6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 102

- 571,

title I, Sec. 107(7), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103

- 80,

Sec. 3(k), Aug. 13, 1993, 107 Stat. 776; Pub. L. 104

- 170, title IV,

Sec. 405, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 105

- 324, Sec. 2(b), Oct.

30, 1998, 112 Stat. 3036.)

References in Text

The Federal Rules of Civil Procedure, referred to in subsec.

(g)(2)(B), are set out in the Appendix to Title 28, Judiciar y and

Judicial Procedure.

Section 346 of this title, referred to in subsec. (j)(1), originally

consisted of subsecs. (a) and (b). Subsec. (a) was redesignated as the

entire section 346 and subsec. (b) was repealed by Pub. L. 86

- 618, title

I, Sec. 1 03(a)(1), 74 Stat. 398.

The Federal Insecticide, Fungicide, and Rodenticide Act, referred to

in subsecs. (l), (n)(1)(A), (r), and (s), is act June 25, 1947, ch. 125,

as amended generally by Pub. L. 92

- 516, Oct. 21, 1972, 86 Stat. 973,

which is class ified generally to subchapter II (Sec. 136 et seq.) of

chapter 6 of Title 7, Agriculture. For complete classification of this

Act to the Code, see Short Title note set out under section 136 of Title

7 and Tables.

Section 4365 of title 42, referred t o in subsec. (p)(2), was in the

original ``section 8 of the Environmental Research, Development, and

Demonstration Act of 1978'', and was translated as meaning section 8 of

the Environmental Research, Development, and Demonstration Authorization

Act of 1978, to reflect the probable intent of Congress.

The Toxic Substances Control Act, referred to in subsec. (s), is

Pub. L. 94

- 469, Oct. 11, 1976, 90 Stat. 2003, as amended, which is

classified generally to chapter 53 (Sec. 2601 et seq.) of Title 15,

Commerce and Trade. For complete classification of this Act to the Code,

see Short Title note set out under section 2601 of Title 15 and Tables.

Codification

August 3, 1996, referred to in subsecs. (k), (n)(1)(B), (2)(A), and

(p)(1), (2), (7), was in the original references to the date of

enactment of this subsection and the date of enactment of this section,

which was translated as meaning the date of enactment of Pub. L. 104

- 170, which amended this section generally, to reflect the probable

intent of Congress.

Amendments

1998

-- Subsec. (j)(4). Pub. L. 105

- 324 added par. (4).

1996

-- Pub. L. 104

- 170 amended section generally, substituting, in

subsec. (a), provisions relating to requirement for tolerance or

exemption for provisions relating to conditions for safety; in subsec.

(b), provisions relating to authority and standard for tolerance for

provisions relating to establishment of tolerances; in subsec. (c),

provisions rela ting to authority and standard for exemptions for

provisions relating to exemptions; in subsec. (d), provisions relating

to petition for tolerance or exemption for provisions relating to

regulations pursuant to petition, publication of notice, time for

issuance, referral to advisory committees, effective date, and hearings;

in subsec. (e), provisions relating to action on Administrator's own

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initiative for provisions relating to regulations pursuant to

Administrator's proposals; in subsec. (f), provi sions relating to

special data requirements for provisions relating to data submitted as

confidential; in subsec. (g), provisions relating to effective date,

objections, hearings, and administrative review for provisions relating

to advisory committees and their appointment, composition, compensation,

and clerical assistance; in subsec. (h), provisions relating to judicial

review for provisions relating to right of consultation; in subsec. (i),

provisions relating to confidentiality and use of data f or provisions

relating to judicial review; in subsec. (j), provisions relating to

status of previously issued regulations for provisions relating to

temporary tolerances; in subsec. (k), provisions relating to transitions

for provisions relating to reg ulations based on public hearings before

January 1, 1953; in subsec. (l), provisions relating to harmonization

with action under other laws for provisions relating to pesticides under

Federal Insecticide, Fungicide, and Rodenticide Act, functions of

Ad ministrator of Environmental Protection Agency, certifications,

hearings, time limitations, opinions, and regulations; in subsec. (m),

provisions relating to fees for provisions relating to amendment of

regulations; in subsec. (n), provisions relating t o national uniformity

of tolerances for provisions relating to guaranties; in subsec. (o),

provisions relating to consumer right to know for provisions relating to

payment of fees, services or functions conditioned on payment, and

waiver or refund of f ees; and adding subsecs. (p) to (s).

1993

-- Pub. L. 103

- 80, Sec. 3(k)(6), substituted ``Administrator''

for ``Secretary'' wherever appearing except when followed by ``of

Agriculture''.

Subsec. (a)(1). Pub. L. 103

- 80, Sec. 3(k)(1), substituted

``A dministrator of the Environmental Protection Agency (hereinafter in

this section referred to as the `Administrator')'' for ``Secretary of

Health and Human Services''.

Subsec. (d)(5). Pub. L. 103

- 80, Sec. 3(k)(2), substituted ``section

556(c) of titl e 5'' for ``section 7(c) of the Administrative Procedure

Act (5 U.S.C., sec. 1006(c))''.

Subsec. (l). Pub. L. 103

- 80, Sec. 3(k)(3), substituted ``In the

event'' for ``It the event'' before ``a hearing is requested''.

Subsec. (n). Pub. L. 103

- 80, Sec. 3(k)(4), made technical amendment

to reference to section 333(c) of this title to reflect amendment of

corresponding provision of original act.

