(e) SECTION 6(c).—Section 6(c) (7 U.S.C. 136d(c))
is amended in paragraph (4) by striking out ‘‘section 16’’
and inserting in lieu thereof ‘‘section 16(b)(1)’’.
(f) SECTION 6(d).—Section 6(d) (7 U.S.C. 136d(d))
is amended—
(1) by revising the first sentence to read as fol-
lows: ‘‘If a hearing is requested pursuant to section
3(c)(2)(B)(iv), 3(c)(6), 4(e)(3)(B)(iii)(III), 6(c)(2),
or 6(e)(2), such hearing shall be held for the pur-
pose of receiving evidence relevant and material to
the issues raised by the request for hearing.’’; and
(2) by striking all that follows the eighth sen-
tence and inserting the following: ‘‘A hearing under
this subsection shall be held in accordance with the
provisions of sections 554, 556, and 557 of title 5,
United States Code. As soon as practicable after the
completion of the hearing, the Administration shall
issue a final order setting forth the Administrator’s
decision. Such order and decision shall be based only
on substantial evidence of record of such hearing,
shall set forth detailed findings of fact upon which
the order is based, and shall be subject to judicial
review under section 16(b)(1).’’.
(g) SECTION
16(a).—Section 16(a) (7 U.S.C.
136n(a)) is amended by inserting ‘‘or a proceeding under
section 6(b)’’ after ‘‘a hearing’’.
(h) SECTION
16(b).—Section 16(b) (17 U.S.C.
136n(b)) is amended—
(1) by striking out ‘‘(b) REVIEW BY COURT OF
APPEALS.—In the case of’’ and inserting in lieu
thereof the following:
‘‘(b) REVIEW BY COURT OF APPEALS.—
‘‘(1) REVIEW
OF
CERTAIN
ORDERS.—In the
case of’’;
(2) by striking ‘‘under this section’’ in the sixth
sentence of paragraph (1) (as so designated) and in-
serting ‘‘under this paragraph’’; and
(3) by adding at the end the following new
paragraph:
‘‘(2) REVIEW OF CERTAIN RULES.—In the case
of actual controversy as to the validity of any rule
issued by the Administrator under section 6(b)(9),
any decision by the Administrator under section
6(b)(4) or 6(b)(9) not to issue a proposed rule or to
withdraw a proposed rule, or any denial of a petition
to revoke or amend a final rule under section
6(b)(12), any person who will be adversely affected
by such rule or decision and who has filed comments
in the proceeding leading to the rule or decision may
obtain judicial review by filing a petition in the Unit-
ed States court of appeals for the circuit wherein
such person resides or has a place of business, with-
in 60 days after the entry of such order. A copy of
the petition shall be forthwith transmitted to the Ad-
ministrator or any officer designated by the Admin-
istrator for that purpose, and thereupon the Admin-
istrator shall file in court the record of the proceed-
ings on which the Administrator based such rule or
decision, as provided in section 2112 of title 28,
United States Code. Upon the filing of such petition
the court shall have exclusive jurisdiction to affirm
or set aside such rule or decision in whole or in part.
The standard review shall be that set forth in sec-
tion 706 of title 5, United States Code. The judg-
ment of the court under this paragraph shall be
final, subject to review by the Supreme Court upon
certiorari or certification as provided in section 1254
of title 28 of the United States Code. The com-
mencement of proceedings under this section shall
not, unless specifically ordered by the court to the
contrary, operate as a stay of an order.’’.
(i) SECTION
25(a).—Section 25(a) (7 U.S.C.
136w(a)) is amended by adding a new paragraph (5) at
the end, to read as follows:
‘‘(5) EXCEPTION.—The requirements of this
subsection shall not apply to any rule or rulemaking
proceeding under section 6(b).’’.
(j) SECTION
25(d).—Section 25(d) (7 U.S.C.
136w(d)) is amended—
(1) in the first sentence by striking out ‘‘in no-
tices of intent issued under subsection 6(b) and’’;
and
(2) in the second sentence by striking out ‘‘no-
tices of intent and’’ and by striking out ‘‘section
6(b) or’’.
(k) SECTION
25(e).—Section 25(e) (7 U.S.C.
136w(e)) is amended by striking out the period at the end
of the second sentence and substituting ‘‘, except for any
action that may be taken under section 6(b).’’.
