I
104TH CONGRESS
1ST SESSION
H. R. 1627
To amend the Federal Insecticide, Fungicide, and Rodenticide Act and the
Federal Food, Drug, and Cosmetic Act, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MAY 12, 1995
Mr. BLILEY (for himself, Mr. TOWNS, Mr. ROBERTS, Mr. DE LA GARZA, Mr.
EMERSON, Mr. CONDIT, Mr. BILIRAKIS, Mr. GUNDERSON, Mr. STEN-
HOLM, Mr. COMBEST, Mr. MONTGOMERY, Mr. ALLARD, Mr. YOUNG of
Alaska, Mr. JOHNSON of South Dakota, Mr. WALKER, Mr. DOOLEY, Mr.
FIELDS of Texas, Mr. HALL of Texas, Mr. BARRETT of Nebraska, Mrs.
THURMAN, Mr. HASTERT, Mr. POMEROY, Mr. WOLF, Mr. BISHOP, Mr.
STUMP, Mrs. LINCOLN, Mr. EVERETT, Mr. PAXON, Mr. GOODLATTE, Mr.
DOOLITTLE, Mr. CANADY of Florida, Mr. POMBO, Mr. KINGSTON, Mr.
WALSH, Mr. HOEKSTRA, Mr. BAKER of Louisiana, Mr. CALVERT, Mr.
SMITH of Michigan, Mr. COX of California, Mr. CRAPO, Mr. LUCAS, Mr.
LEWIS
of 
Kentucky, 
Mr. 
SHADEGG, 
Mr. 
HOSTETTLER, 
Mrs.
CHENOWETH, Mr. HUTCHINSON, Mr. CHAMBLISS, Mr. LATHAM, Mr.
LAHOOD, Mr. TAYLOR
of North Carolina, Mr. BEREUTER, Mr.
WHITFIELD, Mr. NETHERCUTT, Mr. BOUCHER, Mr. OXLEY, Mr. SKEEN,
Mr. BOEHNER, Mr. STUPAK, Mr. THORNBERRY, Mr. BRYANT of Ten-
nessee, Mr. HASTINGS of Washington, Mr. POSHARD, Mr. BURR, Mr.
SENSENBRENNER, Mr. TALENT, Ms. DANNER, Mr. HEFLEY, Mr. ORTON,
Mr. UPTON, Mr. BILBRAY, Mr. FOLEY, Mr. MCCRERY, Mr. COOLEY, Mr.
MCHUGH, Mr. GANSKE, Mr. EWING, Mr. HOLDEN, Mr. MANZULLO, Mr.
HAYWORTH, Mr. CHRYSLER, Mr. GILLMOR, Mr. METCALF, Mrs.
SEASTRAND, Mr. MINGE, Mr. DICKEY, Mr. NORWOOD, Mr. DUNCAN, Mr.
BARTON of Texas, Mr. GORDON, Mr. SCHAEFER, Mr. CLINGER, Mr.
MOORHEAD, Mr. RADANOVICH, Mr. HANCOCK, Mr. ROSE, Mr. BUYER,
and Mr. QUILLEN) introduced the following bill; Titles I–III, referred to
the Committee on Agriculture; Title IV, referred to the Committee on
Commerce
HR 1627 IH
A BILL
To 
amend 
the 
Federal 
Insecticide, 
Fungicide, 
and
Rodenticide Act and the Federal Food, Drug, and Cos-
metic Act, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Food Quality Protec-
tion Act of 1995’’.
TITLE I—CANCELLATION AND
SUSPENSION
SEC. 101. REFERENCE.
Whenever in this title an amendment or repeal is ex-
pressed in terms of an amendment to, or repeal of, a sec-
tion or other provision, the reference shall be considered
to be made to a section or other provision of the Federal
Insecticide, Fungicide, and Rodenticide Act.
SEC. 102. CANCELLATION.
Section 6(b) (7 U.S.C. 136d(b)) is amended to read
as follows:
‘‘(b) CANCELLATION AND CHANGE IN CLASSIFICA-
TION OR OTHER TERMS OR CONDITIONS OF REGISTRA-
TION.—
‘‘(1) AUTHORITY.—Notwithstanding any other
provision of this Act, the Administrator may, by use
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of informal rulemaking under this subsection, pre-
scribe requirements regarding the composition, pack-
aging, and labeling of a pesticide (or a group of pes-
ticides containing a common active ingredient), or
may classify any such pesticide, or may prohibit the
registration or continued registration of any such
pesticide for some or all purposes, to the extent nec-
essary to assure that the pesticide, when used in ac-
cordance with widespread and commonly recognized
practice, does not generally cause unreasonable ad-
verse effects on the environment.
‘‘(2) BASIS
FOR
RULE.—The Administrator
may not initiate a rulemaking under this subsection
unless the rulemaking is based on a validated test or
other significant evidence raising prudent concerns
of unreasonable adverse effects to man or to the en-
vironment.
‘‘(3) PRENOTICE
OF
RULEMAKING
PROCE-
DURES.—
‘‘(A) The Administrator may not initiate a
rulemaking under paragraph (1) until the Ad-
ministrator has furnished to the registrant of
each affected pesticide a notice that includes a
summary of the validated test or other signifi-
cant evidence upon which the Administrator
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or comments thereon. Upon such request, the
Administrator shall schedule a hearing not to
exceed 20 days duration, to commence not later
than 30 days and to conclude not later than 90
days after the close of the comment period. The
Administrator shall announce the time, place,
and purpose of the hearing in the Federal Reg-
ister. The hearing shall be limited to addressing
questions of fact raised by materials in the
docket. A transcript shall be made of any oral
presentation, discussion, or debate and included
in the docket.
‘‘(B) The Administrator shall appoint a
hearing examiner who shall have the authority
to administer oaths, issue subpoenas, regulate
the course of the hearing, conduct prehearing
conferences, schedule presentations, and exclude
irrelevant, immaterial, or unduly repetitious evi-
dence, or evidence that should have been sub-
mitted under subparagraph (5)(B).
‘‘(C) The hearing examiner shall conduct
the hearing in a manner that encourages dis-
cussion and debate on questions of fact regard-
ing the docket, and conforms with the deadlines
set in this paragraph. The Administrator shall
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designate one or more employees of the Envi-
ronmental Protection Agency to participate in
the hearing. Any person who submitted a com-
ment on the proposed rule may participate in
the hearing and shall be entitled to present evi-
dence and argument to support the partici-
pant’s position or rebut a contrary position and
may choose to present materials in oral or writ-
ten form. The presentation of evidence and ar-
gument shall not delay the conclusion of the
hearing beyond 20 days of its commencement.
