Union Calendar No. 364
104TH CONGRESS
2D SESSION
H. R. 1627
[Report No. 104–669, Parts I and II]
A BILL
To amend the Federal Insecticide, Fungicide, and
Rodenticide Act and the Federal Food, Drug,
and Cosmetic Act, and for other purposes.
JULY 23, 1996
Reported from the Committee on Commerce with an
amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be
printed
IB
Union Calendar No. 364
104TH CONGRESS
2D SESSION
H. R. 1627
[Report No. 104–669, Parts I and II]
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
JULY 11, 1996
Reported from the Committee on Agriculture with amendments
[Omit the part struck through and insert the part printed in italic]
JULY 23, 1996
Additional sponsors: Mr. HAYES, Mr. PETERSON of Minnesota, Mr. COBLE,
Mr. MCINTOSH, Mr. BALLENGER, Mr. BUNN of Oregon, Mr. LAUGHLIN,
Mr. FUNDERBURK, Mr. PICKETT, Mr. BARR of Georgia, Mr. FAZIO of
California, Mr. COLLINS of Georgia, Mr. SOLOMON, Mr. GEKAS, Mr.
BONO, Mr. JONES, Mr. BAKER of California, Mr. GUTKNECHT, Mr. SISI-
SKY, Mr. KLUG, Mr. GALLEGLY, Mr. JACOBS, Mr. BURTON of Indiana,
Mr. ARCHER, Mr. CAMP, Mr. CHRISTENSEN, Mr. COBURN, Mr. HERGER,
Mr. KANJORSKI, Mr. COSTELLO, Mr. FRANKS of Connecticut, Mr.
THORNTON, Mr. HEFNER, Mr. THOMAS, Mr. BROWNBACK, Mr. ROGERS,
Mr. HEINEMAN, Mr. DORNAN, Mr. WATTS of Oklahoma, Mr. LINDER,
Mr. GOODLING, Mr. ROHRABACHER, Mr. CRANE, Mr. FORD, Mr.
SPENCE, Mr. PARKER, Mr. LEWIS of California, Mr. STOCKMAN, Mr.
DAVIS, Mr. MCKEON, Mr. WICKER, Mr. TIAHRT, Mr. HILLIARD, Mr.
THOMPSON, Mr. HOBSON, Mr. HOUGHTON, Mr. BONILLA, Mr. BUNNING
of Kentucky, Mr. LEACH, Ms. DUNN of Washington, Mr. MATSUI, Mr.
SPRATT, Mrs. SMITH of Washington, Mr. CLYBURN, Mr. TANNER, Mr.
PETERSON of Florida, Mr. MICA, Mr. PACKARD, Mr. PETE GEREN of
Texas, Mr. EHRLICH, Mr. BATEMAN, Mr. CHAPMAN, Mr. MILLER of
Florida, Mr. SKELTON, Mr. RIGGS, Mr. VOLKMER, Mr. MCCOLLUM, Mr.
FARR of California, Mr. TATE, Mr. PAYNE OF VIRGINIA, Mr. HUNTER,
Mr. CRAMER, Mr. BREWSTER, Mr. WELLER, Mr. MCINNIS, Mrs.
MYRICK, Mr. HILLEARY, Mrs. CUBIN, Mr. GILCHREST, Mr. NUSSLE, Mr.
WILIAMS, Mr. KNOLLENBERG, Mr. LARGENT, Mr. ENGEL, Mr. LIVING-
STON, Mr. ROTH, Mr. LIGHTFOOT, Mr. CALLAHAN, Mr. LIPINSKI, Mr.
DELAY, Mr. SHUSTER, Mr. GOSS, Mr. ROYCE, Mr. BEVILL, Mr. DEAL
of Georgia, Mr. WELDON of Florida, Mr. SOUDER, Mr. ANDREWS, Mr.
DREIER, Mr. BARTLETT of Maryland, Mr. CUNNINGHAM, Mr. STEARNS,
Mr. BACHUS, Mr. SCARBOROUGH, Mrs. FOWLER, Mr. TRAFICANT, Mr.
PORTER, Mr. BASS, Mr. ENGLISH of Pennsylvania, Mrs. VUCANOVICH,
Mr. CASTLE, Mr. KIM, Mr. SMITH of Texas, Ms. PRYCE, Mr. PETRI, Mr.
HANSEN, Mr. ISTOOK, Mr. WATT of North Carolina, Mr. LONGLEY, Mr.
HAMILTON, Mr. MANTON, Mr. MYERS of Indiana, Mr. LATOURETTE,
Mrs. CLAYTON, Mr. BARCIA of Michigan, Mr. BOEHLERT, Mr. DICKS,
Mr. WAMP, Mr. MCDADE, Mr. GRAHAM, Mr. KOLBE, Mr. NEY, Mrs.
ROUKEMA, Mr. CAMPBELL, Mr. GILMAN, Mr. DINGELL, and Mr. WAX-
MAN
JULY 23, 1996
Reported from the Committee on Commerce with an amendment, committed
to the Committee of the Whole House on the State of the Union, and
ordered to be printed
[Omit the part in bold brackets and insert the part printed in boldface roman]
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
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
proposes to base the rulemaking and the basis
for a determination that such test or evidence
raises
prudent
concerns
that
the
pesticide
causes unreasonable adverse risks to man or to
the environment. A registrant shall have 30
days after receipt of a notice provided under
this subparagraph to respond to such notice.
‘‘(B) At the same time that the Adminis-
trator furnishes notice to registrants of the pes-
ticide under subparagraph (A), the Adminis-
trator shall also furnish such notice to the Sec-
retary of Agriculture and the Secretary of
Health and Human Services. Upon receipt of
such notification, the Secretary of Agriculture,
when an agricultural commodity is affected,
shall prepare an analysis of the benefit and use
data of the pesticide and provide the analysis to
the Administrator within the time limits of this
paragraph.
‘‘(C) Not more than 60 days after issuing
a notice under this paragraph, the Adminis-
trator shall either—
‘‘(i) issue a notice of proposed rule-
making under paragraph (5); or
‘‘(ii) issue a notice of a decision not to
initiate a rulemaking.
‘‘(4) DOCKET.—For each rulemaking under
paragraph (1), the Administrator shall establish a
docket. The docket shall include a copy of the notice
under paragraph (3), of the notice of proposed rule-
making under paragraph (5), of each timely com-
ment filed with the Administrator, of the report of
the Scientific Advisory Panel under paragraph (7),
of a record of each hearing held by the Adminis-
trator in connection with the rulemaking of the deci-
sion of the hearing examiner under paragraph (6),
and of the final rule or decision to withdraw the
rule. Information in the docket shall be made avail-
able to the public consistent with the requirements
of section 10. No factual material that has not been
entered into the docket in a timely manner may be
relied upon by the Administrator in issuing a final
rule or in withdrawing a proposed rule or by any
person in a judicial review proceeding, except for—
‘‘(A) information of which the Adminis-
trator may properly take official notice; or
‘‘(B) information of which a court may
properly take judicial notice.
‘‘(5) NOTICE OF PROPOSED RULEMAKING.—
‘‘(A) The notice of proposed rulemaking
shall include a statement of its basis and pur-
pose, a request for any additional data needed,
and a bibliography of all significant scientific
data and studies on which the proposed rule is
based. The statement of basis and purpose shall
include a summary of—
‘‘(i) the factual data on which the pro-
posed rule is based;
‘‘(ii) the major scientific assumptions,
legal interpretations, and policy consider-
ations underlying the proposed rule;
‘‘(iii) a summary of available risk-ben-
efit information, including benefits and use
information as provided by the Secretary
of Agriculture; and
‘‘(iv) the Administrator’s analysis and
tentative conclusions regarding the bal-
ancing of such risks and benefits.
‘‘(B) Registrants of the pesticide and any
person who submits comments on the proposed
rule shall make a report to the Administrator of
all scientific data and studies in such person’s
possession concerning the risks and benefits of
the pesticide that are the subject of the rule-
making and were not included in the bibliog-
raphy included in the notice required in sub-
paragraph (A). If such person receives addi-
tional scientific data or studies pertinent to the
rulemaking that were not included in such bibli-
ography, the person shall make a report of such
scientific data and studies to the Administrator
promptly after receipt. If the Administrator re-
ceives reports containing additional data con-
cerning risks or benefits, the Administrator
shall revise the bibliography to reflect such data
and make the revised bibliography available to
the public.
‘‘(C) The Administrator shall provide a
comment period of not less than 90 days after
the publication of the notice of proposed rule-
making. During such period any person may
submit comments, data, or documentary infor-
mation on the proposed rule. Promptly upon re-
ceipt by the Administrator, all written com-
ments and documentary information on the pro-
posed rule received from any person for inclu-
sion in the docket during the comment period,
shall be place in the docket.
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
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.
‘‘(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
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
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.—
‘‘(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
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-
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-
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
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
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-
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.
(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-
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),
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
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—
(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
‘‘(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.’’.
(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
‘‘(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.’’.
(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 Food Quality 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-
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
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
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 Food Quality Protection Act of 1996 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
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)’’;
(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.—
‘‘(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
months after the submission of the
complete application, and the failure
of the Administrator to complete such
a review and evaluation under clause
(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,
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
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).
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
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
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
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
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
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
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—
‘‘(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
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.’’.
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.
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
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.
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Food Quality Protection
Act of 1996’’.
TITLE I—SUSPENSION-
APPLICATORS
SEC. 101. REFERENCE.
Whenever in this title an amendment or repeal is ex-
pressed in terms of an amendment to, or repeal of, a section
or other provision, the reference shall be considered to be
made to a section or other provision of the Federal Insecti-
cide, Fungicide, and Rodenticide Act.
Subtitle A—Suspension
SEC. 102. SUSPENSION.
(a) SECTION 6(c)(1).—The second sentence of section
6(c)(1) (7 U.S.C. 136d(c)(1)) is amended to read: ‘‘Except
as provided in paragraph (3), no order of suspension may
be issued under this subsection unless the Administrator has
issued, or at the same time issues, a notice of intention to
cancel the registration or change the classification of the
pesticide 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 sentence
the following new sentence: ‘‘The Administrator may issue
an emergency order under this paragraph before issuing a
notice of intention to cancel the registration or change the
classification of the pesticide under subsection (b) and the
Administrator shall proceed to issue the notice under sub-
section (b) within 90 days of issuing an emergency order.
If the Administrator does not issue a notice under sub-
section (b) within 90 days of issuing an emergency order,
the emergency order shall expire.’’.
SEC. 103. 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 suf-
ficient information with respect to the dietary
risk of a particular active ingredient, but in any
event no later than the time the Administrator
makes a determination under subparagraph (C)
or (D) with respect to pesticides containing a
particular active ingredient, the Administrator
shall—
‘‘(i) reassess each associated tolerance
and exemption from the requirement for a
tolerance issued under section 408 of the
Federal Food, Drug, and Cosmetic Act (21
U.S.C. 346a) taking into account available
information and reasonable assumptions
concerning the dietary exposure levels of
food consumers (and major identifiable sub-
groups of food consumers, including infants
and children) to residue of the pesticide in
food and available information and reason-
able assumptions concerning the variability
of the sensitivities of major identifiable
groups, including infants and children;
‘‘(ii) determine whether such tolerance
or exemption meets the requirements of that
Act;
‘‘(iii) determine whether additional tol-
erances 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 proceed-
ings under this Act and section 408 of the
Federal Food, Drug, and Cosmetic Act as
are warranted by such determinations.’’.
SEC. 104. SCIENTIFIC ADVISORY PANEL.
Section 25(d) (7 U.S.C. 136w(d)) is amended—
(1) in the first sentence, by striking ‘‘The Ad-
ministrator 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
Panel. Members of the Board shall be selected in the
same manner as members of temporary subpanels cre-
ated under paragraph (1). Members of the Board shall
be compensated in the same manner as members of
the Panel.’’.
SEC. 105. NITROGEN STABILIZER.
(a) SECTION 2.—Section 2 (7 U.S.C. 136) is amend-
ed—
(1) in subsection (a)—
(A) in paragraph (1) by striking ‘‘or’’ after
‘‘defoliant,’’ and inserting ‘‘, or nitrogen sta-
bilizer’’ after ‘‘desiccant’’;
(B) at the end of paragraph (3) by striking
‘‘and’’;
after January 1, 1992, the distributor or seller
of the substance or mixture has made no specific
claim of prevention or hindering of the process
of nitrification, denitrification, ammonia vola-
tilization urease production regardless of the ac-
tual use or purpose for, or future use or purpose
for, the substance or mixture.
Statements made in materials required to be submitted to
any State legislative or regulatory authority, or required
by such authority to be included in the labeling or other
literature accompanying any such substance or mixture
shall not be deemed a specific claim within the meaning
of this subsection.’’.
(b) SECTION 3(f).—Section 3(f) (7 U.S.C. 136a(f)) is
amended by adding at the end the following:
‘‘(4) MIXTURES OF NITROGEN STABILIZERS AND
FERTILIZER PRODUCTS.—Any mixture or other com-
bination of—
‘‘(A) 1 or more nitrogen stabilizers reg-
istered under this Act; and
‘‘(B) 1 or more fertilizer products,
shall not be subject to the provisions of this section or
sections 4, 5, 7, 15, and 17(a)(2) if the mixture or
other combination is accompanied by the labeling re-
quired under this Act for the nitrogen stabilizer con-
tained in the mixture or other combination, the mix-
ture or combination is mixed or combined in accord-
ance with such labeling, and the mixture or combina-
tion does not contain any active ingredient other than
the nitrogen stabilizer.’’.
SEC. 106. AUTHORITY OF STATES.
(a) DEFINITIONS.—Section 2 (7 U.S.C. 136), as
amended by section 105, is further amended—
(1) in subsection (aa), by adding at the end the
following new sentence: ‘‘The term ‘State’ does not in-
clude a local government, as defined in subsection
(ii), and is not intended to grant any authority or
to otherwise refer to local governments or political
subdivisions of a State.’’; and
(2) by adding at the end the following:
‘‘(ii) LOCAL GOVERNMENT.—The term ‘local govern-
ment’ means any political subdivision of a State including
counties, townships, cities, towns, parishes, and boroughs,
whether home rule entities or not, or any local agency or
body of any type which has an organized existence, govern-
mental character, and substantial autonomy including
independent or autonomous school districts, housing au-
thorities, and other special districts.’’.
(b) RECORDS.—Section 8(b) (7 U.S.C. 136f(b)) is
amended by striking ‘‘or political subdivision’’ in the first
sentence.