TITLE II—DATA COLLECTION
SEC. 201. COLLECTION OF PESTICIDE USE INFORMATION.
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. Such
data shall be collected by surveys of farmers or from other
sources offering statistically reliable data. The Secretary
shall, as appropriate, coordinate with the Administrator
of the Environmental Protection Agency in the design of
such surveys and make available to the Administrator the
aggregate results of such surveys to assist the Adminis-
trator in developing exposure calculations and benefits de-
terminations with respect to pesticide regulatory decisions.
SEC. 202. INTEGRATED PEST MANAGEMENT.
Section 28(c) of the Federal Insecticide, Fungicide,
and Rodenticide Act (7 U.S.C. 136w–3(c)) is amended—
(1) by designating the text of such section as
paragraph (1) with the margin indented one em, and
(2) by adding at the end the following:
‘‘(2) The Administrator and the Secretary of Agri-
culture shall research, develop, and disseminate integrated
pest management techniques and other pest control meth-
ods that enable producers to reduce or eliminate applica-
tions of pesticides which pose a greater than negligible die-
tary risk to humans, with a special focus on crops critical
to a balanced, healthy diet and which are considered as
minor crops in terms of acreage produced.’’.
TITLE III—AMENDMENTS TO THE FED-
ERAL FOOD, DRUG, AND COSMETIC
ACT
SEC. 301. REFERENCE.
Whenever in this title an amendment is expressed in
terms of an amendment to a section or other provision,
or refers to 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. 302. DEFINITIONS.
(a) Section 201(q) (21 U.S.C. 321(q)) is amended to
read as follows:
‘‘(q)(1) The term ‘pesticide chemical’ means—
‘‘(A) any substance that is a pesticide within
the meaning of the Federal Insecticide, Fungicide,
and Rodenticide Act, or
‘‘(B) any active or inert ingredient of a pes-
ticide within the meaning of the Federal Insecticide,
Fungicide, and Rodenticide Act.
‘‘(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
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 ‘pesticide chemical’ or ‘pesticide chemical
residue’ if—
‘‘(A) its occurrence as a residue on a raw agri-
cultural commodity or processed food is attributable
primarily to natural causes or to human activities
not involving the use of any substances for a pes-
ticidal purpose in the production, storage, process-
ing, or transportation of any raw agricultural com-
modity or processed food, and
‘‘(B) the Administrator, after consultation with
the Secretary, 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) 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 (21 U.S.C. 321) is amended by add-
ing at the end the following:
‘‘(bb) The term ‘processed food’ means any food
other than a raw agricultural commodity and includes any
raw agricultural commodity that has been subject to proc-
essing, such as canning, cooking, freezing, dehydration, or
milling.
‘‘(cc) The term ‘Administrator’ means the Adminis-
trator of the United States Environmental Protection
Agency.’’.
SEC. 303. PROHIBITED ACTS.
Section 301(j) (21 U.S.C. 331(j)) is amended—
(1) by striking the period at the end; and
(2) by adding at the end ‘‘, or the violation of
section 408(g)(2) or any regulation issued under
that section.’’.
SEC. 304. ADULTERATED FOOD.
Section 402(a)(2) (21 U.S.C. 342(a)(2)) is amended
to read as follows:
‘‘(2)(A) if it bears or contains any added poi-
sonous 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;
‘‘(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’’.
SEC. 305. 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.—For the purposes of this
section, the term ‘food,’ when used as a noun with-
out modification, shall mean a raw agricultural com-
modity or processed food. Except as provided in
paragraph (2) or (3), any pesticide chemical residue
in or on a food shall be deemed unsafe for the pur-
pose of section 402(a)(2)(B) unless—
‘‘(A) a tolerance for such pesticide chemi-
cal residue in or on such food is in effect under
this section and the concentration 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.
‘‘(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 chem-
ical 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 proc-
essed food if the concentration of the pesticide
chemical residue in the processed food when
ready for consumption or use is not greater
than the tolerance prescribed for the pesticide
chemical residue in the raw agricultural com-
modity.
