H. R. 1627—24
(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 Environ-
mental Protection Agency and the Department of Health and
Human Services, provide for the improved data collection of pes-
ticide 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.
SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION.
(a) IN GENERAL.—The Secretary of Agriculture shall collect
data of statewide or regional significance on the use of pesticides
to control pests and diseases of major crops and crops of dietary
significance, including fruits and vegetables.
(b) COLLECTION.—The data shall be collected by surveys of
farmers or from other sources offering statistically reliable data.
(c) COORDINATION.—The Secretary of Agriculture shall, as
appropriate, coordinate with the Administrator of the Environ-
mental Protection Agency in the design of the surveys and make
available to the Administrator the aggregate results of the surveys
to assist the Administrator.
SEC. 303. INTEGRATED PEST MANAGEMENT.
The Secretary of Agriculture, in cooperation with the Adminis-
trator, shall implement research, demonstration, and education pro-
grams to support adoption of Integrated Pest Management.
Integrated Pest Management is a sustainable approach to managing
pests by combining biological, cultural, physical, and chemical tools
in a way that minimizes economic, health, and environmental risks.
The Secretary of Agriculture and the Administrator shall make
information on Integrated Pest Management widely available to
pesticide users, including Federal agencies. Federal agencies shall
use Integrated Pest Management techniques in carrying out pest
management activities and shall promote Integrated Pest Manage-
ment through procurement and regulatory policies, and other activi-
ties.
SEC. 304. COORDINATION OF CANCELLATION.
Section 2(bb) (7 U.S.C. 136(bb)) is amended—
(1) by inserting ‘‘(1)’’ after ‘‘means’’; and
(2) by striking the period at the end of the first sentence
and inserting ‘‘, or (2) a human dietary risk from residues
that result from a use of a pesticide in or on any food inconsist-
ent with the standard under section 408 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 346a).’’.
SEC. 305. PESTICIDE USE INFORMATION STUDY.
(a) The Secretary of Agriculture shall, in consultation with
the Administrator of the Environmental Protection Agency, prepare
a report to Congress evaluating the current status and potential
improvements in Federal pesticide use information gathering activi-
ties. This report shall at least include—
(1) an analysis of the quality and reliability of the informa-
tion collected by the Department of Agriculture, the Environ-
mental Protection Agency, and other Federal agencies regarding
the agricultural use of pesticides; and
(2) an analysis of options to increase the effectiveness of
national pesticide use information collection, including an
H. R. 1627—25
analysis of costs, burdens placed on agricultural producers and
other pesticide users, and effectiveness in tracking risk reduc-
tion by those options.
(b) The Secretary shall submit this report to Congress not
later than 1 year following the date of enactment of this section.
TITLE IV—AMENDMENTS TO THE FED-
ERAL FOOD, DRUG, AND COSMETIC
ACT
SEC 401. SHORT TITLE AND REFERENCE.
(a) SHORT TITLE.—This title may be cited as the ‘‘Food Quality
Protection Act of 1996 ’’.
(b) REFERENCE.—Whenever in this title an amendment or
repeal is expressed in terms of an amendment to, or repeal of,
a section or other provision, the reference shall be considered to
be made to a section or other provision of the Federal Food, Drug,
and Cosmetic Act.
SEC. 402. DEFINITIONS.
(a) SECTION
201(q).—Section 201(q) (21 U.S.C. 321(q)) is
amended to read as follows:
‘‘(q)(1) The term ‘pesticide chemical’ means any substance that
is a pesticide within the meaning of the Federal Insecticide, Fun-
gicide, and Rodenticide Act, including all active and inert ingredi-
ents of such pesticide.
‘‘(2) The term ‘pesticide chemical residue’ means a residue
in or on raw agricultural commodity or processed food of—
‘‘(A) a pesticide chemical; or
‘‘(B) any other added substance that is present on or in
the commodity or food primarily as a result of the metabolism
or other degradation of a pesticide chemical.