(c) DELEGATION AND COOPERATION.—Section 22(b)
(7 U.S.C. 136t(b)) is amended by striking ‘‘or any political
subdivision thereof’’.
(d) AUTHORITY OF STATES.—Section 24 (7 U.S.C.
136v) is amended by adding at the end the following:
‘‘(d) LOCAL REGULATION.—Subject to subsection (e),
a local government shall not impose or continue in effect
any requirement or regulation regarding pesticides or de-
vices.
‘‘(e) LOCALLY SPECIFIC STATE REGULATION.—Noth-
ing in this section shall prohibit a State from enforcing
laws, enacting laws, or implementing regulations applica-
ble to local governments regarding the sale or use of any
federally registered pesticide or device.’’.
(e) AUTHORITY OF ADMINISTRATOR.—The first sen-
tence of section 25(e) (7 U.S.C. 136w(e)) is amended by
striking ‘‘or political subdivision thereof’’.
SEC. 107. PERIODIC REGISTRATION REVIEW.
(a) SECTION 6.—Section 6 (7 U.S.C. 136d) is amend-
ed—
(1) in subsection (a), by striking the heading
and inserting the following:
‘‘(a) EXISTING STOCKS AND INFORMATION.—’’; and
(2) by amending paragraph (1) of subsection (a)
to read as follows:
‘‘(1) EXISTING
STOCKS.—The Administrator
may permit the continued sale and use of existing
stocks of a pesticide whose registration is suspended
or canceled under this section, or section 3 or 4, to
such extent, under such conditions, and for such uses
as the Administrator determines that such sale or use
is not inconsistent with the purposes of this Act.’’.
(b) SECTION 3.—Section 3 (7 U.S.C. 136a) is amended
by adding at the end the following:
‘‘(g) REGISTRATION REVIEW.—
‘‘(1)(A) GENERAL
RULE.—The registrations of
pesticides are to be periodically reviewed. The Admin-
istrator shall by regulation establish a procedure for
accomplishing the periodic review of registrations.
The goal of these regulations shall be a review of a
pesticide’s registration every 15 years. No registration
shall be canceled as a result of the registration review
process unless the Administrator follows the proce-
dures and substantive requirements of section 6.
‘‘(B) LIMITATION.—Nothing in this subsection
shall prohibit the Administrator from undertaking
any other review of a pesticide pursuant to this Act.
‘‘(2)(A) DATA.—The Administrator shall use the
authority in subsection (c)(2)(B) to require the sub-
mission of data when such data are necessary for a
registration review.
‘‘(B) DATA
SUBMISSION, COMPENSATION, AND
EXEMPTION.—For purposes of this subsection, the pro-
visions of subsections (c)(1), (c)(2)(B), and (c)(2)(D)
shall be utilized for and be applicable to any data re-
quired for registration review.’’.
Subtitle B—Training for Mainte-
nance Applicators and Service
Technicians
SEC. 120. MAINTENANCE APPLICATORS AND SERVICE TECH-
NICIANS DEFINITIONS.
Section 2 (7 U.S.C. 136), as amended by section 106,
is amended by adding at the end the following:
‘‘(jj) MAINTENANCE APPLICATOR.—The term ‘mainte-
nance applicator’ means any individual who, in the prin-
cipal course of such individual’s employment, uses, or su-
pervises the use of, a pesticide not classified for restricted
use (other than a ready to use consumer products pes-
ticides); for the purpose of providing structural pest control
or lawn pest control including janitors, general mainte-
nance personnel, sanitation personnel, and grounds mainte-
nance personnel. The term ‘maintenance applicator’ does
not include private applicators as defined in section 2(e)(2);
individuals who use antimicrobial pesticides, sanitizers or
disinfectants; individuals employed by Federal, State, and
local governments or any political subdivisions thereof, or
individuals who use pesticides not classified for restricted
use in or around their homes, boats, sod farms, nurseries,
greenhouses, or other noncommercial property.
‘‘(kk) SERVICE TECHNICIAN.—The term ‘service tech-
nician’ means any individual who uses or supervises the
use of pesticides (other than a ready to use consumer prod-
ucts pesticide) for the purpose of providing structural pest
control or lawn pest control on the property of another for
a fee. The term ‘service technician’ does not include individ-
uals who use antimicrobial pesticides, sanitizers or dis-
infectants; or who otherwise apply ready to use consumer
products pesticides.’’.
SEC. 121. MINIMUM REQUIREMENTS FOR TRAINING OF
MAINTENANCE APPLICATORS AND SERVICE
TECHNICIANS.
The Federal Insecticide, Fungicide, and Rodenticide
Act (7 U.S.C. 136 et seq.) is amended—
(1) by redesignating sections 30 and 31 as sec-
tions 33 and 34, respectively; and
(2) by adding after section 29 the following:
‘‘SEC. 30. MINIMUM REQUIREMENTS FOR TRAINING OF
MAINTENANCE APPLICATORS AND SERVICE
TECHNICIANS.
‘‘Each State may establish minimum requirements for
training of maintenance applicators and service techni-
cians. Such training may include instruction in the safe
and effective handling and use of pesticides in accordance
with the Environmental Protection Agency approved label-
ing, and instruction in integrated pest management tech-
niques. The authority of the Administrator with respect to
minimum requirements for training of maintenance appli-
cators and service technicians shall be limited to ensuring
that each State understands the provisions of this section.’’.
TITLE II—MINOR USE CROP PRO-
TECTION, 
ANTIMICROBIAL
PESTICIDE 
REGISTRATION
REFORM, 
AND 
PUBLIC
HEALTH PESTICIDES
SEC. 201. REFERENCE.
Whenever in this title an amendment or repeal is ex-
pressed in terms of an amendment to, or repeal of, a section
or other provision, the reference shall be considered to be
made to a section or other provision of the Federal Insecti-
cide, Fungicide, and Rodenticide Act.
Subtitle A—Minor Use Crop
Protection
SEC. 210. MINOR CROP PROTECTION.
(a) DEFINITION.—Section 2 (7 U.S.C. 136), as amend-
ed by section 120, is further amended by adding at the end
the following:
‘‘(ll) 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, as determined by the Sec-
retary of Agriculture; or
‘‘(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 eco-
nomic 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;
‘‘(B) the alternatives to the pesticide use
pose greater risks to the environment or human
health;
‘‘(C) the minor use pesticide plays or will
play a significant part in managing pest resist-
ance; or
‘‘(D) the minor use pesticide plays or will
play a significant part in an integrated pest
management program.
The status as a minor use under this subsection shall con-
tinue as long as the Administrator has not determined that,
based on existing data, such use may cause an unreasonable
adverse effect on the environment and the use otherwise
qualifies for such status.’’.
(b) EXCLUSIVE USE OF MINOR USE PESTICIDES.—
Section 3(c)(1)(F) (7 U.S.C. 136a(c)(1)(F)) is amended—
(1) by redesignating clauses (ii) and (iii) as
clauses (iii) and (iv), respectively; and
(2) by inserting after clause (i) the following:
‘‘(ii) The period of exclusive data use
provided under clause (i) shall be extended
1 additional year for each 3 minor uses reg-
istered after the date of enactment of this
clause and within 7 years of the commence-
ment of the exclusive use period, up to a
total of 3 additional years for all minor
uses registered by the Administrator if the
Administrator, in consultation with the
Secretary of Agriculture, determines that,
based on information provided by an appli-
cant for registration or a registrant, that—
‘‘(I) there are insufficient effica-
cious alternative registered pesticides
available for the use;
‘‘(II) the alternatives to the minor
use pesticide pose greater risks to the
environment or human health;
‘‘(III) the minor use pesticide
plays or will play a significant part in
managing pest resistance; or
‘‘(IV) the minor use pesticide
plays or will play a significant part in
an integrated pest management pro-
gram.
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 1 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 pe-
riod or if the Administrator determines that
the registrant is not actually marketing the
product for such minor uses.’’;
(3) in clause (iv), as amended by paragraph (1),
by striking ‘‘and (ii)’’ and inserting ‘‘, (ii), and
(iii)’’; and
(4) at the end of the section, as amended by
paragraph (1), by adding the following:
‘‘(v) The period of exclusive use pro-
vided under clause (ii) shall not take into
effect until 1 year after enactment of this
clause, except where an applicant or reg-
istrant is applying for the registration of a
pesticide containing an active ingredient
not previously registered.
‘‘(vi) With respect to data submitted
after the date of enactment of this clause by
an applicant or registrant to support an
amendment adding a new use to an existing
registration that does not retain any period
of exclusive use, if such data relates solely
to a minor use of a pesticide, such data
shall not, without the written permission of
the original data submitter, be considered
by the Administrator to support an appli-
cation for a minor use by another person
during the period of 10 years following the
date of submission of such data. The appli-
cant or registrant at the time the new
minor use is requested shall notify the Ad-
ministrator that to the best of their knowl-
edge the exclusive use period for the pes-
ticide has expired and that the data per-
taining solely to the minor use of a pes-
ticide is eligible for the provisions of this
paragraph. If the minor use registration
which is supported by data submitted pur-
suant to this subsection is voluntarily can-
celed or if such data are subsequently used
to support a nonminor use, the data shall
no longer be subject to the exclusive use pro-
visions of this clause but shall instead be
considered by the Administrator in accord-
ance with the provisions of clause (i), as
appropriate.’’.
(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 dead-
line for submission of data under section 4
for the other uses of the pesticide established
as of the date of enactment of the Minor Use
Crop Protection Act of 1996, 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, pro-
vides a schedule, including interim
dates to measure progress, to assure
that the data production will be com-
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 that based on existing data,
such extension would not significantly
increase the risk of any unreasonable
adverse effect on the environment. If
the Administrator grants an extension
under this clause, the Administrator
shall monitor the development of the
data and shall ensure that the reg-
istrant is meeting the schedule for the
production of the data. If the Adminis-
trator determines that the registrant is
not meeting or has not met the sched-
ule for the production of such data, the
Administrator may proceed in accord-
ance with clause (iv) regarding the
continued registration of the affected
products with the minor use and shall
inform the public of such action. Not-
withstanding the provisions of this
clause, the Administrator may take ac-
tion to modify or revoke the extension
under this clause 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 reg-
istrant, a notice revoking the extension
of time for submission of data. Such
data shall instead be due in accordance
with the date established by the Ad-
ministrator 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 reg-
istrant, the Administrator shall, in the case of a
minor use, extend the deadline for the production 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 this
section for the other uses of the pesticide established
as of the date of enactment of the Food Quality Pro-
tection Act of 1996 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, includ-
ing interim dates to measure progress, to assure
that the data production will be completed before
the expiration of the extension period;
‘‘(iii) the Administrator has deter-
mined that such extension will not signifi-
cantly delay the Administrator’s schedule
for issuing a reregistration eligibility deter-
mination required under this section; and
‘‘(iv) the Administrator has determined
that based on existing data, such extension
would not significantly increase the risk of
any unreasonable adverse effect on the envi-
ronment. If the Administrator grants an ex-
tension under this subparagraph, the Ad-
ministrator shall monitor the development
of the data and shall ensure that the reg-
istrant is meeting the schedule for the pro-
duction of the data. If the Administrator
determines that the registrant is not meet-
ing or has not met the schedule for the pro-
duction 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 registration of the affected prod-
ucts with the minor use and shall inform
the public of such action. Notwithstanding
the provisions of this subparagraph, the Ad-
ministrator may take action to modify or
revoke the extension under this subpara-
graph if the Administrator determines that
the extension for the minor use may cause
an unreasonable adverse affect on the envi-
ronment. In such circumstance, the Admin-
istrator shall provide written notice to the
registrant revoking the extension of time for
submission of data. Such data shall instead
be due in accordance with the date then es-
tablished by the Administrator for submis-
sion 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)’’;
(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 applicable
data requirements if the Administrator deter-
mines that the absence of such data will not pre-
vent 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 en-
vironment.’’.
(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.—
‘‘(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 pro-
posed to be registered solely for minor
uses, or proposes a registration amend-
ment solely for minor uses to an exist-
ing registration; or
‘‘(II) for a registration or a reg-
istration amendment that proposes sig-
nificant minor uses.
‘‘(ii) For the purposes of clause (i)—
‘‘(I) the term ‘as expeditiously as
possible’ means that the Administrator
shall, to the greatest extent practicable,
complete a review and evaluation of all
data, submitted with a complete appli-
cation, within 12 months after the sub-
mission of the complete application,
and the failure of the Administrator to
complete such a review and evaluation
under clause (i) shall not be subject to
judicial review; and
‘‘(II) the term ‘significant minor
uses’ means 3 or more minor uses pro-
posed for every nonminor use, a minor
use that would, in the judgment of the
Administrator, serve as a replacement
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 Administrator 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 re-
quired by the Administrator, pursuant to para-
graph (2)(E), and if the Administrator denies in
whole or in part such data waiver request, the
registrant shall have a full-time period for pro-
viding such data. For purposes of this subpara-
graph, the term ‘full-time period’ means the time
period originally established by the Adminis-
trator for submission of such data, beginning
with the date of receipt by the registrant 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 support 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 written request of the reg-
istrant, 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 Food Quality Pro-
tection Act of 1996, for the submission of data
under this section for the supported uses identi-
fied pursuant to this paragraph unless the Ad-
ministrator determines that the absence of the
data is significant enough to cause human health
or environmental concerns. On such a deter-
mination the Administrator may refuse the re-
quest for extension by the registrant. Upon re-
ceipt of the request from the registrant, the Ad-
ministrator shall publish in the Federal Register
a notice of the receipt of the request and the ef-
fective date upon which the uses not being sup-
ported will be voluntarily deleted from the reg-
istration pursuant to section 6(f)(1). If the Ad-
ministrator grants an extension under this para-
graph, the Administrator shall monitor the devel-
opment of the data for the uses being supported
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 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). Not-
withstanding this subparagraph, the Adminis-
trator may deny, modify, or revoke the tem-
porary extension under this paragraph if the Ad-
ministrator determines that the continuation of
the minor use may cause an unreasonable ad-
verse 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 estab-
lish 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 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 pes-
ticide 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 time-
ly and adequate fashion to support other nonfood
uses of the pesticide, the Administrator, at the
written request of the registrant, shall not take
any action pursuant to this subparagraph in re-
gard to such unsupported minor use until the
final deadline established as of the date of enact-
ment of the Food Quality Protection Act of 1996,
for the submission of data under this section for
the supported uses identified pursuant to this
subparagraph unless the Administrator deter-
mines 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 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 pursu-
ant to section 6(f)(1). If the Administrator
grants an extension under this subparagraph, 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 production of such data. If the Adminis-
trator determines that the registrant is not meet-
ing or has not met the schedule for the produc-
tion of such data, the Administrator may pro-
ceed in accordance with section 3(c)(2)(B)(iv) re-
garding 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). Notwithstanding this sub-
paragraph, the Administrator may deny,modify,
or revoke the temporary extension under this
subparagraph if the Administrator determines
that the continuation of the minor use may
cause an unreasonable adverse effect on the envi-
ronment. In The event of modification or revoca-
tion, the Administrator shall provide, in writing,
to the registrant a notice revoking the temporary
extension and establish a new effective date by
which the minor use shall be deleted from the
registration.’’.