‘‘(B) If an exemption from the requirement
for a tolerance is in effect under this section for
a pesticide chemical residue in or on a raw agri-
cultural commodity, a pesticide chemical residue
that is present in or on a processed food be-
cause the food is made from that raw agricul-
tural commodity shall not be considered unsafe
within the meaning 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 substance that itself is a pes-
ticide 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 tol-
erance 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 ex-
posure to the precursor substance, and
‘‘(B) either—
‘‘(i) a tolerance is in effect under this
section for residues of the precursor sub-
stance 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 resi-
dues of the precursor substance does not state
that it applies only to particular named sub-
stances or states that it does not apply to resi-
dues of the degradation product.
‘‘(4) EFFECT
OF
TOLERANCE
OR
EXEMP-
TION.—While a tolerance or exemption from the re-
quirement for a tolerance is in effect under this sec-
tion 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 consid-
ered to be adulterated within the meaning of section
402(a)(1).
‘‘(b) AUTHORITY
AND
STANDARD
FOR
TOLER-
ANCES.—
‘‘(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 initiative
under subsection (e).
‘‘(2) STANDARD.—(A) A tolerance may not be
established for a pesticide chemical residue in or on
a food at a level that is higher than a level that the
Administrator determines is adequate to protect the
public health.
‘‘(B) The Administrator shall modify or revoke
a tolerance if it is at a level higher than the level
that the Administrator determines is adequate to
protect the public health.
‘‘(C) In making a determination under this
paragraph the Administrator shall take into account,
among other relevant factors, the validity, complete-
ness, and reliability of the available data from stud-
ies of the pesticide chemical residue, the nature of
any toxic effects shown to be caused by the pesticide
chemical in such studies, available information and
reasonable assumptions concerning the relationship
of the results of such studies to human risk, avail-
able information and reasonable assumptions con-
cerning the dietary exposure levels of food consum-
ers (and major identifiable subgroups of food con-
sumers) to the pesticide chemical residue, and avail-
able information and reasonable assumptions con-
cerning the variability of the sensitivities of major
identifiable groups and shall consider other factors
to the extent required by subparagraph (F).
‘‘(D) For purposes of subparagraph (A), a tol-
erance level for a pesticide chemical residue in or on
a food shall be deemed to be adequate to protect the
public health if the dietary risk posed to food con-
sumers by such level of the pesticide chemical resi-
due is negligible. The Administrator shall by regula-
tion set forth the factors and methods for determin-
ing whether such a risk is negligible.
‘‘(E) Where reliable data are available, the Ad-
ministrator shall calculate the dietary risk posed to
food consumers by a pesticide chemical on the basis
of the percent of food actually treated with the pes-
ticide chemical and the actual residue levels of the
pesticide chemical that occur in food. In particular,
the Administrator shall take into account aggregate
pesticide use and residue data collected by the De-
partment of Agriculture.
‘‘(F) For purposes of subparagraph (A), a level
of a pesticide chemical residue in or on a food that
poses a greater than negligible dietary risk to con-
sumers of the food shall be deemed to be adequate
to protect the public health if the Administrator de-
termines that such risk is not unreasonable be-
cause—
‘‘(i) use of the pesticide that produces the
residue protects humans or the environment
from adverse effects on public health or welfare
that would, directly or indirectly, result in
greater risk to the public or the environment
than the dietary risk from the pesticide chemi-
cal residue; or
‘‘(ii) use of the pesticide avoids risks to
workers, the public, or the environment that
would be expected to result from the use of an-
other pesticide or pest control method on the
same food and that are greater than the risks
that result from dietary exposure to the pes-
ticide chemical residue; or
‘‘(iii) the unavailability of the pesticide
would limit the availability to consumers of an
adequate, wholesome, and economical food sup-
ply, taking into account regional and domestic
effects, and such adverse effects are likely to
outweigh the risk posed by the pesticide resi-
due.
In making the determination under this subpara-
graph, the Administrator shall not consider the ef-
fects on any pesticide registrant, manufacturer, or
marketer of a pesticide.
‘‘(3) LIMITATIONS.—(A) A tolerance may be is-
sued under the authority of paragraph (2)(E) only
if the Administrator has assessed the extent to
which efforts are being made to develop either an al-
ternative method of pest control or an alternative
pesticide chemical for use on such commodity or
food that would meet the requirements of paragraph
(2)(D).
‘‘(B) A tolerance for a pesticide chemical resi-
due in or on a food shall not be established 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.
