Attachment C_FFDCA section 408(a)

§ 346

TITLE 21—FOOD AND DRUGS

processed, labeled, or repacked in substantial
quantities at establishments other than those
where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this chapter
upon removal from such processing, labeling, or
repacking establishment. This section does not
apply to the labeling requirements of sections
343(q) and 343(r) of this title.
(June 25, 1938, ch. 675, § 405, 52 Stat. 1049; Pub. L.
101–535, § 5(a), Nov. 8, 1990, 104 Stat. 2362.)
AMENDMENTS
1990—Pub. L. 101–535 inserted at end ‘‘This section
does not apply to the labeling requirements of sections
343(q) and 343(r) of this title.’’

Page 96

into account the extent to which the use of such
substance is required or cannot be avoided in
the production of each such article, and the
other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.
(June 25, 1938, ch. 675, § 406, 52 Stat. 1049; Pub. L.
85–929, § 3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L.
86–618, title I, § 103(a)(1), July 12, 1960, 74 Stat.
398.)
AMENDMENTS
1960—Pub. L. 86–618 repealed subsec. (b) which required Secretary to promulgate regulations for listing
of coal-tar colors.
1958—Subsec. (a). Pub. L. 85–929 substituted ‘‘clause
(2)(A)’’ for ‘‘clause (2)’’ in first sentence.

EFFECTIVE DATE OF 1990 AMENDMENT

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 101–535 effective six months
after the date of the promulgation of final regulations
to implement section 343(r) of this title, or if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations
(Nov. 8, 1992), with exception for persons marketing
food the brand name of which contains a term defined
by the Secretary under section 343(r)(2)(A)(i) of this
title, see section 10(a) of Pub. L. 101–535, set out as a
note under section 343 of this title.

Amendment by Pub. L. 86–618 effective July 12, 1960,
subject to the provisions of section 203 of Pub. L. 86–618,
see section 202 of Pub. L. 86–618, set out as a note under
section 379e of this title.

CONSTRUCTION OF AMENDMENTS BY PUB. L. 101–535
Amendments by Pub. L. 101–535 not to be construed to
alter authority of Secretary of Health and Human
Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et
seq.), the Poultry Products Inspection Act (21 U.S.C. 451
et seq.), and the Egg Products Inspection Act (21 U.S.C.
1031 et seq.), see section 9 of Pub. L. 101–535, set out as
a note under section 343 of this title.
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare
[now Health and Human Services], and of Food and
Drug Administration in the Department of Agriculture
to Federal Security Agency, see notes set out under
section 321 of this title.

§ 346. Tolerances for poisonous or deleterious
substances in food; regulations
Any poisonous or deleterious substance added
to any food, except where such substance is required in the production thereof or cannot be
avoided by good manufacturing practice shall be
deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title;
but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein
or thereon to such extent as he finds necessary
for the protection of public health, and any
quantity exceeding the limits so fixed shall also
be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this
title. While such a regulation is in effect limiting the quantity of any such substance in the
case of any food, such food shall not, by reason
of bearing or containing any added amount of
such substance, be considered to be adulterated
within the meaning of clause (1) of section 342(a)
of this title. In determining the quantity of such
added substance to be tolerated in or on different articles of food the Secretary shall take

EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR,
DEFOLIANT, AND DESICCANT AMENDMENT OF 1959
Effective date of subsec. (a) as in force prior to July
22, 1954, with respect to particular commercial use of a
nematocide, plant regulator, defoliant, or desiccant in
or on a raw agricultural commodity made before Jan.
1, 1958, see section 3(b) of Pub. L. 86–139, Aug. 7, 1959, 73
Stat. 288.
EFFECTIVE DATE OF 1958 AMENDMENT
For effective date of amendment by Pub. L. 85–929,
see section 6(b), (c) of Pub. L. 85–929, set out as a note
under section 342 of this title.
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, transferred to Administrator of Environmental Protection Agency by Reorg. Plan No. 3 of 1970,
§ 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.
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare
[now Health and Human Services], and of Food and
Drug Administration to Federal Security Agency, see
notes set out under section 321 of this title.

§ 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 modifica-

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TITLE 21—FOOD AND DRUGS

tion, 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

§ 346a

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

§ 346a

TITLE 21—FOOD AND DRUGS
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

Page 98

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 postnatal 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

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TITLE 21—FOOD AND DRUGS

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

§ 346a

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.