(2) 
DATA.—Section 
3(c)(2)(B) 
(7 
U.S.C.
136a(c)(2)(B)), as amended by subsection (c)(1), 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 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 support other
nonfood uses of the pesticide, the Adminis-
trator, at the written request of the reg-
(2) in paragraph (3)(A) by striking ‘‘90-day’’
and inserting ‘‘180-day’’.
(h) 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 PESTICIDE.—When an application is filed
with the Administrator for the registration of a pes-
ticide for a minor use and another registrant subse-
quently 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 pending
application as if the voluntary cancellation had not
yet taken place except that the Administrator shall
not take such action if the Administrator determines
that such minor use may cause an unreasonable ad-
verse effect on the environment. In order to rely on
this subsection, the applicant must certify that it
agrees to satisfy any outstanding data requirements
necessary to support the reregistration of the pesticide
in accordance with the data submission schedule es-
tablished by the Administrator.’’.
(i) ENVIRONMENTAL PROTECTION AGENCY MINOR USE
PROGRAM.—The Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.), as amended by sec-
tion 121, is amended by adding after section 30 the follow-
ing:
‘‘SEC. 31. ENVIRONMENTAL PROTECTION AGENCY MINOR
USE PROGRAM.
‘‘(a) 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.
‘‘(b) The Office of Pesticide Programs shall prepare a
public report concerning the progress made on the registra-
tion of minor uses, including implementation of the exclu-
sive use as an incentive for registering new minor uses,
within 3 years of the passage of the Food Quality Protection
Act of 1996.’’.
(j) DEPARTMENT OF AGRICULTURE MINOR USE PRO-
GRAM.—The 
Federal 
Insecticide, 
Fungicide, 
and
Rodenticide Act (7 U.S.C. 136 et seq.), as amended by sub-
section (i), is amended by adding after section 31 the follow-
ing:
‘‘SEC. 32. DEPARTMENT OF AGRICULTURE MINOR USE PRO-
GRAM.
‘‘(a) IN GENERAL.—The Secretary of Agriculture
(hereinafter in this section referred to as the ‘Secretary’)
shall assure the coordination of the responsibilities of the
Department of Agriculture related to minor uses of pes-
ticides, including—
‘‘(1) carrying out the Inter-Regional Project
Number 4 (IR–4) as described in section 2 of Public
Law 89–106 (7 U.S.C. 450i(e)) and the national pes-
ticide resistance monitoring program established
under section 1651 of the Food, Agriculture, Con-
servation, and Trade Act of 1990 (7 U.S.C. 5882);
‘‘(2) supporting integrated pest management re-
search;
‘‘(3) consulting with growers to develop data for
minor uses; and
‘‘(4) providing assistance for minor use registra-
tions, tolerances, and reregistrations with the Envi-
ronmental Protection Agency.
‘‘(b)(1) MINOR USE PESTICIDE DATA.—
‘‘(A) GRANT
AUTHORITY.—The Secretary, in
consultation with the Administrator, shall establish a
program to make grants for the development of data
to support minor use pesticide registrations and re-
registrations. The amount of any such grant shall not
exceed 1⁄2 of the cost of the project for which the grant
is made.
‘‘(B) APPLICANTS.—Any person who wants to
develop data to support minor use pesticide registra-
tions and reregistrations may apply for a grant
under subparagraph (A). Priority shall be given to an
applicant for such a grant who does not directly re-
ceive funds from the sale of pesticides registered for
minor uses.
‘‘(C) DATA OWNERSHIP.—Any data that is devel-
oped under a grant under subparagraph (A) shall be
jointly owned by the Department of Agriculture and
the person who received the grant. Such a person shall
enter into an agreement with the Secretary under
which such person shall share any fee paid to such
person under section 3(c)(1)(F).
‘‘(2) MINOR USE PESTICIDE DATA REVOLVING FUND.—
‘‘(A) ESTABLISHMENT.—There is established in
the Treasury of the United States a revolving fund to
be known as the Minor Use Pesticide Data Revolving
Fund. The Fund shall be available without fiscal year
limitation to carry out the authorized purposes of this
subsection.
‘‘(B) CONTENTS OF THE FUND.—There shall be
deposited in the Fund—
‘‘(i) such amounts as may be appropriated
to support the purposes of this subsection; and
‘‘(ii) fees collected by the Secretary for any
data developed under a grant under paragraph
(1)(A).
‘‘(C) AUTHORIZATIONS
OF
APPROPRIATIONS.—
There are authorized to be appropriated for each fis-
cal year to carry out the purposes of this subsection
$10,000,000 to remain available until expended.’’.
Subtitle B—Antimicrobial Pesticide
Registration Reform
SEC. 221. DEFINITIONS.
Section 2 (7 U.S.C. 136), as amended by section
210(a) is further amended—
(1) in subsection (u), by adding at the end the
following: ‘‘The term ‘pesticide’ does not include liq-
uid chemical sterilant products (including any
sterilant or subordinate disinfectant claims on such
products) for use on a critical or semi-critical device,
as defined in section 201 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321). For purposes of
the preceding sentence, the term ‘critical device’ in-
cludes any device which is introduced directly into
the human body, either into or in contact with the
bloodstream or normally sterile areas of the body and
the term ‘semi-critical device’ includes any device
which contacts intact mucous membranes but which
does not ordinarily penetrate the blood barrier or oth-
erwise enter normally sterile areas of the body.’’; and
(2) by adding at the end the following:
‘‘(mm) ANTIMICROBIAL PESTICIDE.—
‘‘(1) IN GENERAL.—The term ‘antimicrobial pes-
ticide’ means a pesticide that—
‘‘(A) is intended to—
‘‘(i) disinfect, sanitize, reduce, or miti-
gate growth or development of micro-
biological organisms; or
‘‘(ii) protect inanimate objects, indus-
trial processes or systems, surfaces, water,
or other chemical substances from contami-
nation, fouling, or deterioration caused by
bacteria, viruses, fungi, protozoa, algae, or
slime; and
‘‘(B) in the intended use is exempt from, or
otherwise not subject to, a tolerance under section
408 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 346a and 348) or a food additive reg-
ulation under section 409 of such Act.
‘‘(2) 
EXCLUDED
PRODUCTS.—The 
term
‘antimicrobial pesticide’ does not include —
‘‘(A) a wood preservative or antifouling
paint product for which a claim of pesticidal ac-
tivity other than or in addition to an activity
described in paragraph (1) is made;
‘‘(B) an agricultural fungicide product; or
‘‘(C) an aquatic herbicide product.
‘‘(3) 
INCLUDED
PRODUCTS.—The 
term
‘antimicrobial pesticide’ does include any other chem-
ical sterilant product (other than liquid chemical
sterilant products exempt under subsection (u)), any
other disinfectant product, any other industrial
microbiocide product, and any other preservative
product that is not excluded by paragraph (2).’’.
SEC. 222. FEDERAL AND STATE DATA COORDINATION.
Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as
amended by section 210(f)(2), is amended by adding at the
end the following:
‘‘(viii)(I) If data required to support reg-
istration of a pesticide under subparagraph (A)
is requested by a Federal or State regulatory au-
thority, the Administrator shall, to the extent
practicable, coordinate data requirements, test
protocols, timetables, and standards of review
and reduce burdens and redundancy caused to
the registrant by multiple requirements on the
registrant.
‘‘(II) The Administrator may enter into a
cooperative agreement with a State to carry out
subclause (I).
‘‘(III) Not later than 1 year after the date
of enactment of this clause, the Administrator
shall develop a process to identify and assist in
alleviating future disparities between Federal
and State data requirements.’’.
SEC. 223. LABEL AND LABELING.
Section 3(c) (7 U.S.C. 136a(c)) is amended by adding
at the end the following:
‘‘(9) LABELING.—
‘‘(A) ADDITIONAL STATEMENTS.—Subject to
subparagraphs (B) and (C), it shall not be a vio-
lation of this Act for a registrant to modify the
labeling of an antimicrobial pesticide product to
include relevant information on product efficacy,
product composition, container composition or
design, or other characteristics that do not relate
to any pesticidal claim or pesticidal activity.
‘‘(B) REQUIREMENTS.—Proposed labeling
information under subparagraph (A) shall not be
false or misleading, shall not conflict with or de-
tract from any statement required by law or the
Administrator as a condition of registration,
and shall be substantiated on the request of the
Administrator.
‘‘(C) NOTIFICATION AND DISAPPROVAL.—
‘‘(i) 
NOTIFICATION.—A 
registration
may be modified under subparagraph (A)
if—
‘‘(I) the registrant notifies the Ad-
ministrator in writing not later than
60 days prior to distribution or sale of
a product bearing the modified label-
ing; and
‘‘(II) the Administrator does not
disapprove of the modification under
clause (ii).
‘‘(ii) DISAPPROVAL.—Not later than 30
days after receipt of a notification under
clause (i), the Administrator may dis-
approve the modification by sending the
registrant notification in writing stating
that the proposed language is not acceptable
and stating the reasons why the Adminis-
trator finds the proposed modification unac-
ceptable.
‘‘(iii) RESTRICTION ON SALE.—A reg-
istrant may not sell or distribute a product
bearing a disapproved modification.
‘‘(iv) OBJECTION.—A registrant may
file an objection in writing to a disapproval
under clause (ii) not later than 30 days
after receipt of notification of the dis-
approval.
‘‘(v) FINAL ACTION.—A decision by the
Administrator following receipt and consid-
eration of an objection filed under clause
(iv) shall be considered a final agency ac-
tion.
‘‘(D) USE DILUTION.—The label or labeling
required under this Act for an antimicrobial pes-
ticide that is or may be diluted for use may have
a different statement of caution or protective
measures for use of the recommended diluted so-
lution of the pesticide than for use of a con-
centrate of the pesticide if the Administrator de-
termines that—
‘‘(i) adequate data have been submitted
to support the statement proposed for the
diluted solution uses; and
‘‘(ii) the label or labeling provides ade-
quate protection for exposure to the diluted
solution of the pesticide.’’.
SEC. 
224. 
REGISTRATION 
REQUIREMENTS 
FOR
ANTIMICROBIAL PESTICIDES.
Section 3 (7 U.S.C. 136a), as amended by section
107(b), is further amended by adding at the end the follow-
ing:
‘‘(h) 
REGISTRATION
REQUIREMENTS
FOR
ANTIMICROBIAL PESTICIDES.—
‘‘(1) EVALUATION OF PROCESS.—To the maxi-
mum extent practicable consistent with the degrees of
risk presented by a antimicrobial pesticide and the
type of review appropriate to evaluate the risks, the
Administrator shall identify and evaluate reforms to
the antimicrobial registration process that would re-
duce review periods existing as of the date of enact-
ment of this subsection for antimicrobial pesticide
product registration applications and applications for
amended registration of antimicrobial pesticide prod-
ucts, including—
‘‘(A) new antimicrobial active ingredients;
‘‘(B) new antimicrobial end-use products;
‘‘(C) substantially similar or identical
antimicrobial pesticides; and
‘‘(D) amendments to antimicrobial pesticide
registrations.
‘‘(2) REVIEW TIME PERIOD REDUCTION GOAL.—
Each reform identified under paragraph (1) shall be
designed to achieve the goal of reducing the review pe-
riod following submission of a complete application,
consistent with the degree of risk, to a period of not
more than—
‘‘(A) 540 days for a new antimicrobial ac-
tive ingredient pesticide registration;
‘‘(B) 270 days for a new antimicrobial use
of a registered active ingredient;
‘‘(C) 
120 
days 
for 
any 
other 
new
antimicrobial product;
‘‘(D) 90 days for a substantially similar or
identical antimicrobial product;
‘‘(E) 90 days for an amendment to an
antimicrobial registration that does not require
scientific review of data; and
‘‘(F) 90 to 180 days for an amendment to
an antimicrobial registration that requires sci-
entific review of data and that is not otherwise
described in this paragraph.
‘‘(3) IMPLEMENTATION.—
‘‘(A) PROPOSED RULEMAKING.—
‘‘(i) ISSUANCE.—Not later than 270
days after the date of enactment of this sub-
section, the Administrator shall publish in
the Federal Register proposed regulations to
accelerate and improve the review of
antimicrobial pesticide products designed to
implement, to the extent practicable, the
goals set forth in paragraph (2).
‘‘(ii) REQUIREMENTS.—Proposed regu-
lations issued under clause (i) shall—
‘‘(I) define the various classes of
antimicrobial use patterns, including
household, industrial, and institutional
disinfectants and sanitizing pesticides,
preservatives, water treatment, and
pulp and paper mill additives, and
other such products intended to dis-
infect, sanitize, reduce, or mitigate
growth 
or 
development 
of 
micro-
biological organisms, or protect inani-
mate objects, industrial processes or
systems, surfaces, water, or other chem-
ical substances from contamination,
fouling, or deterioration caused by bac-
teria, viruses, fungi, protozoa, algae, or
slime;
‘‘(II) differentiate the types of re-
view undertaken for antimicrobial pes-
ticides;
‘‘(III) conform the degree and
type of review to the risks and benefits
presented by antimicrobial pesticides
and the function of review under this
Act, considering the use patterns of the
product, toxicity, expected exposure,
and product type;
‘‘(IV) ensure that the registration
process 
is 
sufficient 
to 
maintain
antimicrobial pesticide efficacy and
that antimicrobial pesticide products
continue to meet product performance
standards and effectiveness levels for
each type of label claim made; and
‘‘(V) implement effective and reli-
able deadlines for process management.
‘‘(iii) COMMENTS.—In developing the
proposed regulations, the Administrator
shall solicit the views from registrants and
other affected parties to maximize the effec-
tiveness of the rule development process.