‘‘(C) A tolerance for a pesticide chemical resi-
due in or on a food shall not be established at a level
lower than the limit of detection of the method for
detecting and measuring the pesticide chemical resi-
due specified by the Administrator under subpara-
graph (B).
‘‘(4) INTERNATIONAL
STANDARDS.—In estab-
lishing a tolerance for a pesticide chemical residue in
or on a food, the Administrator shall take into ac-
count any maximum residue level for the chemical in
or on the food that has been established by the
Codex Alimentarius Commission. The Administrator
shall determine whether the Codex maximum residue
level is adequate to protect the health of United
States’ consumers and whether the data supporting
the maximum residue level are valid, complete, and
reliable. If the Administrator determines not to
adopt a Codex maximum residue level, the Adminis-
trator shall publish a notice in the Federal Register
setting forth the reasons.
‘‘(c) AUTHORITY
AND
STANDARD
FOR
EXEMP-
TIONS.—
‘‘(1) AUTHORITY.—The Administrator may
issue a regulation establishing, modifying, or revok-
ing an exemption from the requirement for a toler-
ance 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 initiative
under subsection (e).
‘‘(2) STANDARD.—(A) An exemption from the
requirement for a tolerance for a pesticide chemical
residue in or on a food may be established only if
the Administrator determines that a tolerance is not
needed to protect the public health, in view of the
levels of dietary exposure to the pesticide chemical
residue that could reasonably be expected to occur.
‘‘(B) An exemption from the requirement for a
tolerance for a pesticide chemical residue in or on a
food shall be revoked if the Administrator, in re-
sponse to a petition for the revocation of the exemp-
tion or at the Administrator’s own initiative deter-
mines that the exemption does not satisfy the cri-
terion of subparagraph (A).
‘‘(C) In making a determination under this sub-
paragraph, the Administrator shall take into ac-
count, among other relevant factors, the factors set
forth in subsection (b)(2)(C).
‘‘(3) LIMITATION.—An exemption from the re-
quirement for a tolerance for a pesticide chemical
residue in or on a food shall not be established by
the Administrator unless the Administrator deter-
mines, after consultation with the Secretary—
‘‘(A) that there is a practical method for
detecting and measuring the levels of such pes-
ticide chemical residue in or on such food; or
‘‘(B) that there is no need for such a
method, and states the reasons for such deter-
mination in the order issuing the regulation es-
tablishing or modifying the regulation.
‘‘(d) PETITION FOR TOLERANCE OR EXEMPTION.—
‘‘(1) PETITIONS AND PETITIONERS.—Any per-
son may file with the Administrator a petition pro-
posing 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 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 ex-
emption for a pesticide chemical residue shall
be supported by such data and information as
are specified in regulations issued by the Ad-
ministrator, including—
‘‘(i)(I) an informative summary of the
petition and of the data, information, and
arguments submitted or cited in support of
the petition,
‘‘(II) a statement that the petitioner
agrees that such summary or any informa-
tion 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 is-
sued under this section,
‘‘(ii) the name, chemical identity, and
composition of the pesticide chemical resi-
due and of the pesticide chemical that pro-
duces the residue,
‘‘(iii) data showing the recommended
amount, frequency, method, and time of
application of that pesticide chemical,
‘‘(iv) full reports of tests and inves-
tigations made with respect to the safety of
the pesticide chemical, including full infor-
mation as to the methods and controls
used in conducting those tests and inves-
tigations,
‘‘(v) full reports of tests and inves-
tigations made with respect to the nature
and amount of the pesticide chemical resi-
due that is likely to remain in or on the
food, including a description of the analyt-
ical methods used,
‘‘(vi) a practical method for detecting
and measuring the levels of the pesticide
chemical residue in or on the food, or a
statement why such a method is not need-
ed,
‘‘(vii) practical methods for removing
any amount of the residue that would ex-
ceed any proposed tolerance,
‘‘(viii) a proposed tolerance for the
pesticide chemical residue, if a tolerance is
proposed,
‘‘(ix) all relevant data bearing on the
physical or other technical effect that the
pesticide chemical is intended to have and
the quantity of the pesticide chemical that
is required to produce the effect,
‘‘(x) if the petition relates to a toler-
ance for a processed food, reports of inves-
tigations conducted using the processing
method(s) used to produce that food,
‘‘(xi) such information as the Admin-
istrator may require to make the deter-
mination under subsection (b)(2)(E), and
‘‘(xii) such other data and information
as the Administrator requires by regulation
to support the petition.