‘‘(D) Subject to subparagraph (B), an in-
terested person is entitled—
‘‘(i) to present such person’s position
orally or by documentary submissions (or
both); and
‘‘(ii) if the Administrator determines
that there are disputed issues of material
fact necessary to resolve, to present such
rebuttal submissions and to conduct such
cross-examination of persons as the hear-
ing examiner determines (I) to be appro-
priate, and (II) to be required for a full
and true disclosure with respect to such is-
sues.
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‘‘(E) As soon as practicable after comple-
tion of the hearing but not later than 180 days
after the close of the public comment period,
the hearing examiner shall issue a decision.
Such decision shall be based only on substantial
evidence of record of such hearing (including
the report of the Scientific Advisory Panel) and
shall set forth detailed findings of fact upon
which the decision is based.
‘‘(7) 
REVIEW
BY
SCIENTIFIC
ADVISORY
PANEL.—At the time the Administrator issues a no-
tice of proposed rulemaking under paragraph (5),
the Administrator shall provide a copy of such notice
to the Scientific Advisory Panel established under
section 25(d). The hearing examiner (or Adminis-
trator if no hearing is requested) shall request the
comments, evaluations, and recommendations of the
Panel as to the impact on health and the environ-
ment of the proposed rule and on any disputed ma-
terial issues of fact or scientific policy that appear
to be of significance in the hearing. The Panel may
hold a public hearing to discuss the proposed rule.
The Panel shall provide a report to the hearing ex-
aminer (or Administrator if no hearing is requested)
not later than 120 days after the close of comment
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period. The Administrator shall allow a reasonable
time for written public comment on the Panel’s re-
port. A copy of the Panel’s report and any com-
ments shall be included in the rulemaking docket.
‘‘(8) FINAL ACTION.—Not later than 365 days
after issuing a notice of proposed rulemaking and
after considering all material in the docket, the Ad-
ministrator shall publish in the Federal Register ei-
ther a final rule or a withdrawal of the proposed
rule. The Administrator may not prohibit a use of
a pesticide if alternative requirements will assure
that the pesticide, when used in accordance with
widespread and commonly recognized practice, will
not generally cause unreasonable adverse effects on
the environment. In taking any final action, the Ad-
ministrator shall take into account the impact of the
action on production and prices of agricultural com-
modities, retail food prices, and otherwise on agricul-
tural economy, and shall use the least burdensome
requirements to achieve the purposes of this Act.
The final rule or withdrawal of the proposal shall be
accompanied by a statement that—
‘‘(A) explains the reasons for the action;
‘‘(B) responds to any comments made by
the Secretary of Agriculture or the Secretary of
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Health and Human Services, and responds to
any report of the Scientific Advisory Panel;
‘‘(C) responds to each significant comment
contained in the docket; and
‘‘(D) in the case of a final rule—
‘‘(i) explains the reasons for any
major difference between the final rule and
the proposed rule;
‘‘(ii) describes the impact of the final
rule on production and prices of agricul-
tural commodities, retail food prices, and
otherwise on the agricultural economy; and
‘‘(iii) explains any significant dis-
agreements the Administrator may have
with the comments, evaluations, or rec-
ommendations contained in the report
under paragraph (7) or the benefits and
use information described in paragraph
(5)(A)(iii) and analysis in paragraph
(5)(D) as it bears on the final rule.
A final rule issued under this subsection shall
be effective upon the date of its publication in
the Federal Register.
‘‘(9) MODIFICATION OR CANCELLATION.—
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‘‘(A) A final rule shall state any require-
ments, classifications, or prohibitions imposed
by the rule, and shall state that each affected
registrant shall have a 30-day period from the
date of publication of the rule in the Federal
Register to apply for an amendment to the reg-
istration to comply with the rule or to request
voluntary cancellation of the registration. How-
ever, if the rule unconditionally prohibits all
uses of a pesticide, the rule may provide that
cancellation of the registration of the pesticide
is effective upon publication of the rule.
‘‘(B) Notwithstanding any other provision
of this Act, if an application for an amendment
to the registration to make it comply with a
rule issued under subparagraph (A) is not sub-
mitted within such 30-day period, the Adminis-
trator may issue and publish in the Federal
Register an order canceling the registration, ef-
fective upon the date of publication of the order
in the Federal Register.
‘‘(10) DENIAL
OF
APPLICATIONS.—Notwith-
standing any other provision of this Act, no applica-
tion for initial or amended registration of any pes-
ticide under section 3 or 24(c) may be approved if
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the registration would be inconsistent with a rule in
effect under this subsection.
‘‘(11) AMENDMENT OF RULE.—A registrant, or
other interested person with the concurrence of the
registrant, may petition for the amendment or rev-
ocation of a rule that has been issued under this
subsection. The petition shall state the factual mate-
rial and argument that form the basis for the peti-
tion. The Administrator shall publish a notice of the
petition in the Federal Register and allow a 60-day
comment period thereon. Not later than 180 days
after publication of the notice, the Administrator
shall determine whether to deny the petition or to
propose to amend or revoke the rule, and publish the
determination and its basis in the Federal Register.
In making such a determination, the Administrator
shall give due regard to the desirability of finality,
to the opportunity that the petitioner had to present
the factual material and argument in question in the
prior rulemaking proceeding, and to any new evi-
dence submitted by the petitioner. If the Adminis-
trator proposes to amend or revoke the rule, then
the procedures established by paragraph (1) and
paragraphs (5) through (8) apply. A denial of a peti-
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tion shall be judicially reviewable as provided in
paragraph (12).
‘‘(12) JUDICIAL
REVIEW.—A decision not to
initiate a rulemaking published under paragraph (3),
a final rule or a withdrawal of a proposed rule pub-
lished under paragraph (8) or a denial of a petition
under paragraph (11) shall be judicially reviewable
in the manner specified by section 16(b)(2).’’.
SEC. 103. PESTICIDES IN REVIEW.