‘‘(B) FINAL REGULATIONS.—
‘‘(i) ISSUANCE.—The Administrator
shall issue final regulations not later than
240 days after the close of the comment pe-
riod for the proposed regulations.
‘‘(ii) FAILURE TO MEET GOAL.—If a
goal described in paragraph (2) is not met
by the final regulations, the Administrator
shall identify the goal, explain why the goal
was not attained, describe the element of the
regulations included instead, and identify
future steps to attain the goal.
‘‘(iii) 
REQUIREMENTS.—In 
issuing
final regulations, the Administrator shall—
‘‘(I) consider the establishment of
a certification process for regulatory
actions involving risks that can be re-
sponsibly managed, consistent with the
degree of risk, in the most cost-efficient
manner;
‘‘(II) consider the establishment of
a certification process by approved lab-
oratories as an adjunct to the review
process;
‘‘(III) use all appropriate and
cost-effective review mechanisms, in-
cluding—
‘‘(aa) expanded use of notifi-
cation and non-notification proce-
dures;
‘‘(bb) revised procedures for
application review; and
‘‘(cc) allocation of appro-
priate resources to ensure stream-
lined 
management 
of
antimicrobial pesticide registra-
tions; and
‘‘(IV) clarify criteria for deter-
mination of the completeness of an ap-
plication.
‘‘(C) EXPEDITED REVIEW.—This subsection
does not affect the requirements or extend the
deadlines or review periods contained in sub-
section (c)(3).
‘‘(D) ALTERNATIVE
REVIEW
PERIODS.—If
the final regulations to carry out this paragraph
are not effective 630 days after the date of enact-
ment of this subsection, until the final regula-
tions become effective, the review period, begin-
ning on the date of receipt by the Agency of a
complete application, shall be—
‘‘(i) 2 years for a new antimicrobial
active ingredient pesticide registration;
‘‘(ii) 1 year for a new antimicrobial
use of a registered active ingredient;
‘‘(iii) 180 days for any other new
antimicrobial product;
‘‘(iv) 90 days for a substantially simi-
lar or identical antimicrobial product;
‘‘(v) 90 days for an amendment to an
antimicrobial registration that does not re-
quire scientific review of data; and
‘‘(vi) 240 days for an amendment to
an antimicrobial registration that requires
scientific review of data and that is not oth-
erwise described in this subparagraph.
‘‘(E) WOOD PRESERVATIVES.—An applica-
tion for the registration, or for an amendment to
the registration, of a wood preservative product
for which a claim of pesticidal activity listed in
section 2(mm) is made (regardless of any other
pesticidal claim that is made with respect to the
100
product) shall be reviewed by the Administrator
within the same period as that established under
this paragraph for an antimicrobial pesticide
product application, consistent with the degree of
risk posed by the use of the wood preservative
product, if the application requires the applicant
to satisfy the same data requirements as are re-
quired to support an application for a wood pre-
servative product that is an antimicrobial pes-
ticide.
‘‘(F) NOTIFICATION.—
‘‘(i) IN
GENERAL.—Subject to clause
(iii), the Administrator shall notify an ap-
plicant whether an application has been
granted or denied not later than the final
day of the appropriate review period under
this paragraph, unless the applicant and
the Administrator agree to a later date.
‘‘(ii) FINAL DECISION.—If the Admin-
istrator fails to notify an applicant within
the period of time required under clause (i),
the failure shall be considered an agency ac-
tion unlawfully withheld or unreasonably
delayed for purposes of judicial review
101
under chapter 7 of title 5, United States
Code.
‘‘(iii) 
EXEMPTION.—This 
subpara-
graph does not apply to an application for
an antimicrobial pesticide that is filed
under subsection (c)(3)(B) prior to 90 days
after the date of enactment of this sub-
section.
‘‘(4) ANNUAL REPORT.—
‘‘(A) SUBMISSION.—Beginning on the date
of enactment of this subsection and ending on the
date that the goals under paragraph (2) are
achieved, the Administrator shall, not later than
March 1 of each year, prepare and submit an
annual report to the Committee on Agriculture
of the House of Representatives and the Commit-
tee on Agriculture, Nutrition, and Forestry of the
Senate.
‘‘(B) REQUIREMENTS.—A report submitted
under subparagraph (A) shall include a descrip-
tion of—
‘‘(i) measures taken to reduce the back-
log of pending registration applications;
‘‘(ii) progress toward achieving reforms
under this subsection; and
102
‘‘(iii) recommendations to improve the
activities of the Agency pertaining to
antimicrobial registrations.’’.
SEC. 225. DISPOSAL OF HOUSEHOLD, INDUSTRIAL, OR IN-
STITUTIONAL ANTIMICROBIAL PRODUCTS.
Section 19(h) (7 U.S.C. 136q(h)) is amended—
(1) by striking ‘‘Nothing in’’ and inserting the
following:
‘‘(1) IN GENERAL.—Nothing in’’; and
(2) by adding at the end the following:
‘‘(2) ANTIMICROBIAL
PRODUCTS.—A household,
industrial, or institutional antimicrobial product that
is not subject to regulation under the Solid Waste
Disposal Act (42 U.S.C. 6901 et seq.) shall not be sub-
ject to the provisions of subsections (a), (e), and (f),
unless the Administrator determines that such prod-
uct must be subject to such provisions to prevent an
unreasonable adverse effect on the environment.’’.
Subtitle C—Public Health
Pesticides
SEC. 230. DEFINITIONS.
(a) ADVERSE EFFECTS.—Section 2(bb) (7 U.S.C.
136(bb)) is amended by adding at the end the following:
‘‘The Administrator shall consider the risks and benefits of
public health pesticides separate from the risks and benefits
103
of other pesticides. In weighing any regulatory action con-
cerning a public health pesticide under this Act, the Admin-
istrator shall weigh any risks of the pesticide against the
health risks such as the diseases transmitted by the vector
to be controlled by the pesticide.’’.
(b) NEW DEFINITIONS.—Section 2 (7 U.S.C. 136), as
amended by section 221, is amended by adding at the end
the following:
‘‘(nn) PUBLIC HEALTH PESTICIDE.—The term ‘public
health pesticide’ means any minor use pesticide product
registered for use and used predominantly in public health
programs for vector control or for other recognized health
protection uses, including the prevention or mitigation of
viruses, bacteria, or other microorganisms (other than vi-
ruses, bacteria, or other microorganisms on or in living
man or other living animal) that pose a threat to public
health.
‘‘(oo) VECTOR.—The term ‘vector’ means any orga-
nism capable of transmitting the causative agent of human
disease or capable of producing human discomfort or in-
jury, including mosquitoes, flies, fleas, cockroaches, or other
insects and ticks, mites, or rats.’’.
SEC. 231. REGISTRATION.
Section 3(c)(2)(A) (7 U.S.C. 136a(c)(2)(A)) is amend-
ed—
104
(1) by inserting after ‘‘pattern of use,’’ the fol-
lowing: ‘‘the public health and agricultural need for
such minor use,’’; and
(2) by striking ‘‘potential exposure of man and
the environment to the pesticide’’ and inserting ‘‘po-
tential beneficial or adverse effects on man and the
environment’’.
SEC. 232. REREGISTRATION.
Section 4 (7 U.S.C. 136a–1) is amended—
(1) in subsection (i)(4), by redesignating sub-
paragraphs (B) and (C) as subparagraphs (C) and
(D), respectively, and by adding after subparagraph
(A) the following:
‘‘(B) The Administrator shall exempt any
public health pesticide from the payment of the
fee prescribed under paragraph (3) if, in con-
sultation with the Secretary of Health and
Human Services, the Administrator determines,
based on information supplied by the registrant,
that the economic return to the registrant from
sales of the pesticide does not support the reg-
istration or reregistration of the pesticide.’’;
(2) in subsection (i)(5), by redesignating sub-
paragraphs (F) and (G) as subparagraphs (G) and
105
(H), respectively, and by adding after subparagraph
(E) the following:
‘‘(F) The Administrator shall exempt any
public health pesticide from the payment of the
fee prescribed under paragraph (3) if, in con-
sultation with the Secretary of Health and Hu-
mans Services, the Administrator determines,
based on information supplied by the registrant,
that the economic return to the registrant from
sales of the pesticide does not support the reg-
istration or reregistration of the pesticide.’’;
(3) in subsection (i)(7)(B), by striking ‘‘or to de-
termine’’ and inserting ‘‘, to determine’’ and by in-
serting before the period the following: ‘‘, or to deter-
mine the volume usage for public health pesticides’’;
and
(4) in subsection (k)(3)(A), by striking ‘‘or’’ at
the end of clause (i), by striking the period at the end
of clause (ii) and inserting thereof ‘‘; or’’, and by
adding after clause (ii) the following:
‘‘(iii) proposes the initial or amended
registration of an end use pesticide that, if
registered as proposed, would be used for a
public health pesticide.’’.
106
SEC. 233. CANCELLATION.
Section 6(b) (7 U.S.C. 136d(b)) is amended by adding
after the eighth sentence the following: ‘‘When a public
health use is affected, the Secretary of Health and Human
Services should provide available benefits and use informa-
tion, or an analysis thereof, in accordance with the proce-
dures followed and subject to the same conditions as the Sec-
retary of Agriculture in the case of agricultural pesticides.’’.
SEC. 234. VIEWS OF THE SECRETARY OF HEALTH AND
HUMAN SERVICES.
Section 21 (7 U.S.C. 136s) is amended by redesignat-
ing subsections (b) and (c) as subsections (c) and (d), re-
spectively, and by adding after subsection (a) the following:
‘‘(b) SECRETARY
OF HEALTH
AND HUMAN SERV-
ICES.—The Administrator, before publishing regulations
under this Act for any public health pesticide, shall solicit
the views of the Secretary of Health and Human Services
in the same manner as the views of the Secretary of Agri-
culture are solicited under section 25(a)(2).’’.
SEC. 235. AUTHORITY OF ADMINISTRATOR.
Section 25(a)(1) (7 U.S.C. 136w(a)(1)) is amended—
(1) by inserting after ‘‘various classes of pes-
ticides’’ the following: ‘‘, including public health pes-
ticides,’’; and
107
(2) by striking ‘‘and nonagricultural pesticides’’
and inserting ‘‘, nonagricultural, and public health
pesticides’’.
SEC. 236. IDENTIFICATION OF PESTS.
Section 28 (7 U.S.C. 136w–3) is amended by adding
at the end the following:
‘‘(d) PUBLIC HEALTH PESTS.—The Administrator, in
coordination with the Secretary of Agriculture and the Sec-
retary of Health and Human Services, shall identify pests
of significant public health importance and, in coordina-
tion with the Public Health Service, develop and implement
programs to improve and facilitate the safe and necessary
use of chemical, biological, and other methods to combat and
control such pests of public health importance.’’.
SEC. 237. PUBLIC HEALTH DATA.
Section 4 (7 U.S.C. 136a–1) is amended by adding
at the end the following:
‘‘(m) AUTHORIZATION OF FUNDS TO DEVELOP PUB-
LIC HEALTH DATA.—
‘‘(1) DEFINITION.—For the purposes of this sec-
tion, ‘Secretary’ means the Secretary of Health and
Human Services, acting through the Public Health
Service.
‘‘(2) CONSULTATION.—In the case of a pesticide
registered for use in public health programs for vector
108
control or for other uses the Administrator determines
to be human health protection uses, the Administrator
shall, upon timely request by the registrant or any
other interested person, or on the Administrator’s own
initiative may, consult with the Secretary prior to
taking final action to suspend registration under sec-
tion 3(c)(2)(B)(iv), or cancel a registration under sec-
tion 4, 6(e), or 6(f). In consultation with the Sec-
retary, the Administrator shall prescribe the form and
content of requests under this section.
‘‘(3) BENEFITS TO SUPPORT FAMILY.—The Ad-
ministrator, after consulting with the Secretary, shall
make a determination whether the potential benefits
of continued use of the pesticide for public health or
health protection purposes are of such significance as
to warrant a commitment by the Secretary to conduct
or to arrange for the conduct of the studies required
by the Administrator to support continued registra-
tion under section 3 or registration under section 4.
‘‘(4) ADDITIONAL
TIME.—If the Administrator
determines that such a commitment is warranted and
in the public interest, the Administrator shall notify
the Secretary and shall, to the extent necessary,
amend a notice issued under section 3(c)(2)(B) to
109
specify additional reasonable time periods for submis-
sion of the data.
‘‘(5) ARRANGEMENTS.—The Secretary shall make
such arrangements for the conduct of required studies
as the Secretary finds necessary and appropriate to
permit submission of data in accordance with the
time periods prescribed by the Administrator. Such
arrangements may include Public Health Service in-
tramural research activities, grants, contracts, or co-
operative agreements with academic, public health, or
other organizations qualified by experience and train-
ing to conduct such studies.
‘‘(6) SUPPORT.—The Secretary may provide for
support of the required studies using funds authorized
to be appropriated under this section, the Public
Health Service Act, or other appropriate authorities.
After a determination is made under subsection (d),
the Secretary shall notify the Committees on Appro-
priations of the House Representatives and the Senate
of the sums required to conduct the necessary studies.
‘‘(7) AUTHORIZATION
OF
APPROPRIATIONS.—
There is authorized to be appropriated to carry out
the purposes of this section $12,000,000 for fiscal year
1997, and such sums as may be necessary for succeed-
ing fiscal years.’’.
110
Subtitle D—Expedited Registration
of Reduced Risk Pesticides
SEC. 250. EXPEDITED REGISTRATION OF PESTICIDES .
Section 3(c) (7 U.S.C. 136a(c)), as amended by section
223, is amended—
(1) by adding at the end of paragraph (1) the
following:
‘‘(G) If the applicant is requesting that the
registration or amendment to the registration of
a pesticide be expedited, an explanation of the
basis for the request must be submitted, in ac-
cordance with paragraph (10) of this sub-
section.’’; and
(2) by adding at the end the following:
‘‘(10) 
EXPEDITED
REGISTRATION
OF
PES-
TICIDES.—
‘‘(A) Not later than 1 year after the date of
enactment of this paragraph, the Administrator
shall, utilizing public comment, develop proce-
dures and guidelines, and expedite the review of
an application for registration of a pesticide or
an amendment to a registration that satisfies
such guidelines.
