Attachment D
Federal Food, Drug, and Cosmetic Act (FFDCA)
Section 408 - Tolerances and Exemptions for Pesticide Chemical Residues
(21 U.S.C. 346a)
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: 21USC346a]
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 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 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
``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--
(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;
(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 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--
(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 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, 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 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 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].
(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.
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\1\ See References in Text note below.
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(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:
(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 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 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
(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
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
(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.
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\2\ See References in Text note below.
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(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.
(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 or revoke the tolerance or exemption if
the tolerance or exemption does not meet such requirements.
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\3\ So in original. Probably should be ``subsection''.
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(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.].
(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.
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, Judiciary 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. 103(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 classified 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 to 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 relating 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
initiative for provisions relating to regulations pursuant to
Administrator's proposals; in subsec. (f), provisions 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 for 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 regulations 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
Administrator 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 to 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 fees; 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
``Administrator 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 title 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
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 provisions 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 actually 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 court 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 section 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 Secretary 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 close 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 to 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
compliance 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 Appendix to Title 5, Government
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
Federal 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 extent 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 pesticide 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.''
| File Type | application/msword |
| File Title | Attachment A |
| Author | CSMOOT |
| Last Modified By | CSMOOT |
| File Modified | 2008-04-14 |
| File Created | 2008-04-14 |