If the Administrator, on or before January 1, 1995,
has published a document instituting a special review pro-
ceeding or public interim administrative review proceeding
with respect to a particular pesticide or active ingredient
thereof, the Administrator may, in lieu of proceeding
under section 6(b) of the Federal Insecticide, Fungicide,
and Rodenticide Act, as amended by the Food Quality
Protection Act of 1995, elect to continue such review pro-
ceeding and, upon its completion, take action as warranted
in accordance with sections 3(c)(6), 6(b), and 6(d) as
those sections were in effect on the day before the date
of enactment of the Food Quality Protection Act of 1995.
SEC. 104. SUSPENSION.
(a) SECTION 6(c)(1).—The second sentence of sec-
tion 6(c)(1) (7 U.S.C. 136d(c)(1)) is amended to read:
‘‘Except as provided in paragraph (3), no order of suspen-
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sion may be issued under this subsection unless the Ad-
ministrator has issued, or at the same time issues, a pro-
posed rule under subsection (b).’’.
(b) SECTION 6(c)(3).—Section 6(c)(3) (7 U.S.C.
136d(c)(3)) is amended by inserting after the first sen-
tence the following new sentence: ‘‘The Administrator may
issue an emergency order under this paragraph before is-
suing a proposed rule under subsection (b), provided that
the Administrator shall proceed expeditiously to issue a
proposed rule.’’.
SEC. 105. TOLERANCE REEVALUATION AS PART OF REREG-
ISTRATION.
Section 4(g)(2) (7 U.S.C. 136a–1(g)(2)) is amended
by adding at the end the following:
‘‘(E) As soon as the Administrator has
sufficient information with respect to the die-
tary risk of a particular active ingredient, but
in any event no later than the time the Admin-
istrator makes a determination under subpara-
graph (C) or (D) with respect to pesticides con-
taining a particular active ingredient, the Ad-
ministrator shall—
‘‘(i) reassess each associated tolerance
and exemption from the requirement for a
tolerance issued under section 408 of the
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Federal Food, Drug, and Cosmetic Act (21
U.S.C. 346a);
‘‘(ii) determine whether such tolerance
or exemption meets the requirements of
that Act;
‘‘(iii) determine whether additional
tolerances or exemptions should be issued;
‘‘(iv) publish in the Federal Register a
notice setting forth the determinations
made under this subparagraph; and
‘‘(v) commence promptly such pro-
ceedings under this Act and section 408 of
the Federal Food, Drug, and Cosmetic Act
as are warranted by such determinations.’’.
SEC. 106. SCIENTIFIC ADVISORY PANEL.
The first sentence of section 25(d) (7 U.S.C.
136w(d)) is amended—
(1) by striking ‘‘The Administrator shall’’ and
inserting ‘‘(1) IN
GENERAL.—The Administrator
shall’’; and
(2) by adding at the end the following:
‘‘(2) SCIENCE REVIEW BOARD.—There is estab-
lished a Science Review Board to consist of 60 sci-
entists who shall be available to the Scientific Advi-
sory Panel to assist in reviews conducted by the
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Panel. The Scientific Advisory Panel shall select the
scientists from 60 nominations submitted each by
the National Science Foundation and the National
Institutes of Health. Members of the Board shall be
compensated in the same manner as members of the
Panel.’’.
SEC. 107 CONFORMING AMENDMENTS.
(a) SECTION 3(c)(6).—Section 3(c)(6) (7 U.S.C.
136a(c)(6)) is amended to read as follows:
‘‘(6) DENIAL OF APPLICATION FOR REGISTRA-
TION.—
‘‘(A) Except as provided in subparagraph
(B), if the Administrator proposes to deny an
application for registration because it does not
satisfy the requirements of paragraph (5), the
Administrator shall notify the applicant of the
proposal and the reasons (including the factual
basis thereof). Unless the applicant makes the
necessary corrections to the application and no-
tifies the Administrator thereof during the 30-
day period beginning with the day after the
date the applicant receives the notice, or unless
during that time the applicant submits a re-
quest for a hearing, the Administrator may
issue an order denying the application. If dur-
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ing that time the Administrator does not receive
such corrections to the application or such a re-
quest for hearing, the Administrator may issue
an order denying the application. Such an order
shall be published in the Federal Register and
shall not be subject to judicial review. If during
that time the Administrator receives a request
for a hearing, a hearing shall be conducted
under section 6(d) of the Act. If such a hearing
is held, a decision after completion of such
hearing shall be final and shall be subject to ju-
dicial review under section 16(b)(1) of this Act.
‘‘(B) The Administrator may deny an ap-
plication for registration because it does not
comply with the requirements of a rule issued
under section 6(b) of this Act. The Adminis-
trator shall notify the applicant of such denial.
Such notice shall explain why the application
does not comply with such requirements and
shall state that the applicant may petition to
amend or revoke such rule under section
6(b)(12) of this Act.’’.
(b) SECTION 3(c)(8).—Section 3(c)(8) (7 U.S.C.
136a(c)(8)) is repealed.
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(c) SECTION 3(d).—Section 3(d) (7 U.S.C. 136a(d))
is amended—
(1) in paragraph (1)(A), by striking ‘‘on the
initial classification and registered pesticides’’ and
inserting ‘‘under section 6(b) of this Act. Registered
pesticides’’; and
(2) in paragraph (2), by striking ‘‘the Adminis-
trator shall notify the registrant’’ and all that fol-
lows through the end of the paragraph, and insert-
ing ‘‘the Administrator may initiate a proceeding
under section 6(b) of the Act.’’.
(d) SECTION 4(e).—Section 4(e)(3)(B)(iii)(III) (7
U.S.C. 136a–1(e)(3)(B)(iii)(III)) is amended—
(1) by striking ‘‘section 6(d), except that the’’
and inserting ‘‘section 6(d). The’’; and
(2) by inserting after ‘‘guidelines.’’ the follow-
ing: ‘‘If a hearing is held, a decision after completion
of such hearing shall be final.’’.
(e) SECTION 6(c).—Section 6(c) (7 U.S.C. 136d(c))
is amended in paragraph (4) by striking ‘‘section 16’’ and
inserting ‘‘section 16(b)(1)’’.
(f) SECTION 6(d).—Section 6(d) (7 U.S.C. 136d(d))
is amended—
(1) by amending the first sentence to read as
follows: ‘‘If a hearing is requested pursuant to sec-
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tion 3(c)(2)(B)(iv), 3(c)(6), 4(e)(3)(B)(iii)(III), 6(b),
6(c)(2), or 6(e)(2), such hearing shall be held for the
purpose of receiving evidence relevant and material
to the issues raised by the request for hearing.’’; and
(2) by striking the ninth sentence and all that
follows through the end of the subsection and insert-
ing 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.’’.