‘‘(B) Any application for registration or an
amendment, including biological and conven-
111
tional pesticides, will be considered for expedited
review under this paragraph. An application for
registration or an amendment shall qualify for
expedited review if use of the pesticide proposed
by the application may reasonably be expected to
accomplish 1 or more of the following:
‘‘(i) Reduce the risks of pesticides to
human health.
‘‘(ii) Reduce the risks of pesticides to
nontarget organisms.
‘‘(iii) Reduce the potential for con-
tamination of groundwater, surface water,
or other valued environmental resources.
‘‘(iv) Broaden the adoption of inte-
grated pest management strategies, or make
such strategies more available or more effec-
tive.
‘‘(C) The Administrator, not later than 30
days after receipt of an application for expedited
review, shall notify the applicant whether the ap-
plication is complete. If it is found to be incom-
plete, the Administrator may either reject the re-
quest for expedited review or ask the applicant
for additional information to satisfy the guide-
lines developed under subparagraph (A).’’.
112
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 implementa-
tion of survey procedures to ensure that adequate data on
food consumption patterns of infants and children are col-
lected.
(b) PROCEDURES.—To the extent practicable, the pro-
cedures referred to in subsection (a) shall include the collec-
tion of data on food consumption patterns of a statistically
valid sample of infants and children.
(c) RESIDUE DATA COLLECTION.—The Secretary of
Agriculture shall ensure that the residue data collection ac-
tivities conducted by the Department of Agriculture in co-
operation with the Environmental Protection Agency and
the Department of Health and Human Services, provide for
the improved data collection of pesticide residues, including
guidelines for the use of comparable analytical and stand-
113
ardized reporting methods, and the increased sampling of
foods most likely consumed by infants and children.
SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION.
(a) IN GENERAL.—The Secretary of Agriculture shall
collect data of statewide or regional significance on the use
of pesticides to control pests and diseases of major crops
and crops of dietary significance, including fruits and vege-
tables.
(b) COLLECTION.—The data shall be collected by sur-
veys of farmers or from other sources offering statistically
reliable data.
(c) COORDINATION.—The Secretary of Agriculture
shall, as appropriate, coordinate with the Administrator of
the Environmental Protection Agency in the design of the
surveys and make available to the Administrator the aggre-
gate results of the surveys to assist the Administrator.
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
114
information on Integrated Pest Management widely avail-
able to pesticide users, including Federal agencies. Federal
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.
SEC. 304. COORDINATION OF CANCELLATION.
Section 2(bb) (7 U.S.C. 136(bb)) is amended—
(1) by inserting ‘‘(1)’’ after ‘‘means’’; and
(2) by striking the period at the end of the first
sentence and inserting ‘‘, or (2) a human dietary risk
from residues that result from a use of a pesticide in
or on any food inconsistent with the standard the Ad-
ministrator determines is adequate to protect the pub-
lic health under section 408 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 346a).’’.
SEC. 305. PESTICIDE USE INFORMATION STUDY.
(a) The Secretary of Agriculture shall, in consultation
with the Administrator of the Environmental Protection
Agency, prepare a report to Congress evaluating the current
status and potential improvements in Federal pesticide use
information gathering activities. This report shall at least
include—
(1) an analysis of the quality and reliability of
the information collected by the Department of Agri-
115
culture, the Environmental Protection Agency, and
other Federal agencies regarding the agricultural use
of pesticides; and
(2) an analysis of options to increase the effec-
tiveness of national pesticide use information collec-
tion, including an analysis of costs, burdens placed
on agricultural producers and other pesticide users,
and effectiveness in tracking risk reduction by those
options.
(b) The Secretary shall submit this report to Congress
not later than 1 year following the date of enactment of
this section.
øTITLE IV—AMENDMENTS TO THE FED-
ERAL FOOD, DRUG, AND COSMETIC
ACT
øSEC. 401. REFERENCE.
øWhenever 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.
øSEC. 402. DEFINITIONS.
ø(a) Section 201(q) (21 U.S.C. 321(q)) is amended
to read as follows:
ø‘‘(q)(1) The term ‘pesticide chemical’ means—
116
ø‘‘(A) any substance that is a pesticide within
the meaning of the Federal Insecticide, Fungicide,
and Rodenticide Act; or
ø‘‘(B) any active ingredient of a pesticide with-
in the meaning of the Federal Insecticide, Fungicide,
and Rodenticide Act.
ø‘‘(2) The term ‘pesticide chemical residue’ means a
residue in or on raw agricultural commodity or processed
food of—
ø‘‘(A) a pesticide chemical; or
ø‘‘(B) any other added substance that is
present in the commodity or food primarily as a re-
sult of the metabolism or other degradation of a pes-
ticide chemical.
ø‘‘(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—
ø‘‘(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
117
ø‘‘(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.’’.
ø(b) Paragraphs (1) and (2) of section 201(s) (21
U.S.C. 321(s)) are amended to read as follows:
ø‘‘(1) a pesticide chemical residue in or on a
raw agricultural commodity or processed food; or
ø‘‘(2) a pesticide chemical; or’’.
ø(c) Section 201 (21 U.S.C. 321) is amended by add-
ing at the end the following:
ø‘‘(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.
ø‘‘(cc) The term ‘Administrator’ means the Adminis-
trator of the United States Environmental Protection
Agency.’’.
øSEC. 403. PROHIBITED ACTS.
øSection 301(j) (21 U.S.C. 331(j)) is amended—
ø(1) by striking the period at the end; and
118
ø(2) by inserting at the end ‘‘, or the violation
of section 408(g)(2) or any regulation issued under
that section.’’.
øSEC. 404. ADULTERATED FOOD.
øSection 402(a)(2) (21 U.S.C. 342(a)(2)) is amended
to read as follows:
ø‘‘(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;
ø‘‘(B) if it bears or contains a pesticide chemi-
cal residue that is unsafe within the meaning of sec-
tion 408(a); or
ø‘‘(C) if it is or if it bears or contains—
ø‘‘(i) any food additive that is unsafe with-
in the meaning of section 409; or
ø‘‘(ii) a new animal drug (or conversion
product thereof) that is unsafe within the
meaning of section 512; or’’.
119
øSEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES.
øSection 408 (21 U.S.C. 346a) is amended to read
as follows:
ø‘‘TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMI-
CAL RESIDUES
ø‘‘SEC. 408. (a) REQUIREMENT FOR TOLERANCE OR
EXEMPTION.—
ø‘‘(1) GENERAL RULE.—For the purposes of
this section, the term ‘food,’ when used as a noun
without modification, shall mean a raw agricultural
commodity or processed food. 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—
ø‘‘(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
ø‘‘(B) an exemption from the requirement
of a tolerance is in effect under this section for
the pesticide chemical residue.
ø‘‘(2) 
PROCESSED
FOOD.—Notwithstanding
paragraph (1)—
ø‘‘(A) if a tolerance is in effect under this
section for a pesticide chemical residue in or on
120
a raw agricultural commodity, a pesticide chem-
ical residue that is present in or on a processed
food because the food is made from that raw
agricultural commodity shall not be considered
unsafe 
within 
the 
meaning 
of 
section
402(a)(2)(B) despite the lack of a tolerance for
the pesticide chemical residue in or on the proc-
essed food if the concentration of the pesticide
chemical residue in the processed food when
ready for consumption or use is not greater
than the tolerance prescribed for the pesticide
chemical residue in the raw agricultural com-
modity.
ø‘‘(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).
ø‘‘(3) RESIDUES
OF
DEGRADATION
PROD-
UCTS.—If a pesticide chemical residue is present in
or on a food because it is a metabolite or other deg-
radation product of a precursor substance that itself
121
is a pesticide chemical or pesticide chemical residue,
such a residue shall not be considered to be unsafe
within the meaning of section 402(a)(2)(B) despite
the lack of a tolerance or exemption from the need
for a tolerance for such residue in or on such food
if—
ø‘‘(A) the Administrator has not deter-
mined that the degradation product is likely to
pose any potential health risk from dietary ex-
posure that is of a different type than, or of a
greater significance than, any risk posed by die-
tary exposure to the precursor substance; and
ø‘‘(B) either—
ø‘‘(i) a tolerance is in effect under
this section for residues of the precursor
substance in or on the food, and the com-
bined 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 sub-
stance rather than the degradation prod-
uct; or
122
ø‘‘(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
ø‘‘(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.
ø‘‘(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).
ø‘‘(b) AUTHORITY
AND STANDARD
FOR TOLER-
ANCES.—
ø‘‘(1) AUTHORITY.—The Administrator may
issue regulations establishing, modifying, or revoking
a tolerance for a pesticide chemical residue in or on
a food—
ø‘‘(A) in response to a petition filed under
subsection (d); or
123
ø‘‘(B) on the Administrator’s initiative
under subsection (e).
ø‘‘(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.
ø‘‘(B) The Administrator shall modify or revoke
a tolerance if it is at a level higher than the level
that the Administrator determines is adequate to
protect the public health.
ø‘‘(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
124
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).
ø‘‘(D) For purposes of subparagraph (A), a tol-
erance level for a pesticide chemical residue in or on
a food shall be deemed to be adequate to protect the
public health if the dietary risk posed to food con-
sumers by such level of the pesticide chemical resi-
due is negligible. The Administrator shall by regula-
tion set forth the factors and methods, including
tests which are appropriate for the determination of
dietary risk and most likely dietary exposure, for the
determination of negligible dietary risk.
ø‘‘(E) Procedures shall be developed and imple-
mented that ensure that pesticide tolerances ade-
quately safeguard the health of infants and children.
ø‘‘(F) Where reliable data are available, the
Administrator 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
pesticide chemical and the actual residue levels of
the pesticide chemical that occur in food. In particu-
lar, the Administrator shall take into account aggre-
126
availability of an adequate, wholesome, and eco-
nomical food supply for consumers, taking into
account 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.
ø‘‘(3) LIMITATIONS.—(A) A tolerance may be
issued under the authority of paragraph (2)(E) only
if the Administrator has assessed the extent to
which efforts are being made to develop either an al-
ternative method of pest control or an alternative
pesticide chemical for use on such commodity or
food that would meet the requirements of paragraph
(2)(D).
ø‘‘(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.
ø‘‘(C) A tolerance for a pesticide chemical resi-
due in or on a food shall not be established at a level
127
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).
ø‘‘(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
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.
128
ø‘‘(c) AUTHORITY
AND STANDARD
FOR EXEMP-
TIONS.—
ø‘‘(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—
ø‘‘(A) in response to a petition filed under
subsection (d); or
ø‘‘(B) on the Administrator’s initiative
under subsection (e).
ø‘‘(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.
ø‘‘(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).
129
ø‘‘(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).
ø‘‘(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—
ø‘‘(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
ø‘‘(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.
ø‘‘(d) PETITION FOR TOLERANCE OR EXEMPTION.—
ø‘‘(1) PETITIONS AND PETITIONERS.—Any per-
son may file with the Administrator a petition pro-
posing the issuance of a regulation—
ø‘‘(A) establishing, modifying, or revoking
a tolerance for a pesticide chemical residue in
or on a food; or
130
ø‘‘(B) establishing or revoking an exemp-
tion from the requirement of a tolerance for
such a residue.
ø‘‘(2) PETITION CONTENTS.—
ø‘‘(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—
ø‘‘(i)(I) an informative summary of
the petition and of the data, information,
and arguments submitted or cited in sup-
port of the petition;
ø‘‘(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;
ø‘‘(ii) the name, chemical identity,
and composition of the pesticide chemical
residue and of the pesticide chemical that
produces the residue;
131
ø‘‘(iii) data showing the recommended
amount, frequency, method, and time of
application of that pesticide chemical;
ø‘‘(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;
ø‘‘(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;
ø‘‘(vi) a practical method for detect-
ing and measuring the levels of the pes-
ticide chemical residue in or on the food,
or a statement why such a method is not
needed;
ø‘‘(vii) practical methods for removing
any amount of the residue that would ex-
ceed any proposed tolerance;
132
ø‘‘(viii) a proposed tolerance for the
pesticide chemical residue, if a tolerance is
proposed;
ø‘‘(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;
ø‘‘(x) if the petition relates to a toler-
ance for a processed food, reports of inves-
tigations conducted using the processing
method(s) used to produce that food;
ø‘‘(xi) such information as the Admin-
istrator may require to make the deter-
mination under subsection (b)(2)(E); and
ø‘‘(xii) such other data and informa-
tion as the Administrator requires by regu-
lation 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-
135
tioner shall be served by the Administrator on
the petitioner.
ø‘‘(B) An objection may include a request
for a public evidentiary hearing upon the objec-
tion. The Administrator shall, upon the initia-
tive of the Administrator or upon the request of
an interested person and after due notice, hold
a public evidentiary hearing if and to the extent
the Administrator determines that such a public
hearing is necessary to receive factual evidence
relevant to material issues of fact raised by the
objections. The presiding officer in such a hear-
ing may authorize a party to obtain discovery
from other persons and may upon a showing of
good cause made by a party issue a subpoena
to compel testimony or production of documents
from any person. The presiding officer shall be
governed by the Federal Rules of Civil Proce-
dure in making any order for the protection of
the witness or the content of documents pro-
duced and shall order the payment of 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.
136
ø‘‘(C) As soon as practicable after receiv-
ing the arguments of the parties, the Adminis-
trator 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 sub-
paragraph (B), such order and any revision to
the regulation or prior order shall, with respect
to questions of fact at issue in the hearing, be
based only on substantial evidence of record at
such hearing, and shall set forth in detail the
findings of facts and the conclusions of law or
policy upon which the order or regulation is
based.
ø‘‘(D) An order issued under this para-
graph ruling on an objection shall not take ef-
fect before the 90th day after its publication
unless the Administrator finds that emergency
conditions 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.
ø‘‘(7) JUDICIAL REVIEW.—(A) In a case of ac-
tual controversy as to the validity of any order is-
137
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.
ø‘‘(B) A copy of the petition shall be forthwith
transmitted by the clerk of the court to the Adminis-
trator, or any officer designated by the Adminis-
trator for that purpose, and thereupon the Adminis-
trator shall file in the court the record of the pro-
ceedings on which the Administrator based the order
or regulation, as provided in section 2112 of title 28,
United States Code. Upon the filing of such a peti-
tion, the court shall have exclusive jurisdiction to af-
firm or set aside the order or regulation complained
of in whole or in part. The findings of the Adminis-
trator with respect to questions of fact shall be sus-
tained only if supported by substantial evidence
when considered on the record as a whole.