Subsec. (o). Pub. L. 103

- 80, Sec. 3(k)(5), which directed the

substitution of ``Administrator'' for ``Secretary of Health and Human

Services'' wherever appearing in the original text, was executed by

making the substitution in the first sentence before ``shall by

regulation require'', the only place ``Secretary of Health and Human

Services'' appeared in the original text.

1992

-- Subsecs. (a), (d), (h), (i), (l), (m), (o). Pub. L. 102

- 300

substituted ``Health and Human Services'' for ``Health, Education, and

Welfare'' wherever appearing in the original statutory text.

Subsec. (g). Pub. L. 102

- 571 substituted ``379e'' for ``376''.

1984

-- Subsec. (i)(5). Pub. L. 98

- 620 struck out provision that

required the court to advance on the docket and expedite the disposition

of all causes filed therein pursuant to this section.

1972

-- Subsecs. (d) (1), (e), (l). Pub. L. 92

- 516 substituted

references to pesticide for references to economic poison wherever

appearing therein.

1971

-- Subsec. (g). Pub. L. 92

- 157 struck out ``, which the Secretary

shall by rules and regulations prescribe,'' after `` as compensation for

their services a reasonable per diem'' prior to amendment in 1970, by

### 29

Pub. L. 91

- 515, which overlooked such language when amending subsec. (g)

as provided in 1970 Amendment note.

1970

-- Subsec. (g). Pub. L. 91

- 515 substituted prov isions authorizing

members of an advisory committee to receive compensation and travel

expenses in accordance with section 376(b)(5)(D) of this title, for

provisions authorizing such members to receive as compensation a

reasonable per diem for time act ually spent on committee work, and

necessary traveling and subsistence expenses while serving away from

their places of residence.

1958

-- Subsec. (i)(2). Pub. L. 85

- 791, Sec. 20(a), in first sentence,

substituted ``transmitted by the clerk of the cou rt to the Secretary,

or'' for ``served upon the Secretary, or upon'', substituted ``file in

the court the record of the proceedings'' for ``certify and file in the

court a transcript of the proceedings and the record'', and inserted

``as provided in se ction 2112 of title 28'', and which, in second

sentence, substituted ``the filing of such petition'' for ``such

filing''.

Subsec. (i)(3). Pub. L. 85

- 791, Sec. 20(b), in first sentence,

substituted ``transmitted by the clerk of the court to the Secre tary of

Agriculture, or'' for ``served upon the Secretary of Agriculture, or

upon'', substituted ``file in the court the record of the proceedings''

for ``certify and file in the court a transcript of the proceedings and

the record'', and inserted ``as provided in section 2112 of title 28'',

and, in second sentence, substituted ``the filing of such petition'' for

``such filing''.

Effective Date of 1984 Amendment

Amendment by Pub. L. 98

- 620 not applicable to cases pending on Nov.

8, 1984, see section 403 of Pub. L. 98

- 620, set out as an Effective Date

note under section 1657 of Title 28, Judiciary and Judicial Procedure.

Effective Date of 1972 Amendment

Amendment by Pub. L. 92

- 516 effective at clos e of Oct. 21, 1972,

except if regulations are necessary for implementation of any provision

that becomes effective on Oct. 21, 1972, and continuation in effect of

subchapter I of chapter 6 of Title 7, Agriculture, and regulations

thereunder, relating t o control of economic poisons, as in existence

prior to Oct. 21, 1972, until superseded by provisions of Pub. L. 92

- 516

and regulations thereunder, see section 4 of Pub. L. 92

- 516, set out as

an Effective Date note under section 136 of Title 7.

Transfer of Functions

Functions vested in Secretary of Health, Education, and Welfare [now

Health and Human Services] in establishing tolerances for pesticide

chemicals under this section together with authority to monitor

compli ance with tolerances and effectiveness of surveillance and

enforcement and to provide technical assistance to States and conduct

research under this chapter and section 201 et seq. of Title 42, The

Public Health and Welfare, and functions of Department of Agriculture

and Secretary of Agriculture under subsec. (l) of this section

transferred to Administrator of Environmental Protection Agency by

Reorg. Plan No. 3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R.

15623, 84 Stat. 2086, set out in the Ap pendix to Title 5, Government

### 30

Organization and Employees.

Tolerance Fees

Pub. L. 108

- 199, div. G, title V, Sec. 501(d)(2), Jan. 23, 2004, 118

Stat. 422, provided that: ``Notwithstanding section 408(m)(1) of the

Federa l Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(1)), during the

period beginning on October 1, 2003, and ending on September 30, 2008,

the Administrator of the Environmental Protection Agency shall not

collect any tolerance fees under that section.''

Data Collection Activities To Assure Health of Infants and Children

Section 301 of Pub. L. 104

- 170 provided that:

``(a) In General.

-- The Secretary of Agriculture, in consultation

with the Administrator of the Environmental Protection Agency and the

Secretary of Health and Human Services, shall coordinate the development

and implementation of survey procedures to ensure that adequate data on

food consumption patterns of infants and children are collected.

``(b) Procedures.

-- To the exten t practicable, the procedures

referred to in subsection (a) shall include the collection of data on

food consumption patterns of a statistically valid sample of infants and

children.

``(c) Residue Data Collection.

-- The Secretary of Agriculture shall

ensure that the residue data collection activities conducted by the

Department of Agriculture in cooperation with the Environmental

Protection Agency and the Department of Health and Human Services,

provide for the improved data collection of pesticid e residues,

including guidelines for the use of comparable analytical and

standardized reporting methods, and the increased sampling of foods most

likely consumed by infants and children.''

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