(g) SECTION
16(b).—Section 16(b) (17 U.S.C.
136n(b)) is amended—
(1) by striking ‘‘(b) REVIEW BY COURT OF AP-
PEALS.—In the case of’’ and inserting 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)(8),
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any decision by the Administrator under section
6(b)(8) 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)(11), any
person who will be adversely affected by such rule or
decision who filed comments in the proceedings lead-
ing to the rule or decision may obtain judicial review
by filing a petition in the United States court of ap-
peals for the circuit wherein such person resides or
has a place of business, within 60 days after the is-
suance of such rule or decision. The court shall hold
unlawful and set aside such rule or decision if it
finds that a rule of, or ruling by, the hearing exam-
iner under section 6(b)(6), limiting such petitioner’s
cross-examination or oral presentations, has pre-
cluded disclosure of disputed material facts which
was necessary to a full determination by the Admin-
istrator of the rulemaking proceeding taken as a
whole. 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 Administrator
for that purpose, and thereupon the Administrator
shall file in court the record of the proceedings on
which the Administrator based such rule or decision,
as provided in section 2112 of title 28, United
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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 of 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, United States Code. The commencement
of proceedings under this section shall not, unless
specifically ordered by the court to the contrary, op-
erate as a stay of an order.’’.
(h) SECTION
25(a).—Section 25(a) (7 U.S.C.
136w(a)) is amended by adding at the end the following:
‘‘(5) EXCEPTION.—The requirements of this
subsection shall not apply to any rule or rulemaking
proceeding under section 6(b).’’.
(i) SECTION
25(d).—Section 25(d) (7 U.S.C.
136w(d)) is amended—
(1) in the first sentence by striking ‘‘in notices
of intent issued under subsection 6(b) and’’; and
(2) in the second sentence by striking ‘‘notices
of intent and’’ and by striking ‘‘6(b) or’’.
(j) SECTION
25(e).—Section 25(e) (7 U.S.C.
136w(e)) is amended—
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(1) by striking the period at the end of the sec-
ond sentence; and
(2) by inserting at the end of the second sen-
tence ‘‘, except for any action that may be taken
under section 6(b).’’.
TITLE II—MINOR USE CROP PROTECTION
ACT OF 1995
SEC. 201. SHORT TITLE.
(a) SHORT TITLE.—This title may be cited as the
‘‘Minor Use Crop Protection Act of 1995’’.
(b) REFERENCE.—Whenever in this title an amend-
ment 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 provi-
sion 
of 
the 
Federal 
Insecticide, 
Fungicide, 
and
Rodenticide Act.
SEC. 202. MINOR CROP PROTECTION.
(a) DEFINITION.—Section 2 (7 U.S.C. 136) is
amended by adding at the end the following:
‘‘(hh) MINOR USE.—The term ‘minor use’ means the
use of a pesticide on an animal, on a commercial agricul-
tural crop or site, or for the protection of public health
where—
‘‘(1) the total United States acreage for the
crop is less than 300,000 acres; or
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‘‘(2) the Administrator, in consultation with the
Secretary of Agriculture, determines that, based on
information provided by an applicant for registration
or a registrant, the use does not provide sufficient
economic incentive to support the initial registration
or continuing registration of a pesticide for such use;
and—
‘‘(A) there are insufficient efficacious alter-
native registered pesticides available for the
use; or
‘‘(B) the alternatives to the pesticide pose
greater risks to the environment or human
health; or
‘‘(C) the pesticide plays or will play, a sig-
nificant part in managing pest resistance; or
‘‘(D) the pesticide plays or will play a sig-
nificant part in an integrated pest management
program.
The status as a minor use under this subsection
shall continue as long as the Administrator has not
determined that, based on existing data, such use
may cause an unreasonable adverse effect on the en-
vironment and the use otherwise qualifies for such
status.’’.
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(b) EXCLUSIVE USE OF MINOR USE PESTICIDES.—
Section 3(c)(1)(F) (7 U.S.C. 136a(c)(1)(F)) is amended
by redesignating clauses (ii) and (iii) as clauses (iii) and
(iv), respectively, and by inserting after clause (i) the fol-
lowing:
‘‘(ii) The period of exclusive data use
for data submitted to support the applica-
tion for the original registration of a pes-
ticide under clause (i) shall be extended
one additional year for each 3 minor uses
registered after the date of enactment of
this clause and, before the expiration of
the period of exclusive use under this
clause, up to a total of 3 additional years
for all minor uses registered by the Admin-
istrator if the Administrator in consulta-
tion with the Secretary of Agriculture de-
termines that, based on information pro-
vided by an applicant for registration or a
registrant, that—
‘‘(I) there are insufficient effica-
cious alternative registered pesticides
available for the use; or
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‘‘(II) the alternatives to the pes-
ticide pose greater risks to the envi-
ronment or human health; or
‘‘(III) the pesticide plays or will
play a significant part in managing
pest resistance; or
‘‘(IV) the pesticide plays or will
play a significant part in an inte-
grated pest management program.
The registration of a pesticide for a minor
use on a crop grouping established by the
Administrator shall be considered for pur-
poses of this clause one minor use for each
representative crop for which data are pro-
vided in the crop grouping. Any additional
exclusive use period under this clause shall
be modified as appropriate or terminated if
the registrant voluntarily cancels the prod-
uct or deletes from the registration the
minor uses which formed the basis for the
extension of the additional exclusive use
period or if the Administrator determines
that the registrant is not actually market-
ing the product for such minor uses.’’.
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(c) TIME
EXTENSIONS
FOR
DEVELOPMENT
OF
MINOR USE DATA.—
(1) DATA
CALL-IN.—Section 3(c)(2)(B) (7
U.S.C. 136a(c)(2)(B)) is amended by adding at the
end the following:
‘‘(vi) Upon the request of a registrant
the Administrator shall, in the case of a
minor use, extend the deadline for the pro-
duction of residue chemistry data under
this subparagraph for data required solely
to support that minor use until the final
deadline for submission of data under sec-
tion 4 for the other use of the pesticide es-
tablished as of the date of enactment of
the Minor Use Crop Protection Act of
1995, if—
‘‘(I) the data to support other
uses of the pesticide on a food are
being provided;
‘‘(II) the registrant, in submit-
ting a request for such an extension,
provides a schedule, including interim
dates to measure progress, to assure
that the data production will be com-
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pleted before the expiration of the ex-
tension period;
‘‘(III) the Administrator has de-
termined that such extension will not
significantly delay the Administrator’s
schedule for issuing a reregistration
eligibility 
determination 
required
under section 4; and
‘‘(IV) the Administrator has de-
termined in writing that based on ex-
isting data, such extension would not
significantly increase the risk of any
unreasonable adverse effect on the en-
vironment. 