138
ø‘‘(C) If a party applies to the court for leave
to adduce additional evidence, and shows to the sat-
isfaction of the court that the additional evidence is
material and that there were reasonable grounds for
the failure to 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
file with the court any such modified finding, order,
or regulation.
ø‘‘(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.
139
ø‘‘(E) Any issue as to which review is or was
obtainable under paragraph (6) and this paragraph
shall not be the subject of judicial review under any
other provision of law.
ø‘‘(e) ACTION ON ADMINISTRATOR’S OWN INITIA-
TIVE.—
ø‘‘(1) GENERAL
RULE.—The Administrator
may issue a regulation—
ø‘‘(A) establishing, modifying, or revoking
a tolerance for a pesticide chemical or a pes-
ticide chemical residue;
ø‘‘(B) establishing or revoking an exemp-
tion of a pesticide chemical residue from the re-
quirement of a tolerance; or
ø‘‘(C) establishing general procedures and
requirements to implement this section.
A regulation issued under this paragraph shall be-
come effective upon its publication.
ø‘‘(2) NOTICE.—Before issuing a final regula-
tion under paragraph (1), the Administrator shall
issue a notice of proposed rulemaking and provide a
period of not less than 60 days for public comment
on the proposed regulation, except that a shorter pe-
riod for comment may be provided if the Adminis-
trator for good cause finds that it would be contrary
140
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).
ø‘‘(f) SPECIAL DATA REQUIREMENTS.—
ø‘‘(1) REQUIRING SUBMISSION OF ADDITIONAL
DATA.—If the Administrator determines that addi-
tional data or information are reasonably required to
support the continuation of a tolerance or exemption
that is in effect under this section for a pesticide
chemical residue on a food, the Administrator
shall—
ø‘‘(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;
ø‘‘(B) issue a rule requiring that testing
be conducted on a substance or mixture under
section 4 of the Toxic Substances Control Act;
or
ø‘‘(C) publish in the Federal Register,
after first providing notice and an opportunity
141
for comment of not less than 90 days’ duration,
an order—
ø‘‘(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;
ø‘‘(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)
of the Federal Insecticide, Fungicide, and
Rodenticide Act or section 4 of the Toxic
Substances Control Act;
ø‘‘(iii) describing the reports of the
Administrator required to be prepared dur-
ing and after the collection of the data and
information;
ø‘‘(iv) requiring the submission to the
Administrator of the data, information,
and reports referred to in clauses (ii) and
(iii); and
142
ø‘‘(v) establishing dates by which the
submissions described in clauses (i) and
(iv) must be made.
The Administrator may revise any such order
to correct an error.
ø‘‘(2) NONCOMPLIANCE.—If a submission re-
quired by a notice issued in accordance with para-
graph (1)(A) or an order issued under paragraph
(1)(B) is not made by the time specified in such no-
tice or order, the Administrator may by order pub-
lished in the Federal Register modify or revoke the
tolerance or exemption in question.
ø‘‘(3) REVIEW.—An order issued under this
subsection shall be effective upon publication and
shall be subject to review in accordance with para-
graphs (6) and (7) of subsection (d).
ø‘‘(g) CONFIDENTIALITY AND USE OF DATA.—
ø‘‘(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.
143
ø‘‘(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—
ø‘‘(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
ø‘‘(B) contractors with the United States
authorized by the Administrator to examine
such data in the carrying out of contracts under
such statutes.
ø‘‘(3) SUMMARIES.—Notwithstanding any pro-
vision 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.
ø‘‘(h) STATUS
OF PREVIOUSLY ISSUED REGULA-
TIONS.—
144
ø‘‘(1) REGULATIONS
UNDER
SECTION
406.—
Regulations affecting pesticide chemical residues in
or on raw agricultural commodities promulgated, in
accordance with section 701(e), under the authority
of section 406(a) upon the basis of public hearings
instituted before January 1, 1953, shall be deemed
to be regulations issued under this section and shall
be subject to modification or revocation under sub-
sections (d) and (e).
ø‘‘(2) REGULATIONS
UNDER
SECTION
409.—
Regulations that established tolerances for sub-
stances that are pesticide chemical residues on or in
processed food, or that otherwise stated the condi-
tions under which such pesticide chemicals could be
safely used, and that were issued under section 409
on or before the date of the enactment of this para-
graph, shall be deemed to be regulations issued
under this section and shall be subject to modifica-
tion or revocation under subsection (d) or (e).
ø‘‘(3) REGULATIONS
UNDER
SECTION
408.—
Regulations that established tolerances or exemp-
tions under this section that were issued on or be-
fore the date of the enactment of this paragraph
shall remain in effect unless modified or revoked
under subsection (d) or (e).
145
ø‘‘(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—
ø‘‘(1) regarded by the Administrator or the
Secretary 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
ø‘‘(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
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).
ø‘‘(j) HARMONIZATION WITH ACTION UNDER OTHER
LAWS.—
ø‘‘(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
146
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).
ø‘‘(2) REVOCATION OF TOLERANCE OR EXEMP-
TION
FOLLOWING
CANCELLATION
OF
ASSOCIATED
REGISTRATIONS.—If the Administrator, acting under
the Federal Insecticide, Fungicide, and Rodenticide
Act, cancels the registration of each pesticide that
contains a particular pesticide chemical and that is
labeled for use on a particular food, or requires that
the registration of each such pesticide be modified to
prohibit its use in connection with the production,
storage, or transportation of such food, due in whole
or in part to dietary risks to humans posed by resi-
dues of that pesticide chemical on that food, the Ad-
ministrator shall revoke any tolerance or exemption
that allows the presence of the pesticide chemical, or
any pesticide chemical residue that results from its
147
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—
ø‘‘(A) the date by which each such can-
cellation of a registration has become effective;
or
ø‘‘(B) the date on which the use of the
canceled pesticide becomes unlawful under the
terms of the cancellation, whichever is later.
ø‘‘(3) SUSPENSION OF TOLERANCE OR EXEMP-
TION FOLLOWING SUSPENSION OF ASSOCIATED REG-
ISTRATIONS.—
ø‘‘(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-
149
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.
ø‘‘(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—
150
ø‘‘(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
ø‘‘(B) the residue does not exceed a level
that was authorized at the time of that applica-
tion or use to be present on the food under a
tolerance, exemption, food additive regulation,
or other sanction then in effect under this Act;
unless, in the case of any tolerance or exemption re-
voked, suspended, or modified under this subsection
or subsection (d) or (e), the Administrator has is-
sued a determination that consumption of the legally
treated food during the period of its likely availabil-
ity in commerce will pose an unreasonable dietary
risk.
ø‘‘(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—
151
ø‘‘(1) the acceptance for filing of a petition
submitted under subsection (d);
ø‘‘(2) the promulgation of a regulation estab-
lishing, modifying, or revoking a tolerance or estab-
lishing or revoking an exemption from the require-
ment of a tolerance under this section;
ø‘‘(3) the acceptance for filing of objections
under subsection (d)(6); or
ø‘‘(4) the certification and filing in court of a
transcript of the proceedings and the record under
subsection (d)(7);
may be conditioned upon the payment of such fees. The
regulations may further provide for waiver or refund of
fees in whole or in part when in the judgment of the Ad-
ministrator such a waiver or refund is equitable and not
contrary to the purposes of this subsection.
ø‘‘(l) NATIONAL UNIFORMITY OF TOLERANCES.—
ø‘‘(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—
152
ø‘‘(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
ø‘‘(B) was approved for such use in a re-
registration 
eligibility 
determination 
issued
under section 4(g) of that Act on or after the
date of enactment of the Food Quality Protec-
tion Act of 1995.
ø‘‘(2) 
QUALIFYING
FEDERAL
DETERMINA-
TION.—For purposes of this subsection, the term
‘qualifying Federal determination’ means—
ø‘‘(A) a tolerance or exemption from the
requirement for a tolerance for a qualifying pes-
ticide chemical residue that was—
ø‘‘(i) issued under this section after
the date of enactment of the Food Quality
Protection Act of 1995; (or)
ø‘‘(ii) issued (or, pursuant to sub-
section (h) or (i), deemed to have been is-
sued) under this section, and determined
153
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
ø‘‘(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.
ø‘‘(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).
ø‘‘(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
154
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
other statement relating to the presence of the pes-
ticide residue in the food.
ø‘‘(5) PETITION PROCEDURE.—
ø‘‘(A) Any State may petition the Admin-
istrator for authorization to establish in such
State a regulatory limit on a qualifying pes-
ticide chemical residue in or on any food that
is not identical to the qualifying Federal deter-
mination applicable to such qualifying pesticide
chemical residue.
ø‘‘(B) Any petition under subparagraph
(A) shall—
155
ø‘‘(i) satisfy any requirements pre-
scribed, by rule, by the Administrator; and
ø‘‘(ii) be supported by scientific data
about the pesticide chemical residue that is
the subject of the petition or about chemi-
cally related pesticide chemical residues,
data on the consumption within such State
of food bearing the pesticide chemical resi-
due, and data on exposure of humans with-
in such State to the pesticide chemical res-
idue.
ø‘‘(C) Subject to paragraph (6), the Ad-
ministrator may, by order, grant the authoriza-
tion described in subparagraph (A) if the Ad-
ministrator determines that the proposed State
regulatory limit—
ø‘‘(i) is justified by compelling local
conditions;
ø‘‘(ii) would not unduly burden inter-
state commerce; and
ø‘‘(iii) would not cause any food to be
in violation of Federal law.
ø‘‘(D) In lieu of any action authorized
under subparagraph (C), the Administrator
may treat a petition under this paragraph as a
156
petition under subsection (d) to revoke or mod-
ify a tolerance or to revoke an exemption. If the
Administrator determines to treat a petition
under this paragraph as a petition under sub-
section (d), the Administrator shall thereafter
act on the petition pursuant to subsection (d).
ø‘‘(E) Any order of the Administrator
granting or denying the authorization described
in subparagraph (A) shall be subject to review
in the manner described in subsections (d)(6)
and (d)(7).
ø‘‘(6) RESIDUES
FROM
LAWFUL
APPLICA-
TION.—No State or political subdivision may enforce
any regulatory limit on the level of a pesticide chem-
ical residue that may appear in or on any food if,
at the time of the application of the pesticide that
resulted in such residue, the sale of such food with
such residue level was lawful under this Act and
under the law of such State, unless the State dem-
onstrates that consumption of the food containing
such pesticide residue level during the period of the
food’s likely availability in the State will pose an un-
reasonable dietary risk to the health of persons with-
in such State.’’.
157
øSEC. 406. AUTHORIZATION FOR INCREASE MONITORING.
øThere is authorized to be appropriated an additional
$12,000,000 for increased monitoring by the Secretary of
Health and Human Services of pesticide residues in im-
ported and domestic food.¿
TITLE IV—AMENDMENTS TO THE
FEDERAL FOOD, DRUG, AND
COSMETIC ACT
SEC 401. SHORT TITLE AND REFERENCE.
(a) SHORT TITLE.—This title may be cited
as the ‘‘Food Quality Protection Act of 1996 ’’.
(b) REFERENCE.—Whenever in this title an
amendment or repeal is expressed in terms of
an amendment to, or repeal of, a section or
other provision, the reference shall be consid-
ered to be made to a section or other provi-
sion of the Federal Food, Drug, and Cosmetic
Act.
SEC. 402. DEFINITIONS.
(a) SECTION
201(q).—Section 201(q) (21
U.S.C. 321(q)) is amended to read as follows:
‘‘(q)(1) 
The 
term 
‘pesticide 
chemical’
means any substance that is a pesticide with-
in the meaning of the Federal Insecticide,
Fungicide, and Rodenticide Act, including all
active and inert ingredients of such pesticide.
158
‘‘(2) The term ‘pesticide chemical residue’
means a residue in or on raw agricultural
commodity or processed food of—
‘‘(A) a pesticide chemical; or
‘‘(B) any other added substance that
is present on or in the commodity or food
primarily as a result of the metabolism or
other degradation of a pesticide chemi-
cal.
‘‘(3) Notwithstanding paragraphs (1) and
(2), the Administrator may by regulation ex-
cept a substance from the definition of ‘pes-
ticide chemical’ or ‘pesticide chemical resi-
due’ if—
‘‘(A) its occurrence as a residue on or
in a raw agricultural commodity or proc-
essed food is attributable primarily to
natural causes or to human activities not
involving the use of any substances for a
pesticidal purpose in the production,
storage, processing, or transportation of
any raw agricultural commodity or proc-
essed food; and
‘‘(B) the Administrator, after con-
sultation with the Secretary, determines
159
that the substance more appropriately
should be regulated under one or more
provisions of this Act other than sections
402(a)(2)(B) and 408.’’.
(b) SECTION 201(s).—Paragraphs (1) and (2)
of section 201(s) (21 U.S.C. 321(s)) are amend-
ed to read as follows:
‘‘(1) a pesticide chemical residue in or
on a raw agricultural commodity or proc-
essed food; or
‘‘(2) a pesticide chemical; or’’.
(c) SECTION 201.—Section 201 (21 U.S.C.
321) is amended by adding at the end the fol-
lowing:
‘‘(gg) The term ‘processed food’ means any
food other than a raw agricultural commodity
and includes any raw agricultural commodity
that has been subject to processing, such as
canning, cooking, freezing, dehydration, or
milling.
‘‘(hh) The term ‘Administrator’ means the
Administrator of the United States Environ-
mental Protection Agency.’’.
160
SEC. 403. PROHIBITED ACTS.
Section 301(j) (21 U.S.C. 331(j)) is amended
in the first sentence by inserting before the
period the following: ‘‘; or the violating of sec-
tion 408(i)(2) or any regulation issued under
that section.’’.
SEC. 404. ADULTERATED FOOD.
Section 402(a) (21 U.S.C. 342(a)) is amend-
ed by striking ‘‘(2)(A) if it bears’’ and all that
follows through ‘‘(3) if it consists’’ and insert-
ing the following: ‘‘(2)(A) if it bears or con-
tains any added poisonous or added delete-
rious 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 ani-
mal drug) that is unsafe within the meaning
of section 406; or (B) if it bears or contains a
pesticide chemical residue that is unsafe
within the meaning of section 408(a); or (C) if
it is or if it bears or contains (i) any food addi-
tive that is unsafe within the meaning of sec-
tion 409; or (ii) a new animal drug (or conver-
sion product thereof) that is unsafe within the
meaning of section 512; or (3) if it consists’’.
161
SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES.