If information or data required by this subpara-
graph is available to the Administrator, the per-
son submitting the petition may cite the avail-
ability of the information or data in lieu of sub-
mitting it. The Administrator may require a pe-
tition to be accompanied by samples of the pes-
ticide chemical with respect to which the peti-
tion 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 toler-
ance or to revoke an exemption from the re-
quirement for a tolerance.
‘‘(3) NOTICE.—A notice of the filing of a peti-
tion that the Administrator determines has met the
requirements of paragraph (2) shall be published by
the Administrator within 30 days after such deter-
mination. The notice shall announce the availability
of a description of the analytical methods available
to the Administrator for the detection and measure-
ment 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 re-
quired by paragraph (2)(A)(i).
‘‘(4) ACTIONS BY THE ADMINISTRATOR.—The
Administrator shall, after giving due consideration
to a petition filed under paragraph (1) and any
other information available to the Administrator—
‘‘(A) issue a final regulation (which may
vary from that sought by the petition) estab-
lishing, modifying, or revoking a tolerance for
the pesticide chemical residue or an exemption
of the pesticide chemical residue from the re-
quirement of a tolerance;
‘‘(B) issue a proposed regulation under
subsection (e), and thereafter either issue a
final regulation under subsection (e) or an
order denying the petition; or
‘‘(C) issue an order denying the petition.
‘‘(5) EFFECTIVE
DATE.—A regulation issued
under paragraph (4) shall take effect upon publica-
tion.
‘‘(6) FURTHER PROCEEDINGS.—
‘‘(A) Within 60 days after a regulation or
order is issued under paragraph (4), subsection
(e)(1), or subsection (f)(1), any person may file
objections thereto with the Administrator, speci-
fying with particularity the provisions of the
regulation or order deemed objectionable and
stating reasonable grounds therefor. If the reg-
ulation or order was issued in response to a pe-
tition under paragraph (d)(1), a copy of each
objection filed by a person other than the peti-
tioner shall be served by the Administrator on
the petitioner.
‘‘(B) An objection may include a request
for a public evidentiary hearing upon the objec-
tion. The Administrator shall, upon the initia-
tive 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 hear-
ing 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 Proce-
dure in making any order for the protection of
the witness or the content of documents pro-
duced and shall order the payment of reason-
able fees and expenses as a condition to requir-
ing testimony of the witness. On contest, such
a subpoena may be enforced by a Federal dis-
trict court.
‘‘(C) 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 substan-
tial 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.
‘‘(D) An order issued under this paragraph
ruling on an objection shall not take effect be-
fore the 90th day after its publication unless
the Administrator finds that emergency condi-
tions exist necessitating an earlier effective
date, in which event the Administrator shall
specify in the order the Administrator’s find-
ings as to such conditions.
‘‘(7) JUDICIAL REVIEW.—(A) In a case of ac-
tual controversy as to the validity of any order is-
sued under paragraph (6) 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, a petition praying that the order or
regulation be set aside in whole or in part.
‘‘(B) A copy of the petition shall be forthwith
transmitted by the clerk of the court to the Adminis-
trator, or any officer designated by the Adminis-
trator for that purpose, and thereupon the Adminis-
trator shall file in the court the record of the pro-
ceedings 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 peti-
tion, the court shall have exclusive jurisdiction to af-
firm or set aside the order or regulation complained
of in whole or in part. The findings of the Adminis-
trator with respect to questions of fact shall be sus-
tained only if supported by substantial evidence
when considered on the record as a whole.
‘‘(C) 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
‘‘(A) establishing, modifying, or revoking a
tolerance for a pesticide chemical or a pesticide
chemical residue,
‘‘(B) establishing or revoking an exemption
of a pesticide chemical residue from the require-
ment of a tolerance, or
‘‘(C) establishing general procedures and
requirements to implement this section.
A regulation issued under this paragraph shall be-
come effective upon its publication.
‘‘(2) NOTICE.—Before issuing a final regulation
under paragraph (1), the Administrator shall issue
a notice of proposed rulemaking and provide a pe-
riod 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 contrary to the
public interest to do so and states the reasons for
the finding in the notice of proposed rulemaking.