If 
the 
Administrator
grants an extension under this clause,
the Administrator shall monitor the
development of the data and shall en-
sure that the registrant is meeting the
schedule for the production of the
data. If the Administrator determines
that the registrant is not meeting or
has not met the schedule for the pro-
duction of such data, the Adminis-
trator may proceed in accordance with
clause (iv) regarding the continued
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registration of the affected products
with the minor use and shall inform
the public of such action. Notwith-
standing the provisions of this clause,
the Administrator may take action to
modify or revoke the extension under
this clause if the Administrator deter-
mines that the extension for the minor
use may cause an unreasonable ad-
verse effect on the environment. In
such circumstance, the Administrator
shall provide, in writing to the reg-
istrant, a notice revoking the exten-
sion of time for submission of data.
Such data shall instead be due in ac-
cordance with the date established by
the Administrator for the submission
of the data.’’.
(2) 
REREGISTRATION.—Sections 
4(d)(4)(B),
4(e)(2)(B), 
and 
4(f)(2)(B) 
(7 
U.S.C. 
136a–
1(d)(4)(B), (e)(2)(B), and (f)(2)(B)) are each
amended by adding at the end the following: ‘‘Upon
the request of a registrant, the Administrator shall,
in the case of a minor use, extend the deadline for
the production of residue chemistry data under this
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subparagraph for data required solely to support
that minor use until the final deadline for submis-
sion of data under this section for the other uses of
the pesticide established as of the date of enactment
of the Minor Use Crop Protection Act of 1995 if—
‘‘(i) the data to support other uses of the
pesticide on a food are being provided;
‘‘(ii) the registrant, in submitting a request
for such an extension provides a schedule, in-
cluding interim dates to measure progress, to
assure that the data production will be com-
pleted before the expiration of the extension
period;
‘‘(iii) the Administrator has determined
that such extension will not significantly delay
the Administrator’s schedule for issuing a re-
registration eligibility determination required
under this section; and
‘‘(iv) the Administrator has determined in
writing that based on existing data, such exten-
sion would not significantly increase the risk of
any unreasonable adverse effect on the environ-
ment. If the Administrator grants an extension
under this subparagraph, the Administrator
shall monitor the development of the data and
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shall ensure that the registrant is meeting the
schedule for the production of the data. If the
Administrator determines that the registrant is
not meeting or has not met the schedule for the
production of such data, the Administrator may
proceed in accordance with clause (iv) of section
3(c)(2)(B) or other provisions of this section, as
appropriate, regarding the continued registra-
tion of the affected products with the minor use
and shall inform the public of such action. Not-
withstanding the provisions of this subpara-
graph, the Administrator may take action to
modify or revoke the extension under this sub-
paragraph if the Administrator determines that
the extension for the minor use may cause an
unreasonable adverse effect on the environment.
In such circumstance, the Administrator shall
provide, in writing to the registrant, a notice re-
voking the extension of time for submission of
data. Such data shall instead be due in accord-
ance with the date then established by the Ad-
ministrator for submission of the data.’’.
(d) MINOR USE WAIVER.—Section 3(c)(2) (7 U.S.C.
136a(c)(2)) is amended—
(1) by inserting ‘‘IN GENERAL.—’’ after ‘‘(A)’’;
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(2) by inserting ‘‘ADDITIONAL DATA.—’’ after
‘‘(B)’’;
(3) by inserting ‘‘SIMPLIFIED PROCEDURES.—’’
after ‘‘(C)’’; and
(4) by adding at the end the following:
‘‘(E) MINOR
USE
WAIVER.—In handling
the registration of a pesticide for a minor use,
the Administrator may waive otherwise applica-
ble data requirements if the Administrator de-
termines that the absence of such data will not
prevent the Administrator from determining—
‘‘(i) the incremental risk presented by
the minor use of the pesticide; and
‘‘(ii) that such risk, if any, would not
be an unreasonable adverse effect on the
environment.’’.
(e) EXPEDITING MINOR USE REGISTRATIONS.—Sec-
tion 3(c)(3) (7 U.S.C. 136a(c)(3)) is amended—
(1) by inserting after ‘‘(A)’’ the following: ‘‘IN
GENERAL.—’’;
(2) by inserting after ‘‘(B)’’ the following:
‘‘IDENTICAL OR SUBSTANTIALLY SIMILAR.—’’; and
(3) by adding at the end the following:
‘‘(C) MINOR USE REGISTRATION.—
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‘‘(i) The Administrator shall, as expe-
ditiously as possible, review and act on any
complete application—
‘‘(I) that proposes the initial reg-
istration of a new pesticide active in-
gredient if the active ingredient is
proposed to be registered solely for
minor uses, or proposes a registration
amendment solely for minor uses to
an existing registration; or
‘‘(II) for a registration or a reg-
istration amendment that proposes
significant minor uses.
‘‘(ii) For the purposes of clause (i)—
‘‘(I) the term ‘as expeditiously as
possible’ means that the Adminis-
trator shall to the greatest extent
practicable complete a review and
evaluation of all data, submitted with
a complete application, within 12
months after the submission of the
complete application, and the failure
of the Administrator to complete such
a review and evaluation under clause
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(i) shall not be subject to judicial re-
view; and
‘‘(II) the term ‘significant minor
uses’ means 3 or more minor uses
proposed for every non-minor use, a
minor use that would, in the judgment
of the Administrator, serve as a re-
placement for any use which has been
canceled in the 5 years preceding the
receipt of the application, or a minor
use that in the opinion of the Admin-
istrator would avoid the reissuance of
an emergency exemption under section
18 for that minor use.
