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US CODE: Title 21,346a. Tolerances and exemptions for pesticide chemical residues

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TITLE 21 > CHAPTER 9 > SUBCHAPTER IV > § 346a

§ 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 agricultural 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 under this section, such
residue in or on the raw agricultural commodity has been removed to the extent
possible in good manufacturing practice, and the concentration of the pesticide
chemical residue in the processed food is not greater 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 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.
(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

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precursor substance;
(B) either—
(i) a tolerance is in effect under this section for residues of the 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 be 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 under 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 substances 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
this 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 title.
(b) Authority and standard for tolerance
(1) Authority
The Administrator may issue regulations establishing, modifying, 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 pesticide 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 health (referred to in this section as a

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“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 to in this section as a
“threshold effect”), the Administrator determines that the level of
aggregate exposure is safe.
(ii) Determination of tolerance Notwithstanding subparagraph (A)(i), a
tolerance 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 tolerance 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 would 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 production 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 yearly
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 the 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 notice 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
been 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).
(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—

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(I) available information about consumption patterns 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 general population;
(II) available information concerning the special susceptibility of
infants and children to the pesticide chemical residues, including
neurological differences between 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 children 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 Administrator 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, modifying, 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 of the results of such
studies to human risk;
(iv) available information concerning the dietary consumption patterns of
consumers (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, including 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 the variability of the sensitivities of
major identifiable subgroups of consumers;

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(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 experience 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 anticipated 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 Administration.
(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, demonstrating 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 on, 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 this section, as
appropriate, to modify or revoke the tolerance.
(F) Percent of food actually treated
In establishing, modifying, leaving in effect, or revoking a tolerance for a
pesticide chemical residue, the Administrator 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 Department 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
pesticide 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 consumption 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 estimate 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 unless 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) Detection 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

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method for detecting and measuring the pesticide chemical 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 whether 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 Administrator 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
(B) on the Administrator’s initiative under subsection (e) of this section.
(2) Standard
(A) General rule
(i) Standard The Administrator may establish 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 and 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 food 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 pesticide 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 for tolerance or exemption
(1) Petitions and petitioners
Any person may file with the Administrator a petition proposing the issuance of a
regulation—

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(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
(A) Establishment
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 that 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 issued 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 information 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 or 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 petition 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 similar 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 granted 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 requires by
regulation to support the petition.
If information or data required by this subparagraph is available to the

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Administrator, the person submitting the petition may cite the availability of the
information or data 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.
(B) Modification or revocation
The Administrator 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) establishing, 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 subsection; 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 chemical 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) of this section, the
Administrator 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 for 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 subclause (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 condition 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,

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issue a regulation under subsection (e)(1) of this section 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 subsection (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 exemption 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 final 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 submission 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 residue 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 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 Administrator 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 information

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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 Administrator 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 submission 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
Within 60 days after a regulation or order is issued under subsection (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 objectionable 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 factual 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 the 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 regulation 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 issue 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

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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 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 officer 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
of 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
Administrator, 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) Final 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 same extent
provided by sections 3 and 10 of the Federal Insecticide, Fungicide, and Rodenticide
Act [7 U.S.C. 136a, 136h].

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(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 Administrator
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 chapter 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 provision 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 agricultural 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 issued 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.

(2) Regulations under section 348
Regulations that established tolerances for substances that are pesticide chemical
residues in or on processed food, or that otherwise stated the conditions under which
such pesticide chemicals 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
chemical” 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:

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(A) Notwithstanding paragraph (2), any regulation applying to the use of the
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 deemed 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 resulting 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 321
(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 of 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) Harmonization 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 that suspends or revokes a
tolerance or exemption for a pesticide chemical residue in or on food, the Administrator
shall coordinate such action with any related necessary action under the Federal
Insecticide, Fungicide, and Rodenticide Act [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, cancels 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 connection 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 allows 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 paragraph 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 becomes 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

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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 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 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 each 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 considered 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 associated
suspension of tolerance or exemption.
(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 be 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 this 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 allows 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 under 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 Administrator 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 emergency 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 establish 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 exemption without providing notice or a period for comment on the
tolerance or exemption. The Administrator shall promulgate regulations within 365

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days after August 3, 1996, governing the establishment of tolerances and exemptions
under this paragraph. Such regulations shall be 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 adequate 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 proceedings 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
Administrator 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 Processing 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
Administrator’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 residue” 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 applicable 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 section 4(g) of that Act [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 exemption 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 subsection (b)(2)(A) (in the case of a
tolerance) or (c)(2) (in the case of an exemption) of this section; or

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(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 tolerance) 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 accordance 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 qualifying 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 Federal 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 authorization 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 Administrator; and
(ii) be supported by scientific data 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 the 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) Treatment
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 exemption. If the Administrator

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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 this 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
the 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 urgent 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 chemical 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 State,
unless the State demonstrates that consumption of the 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 such 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
warning 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 information,
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 used.
(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 paragraph (2).
Nothing in this subsection shall prevent retail grocers from providing additional
information.
(p) Estrogenic substances screening program

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(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 later 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 Rodenticide
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 program.

(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) Collection 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 substance 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 paragraph,
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 period
beginning on the date that the registrant receives the notice of intent to
suspend, unless during that period a person adversely affected by the notice
requests a hearing or the Administrator determines that the registrant has
complied fully with this paragraph.

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(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 under
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 under
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 chapter, 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 the 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—
(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 subsections [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

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or revoke the tolerance or exemption if the tolerance or exemption does not meet such
requirements.
(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
appear 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 established 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 action 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 pesticide 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 permit.
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.].

[1] See References in Text note below.
[2] See References in Text note below.
[3] So in original. Probably should be “subsection”.
LII has no control over and does not endorse any external Internet
site that contains links to or references LII.

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