The Administrator shall provide an opportunity for
a public hearing during the rulemaking under proce-
dures provided in subsection (d)(6)(B).
‘‘(f) SPECIAL DATA REQUIREMENTS.—
‘‘(1) REQUIRING SUBMISSION OF ADDITIONAL
DATA.—If the Administrator determines that addi-
tional 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 persons
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,
‘‘(B) issue a rule requiring that testing be
conducted on a substance or mixture under sec-
tion 4 of the Toxic Substances Control Act, or
‘‘(C) publish in the Federal Register, after
first providing notice and an opportunity for
comment of not less than 90 days’ duration, an
order—
‘‘(i) requiring the submission to the
Administrator by one or more interested
persons of a notice identifying the person
or persons who will submit the required
data and information,
‘‘(ii) describing the type of data and
information required to be submitted to
the Administrator and stating why the
data and information could not be obtained
under the authority of section 3(c)(2)(B)
of the Federal Insecticide, Fungicide, and
Rodenticide Act or section 4 of the Toxic
Substances Control Act,
‘‘(iii) describing the reports to the Ad-
ministrator required to be prepared during
and after the collection of the data and in-
formation,
‘‘(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 revise any such order to cor-
rect an error.
‘‘(2) NONCOMPLIANCE.—If a submission re-
quired by a notice issued in accordance with para-
graph (1)(A) or an order issued under paragraph
(1)(B) is not made by the time specified in such no-
tice or order, the Administrator may by order pub-
lished in the Federal Register modify or revoke the
tolerance or exemption in question.
‘‘(3) REVIEW.—An order issued under this sub-
section shall be effective upon publication and shall
be subject to review in accordance with paragraphs
(6) and (7) of subsection (d).
‘‘(g) CONFIDENTIALITY AND USE OF DATA.—
‘‘(1) GENERAL RULE.—Data and information
that are submitted to the Administrator under this
section in support of a tolerance shall be entitled to
confidential treatment for reasons of business con-
fidentiality and to exclusive use and data compensa-
tion, to the same extent provided by sections 3 and
10 of the Federal Insecticide, Fungicide and
Rodenticide Act.
‘‘(2) EXCEPTIONS.—Data that are entitled to
confidential treatment under paragraph (1) may
nonetheless be disclosed to the Congress of the Unit-
ed States, and may be disclosed, under such security
requirements as the Administrator may provide by
regulation, to—
‘‘(A) employees of the United States au-
thorized by the Administrator to examine such
data in the carrying out of their official duties
under this Act or other Federal statutes in-
tended to protect the public health, or
‘‘(B) contractors with the United States
authorized by the Administrator to examine
such data in the carrying out of contracts under
such statutes.
‘‘(3) SUMMARIES.—Notwithstanding any provi-
sion of this subsection or other law, the Adminis-
trator may publish the informative summary re-
quired by subsection (d)(2)(A)(i) and may, in issu-
ing a proposed or final regulation or order under
this section, publish an informative summary of the
data relating to the regulation or order.
‘‘(h) STATUS
OF PREVIOUSLY ISSUED REGULA-
TIONS.—
‘‘(1) REGULATIONS UNDER SECTION 406.—Reg-
ulations affecting pesticide chemical residues in or
on raw agricultural commodities promulgated, in ac-
cordance with section 701(e), under the authority of
section 406(a) upon the basis of public hearings in-
stituted before January 1, 1953, shall be deemed to
be regulations issued under this section and shall be
subject to modification or revocation under sub-
sections (d) and (e).
‘‘(2) REGULATIONS UNDER SECTION 409.—Reg-
ulations that established tolerances for substances
that are pesticide chemical residues on or in proc-
essed food, or that otherwise stated the conditions
under which such pesticide chemicals could be safely
used, and that were issued under section 409 on or
before the date of the enactment of this paragraph,
shall be deemed to be regulations issued under this
section and shall be subject to modification or rev-
ocation under subsection (d) or (e).
‘‘(3) REGULATIONS UNDER SECTION 408.—Reg-
ulations that established tolerances or exemptions
under this section that were issued on or before the
date of the enactment of this paragraph shall remain
in effect unless modified or revoked under subsection
(d) or (e).