‘‘(D) ADEQUATE TIME FOR SUBMISSION OF
MINOR USE DATA.—If a registrant makes a re-
quest for a minor use waiver, regarding data
required by the Administrator, pursuant to
paragraph (2)(E), and if the Administrator de-
nies in whole or in part such data waiver re-
quest, the registrant shall have a full time pe-
riod for providing such data. For purposes of
this subparagraph, the term ‘full time period’
means the time period originally established by
the Administrator for submission of such data,
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beginning with the data of receipt by the reg-
istrant of the Administrator’s notice of denial.’’.
(f) TEMPORARY EXTENSION OF REGISTRATION FOR
UNSUPPORTED MINOR USES.—
(1) REREGISTRATION.—
(A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C.
136a–1(d)(6) and (f)(3)) are each amended by
adding at the end the following: ‘‘If the reg-
istrant does not commit to support a specific
minor use of the pesticide, but is supporting
and providing data in a timely and adequate
fashion to support uses of the pesticide on a
food, or if all uses of the pesticide are nonfood
uses and the registrant does not commit to sup-
port a specific minor use of the pesticide but is
supporting and providing data in a timely and
adequate fashion to support other nonfood uses
of the pesticide, the Administrator, at the writ-
ten request of the registrant, shall not take any
action pursuant to this paragraph in regard to
such unsupported minor use until the final
deadline established as of the date of enactment
of the Minor Use Crop Protection Act of 1995,
for the submission of data under this section
for the supported uses identified pursuant to
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this paragraph unless the Administrator deter-
mines that the absence of the data is significant
enough to cause human health or environmental
concerns. On such a determination the Admin-
istrator may refuse the request for extension by
the registrant. Upon receipt of the request from
the registrant, the Administrator shall publish
in the Federal Register a notice of the receipt
of the request and the effective date upon which
the uses not being supported will be voluntarily
deleted from the registration pursuant to sec-
tion 6(f)(1). If the Administrator grants an ex-
tension under this paragraph, the Adminis-
trator shall monitor the development of the
data for the uses being supported and shall en-
sure that the registrant is meeting the schedule
for the production of such data. If the Adminis-
trator determines that the registrant is not
meeting or has not met the schedule for the
production of such data, the Administrator may
proceed 
in 
accordance 
with 
section
3(c)(2)(B)(iv) regarding the continued registra-
tion of the affected products with the minor
and other uses and shall inform the public of
such action in accordance with section 6(f)(2).
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Notwithstanding this subparagraph, the Admin-
istrator may deny, modify, or revoke the tem-
porary extension under this paragraph if the
Administrator determines that the continuation
of the minor use may cause an unreasonable
adverse effect on the environment. In the event
of modification or revocation the Administrator
shall provide, in writing, to the registrant, a no-
tice revoking the temporary extension and es-
tablish a new effective date by which the minor
use shall be deleted from the registration.’’.
(B) Section 4(e)(3)(A) (7 U.S.C. 136a–
1(e)(3)(A)) is amended by adding at the end
the following: ‘‘If the registrant does not com-
mit to support a specific minor use of the pes-
ticide, but is supporting and providing data in
a timely and adequate fashion to support uses
of the pesticide on a food, or if all uses of the
pesticide are nonfood uses and the registrant
does not commit to support a specific minor use
of the pesticide but is supporting and providing
data in a timely and adequate fashion to sup-
port other nonfood uses of the pesticide, the
Administrator, at the written request of the
registrant, shall not take any action pursuant
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to this subparagraph in regard to such unsup-
ported minor use until the final deadline estab-
lished as of the date of enactment of the Minor
Use Crop Protection Act of 1995, for the sub-
mission of data under this section for the sup-
port uses identified pursuant to this subpara-
graph unless the Administrator determines that
the absence of the data is significant enough
to cause human health or environmental con-
cerns. On the basis of such determination the
Administrator may refuse the request for exten-
sion by the registrant. Upon receipt of the re-
quest from the registrant, the Administrator
shall publish in the Federal Register a notice
of the receipt of the request and the effective
date upon which the uses not being supported
will be voluntarily deleted from the registration
pursuant to section 6(f)(1). If the Adminis-
trator grants an extension under this subpara-
graph, the Administrator shall monitor the de-
velopment of the data for the uses being sup-
ported and shall ensure that the registrant is
meeting the schedule for the production of such
data. If the Administrator determines that the
registrant is not meeting or has not met the
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schedule for the production of such data, the
Administrator may proceed in accordance with
section 3(c)(2)(B)(iv) regarding the continued
registration of the affected products with the
minor and other uses and shall inform the pub-
lic of such action in accordance with section
6(f)(2). Notwithstanding this subparagraph, the
Administrator may deny, modify, or revoke the
temporary extension under this subparagraph if
the Administrator determines that the continu-
ation of the minor use may cause an unreason-
able adverse effect on the environment. In the
event of modification or revocation, the Admin-
istrator shall provide, in writing, to the reg-
istrant, a notice revoking the temporary exten-
sion and establish a new effective date by which
the minor use shall be deleted from the reg-
istration.’’.
(2) 
DATA.—Section 
3(c)(2)(B) 
(7 
U.S.C.
136a(c)(2)(B)), as amended by subsection (c), is
further amended by adding at the end the following:
‘‘(vii) If the registrant does not commit to
support a specific minor use of the pesticide,
but is supporting and providing data in a timely
and adequate fashion to support uses of the
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pesticide on a food, or if all uses of the pes-
ticide are nonfood uses and the registrant does
not commit to support a specific minor use of
the pesticide but is supporting and providing
data in a timely and adequate fashion to sup-
port other nonfood uses of the pesticide, the
Administrator, at the written request of the
registrant, shall not take any action pursuant
to this clause in regard to such unsupported
minor use until the final deadline established as
of the date of enactment of the Minor Use Crop
Production Act of 1995, for the submission of
data under section 4 for the supported uses
identified pursuant to this clause unless the Ad-
ministrator determines that the absence of the
data is significant enough to cause human
health or environmental concerns. On the basis
of such determination, the Administrator may
refuse the request for extension by the reg-
istrant. Upon receipt of the request from the
registrant, the Administrator shall publish in
the Federal Register a notice of receipt of the
request and the effective date upon which the
uses not being supported will be voluntarily de-
leted from the registration pursuant to section
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6(f)(1). If the Administrator grants an exten-
sion under this clause, the Administrator shall
monitor the development of the data for the
uses being supported and shall ensure that the
registrant is meeting the schedule for the pro-
duction of such data. If the Administrator de-
termines that the registrant is not meeting or
has not met the schedule for the production of
such data, the Administrator may proceed in
accordance with clause (iv) of this subpara-
graph regarding the continued registration of
the affected products with the minor and other
uses and shall inform the public of such action
in accordance with section 6(f)(2). Notwith-
standing the provisions of this clause, the Ad-
ministrator may deny, modify, or revoke the
temporary extension under this subparagraph if
the Administrator determines that the continu-
ation of the minor use may cause an unreason-
able adverse effect on the environment. In the
event of modification or revocation, the Admin-
istrator shall provide, in writing, to the reg-
istrant, a notice revoking the temporary exten-
sion and establish a new effective date by which
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the minor use shall be deleted from the reg-
istration.’’.