‘‘(3) Notwithstanding paragraphs (1) and (2), the Administrator
may by regulation except a substance from the definition of ‘pes-
ticide chemical’ or ‘pesticide chemical residue’ if—
‘‘(A) its occurrence as a residue on or in a raw agricultural
commodity or processed food is attributable primarily to natural
causes or to human activities not involving the use of any
substances for a pesticidal purpose in the production, storage,
processing, or transportation of any raw agricultural commodity
or processed food; and
‘‘(B) the Administrator, after consultation with the Sec-
retary, determines that the substance more appropriately
should be regulated under one or more provisions of this Act
other than sections 402(a)(2)(B) and 408.’’.
(b) SECTION 201(s).—Paragraphs (1) and (2) of section 201(s)
(21 U.S.C. 321(s)) are amended to read as follows:
‘‘(1) a pesticide chemical residue in or on a raw agricultural
commodity or processed food; or
‘‘(2) a pesticide chemical; or’’.
(c) SECTION 201.—Section 201 (21 U.S.C. 321) is amended by
adding at the end the following:
‘‘(gg) The term ‘processed food’ means any food other than
a raw agricultural commodity and includes any raw agricultural
H. R. 1627—26
commodity that has been subject to processing, such as canning,
cooking, freezing, dehydration, or milling.
‘‘(hh) The term ‘Administrator’ means the Administrator of
the United States Environmental Protection Agency.’’.
SEC. 403. PROHIBITED ACTS.
Section 301(j) (21 U.S.C. 331(j)) is amended in the first sentence
by inserting before the period the following: ‘‘; or the violating
of section 408(i)(2) or any regulation issued under that section.’’.
SEC. 404. ADULTERATED FOOD.
Section 402(a) (21 U.S.C. 342(a)) is amended by striking ‘‘(2)(A)
if it bears’’ and all that follows through ‘‘(3) if it consists’’ and
inserting the following: ‘‘(2)(A) if it bears or contains any added
poisonous or added deleterious substance (other than a substance
that is a pesticide chemical residue in or on a raw agricultural
commodity or processed food, a food additive, a color additive,
or a new animal drug) that is unsafe within the meaning of section
406; or (B) if it bears or contains a pesticide chemical residue
that is unsafe within the meaning of section 408(a); or (C) if it
is or if it bears or contains (i) any food additive that is unsafe
within the meaning of section 409; or (ii) a new animal drug
(or conversion product thereof) that is unsafe within the meaning
of section 512; or (3) if it consists’’.
SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL
RESIDUES.
Section 408 (21 U.S.C. 346a) is amended to read as follows:
‘‘TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
‘‘SEC. 408. (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 402(a)(2)(B)
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 402(a)(2)(B) 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
H. R. 1627—27
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 mean-
ing of section 402(a)(2)(B).
‘‘(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 sub-
stance 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 402(a)(2)(B) 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 precur-
sor 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 toler-
ance 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 402(a)(1).
‘‘(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); or
‘‘(B) on the Administrator’s own initiative under sub-
section (e).
As used in this section, the term ‘modify’ shall not mean
expanding the tolerance to cover additional foods.
H. R. 1627—28
‘‘(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 deter-
mines 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 reason-
able certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other expo-
sures 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 non-
threshold effect is appropriately assessed by quan-
titative 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 deter-
mines that the level of aggregate exposure is safe.
‘‘(ii) DETERMINATION
OF
TOLERANCE.—Notwith-
standing subparagraph (A)(i), a tolerance for an eligible
pesticide chemical residue may be left in effect or modi-
fied 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 pro-
duces the residue is necessary to avoid a significant
H. R. 1627—29
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 non-
threshold 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 appro-
priate, 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 speci-
fied 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) to modify or revoke the toler-
ance.