‘‘(i) TRANSITIONAL PROVISION.—If, on the day be-
fore the date of the enactment of this subsection, a sub-
stance that is a pesticide chemical was, with respect to
a particular pesticidal use of the substance and any result-
ing pesticide chemical residue in or on a particular food—
‘‘(1) regarded by the Administrator or the Sec-
retary as generally recognized as safe for use within
the meaning of the provisions of section 408(a) or
201(s) as then in effect, or
‘‘(2) regarded by the Secretary as a substance
described by section 201(s)(4),
such a pesticide chemical residue shall be regarded as ex-
empt from the requirement for a tolerance, as of the date
of enactment of this subsection. The Administrator shall
by regulation indicate which substances are described by
this subsection. An exemption under this subsection may
be revoked or modified as if it had been issued under sub-
section (c).
‘‘(j) HARMONIZATION WITH ACTION UNDER OTHER
LAWS.—
‘‘(1) LIMITATION.—Notwithstanding any other
provision of this Act, a final rule under this section
that revokes, modifies, or suspends a tolerance or
exemption for a pesticide chemical residue in or on
a food may be issued only if the Administrator has
first taken any necessary action under the Federal
Insecticide, Fungicide, and Rodenticide Act with re-
spect to the registration of the pesticide(s) whose
use results in such residue to ensure that any au-
thorized use of the pesticide in producing, storing,
processing, or transporting food that occurs after
the issuance of such final rule under this section will
not result in pesticide chemical residues on such
food that are unsafe within the meaning of sub-
section (a).
‘‘(2) REVOCATION OF TOLERANCE OR EXEMP-
TION
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 resi-
dues of that pesticide chemical on that food, the Ad-
ministrator 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. The Administrator shall use
the procedures set forth in subsection (e) in taking
action under this paragraph. A revocation under this
paragraph shall become effective not later than 180
days after—
‘‘(A) the date by which each such cancella-
tion of a registration has become effective, or
‘‘(B) EFFECT OF SUSPENSION.—The sus-
pension of a tolerance or exemption under sub-
paragraph (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 sus-
pension of a tolerance or exemption is effective
the tolerance or exemption shall not be consid-
ered to be in effect. If the suspension of use of
the pesticide under that Act is terminated, leav-
ing the registration of the pesticide for such use
in effect under that Act, the Administrator
shall rescind any associated suspension of a tol-
erance or exemption.
‘‘(4) TOLERANCES
FOR
UNAVOIDABLE
RESI-
DUES.—In connection with action taken under para-
graph (2) or (3), or with respect to pesticides whose
registrations were canceled prior to the effective date
of this paragraph, 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 Adminis-
trator may establish a tolerance for the pesticide
chemical residue at a level that permits such un-
avoidable residue to remain in such food. In estab-
lishing such a tolerance, the Administrator shall
take into account the factors set forth in subsection
(b)(2)(A)(iii) and shall use the procedures set forth
in subsection (e). The Administrator shall review
any such tolerance periodically and modify it as nec-
essary so that it allows only that level of the pes-
ticide chemical residue that is unavoidable.
‘‘(5) PESTICIDE
RESIDUES
RESULTING
FROM
LAWFUL
APPLICATION
OF
PESTICIDE.—Notwith-
standing any other provision of this Act, if a toler-
ance or exemption for a pesticide chemical residue in
or on a food has been revoked, suspended, or modi-
fied under this section, an article of that food shall
not be deemed unsafe solely because of the presence
of such pesticide chemical residue in or on such food
if it is shown to the satisfaction of the Secretary
that—
‘‘(A) the residue is present as the result of
an application or use of a pesticide at a time
and in a manner that was lawful under the
Federal Insecticide, Fungicide, and Rodenticide
Act; and
‘‘(B) the residue does not exceed a level
that was authorized at the time of that applica-
tion or use to be present on the food under a
tolerance, exemption, food additive regulation,
or other sanction then in effect under this Act;
unless, in the case of any tolerance or exemption re-
voked, suspended, or modified under this subsection
or subsection (d) or (e), the Administrator has is-
sued a determination that consumption of the legally
treated food during the period of its likely availabil-
ity in commerce will pose an unreasonable dietary
risk.