§ 346a

TITLE 21—FOOD AND DRUGS

(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

Page 100

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

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TITLE 21—FOOD AND DRUGS

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 exemp-

§ 346a

tion 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;

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TITLE 21—FOOD AND DRUGS
(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.

Page 102

(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

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TITLE 21—FOOD AND DRUGS

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

§ 346a

(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:
(A) Notwithstanding paragraph (2), any
regulation applying to the use of the sub1 See

References in Text note below.

§ 346a

TITLE 21—FOOD AND DRUGS

stance 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

Page 104

(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

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TITLE 21—FOOD AND DRUGS

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;

§ 346a

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).
(3) Prohibition
During the period beginning on October 1,
2007, and ending on September 30, 2017, the Administrator shall not collect any tolerance
fees under 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

§ 346a

TITLE 21—FOOD AND DRUGS

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 peti-

Page 106

tion 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.

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TITLE 21—FOOD AND DRUGS

(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.
(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.
2 See

References in Text note below.

§ 346a

(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.

§ 346a

TITLE 21—FOOD AND DRUGS

(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.
(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
3 So

in original. Probably should be ‘‘subsection’’.

Page 108

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, § 408, as added July 22,
1954, ch. 559, § 3, 68 Stat. 511; amended Pub. L.
85–791, § 20, Aug. 28, 1958, 72 Stat. 947; Pub. L.
91–515, title VI, § 601(d)(1), Oct. 30, 1970, 84 Stat.
1311; Pub. L. 92–157, title III, § 303(a), Nov. 18,
1971, 85 Stat. 464; Pub. L. 92–516, § 3(3), Oct. 21,
1972, 86 Stat. 998; Pub. L. 98–620, title IV,
§ 402(25)(A), Nov. 8, 1984, 98 Stat. 3359; Pub. L.
102–300, § 6(b)(1), June 16, 1992, 106 Stat. 240; Pub.
L. 102–571, title I, § 107(7), Oct. 29, 1992, 106 Stat.
4499; Pub. L. 103–80, § 3(k), Aug. 13, 1993, 107 Stat.
776; Pub. L. 104–170, title IV, § 405, Aug. 3, 1996,
110 Stat. 1514; Pub. L. 105–324, § 2(b), Oct. 30, 1998,
112 Stat. 3036; Pub. L. 110–94, § 4(d)(2), Oct. 9, 2007,
121 Stat. 1002; Pub. L. 112–177, § 2(a)(3), Sept. 28,
2012, 126 Stat. 1329.)
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, § 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 (§ 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
(§ 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
2012—Subsec. (m)(3). Pub. L. 112–177 substituted ‘‘September 30, 2017’’ for ‘‘September 30, 2012’’.
2007—Subsec. (m)(3). Pub. L. 110–94 added par. (3).
1998—Subsec. (j)(4). Pub. L. 105–324 added par. (4).

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§ 346a

TITLE 21—FOOD AND DRUGS

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, § 3(k)(6), substituted ‘‘Administrator’’ for ‘‘Secretary’’ wherever appearing except
when followed by ‘‘of Agriculture’’.
Subsec. (a)(1). Pub. L. 103–80, § 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, § 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, § 3(k)(3), substituted ‘‘In
the event’’ for ‘‘It the event’’ before ‘‘a hearing is requested’’.
Subsec. (n). Pub. L. 103–80, § 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, § 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, § 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, § 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 2012 AMENDMENT
Amendment by Pub. L. 112–177 effective Oct. 1, 2012,
see section 2(c) of Pub. L. 112–177, set out as a note
under section 136a–1 of Title 7, Agriculture.
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 110–94 effective Oct. 1, 2007,
see section 6 of Pub. L. 110–94, set out as a note under
section 136a of Title 7, Agriculture.
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.
TOLERANCE FEES
Pub. L. 108–199, div. G, title V, § 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
Pub. L. 104–170, title III, § 301, Aug. 3, 1996, 110 Stat.
1511, provided that:
‘‘(a) IN GENERAL.—The Secretary of Agriculture, in
consultation with the Administrator of the Environ-

§ 346b

TITLE 21—FOOD AND DRUGS

mental 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.’’