Section 408 (21 U.S.C. 346a) is amended to
read as follows:
‘‘TOLERANCES AND EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES
‘‘SEC. 408. (a) REQUIREMENT
FOR TOLER-
ANCE OR EXEMPTION.—
‘‘(1) GENERAL
RULE.—Except as pro-
vided in paragraph (2) or (3), any pes-
ticide chemical residue in or on a food
shall be deemed unsafe for the purpose of
section 402(a)(2)(B) unless—
‘‘(A) a tolerance for such pesticide
chemical residue in or on such food is
in effect under this section and the
quantity of the residue is within the
limits of the tolerance; or
‘‘(B) an exemption from the re-
quirement of a tolerance is in effect
under this section for the pesticide
chemical residue.
For the purposes of this section, the term
‘food’, when used as a noun without
modification, shall mean a raw agricul-
tural commodity or processed food.
162
‘‘(2) PROCESSED FOOD.—Notwithstand-
ing paragraph (1)—
‘‘(A) if a tolerance is in effect
under this section for a pesticide
chemical residue in or on a raw agri-
cultural commodity, a pesticide chem-
ical residue that is present in or on a
processed food because the food is
made from that raw agricultural com-
modity shall not be considered unsafe
within 
the 
meaning 
of 
section
402(a)(2)(B) despite the lack of a tol-
erance for the pesticide chemical res-
idue in or on the processed food if the
pesticide chemical has been used in
or on the raw agricultural commodity
in conformity with a tolerance under
this section, such residue in or on the
raw agricultural commodity has been
removed to the extent possible in
good manufacturing practice, and the
concentration of the pesticide chemi-
cal residue in the processed food is
not greater than the tolerance pre-
scribed for the pesticide chemical res-
163
idue in the raw agricultural commod-
ity; or
‘‘(B) if an exemption for the re-
quirement for a tolerance is in effect
under this section for a pesticide
chemical residue in or on a raw agri-
cultural commodity, a pesticide chem-
ical residue that is present in or on a
processed food because the food is
made from that raw agricultural com-
modity shall not be considered unsafe
within 
the 
meaning 
of 
section
402(a)(2)(B).
‘‘(3) RESIDUES OF DEGRADATION PROD-
UCTS.—If a pesticide chemical residue is
present in or on a food because it is a
metabolite or other degradation product
of a precursor substance that itself is a
pesticide chemical or pesticide chemical
residue, such a residue shall not be con-
sidered to be unsafe within the meaning
of section 402(a)(2)(B) despite the lack of
a tolerance or exemption from the need
for a tolerance for such residue in or on
such food if—
164
‘‘(A) the Administrator has not de-
termined that the degradation prod-
uct is likely to pose any potential
health risk from dietary exposure
that is of a different type than, or of
a greater significance than, any risk
posed by dietary exposure to the pre-
cursor substance;
‘‘(B) either—
‘‘(i) a tolerance is in effect
under this section for residues of
the precursor substance in or on
the food, and the combined level
of residues of the degradation
product and the precursor sub-
stance 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 pre-
cursor 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
165
the precursor substance in or on
the food; and
‘‘(C) the tolerance or exemption
for residues of the precursor sub-
stance does not state that it applies
only to particular named substances
and does not state that it does not
apply to residues of the degradation
product.
‘‘(4) EFFECT OF TOLERANCE OR EXEMP-
TION.—While a tolerance or exemption
from the requirement for a tolerance is in
effect under this section for a pesticide
chemical residue with respect to any
food, the food shall not by reason of bear-
ing or containing any amount of such a
residue be considered to be adulterated
within the meaning of section 402(a)(1).
‘‘(b) AUTHORITY AND STANDARD FOR TOLER-
ANCE.—
‘‘(1) AUTHORITY.—The Administrator
may issue regulations establishing, modi-
fying, or revoking a tolerance for a pes-
ticide chemical residue in or on a food—
166
‘‘(A) in response to a petition filed
under subsection (d); or
‘‘(B) on the Administrator’s own
initiative under subsection (e).
As used in this section, the term ‘modify’
shall not mean expanding the tolerance
to cover additional foods.
‘‘(2) STANDARD.—
‘‘(A) GENERAL RULE.—
‘‘(i) STANDARD.—The Adminis-
trator may establish or leave in
effect a tolerance for a pesticide
chemical residue in or on a food
only if the Administrator deter-
mines that the tolerance is safe.
The Administrator shall modify or
revoke a tolerance if the Adminis-
trator determines it is not safe.
‘‘(ii) DETERMINATION
OF
SAFE-
TY.—As used in this section, the
term ‘safe’, with respect to a toler-
ance for a pesticide chemical resi-
due’, means that the Adminis-
trator has determined that there
is a reasonable certainty that no
167
harm will result from aggregate
exposure to the pesticide chemi-
cal residue, including all antici-
pated dietary exposures and all
other exposures for which there
is reliable information.
‘‘(iii) RULE OF CONSTRUCTION.—
With respect to a tolerance, a pes-
ticide chemical residue meeting
the standard under clause (i) is
not an eligible pesticide chemical
residue for purposes of subpara-
graph (B).
‘‘(B) TOLERANCES FOR ELIGIBLE PES-
TICIDE CHEMICAL RESIDUES.—
‘‘(i) DEFINITION.—As used in
this subparagraph, the term ‘eligi-
ble pesticide chemical residue’
means a pesticide chemical resi-
due as to which—
‘‘(I) the Administrator is
not able to identify a level of
exposure to the residue at
which the residue will not
cause 
or 
contribute 
to 
a
168
known or anticipated harm to
human health (referred to in
this section as a ‘nonthreshold
effect’);
‘‘(II) the lifetime risk of
experiencing the nonthresh-
old effect is appropriately as-
sessed by quantitative risk as-
sessment; and
‘‘(III) with regard to any
known or anticipated harm to
human health for which the
Administrator is able to iden-
tify a level at which the resi-
due will not cause such harm
(referred to in this section as
a ‘threshold effect’), the Ad-
ministrator determines that
the level of aggregate expo-
sure is safe.
‘‘(ii) DETERMINATION OF TOLER-
ANCE.—Notwithstanding subpara-
graph (A)(i), a tolerance for an eli-
gible pesticide chemical residue
169
may be left in effect or modified
under this subparagraph if—
‘‘(I) at least one of the con-
ditions described in clause
(iii) is met; and
‘‘(II) both of the condi-
tions described in clause (iv)
are met.
‘‘(iii) CONDITIONS
REGARDING
USE.—For purposes of clause (ii),
the conditions described in this
clause with respect to a tolerance
for an eligible pesticide chemical
residue are the following:
‘‘(I) Use of the pesticide
chemical that produces the
residue 
protects 
consumers
from adverse effects on health
that would pose a greater risk
than the dietary risk from the
residue.
‘‘(II) Use of the pesticide
chemical that produces the
residue is necessary to avoid
a significant disruption in do-
170
mestic production of an ade-
quate, wholesome, and eco-
nomical food supply.
‘‘(iv) 
CONDITIONS
REGARDING
RISK.—For purposes of clause (ii),
the conditions described in this
clause with respect to a tolerance
for an eligible pesticide chemical
residue are the following:
‘‘(I) The yearly risk associ-
ated with the nonthreshold ef-
fect from aggregate exposure
to the residue does not exceed
10 times the yearly risk that
would be allowed under sub-
paragraph (A) for such effect.
‘‘(II) The tolerance is lim-
ited so as to ensure that the
risk over a lifetime associated
with the nonthreshold effect
from aggregate exposure to
the residue is not greater
than twice the lifetime risk
that would be allowed under
171
subparagraph (A) for such ef-
fect.
‘‘(v) REVIEW.—Five years after
the date on which the Adminis-
trator makes a determination to
leave in effect or modify a toler-
ance under this subparagraph,
and thereafter as the Adminis-
trator deems appropriate, the Ad-
ministrator shall determine, after
notice and opportunity for com-
ment, whether it has been dem-
onstrated to the Administrator
that a condition described in
clause (iii)(I) or clause (iii)(II)
continues to exist with respect to
the tolerance and that the yearly
and lifetime risks from aggregate
exposure to such residue con-
tinue to comply with the limits
specified in clause (iv). If the Ad-
ministrator determines by such
date that such demonstration has
not been made, the Administrator
shall, not later than 180 days after
172
the date of such determination,
issue a regulation under sub-
section (e)(1) to modify or revoke
the tolerance.
‘‘(vi) INFANTS AND CHILDREN.—
Any tolerance under this subpara-
graph shall meet the require-
ments of subparagraph (C).
‘‘(C) EXPOSURE
OF
INFANTS
AND
CHILDREN.—In 
establishing, 
modify-
ing, leaving in effect, or revoking a
tolerance or exemption for a pesticide
chemical residue, the Administrator—
‘‘(i) shall assess the risk of the
pesticide chemical residue based
on—
‘‘(I) available information
about consumption patterns
among infants and children
that are likely to result in dis-
proportionately 
high 
con-
sumption of foods containing
or 
bearing 
such 
residue
among infants and children in
173
comparison 
to 
the 
general
population;
‘‘(II) available information
concerning the special suscep-
tibility of infants and children
to the pesticide chemical resi-
dues, including neurological
differences between infants
and children and adults, and
effects of in utero exposure to
pesticide chemicals; and
‘‘(III) 
available 
informa-
tion concerning the cumu-
lative effects on infants and
children of such residues and
other substances that have a
common mechanism of tox-
icity; and
‘‘(ii) shall—
‘‘(I) ensure that there is a
reasonable certainty that no
harm will result to infants
and children from aggregate
exposure 
to 
the 
pesticide
chemical residue; and
174
‘‘(II) publish a specific de-
termination 
regarding 
the
safety of the pesticide chemi-
cal residue for infants and
children.
The Secretary of Health and Human
Services and the Secretary of Agri-
culture, in consultation with the Ad-
ministrator, shall conduct surveys to
document dietary exposure to pes-
ticides among infants and children.
In the case of threshold effects, for
purposes of clause (ii)(I) an addi-
tional tenfold margin of safety for the
pesticide chemical residue and other
sources of exposure shall be applied
for infants and children to take into
account potential pre- and post-natal
toxicity and completeness of the data
with respect to exposure and toxicity
to infants and children. Notwith-
standing such requirement for an ad-
ditional margin of safety, the Admin-
istrator may use a different margin of
safety for the pesticide chemical resi-
175
due only if, on the basis of reliable
data, such margin will be safe for in-
fants and children.
‘‘(D) 
FACTORS.—In 
establishing,
modifying, leaving in effect, or revok-
ing a tolerance or exemption for a
pesticide chemical residue, the Ad-
ministrator 
shall 
consider, 
among
other relevant factors—
‘‘(i) the validity, completeness,
and reliability of the available
data from studies of the pesticide
chemical and pesticide chemical
residue;
‘‘(ii) the nature of any toxic ef-
fect shown to be caused by the
pesticide chemical or pesticide
chemical residue in such studies;
‘‘(iii) 
available 
information
concerning the relationship of the
results of such studies to human
risk;
‘‘(iv) 
available 
information
concerning the dietary consump-
tion patterns of consumers (and
176
major identifiable subgroups of
consumers);
‘‘(v) 
available 
information
concerning the cumulative effects
of such residues and other sub-
stances 
that 
have 
a 
common
mechanism of toxicity;
‘‘(vi) 
available 
information
concerning the aggregate expo-
sure levels of consumers (and
major identifiable subgroups of
consumers) to the pesticide chem-
ical residue and to other related
substances, including dietary ex-
posure under the tolerance and
all other tolerances in effect for
the pesticide chemical residue,
and exposure from other non-oc-
cupational sources;
‘‘(vii) 
available 
information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers;
‘‘(viii) such information as the
Administrator may require on
177
whether the pesticide chemical
may have an effect in humans
that is similar to an effect pro-
duced by a naturally occurring
estrogen or other endocrine ef-
fects; and
‘‘(ix) safety factors which in
the opinion of experts qualified
by scientific training and experi-
ence to evaluate the safety of food
additives 
are 
generally 
recog-
nized as appropriate for the use
of animal experimentation data.
‘‘(E) DATA
AND
INFORMATION
RE-
GARDING ANTICIPATED AND ACTUAL RESI-
DUE LEVELS.—
‘‘(i) AUTHORITY.—In establishing,
modifying, leaving in effect, or revok-
ing a tolerance for a pesticide chemi-
cal residue, the Administrator may
consider available data and informa-
tion on the anticipated residue levels
of the pesticide chemical in or on
food and the actual residue levels of
the pesticide chemical that have been
178
measured in food, including residue
data collected by the Food and Drug
Administration.
‘‘(ii) REQUIREMENT.—If the Admin-
istrator relies on anticipated or ac-
tual residue levels in establishing,
modifying, or leaving in effect a toler-
ance, the Administrator shall pursu-
ant to subsection (f)(1) require that
data be provided five years after the
date on which the tolerance is estab-
lished, modified, or left in effect, and
thereafter 
as 
the 
Administrator
deems 
appropriate, 
demonstrating
that such residue levels are not above
the levels so relied on. If such data
are not so provided, or if the data do
not demonstrate that the residue lev-
els are not above the levels so relied
on, the Administrator shall, not later
than 180 days after the date on which
the data were required to be pro-
vided, issue a regulation under sub-
section (e)(1), or an order under sub-
179
section (f)(2), as appropriate, to mod-
ify or revoke the tolerance.
‘‘(F) PERCENT
OF
FOOD
ACTUALLY
TREATED.—In establishing, modifying,
leaving in effect, or revoking a toler-
ance for a pesticide chemical residue,
the Administrator may, when assess-
ing chronic dietary risk, consider
available data and information on the
percent of food actually treated with
the pesticide chemical (including ag-
gregate pesticide use data collected
by the Department of Agriculture)
only if the Administrator—
‘‘(i) finds that the data are re-
liable and provide a valid basis to
show what percentage of the food
derived from such crop is likely
to contain such pesticide chemi-
cal residue;
‘‘(ii) finds that the exposure
estimate does not understate ex-
posure for any significant sub-
population group;
180
‘‘(iii) finds that, if data are
available on pesticide use and
consumption of food in a particu-
lar area, the population in such
area is not dietarily exposed to
residues above those estimated by
the Administrator; and
‘‘(iv) provides for the periodic
reevaluation of the estimate of
anticipated dietary exposure.
‘‘(3) DETECTION METHODS.—
‘‘(A) GENERAL
RULE.—A tolerance
for a pesticide chemical residue in or
on a food shall not be established or
modified by the Administrator unless
the Administrator determines, after
consultation with the Secretary, that
there is a practical method for detect-
ing and measuring the levels of the
pesticide chemical residue in or on
the food.