‘‘(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 spe-
cial 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
H. R. 1627—30
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 Adminis-
trator, 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. Notwith-
standing 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 chemi-
cal 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 relation-
ship of the results of such studies to human risk;
‘‘(iv) available information concerning the dietary
consumption patterns of consumers (and major identifi-
able subgroups of consumers);
‘‘(v) available information concerning the cumu-
lative effects of such residues and other substances
that have a common mechanism of toxicity;
‘‘(vi) available information concerning the aggre-
gate exposure levels of consumers (and major identifi-
able 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 varia-
bility of the sensitivities of major identifiable sub-
groups 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 pro-
H. R. 1627—31
duced by a naturally occurring estrogen or other endo-
crine effects; and
‘‘(ix) safety factors which in the opinion of experts
qualified by scientific training and experience to evalu-
ate 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, modify-
ing, or leaving in effect a tolerance, the Administrator
shall pursuant to subsection (f)(1) 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),
or an order under subsection (f)(2), as appropriate, to mod-
ify 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 Adminis-
trator may, when assessing chronic dietary risk, consider
available data and information on the percent of food actu-
ally treated with the pesticide chemical (including aggre-
gate 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 pes-
ticide 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 chemi-
cal residue in or on a food shall not be established or
H. R. 1627—32
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 toler-
ance 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 regula-
tion 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); or
‘‘(B) on the Administrator’s initiative under subsection
(e).
‘‘(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 chemi-
cal 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).
‘‘(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 Sec-
retary—
H. R. 1627—33
‘‘(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 regula-
tion—
‘‘(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 chemi-
cal 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, fre-
quency, method, and time of application of that pes-
ticide 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 con-
trols 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 meth-
ods used;
‘‘(vi) a practical method for detecting and measur-
ing 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 chemi-
cal 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);
H. R. 1627—35
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 pre-
sents 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), the
Administrator shall complete action on such petition
under this paragraph within 1 year.
‘‘(ii) REQUIRED DETERMINATIONS.—If the Adminis-
trator 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) continues
to exist with respect to a tolerance that has been
left in effect or modified under subsection (b)(2)(B).
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) to modify or revoke the tolerance.
‘‘(e) ACTION ON ADMINISTRATOR’S OWN INITIATIVE.—
‘‘(1) GENERAL RULE.—The Administrator may issue a regu-
lation—
‘‘(A) establishing, modifying, suspending under sub-
section (l)(3), or revoking a tolerance for a pesticide chemi-
cal or a pesticide chemical residue;
‘‘(B) establishing, modifying, suspending under sub-
section (l)(3), or revoking an exemption of a pesticide chemi-
cal 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 para-
graph (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 Adminis-
trator 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 toler-
ance 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;
H. R. 1627—36
‘‘(B) issue a rule requiring that testing be conducted
on a substance or mixture under section 4 of the Toxic
Substances Control Act; or
‘‘(C) publish in the Federal Register, after first provid-
ing 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 identify-
ing 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
or section 4 of the Toxic Substances Control Act;
‘‘(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 pertain-
ing to whether the pesticide chemical may have an effect
in humans that is similar to an effect produced by a natu-
rally 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 ques-
tion. In any review of such an order under subsection (g)(2),
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 ADMINISTRA-
TIVE REVIEW.—
‘‘(1) EFFECTIVE DATE.—A regulation or order issued under
subsection (d)(4), (e)(1), or (f)(2) shall take effect upon publica-
tion 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), any person may file objections
thereto with the Administrator, specifying with particular-
ity 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), a copy of each objection filed by
H. R. 1627—37
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 Adminis-
trator 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 rel-
evant 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 reason-
able 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 regula-
tion 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),
or any order issued under subsection (f)(1)(C) or (g)(2)(C), 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 proceed-
ings on which the Administrator based the order or regulation,
as provided in section 2112 of title 28, United States Code.
Upon the filing of such a petition, the court shall have exclusive
jurisdiction to affirm or set aside the order or regulation com-
plained 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
H. R. 1627—38
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 satis-
faction 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 find-
ing, order, or regulation.
‘‘(4) FINAL JUDGMENT; SUPREME COURT REVIEW.—The judg-
ment 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 of the United States Code. 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 409 in support of a tolerance or an exemption from
a tolerance shall be entitled to confidential treatment for rea-
sons 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.
‘‘(2) EXCEPTIONS.—
‘‘(A) IN GENERAL.—Data and information that are enti-
tled 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 informa-
tion in the carrying out of their official duties under
this Act 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
Act 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 sub-
committee of such joint committee.
‘‘(3) SUMMARIES.—Notwithstanding any provision of this
subsection or other law, the Administrator may publish the