§ 346b. Authorization of appropriations
There are authorized to be appropriated, out of
any moneys in the Treasury not otherwise appropriated, such sums as may be necessary for
the purpose and administration of sections
321(q), (r), 342(a)(2), and 346a of this title.
(July 22, 1954, ch. 559, § 4, 68 Stat. 517.)
CODIFICATION
Section was not enacted as part of the Federal Food,
Drug, and Cosmetic Act which comprises this chapter.

§ 347. Intrastate sales of colored oleomargarine
(a) Law governing
Colored oleomargarine or colored margarine
which is sold in the same State or Territory in
which it is produced shall be subject in the same
manner and to the same extent to the provisions
of this chapter as if it had been introduced in
interstate commerce.
(b) Labeling and packaging requirements
No person shall sell, or offer for sale, colored
oleomargarine or colored margarine unless—
(1) such oleomargarine or margarine is packaged,
(2) the net weight of the contents of any
package sold in a retail establishment is one
pound or less,
(3) there appears on the label of the package
(A) the word ‘‘oleomargarine’’ or ‘‘margarine’’
in type or lettering at least as large as any
other type or lettering on such label, and (B)
a full and accurate statement of all the ingredients contained in such oleomargarine or
margarine, and
(4) each part of the contents of the package
is contained in a wrapper which bears the word
‘‘oleomargarine’’ or ‘‘margarine’’ in type or
lettering not smaller than 20-point type.
The requirements of this subsection shall be in
addition to and not in lieu of any of the other
requirements of this chapter.
(c) Sales in public eating places
No person shall possess in a form ready for
serving colored oleomargarine or colored margarine at a public eating place unless a notice
that oleomargarine or margarine is served is
displayed prominently and conspicuously in
such place and in such manner as to render it
likely to be read and understood by the ordinary

Page 110

individual being served in such eating place or is
printed or is otherwise set forth on the menu in
type or lettering not smaller than that normally
used to designate the serving of other food
items. No person shall serve colored oleomargarine or colored margarine at a public eating place, whether or not any charge is made
therefor, unless (1) each separate serving bears
or is accompanied by labeling identifying it as
oleomargarine or margarine, or (2) each separate
serving thereof is triangular in shape.
(d) Exemption from labeling requirements
Colored oleomargarine or colored margarine
when served with meals at a public eating place
shall at the time of such service be exempt from
the labeling requirements of section 343 of this
title (except paragraphs (a) and (f)) if it complies with the requirements of subsection (b) of
this section.
(e) Color content of oleomargarine
For the purpose of this section colored oleomargarine or colored margarine is oleomargarine or margarine having a tint or shade
containing more than one and six-tenths degrees
of yellow, or of yellow and red collectively, but
with an excess of yellow over red, measured in
terms of Lovibond tintometer scale or its equivalent.
(June 25, 1938, ch. 675, § 407, as added Mar. 16,
1950, ch. 61, § 3(c), 64 Stat. 20.)
EFFECTIVE DATE
Act Mar. 16, 1950, ch. 61, § 7, 64 Stat. 22, provided that:
‘‘This Act [enacting this section and sections 347a and
347b of this title and amending sections 331 and 342 of
this title and sections 45 and 55 of Title 15, Commerce
and Trade] shall become effective on July 1, 1950.’’
TRANSFER OF APPROPRIATIONS
Act Mar. 16, 1950, ch. 61, § 5, 64 Stat. 22, provided that:
‘‘So much of the unexpended balances of appropriations, allocations, or other funds (including funds available for the fiscal year ending June 30, 1950) for the use
of the Bureau of Internal Revenue of the Treasury Department in the exercise of functions under the Oleomargarine Tax Act (26 U.S.C., § 2300, subchapter A) [now
section 4591 et seq. of Title 26, Internal Revenue Code],
as the Director of the Bureau of the Budget [now Director of the Office of Management and Budget] may determine, shall be transferred to the Federal Security
Agency (Food and Drug Administration) [now the Department of Health and Human Services] for use in the
enforcement of this Act [see Effective Date note
above].’’

§ 347a. Congressional declaration of policy regarding oleomargarine sales
The Congress finds and declares that the sale,
or the serving in public eating places, of colored
oleomargarine or colored margarine without
clear identification as such or which is otherwise adulterated or misbranded within the
meaning of this chapter depresses the market in
interstate commerce for butter and for oleomargarine or margarine clearly identified and
neither adulterated nor misbranded, and constitutes a burden on interstate commerce in
such articles. Such burden exists, irrespective of
whether such oleomargarine or margarine originates from an interstate source or from the
State in which it is sold.