‘‘(k) FEES.—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 ade-
quate service for the performance of the Administrator’s
functions under this section. Under the regulations, the
performance of the Administrator’s services or other func-
tions under this section, including—
‘‘(1) the acceptance for filing of a petition sub-
mitted under subsection (d),
‘‘(2) the promulgation of a regulation establish-
ing, modifying, or revoking a tolerance or establish-
ing or revoking an exemption from the requirement
of a tolerance under this section,
‘‘(3) the acceptance for filing of objections
under subsection (d)(6), or
‘‘(4) the certification and filing in court of a
transcript of the proceedings and the record under
subsection (d)(7),
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 Ad-
ministrator such a waiver or refund is equitable and not
contrary to the purposes of this subsection.
‘‘(l) NATIONAL UNIFORMITY OF TOLERANCES.—
‘‘(1) QUALIFYING PESTICIDE CHEMICAL RESI-
DUE.—For purposes of this subsection, the term
‘qualifying pesticide chemical residue’ means a pes-
ticide 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,
Rodenticide Act on or after April 25, 1985, on
the basis of data determined by the Adminis-
trator to meet all applicable requirements for
data prescribed by regulations in effect under
that Act on April 25, 1985; or
‘‘(B) was approved for such use in a rereg-
istration eligibility determination issued under
section 4(g) of that Act on or after the date of
enactment of the Food Quality Protection Act
of 1993.
‘‘(2) QUALIFYING FEDERAL DETERMINATION.—
For purposes of this subsection, the term ‘qualifying
Federal determination’ means—
‘‘(A) a tolerance or exemption from the re-
quirement for a tolerance for a qualifying pes-
ticide chemical residue that was—
‘‘(i) issued under this section after the
date of enactment of the Food Quality
Protection Act of 1993;
‘‘(ii) issued (or, pursuant to sub-
section (h) or (i), deemed to have been is-
sued) under this section, and determined
by the Administrator to meet the standard
under subsection (b)(2) (in the case of a
tolerance) or (c)(2) (in the case of an ex-
emption); and
‘‘(B) any statement, issued by the Sec-
retary, of the residue level below which enforce-
ment action will not be taken under this Act
with respect to any qualifying pesticide chemi-
cal residue, if the Secretary finds that such pes-
ticide chemical residue level permitted by such
statement during the period to which such
statement applies protects human health.
‘‘(3) LIMITATION.—The Administrator may
make the determination described in paragraph
(2)(A)(ii) only by issuing a rule in accordance with
the procedure set forth in subsection (d) or (e) 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 (d)(6) and
(d)(7).
‘‘(4) STATE AUTHORITY.—Except as provided
in paragraph (5), 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 es-
tablish or enforce a regulatory limit on a pesticide
chemical residue in or on food if it purports to pro-
hibit or penalize the production, processing, ship-
in such State to the pesticide chemical res-
idue.
‘‘(C) Subject to paragraph (6), the Admin-
istrator may, by order, grant the authorization
described in subparagraph (A) if the Adminis-
trator determines that the proposed State regu-
latory limit—
‘‘(i) is justified by compelling local
conditions;
‘‘(ii) would not unduly burden inter-
state commerce; and
‘‘(iii) would not cause any food to be
in violation of Federal law.
‘‘(D) In lieu of any action authorized
under subparagraph (C), the Administrator
may treat a petition under this paragraph as a
petition under subsection (d) to revoke or mod-
ify a tolerance or to revoke an exemption. If the
Administrator determines to treat a petition
under this paragraph as a petition under sub-
section (d), the Administrator shall thereafter
act on the petition pursuant to subsection (d).
‘‘(E) 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 (d)(6)
and (d)(7).
‘‘(6) 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 resi-
due level was lawful under this Act and under the
law of such State, unless the State demonstrates
that consumption of the food containing such pes-
ticide residue level during the period of the food’s
likely availability in the State will pose an unreason-
able dietary risk to the health of persons within such
State.’’.
SEC. 306. AUTHORIZATION FOR INCREASE MONITORING.
There is authorized to be appropriated an additional
$12,000,000 for increased monitoring by the Secretary of
Health and Human Services of pesticide residues in im-
ported and domestic food.
Æ
HR 1627 SC——2
HR 1627 SC——3
HR 1627 SC——4
HR 1627 SC——5
HR 1627 SC——6 HR 1627 SC——7 eHR 1627 SC 69