(g) UTILIZATION OF DATA FOR VOLUNTARILY CAN-
CELED CHEMICALS.—Section 6(f) (7 U.S.C. 136d(f)) is
amended by adding at the end the following:
‘‘(4) UTILIZATION OF DATA FOR VOLUNTARILY
CANCELED
CHEMICALS.—When an application is
filed with the Administrator for the registration of
a pesticide for a minor use and another registrant
subsequently voluntarily cancels its registration for
an identical or substantially similar pesticide for an
identical or substantially similar use, the Adminis-
trator shall process, review, and evaluate the pend-
ing application as if the voluntary cancellation had
not yet taken place, except that the Administrator
shall not take such action if the Administrator deter-
mines that such minor use may cause an unreason-
able adverse effect on the environment. In order to
rely on this paragraph, the applicant must certify
that it agrees to satisfy any outstanding data re-
quirements necessary to support the reregistration of
the pesticide in accordance with the data submission
schedule established by the Administrator.’’.
(h) ENVIRONMENTAL PROTECTION AGENCY MINOR
USE PROGRAM.—The Federal Insecticide, Fungicide, and
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Rodenticide Act (7 U.S.C. 136 et seq.) is amended by re-
designating sections 30 and 31 as sections 32 and 33, re-
spectively, and adding after section 29 the following:
‘‘SEC. 30. ENVIRONMENTAL PROTECTION AGENCY MINOR
USE PROGRAM.
‘‘The Administrator shall assure coordination of
minor use issues through the establishment of a minor use
program within the Office of Pesticide Programs. Such of-
fice shall be responsible for coordinating the development
of minor use programs and policies and consulting with
growers regarding minor use issues and registrations and
amendments which are submitted to the Environmental
Protection Agency.’’.
(i) DEPARTMENT
OF AGRICULTURE MINOR USE
PROGRAM.—The Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.), as amended by
subsection (h), is amended by adding after section 30 the
following:
‘‘SEC. 31. DEPARTMENT OF AGRICULTURE MINOR USE
PROGRAM.
‘‘(a) IN GENERAL.—The Secretary of Agriculture
(hereinafter in this section referred to as the ‘Secretary’)
shall ensure the coordination of the responsibilities of the
Department of Agriculture related to minor uses of pes-
ticides, including—
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‘‘(1) carrying out the Inter-Regional Project
Number 4 (IR–4) as described in section 2(e) of the
Act entitled ‘An Act to facilitate the work of the De-
partment of Agriculture, and for other purposes’ (7
U.S.C. 4501(e)) and the national pesticide resistance
monitoring program established under section 1651
of the Food, Agriculture, Conservation, and Trade
Act of 1990 (7 U.S.C. 5882);
‘‘(2) supporting integrated pest management
research;
‘‘(3) consulting with growers to develop data for
minor uses; and
‘‘(4) providing assistance for minor use reg-
istrations, tolerances, and reregistrations with the
Environmental Protection Agency.
‘‘(b) MATCHING FUND PROGRAM.—
‘‘(1) ESTABLISHMENT.—The Secretary of Agri-
culture, in consultation with the Administrator, shall
establish and administer a minor use matching fund
program. The matching fund program shall be uti-
lized to ensure the continued availability of minor
use crop protection chemicals, including the develop-
ment of data to support minor use pesticide registra-
tions and reregistrations. Access to the matching
fund program shall be available to any entity which
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desires to develop data to support minor use reg-
istrations. Priority for access to the fund shall be
given those entities that do not directly receive funds
from the sale of products registered on minor uses.
Any entity that seeks such funding under this para-
graph shall be required to match such funds with an
equal amount of its own funds. Any data developed
through the matching fund program shall be jointly
owned by the Department of Agriculture and by the
entity that receives such funding. Any data devel-
oped under this subsection shall be subject to the
provisions of section 3(c)(1)(F). All compensation
received by the Department of Agriculture in return
for the use of such data under the matching fund
program shall be returned to a revolving fund which
will support the matching fund program.
‘‘(2) AUTHORIZATION.—There is authorized to
be appropriated for the revolving fund for the
matching fund program an annual sum not to ex-
ceed $10,000,000.’’.
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TITLE III—DATA COLLECTION ACTIVITIES
TO ASSURE THE HEALTH OF INFANTS
AND CHILDREN AND OTHER MEAS-
URES
SEC. 301. DATA COLLECTION ACTIVITIES TO ASSURE THE
HEALTH OF INFANTS AND CHILDREN.
(a) IN GENERAL.—The Secretary of Agriculture, in
consultation with the Administrator of the Environmental
Protection Agency and the Secretary of Health and
Human Services, shall coordinate the development and im-
plementation of survey procedures to ensure that adequate
data on food consumption patterns of infants and children
are collected.
(b) PROCEDURES.—To the extent practicable, the
procedures referred to in subsection (a) shall include the
collection of data on food consumption patterns of a statis-
tically valid sample of infants and children.
(c) RESIDUE SURVEILLANCE.—The Secretary of Ag-
riculture shall ensure that the residue surveillance activi-
ties conducted by the Department of Agriculture provide
for the improved surveillance of pesticide residues, includ-
ing guidelines for the use of comparable analytical and
standardized reporting methods, and the increased sam-
pling of foods most likely consumed by infants and chil-
dren.
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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 sur-
veys of farmers or from other sources offering statistically
reliable data.
(c) COORDINATION.—The Secretary shall, as appro-
priate, 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 in benefits de-
terminations with respect to pesticide regulatory decisions.
SEC. 303. INTEGRATED PEST MANAGEMENT.
