201
title 28, United States Code. Upon the fil-
ing 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 or-
ders issued following a public evidentiary
hearing, the findings of the Adminis-
trator 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 sat-
isfaction of the court that the additional
evidence is material and that there were
reasonable grounds for the failure to ad-
duce the evidence in the proceeding be-
fore 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 condi-
tions the court deems proper. The Admin-
istrator may modify prior findings as to
202
the facts by reason of the additional evi-
dence so taken and may modify the order
or regulation accordingly. The Adminis-
trator shall file with the court any such
modified finding, order, or regulation.
‘‘(4) FINAL JUDGMENT; SUPREME COURT
REVIEW.—The judgment of the court af-
firming 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 commence-
ment of proceedings under this sub-
section shall not, unless specifically or-
dered by the court to the contrary, oper-
ate 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.—
203
‘‘(1) GENERAL RULE.—Data and infor-
mation 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 ex-
clusive 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 infor-
mation that are entitled to confiden-
tial 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 Adminis-
trator to examine such data and
information in the carrying out of
their official duties under this Act
or 
other 
Federal 
statutes 
in-
204
tended 
to 
protect 
the 
public
health; or
‘‘(ii) 
contractors 
with 
the
United States authorized by the
Administrator to examine such
data and information in the car-
rying 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 ex-
tent of matter within its jurisdiction,
any committee or subcommittee of
such committee or any joint commit-
tee 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 sub-
section (d)(2)(A)(i) and may, in issuing a
proposed or final regulation or order
under this section, publish an inform-
205
ative summary of the data relating to the
regulation or order.
‘‘(j) STATUS OF PREVIOUSLY ISSUED REGULA-
TIONS.—
‘‘(1) REGULATIONS UNDER SECTION 406.—
Regulations affecting pesticide chemical
residues in or on raw agricultural com-
modities 
promulgated, 
in 
accordance
with section 701(e), under the authority
of section 406(a) 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), and shall
be subject to review under subsection (q).
‘‘(2) REGULATIONS UNDER SECTION 409.—
Regulations that established tolerances
for substances that are pesticide chemi-
cal residues in or on processed food, or
that otherwise stated the conditions
under which such pesticide chemicals
could be safely used, and that were is-
sued under section 409 on or before the
date of the enactment of this paragraph,
206
shall be deemed to be regulations issued
under this section and shall be subject to
modification or revocation under sub-
section (d) or (e), and shall be subject to
review under subsection (q).
‘‘(3) REGULATIONS UNDER SECTION 408.—
Regulations 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), and shall be
subject to review under subsection (q).
‘‘(k) TRANSITIONAL PROVISION.—If, on the
day before the date of the enactment of this
subsection, a substance 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 par-
ticular 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) or section
201(s) as then in effect; or
207
‘‘(2) regarded by the Secretary as a
substance described by section 201(s)(4);
such a pesticide chemical residue shall be re-
garded as exempt from the requirement for a
tolerance, as of the date of enactment of this
subsection. The Administrator shall by regu-
lation indicate which substances are de-
scribed by this subsection. Any exemption
under this subsection may be modified or re-
voked as if it had been issued under sub-
section (c).
‘‘(l) HARMONIZATION WITH ACTION UNDER
OTHER LAWS.—
‘‘(1) COORDINATION WITH FIFRA.—To the
extent practicable and consistent with
the review deadlines in subsection (q), in
issuing a final rule under this subsection
that suspends or revokes a tolerance or
exemption for a pesticide chemical resi-
due in or on food, the Administrator shall
coordinate such action with any related
necessary action under the Federal Insec-
ticide, Fungicide, and Rodenticide Act.
‘‘(2) REVOCATION OF TOLERANCE OR EX-
EMPTION FOLLOWING CANCELLATION OF AS-
208
SOCIATED REGISTRATIONS.—If the Adminis-
trator, acting under the Federal Insecti-
cide, Fungicide, and Rodenticide Act,
cancels the registration of each pesticide
that contains a particular pesticide chem-
ical and that is labeled for use on a par-
ticular food, or requires that the registra-
tion 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 die-
tary 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)
shall apply to actions taken under this
paragraph. A revocation under this para-
graph shall become effective not later
than 180 days after—
‘‘(A) the date by which each such
cancellation of a registration has be-
come effective; or
209
‘‘(B) the date on which the use of
the canceled pesticide becomes un-
lawful under the terms of the can-
cellation, whichever is later.
‘‘(3) SUSPENSION OF TOLERANCE OR EX-
EMPTION FOLLOWING SUSPENSION OF ASSOCI-
ATED REGISTRATIONS.—
‘‘(A) SUSPENSION.—If the Adminis-
trator, acting under the Federal In-
secticide, Fungicide, and Rodenticide
Act, suspends the use of each reg-
istered pesticide that contains a par-
ticular 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 chemi-
cal, or any pesticide chemical residue
that results from its use, in or on that
food. Subsection (e) shall apply to ac-
tions taken under this paragraph. A
suspension 
under 
this 
paragraph
210
shall become effective not later than
60 days after the date by which each
such suspension of use has become ef-
fective.
‘‘(B) EFFECT
OF
SUSPENSION.—The
suspension of a tolerance or exemp-
tion under subparagraph (A) shall be
effective as long as the use of each as-
sociated registration of a pesticide is
suspended under the Federal Insecti-
cide, 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 suspen-
sion 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
211
were suspended or canceled prior to the
date of the enactment of this paragraph
under the Federal Insecticide, Fungicide,
and Rodenticide Act, if the Administrator
determines that a residue of the canceled
or suspended pesticide chemical will un-
avoidably 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 es-
tablishing such a tolerance, the Adminis-
trator shall take into account both the
factors set forth in subsection (b)(2) and
the unavoidability of the residue. Sub-
section (e) shall apply to the establish-
ment of such tolerance. The Adminis-
trator shall review any such tolerance pe-
riodically and modify it as necessary so
that it allows no greater level of the pes-
ticide chemical residue than is unavoid-
able.
‘‘(5) PESTICIDE
RESIDUES
RESULTING
FROM LAWFUL APPLICATION OF PESTICIDE.—
Notwithstanding any other provision of
this Act, if a tolerance or exemption for a
212
pesticide chemical residue in or on a food
has been revoked, suspended, or modified
under this section, an article of that food
shall not be deemed unsafe solely be-
cause of the presence of such pesticide
chemical residue in or on such food if it
is shown to the satisfaction of the Sec-
retary 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 In-
secticide, 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 toler-
ance, exemption, food additive regu-
lation, or other sanction then in ef-
fect under this Act;
unless, in the case of any tolerance or ex-
emption revoked, suspended, or modified
under this subsection or subsection (d) or
(e), the Administrator has issued a deter-
213
mination that consumption of the legally
treated food during the period of its like-
ly 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 Insecti-
cide, 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 resi-
due. Such a tolerance or exemption from
a tolerance shall have an expiration date.
The Administrator may establish such a
tolerance or exemption without provid-
ing notice or a period for comment on the
tolerance or exemption. The Adminis-
trator shall promulgate regulations with-
in 365 days after the date of the enact-
ment of this paragraph governing the es-
tablishment of tolerances and exemptions
under this paragraph. Such regulations
shall be consistent with the safety stand-