The Secretary of Agriculture, in cooperation with the
Administrator, shall implement research, demonstration,
and education programs to support adoption of integrated
pest management. Integrated Pest Management is a sus-
tainable approach to managing pests by combining biologi-
cal, 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 avail-
able to pesticide users, including Federal agencies. Federal
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agencies shall use integrated pest management techniques
in carrying out pest management activities and shall pro-
mote integrated pest management through procurement
and regulatory policies, and other activities.
TITLE IV—AMENDMENTS TO THE FED-
ERAL FOOD, DRUG, AND COSMETIC
ACT
SEC. 401. 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. 402. 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 ingredient of a pesticide within
the meaning of the Federal Insecticide, Fungicide,
and Rodenticide Act.
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‘‘(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.’’.
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(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. 403. PROHIBITED ACTS.
Section 301(j) (21 U.S.C. 331(j)) is amended—
(1) by striking the period at the end; and
(2) by inserting at the end ‘‘, or the violation
of section 408(g)(2) or any regulation issued under
that section.’’.
SEC. 404. ADULTERATED FOOD.
Section 402(a)(2) (21 U.S.C. 342(a)(2)) is amended
to read as follows:
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‘‘(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. 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 CHEMI-
CAL RESIDUES
‘‘SEC. 408. (a) REQUIREMENT FOR TOLERANCE OR
EXEMPTION.—
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‘‘(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-
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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 for 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
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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.
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‘‘(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
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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, including infants and children) to the pes-
ticide chemical residue, and available information
and reasonable assumptions concerning the varia-
bility of the sensitivities of major identifiable groups,
including infants and children, 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-
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sumers by such level of the pesticide chemical resi-
due is negligible. The Administrator shall by regula-
tion set forth the factors and methods, including
tests which are appropriate for the determination of
dietary risk and most likely dietary exposure, for the
determination of negligible dietary risk.
‘‘(E) Procedures shall be developed and imple-
mented that ensure that pesticide tolerances ade-
quately safeguard the health of infants and children.
‘‘(F) 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.
‘‘(G) 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
because—
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‘‘(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 that are considered to be greater
than the risks that result from dietary exposure
to the pesticide chemical residue; or
‘‘(iii) the availability of the pesticide would
enable domestic growers to maintain the avail-
ability of an adequate, wholesome, and economi-
cal food supply for consumers, taking into ac-
count national and regional effects.
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
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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, or that a practical method is unavailable or not
feasible.
‘‘(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 determine
whether a maximum residue level for the chemical
has been established by the Codex Alimentarius
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Commission. If a Codex maximum residue level has
been established for the chemical and the Adminis-
trator 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. If the Administrator determines not to
adopt a Codex level, the Administrator shall publish
as part of the final tolerance decision a determina-
tion with supporting data that the Codex level is not
supported by adequate and reliable scientific data,
or is inadequate to protect the health of the United
States’ consumers and that the effect of the toler-
ance on the availability to consumers of an adequate,
wholesome and economical food supply, does not out-
weigh the risk posed by the pesticide residue.
‘‘(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
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‘‘(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
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—
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‘‘(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—
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‘‘(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;
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‘‘(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-
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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
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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.
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‘‘(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
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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 a 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
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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-
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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
court deems proper. The Administrator may modify
prior findings as to the facts by reason of the addi-
tional evidence so taken and may modify the order
or regulation accordingly. The Administrator shall
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file with the court any such modified finding, order,
or regulation.
‘‘(D) The judgment of the court affirming or
setting aside, in whole or in part, any order under
paragraph (6) and any regulation which is the sub-
ject of such an order shall be final, subject to review
by the Supreme Court of the United States as pro-
vided in section 1254 of title 28 of the United States
Code. The commencement of proceedings under this
paragraph shall not, unless specifically ordered by
the court to the contrary, operate as a stay of a reg-
ulation or order.
‘‘(E) Any issue as to which review is or was ob-
tainable under paragraph (6) and this paragraph
shall not be the subject of judicial review under any
other provision of law.
‘‘(e) ACTION
ON ADMINISTRATOR’S OWN INITIA-
TIVE.—
‘‘(1) GENERAL RULE.—The Administrator may
issue a regulation—
‘‘(A) establishing, modifying, or revoking a
tolerance for a pesticide chemical or a pesticide
chemical residue;
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‘‘(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
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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 requiring 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)
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review in accordance with paragraphs (6) and (7) of sub-
section (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 or an exemption
from a tolerance shall be entitled to confidential
treatment for reasons of business confidentiality and
to exclusive use and data compensation, to the same
extent provided by sections 3 and 10 of the Federal
Insecticide, Fungicide, and Rodenticide Act.
‘‘(2) EXCEPTIONS.—Data that are entitled to
confidential treatment under paragraph (1) may
nonetheless be disclosed to the Congress of the
United States, and may be disclosed, under such se-
curity requirements as the Administrator may pro-
vide 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
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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
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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 exempt from
the requirement for a tolerance, as of the date of en-
actment of this subsection. The Administrator shall
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by regulation indicate which substances are de-
scribed by this subsection. All exemption under this
subsection may be revoked or modified as if it had
been issued under subsection (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
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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) the date on which the use of the can-
celed pesticide becomes unlawful under the
terms of the cancellation, whichever is later.
‘‘(3) SUSPENSION OF TOLERANCE OR EXEMP-
TION FOLLOWING SUSPENSION OF ASSOCIATED REG-
ISTRATIONS.—
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‘‘(A) SUSPENSION.—If the Administrator,
acting under the Federal Insecticide, Fungicide,
and Rodenticide Act, suspends the use of each
registered pesticide that contains a particular
pesticide chemical and that is labeled for use on
a particular food, due in whole or in part to die-
tary risks to humans posed by residues of that
pesticide chemical on that food, the Adminis-
trator shall suspend any tolerance or exemption
that allows the presence of the pesticide chemi-
cal, or any pesticide chemical residue that re-
sults from its use, in or on that food. The Ad-
ministrator shall use the procedures set forth
in subsection (e) in taking action under this
paragraph. A suspension under this paragraph
shall become effective not later than 60 days
after the date by which each such suspension
of use has become effective.
‘‘(B) EFFECT OF SUSPENSION.—The 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
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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 toler-
ance 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.
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‘‘(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-
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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-
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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 1995.
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‘‘(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 1995; (or)
‘‘(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.
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‘‘(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-
ping, or other handling of a food because it contains
a pesticide residue (in excess of a prescribed limit),
or if it purports to require that a food containing a
pesticide residue be the subject of a warning or