‘‘(B) DETECTION
LIMIT.—A toler-
ance for a pesticide chemical residue
in or on a food shall not be estab-
lished at or modified to a level lower
181
than the limit of detection of the
method for detecting and measuring
the pesticide chemical residue speci-
fied by the Administrator under sub-
paragraph (A).
‘‘(4) INTERNATIONAL STANDARDS.—In es-
tablishing a tolerance for a pesticide
chemical residue in or on a food, the Ad-
ministrator shall determine whether a
maximum residue level for the pesticide
chemical has been established by the
Codex Alimentarius Commission. If a
Codex maximum residue level has been
established for the pesticide chemical
and the Administrator does not propose
to adopt the Codex level, the Adminis-
trator shall publish for public comment a
notice explaining the reasons for depart-
ing from the Codex level.
‘‘(c) AUTHORITY AND STANDARD FOR EXEMP-
TIONS.—
‘‘(1) AUTHORITY.—The Administrator
may 
issue 
a 
regulation 
establishing,
modifying, or revoking an exemption
from the requirement for a tolerance for
182
a pesticide chemical residue in or on
food—
‘‘(A) in response to a petition filed
under subsection (d); or
‘‘(B) on the Administrator’s initia-
tive under subsection (e).
‘‘(2) STANDARD.—
‘‘(A) GENERAL RULE.—
‘‘(i) STANDARD.—The Adminis-
trator may establish or leave in
effect an exemption from the re-
quirement for a tolerance for a
pesticide chemical residue in or
on food only if the Administrator
determines that the exemption is
safe. 
The 
Administrator 
shall
modify or revoke an exemption if
the Administrator determines it is
not safe.
‘‘(ii) DETERMINATION
OF
SAFE-
TY.—The term ‘safe’, with respect
to an exemption for a pesticide
chemical residue, means that the
Administrator 
has 
determined
that there is a reasonable cer-
183
tainty that no harm will result
from aggregate exposure to the
pesticide chemical residue, in-
cluding all anticipated dietary ex-
posures and all other exposures
for which there is reliable infor-
mation.
‘‘(B) FACTORS.—In making a deter-
mination under this paragraph, the
Administrator shall take into ac-
count, among other relevant consid-
erations, the considerations set forth
in subparagraphs (C) and (D) of sub-
section (b)(2).
‘‘(3) LIMITATION.—An exemption from
the requirement for a tolerance for a pes-
ticide chemical residue in or on food
shall not be established or modified by
the Administrator unless the Adminis-
trator determines, after consultation with
the Secretary—
‘‘(A) that there is a practical
method for detecting and measuring
the levels of such pesticide chemical
residue in or on food; or
184
‘‘(B) that there is no need for such
a method, and states the reasons for
such determination in issuing the
regulation establishing or modifying
the exemption.
‘‘(d) PETITION FOR TOLERANCE OR EXEMP-
TION.—
‘‘(1) PETITIONS AND PETITIONERS.—Any
person may file with the Administrator a
petition proposing the issuance of a regu-
lation—
‘‘(A) establishing, modifying, or
revoking a tolerance for a pesticide
chemical residue in or on a food; or
‘‘(B) establishing, modifying, or
revoking an exemption from the re-
quirement of a tolerance for such a
residue.
‘‘(2) PETITION CONTENTS.—
‘‘(A) ESTABLISHMENT.—A petition
under paragraph (1) to establish a tol-
erance or exemption for a pesticide
chemical residue shall be supported
by such data and information as are
185
specified in regulations issued by the
Administrator, including—
‘‘(i)(I) an informative sum-
mary of the petition and of the
data, information, and arguments
submitted or cited in support of
the petition; and
‘‘(II) a statement that the peti-
tioner agrees that such summary
or any information it contains
may be published as a part of the
notice of filing of the petition to
be 
published 
under 
this 
sub-
section and as part of a proposed
or final regulation issued under
this section;
‘‘(ii) the name, chemical iden-
tity, and composition of the pes-
ticide chemical residue and of the
pesticide chemical that produces
the residue;
‘‘(iii) data showing the rec-
ommended 
amount, 
frequency,
method, and time of application
of that pesticide chemical;
186
‘‘(iv) full reports of tests and
investigations made with respect
to the safety of the pesticide
chemical, including full informa-
tion as to the methods and con-
trols used in conducting those
tests and investigations;
‘‘(v) full reports of tests and
investigations made with respect
to the nature and amount of the
pesticide chemical residue that is
likely to remain in or on the food,
including a description of the an-
alytical methods used;
‘‘(vi) a practical method for
detecting and measuring the lev-
els of the pesticide chemical resi-
due in or on the food, or for ex-
emptions, a statement why such a
method is not needed;
‘‘(vii) a proposed tolerance for
the pesticide chemical residue, if
a tolerance is proposed;
‘‘(viii) if the petition relates to
a tolerance for a processed food,
187
reports 
of 
investigations 
con-
ducted 
using 
the 
processing
method(s) used to produce that
food;
‘‘(ix) such information as the
Administrator 
may 
require 
to
make the determination under
subsection (b)(2)(C);
‘‘(x) such information as the
Administrator may require on
whether the pesticide chemical
may have an effect in humans
that is similar to an effect pro-
duced by a naturally occurring
estrogen or other endocrine ef-
fects;
‘‘(xi) 
information 
regarding
exposure to the pesticide chemi-
cal residue due to any tolerance
or exemption already granted for
such residue;
‘‘(xii) practical methods for re-
moving any amount of the residue
that would exceed any proposed
tolerance; and
188
‘‘(xiii) such other data and in-
formation as the Administrator
requires by regulation to support
the petition.
If information or data required by
this subparagraph is available to the
Administrator, the person submitting
the petition may cite the availability
of the information or data in lieu of
submitting it. The Administrator may
require a petition to be accompanied
by samples of the pesticide chemical
with respect to which the petition is
filed.
‘‘(B) 
MODIFICATION
OR
REVOCA-
TION.—The Administrator may by reg-
ulation establish the requirements for
information and data to support a pe-
tition to modify or revoke a tolerance
or to modify or revoke an exemption
from the requirement for a tolerance.
‘‘(3) NOTICE.—A notice of the filing of
a petition that the Administrator deter-
mines has met the requirements of para-
graph (2) shall be published by the Ad-
189
ministrator within 30 days after such de-
termination. The notice shall announce
the availability of a description of the an-
alytical methods available to the Admin-
istrator 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 state-
ment of why such a method is not need-
ed. The notice shall include the summary
required by paragraph (2)(A)(i)(I).
‘‘(4) ACTIONS BY THE ADMINISTRATOR.—
‘‘(A) IN
GENERAL.—The Adminis-
trator shall, after giving due consid-
eration to a petition filed under para-
graph (1) and any other information
available to the Administrator—
‘‘(i) issue a final regulation
(which may vary from that sought
by 
the 
petition) 
establishing,
modifying, or revoking a toler-
ance for the pesticide chemical
residue or an exemption of the
pesticide chemical residue from
the requirement of a tolerance
190
(which final regulation shall be is-
sued without further notice and
without further period for public
comment);
‘‘(ii) issue a proposed regula-
tion under subsection (e), and
thereafter issue a final regulation
under such subsection; or
‘‘(iii) issue an order denying
the petition.
‘‘(B) 
PRIORITIES.—The 
Adminis-
trator shall give priority to petitions
for the establishment or modification
of a tolerance or exemption for a pes-
ticide chemical residue that appears
to pose a significantly lower risk to
human health from dietary exposure
than pesticide chemical residues that
have tolerances in effect for the same
or similar uses.
‘‘(C) EXPEDITED REVIEW OF CERTAIN
PETITIONS.—
‘‘(i) DATE
CERTAIN
FOR
RE-
VIEW.—If a person files a complete
petition with the Administrator
191
proposing the issuance of a regu-
lation establishing a tolerance or
exemption for a pesticide chemi-
cal residue that presents a lower
risk to human health than a pes-
ticide chemical residue for which
a tolerance has been left in effect
or 
modified 
under 
subsection
(b)(2)(B), the Administrator shall
complete action on such petition
under this paragraph within 1
year.
‘‘(ii) 
REQUIRED
DETERMINA-
TIONS.—If the Administrator is-
sues a final regulation establish-
ing a tolerance or exemption for a
safer pesticide chemical residue
under clause (i), the Adminis-
trator shall, not later than 180
days after the date on which the
regulation is issued, determine
whether a condition described in
subclause (I) or (II) of subsection
(b)(2)(B)(iii) continues to exist
with respect to a tolerance that
192
has been left in effect or modified
under subsection (b)(2)(B). If such
condition does not continue to
exist, the Administrator shall, not
later than 180 days after the date
on 
which 
the 
determination
under the preceding sentence is
made, issue a regulation under
subsection (e)(1) to modify or re-
voke the tolerance.
‘‘(e) ACTION ON ADMINISTRATOR’S OWN INI-
TIATIVE.—
‘‘(1) GENERAL
RULE.—The Adminis-
trator may issue a regulation—
‘‘(A) establishing, modifying, sus-
pending under subsection (l)(3), or re-
voking a tolerance for a pesticide
chemical or a pesticide chemical resi-
due;
‘‘(B) establishing, modifying, sus-
pending under subsection (l)(3), or re-
voking an exemption of a pesticide
chemical residue from the require-
ment of a tolerance; or
193
‘‘(C) establishing general proce-
dures and requirements to implement
this section.
‘‘(2) NOTICE.—Before issuing a final
regulation under paragraph (1), the Ad-
ministrator shall issue a notice of pro-
posed rulemaking and provide a period
of not less than 60 days for public com-
ment on the proposed regulation, except
that a shorter period for comment may
be provided if the Administrator for good
cause finds that it would be in the public
interest to do so and states the reasons
for the finding in the notice of proposed
rulemaking.
‘‘(f) SPECIAL DATA REQUIREMENTS.—
‘‘(1) REQUIRING
SUBMISSION
OF
ADDI-
TIONAL DATA.—If the Administrator deter-
mines that additional data or information
are reasonably required to support the
continuation of a tolerance or exemption
that is in effect under this section for a
pesticide chemical residue on a food, the
Administrator shall—
194
‘‘(A) issue a notice requiring the
person holding the pesticide registra-
tions 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 section 4 of the
Toxic Substances Control Act; or
‘‘(C) publish in the Federal Reg-
ister, after first providing notice and
an opportunity for comment of not
less 
than 
days’ 
duration, 
an
order—
‘‘(i) requiring the submission
to the Administrator by one or
more interested persons of a no-
tice identifying the person or per-
sons who will submit the required
data and information;
‘‘(ii) describing the type of
data and information required to
be submitted to the Administrator
195
and stating why the data and in-
formation could not be obtained
under the authority of section
3(c)(2)(B) of the Federal Insecti-
cide, Fungicide, and Rodenticide
Act or section 4 of the Toxic Sub-
stances Control Act;
‘‘(iii) describing the reports of
the Administrator required to be
prepared during and after the
collection of the data and infor-
mation;
‘‘(iv) requiring the submission
to the Administrator of the data,
information, and reports referred
to in clauses (ii) and (iii); and
‘‘(v) 
establishing 
dates 
by
which the submissions described
in clauses (i) and (iv) must be
made.
The Administrator may under sub-
paragraph (C) revise any such order
to correct an error. The Adminis-
trator may under this paragraph re-
quire data or information pertaining
196
to whether the pesticide chemical
may have an effect in humans that is
similar to an effect produced by a
naturally occurring estrogen or other
endocrine effects.
‘‘(2) NONCOMPLIANCE.—If a submission
required by a notice issued in accordance
with paragraph (1)(A), a rule issued
under paragraph (1)(B), or an order is-
sued under paragraph (1)(C) is not made
by the time specified in such notice, rule,
or order, the Administrator may by order
published in the Federal Register modify
or revoke the tolerance or exemption in
question. In any review of such an order
under subsection (g)(2), the only material
issue shall be whether a submission re-
quired under paragraph (1) was not made
by the time specified.
‘‘(g) EFFECTIVE DATE, OBJECTIONS, HEAR-
INGS, AND ADMINISTRATIVE REVIEW.—
‘‘(1) EFFECTIVE DATE.—A regulation or
order issued under subsection (d)(4),
(e)(1), or (f)(2) shall take effect upon pub-
lication unless the regulation or order
197
specifies otherwise. The Administrator
may stay the effectiveness of the regula-
tion or order if, after issuance of such
regulation or order, objections are filed
with respect to such regulation or order
pursuant to paragraph (2).
‘‘(2) FURTHER PROCEEDINGS.—
‘‘(A) OBJECTIONS.—Within 60 days
after a regulation or order is issued
under 
subsection 
(d)(4), 
(e)(1)(A),
(e)(1)(B), (f)(2), (n)(3), or (n)(5)(C), any
person may file objections thereto
with the Administrator, specifying
with particularity the provisions of
the regulation or order deemed objec-
tionable 
and 
stating 
reasonable
grounds therefor. If the regulation or
order was issued in response to a pe-
tition under subsection (d)(1), a copy
of each objection filed by a person
other than the petitioner shall be
served by the Administrator on the
petitioner.
‘‘(B) HEARING.—An objection may
include a request for a public evi-
198
dentiary hearing upon the objection.
The Administrator shall, upon the ini-
tiative of the Administrator or upon
the request of an interested person
and after due notice, hold a public
evidentiary hearing if and to the ex-
tent the Administrator determines
that such a public hearing is nec-
essary to receive factual evidence rel-
evant to material issues of fact raised
by the objections. The presiding offi-
cer in such a hearing may authorize a
party to obtain discovery from other
persons and may upon a showing of
good cause made by a party issue a
subpoena to compel testimony or pro-
duction of documents from any per-
son. The presiding officer shall be
governed by the Federal Rules of
Civil Procedure in making any order
for the protection of the witness or
the content of documents produced
and shall order the payment of a rea-
sonable fees and expenses as a condi-
tion to requiring testimony of the wit-
199
ness. On contest, such a subpoena
may be enforced by a Federal district
court.
‘‘(C) FINAL
DECISION.—As soon as
practicable after receiving the argu-
ments of the parties, the Adminis-
trator shall issue an order stating the
action taken upon each such objec-
tion and setting forth any revision to
the regulation or prior order that the
Administrator has found to be war-
ranted. If a hearing was held under
subparagraph (B), such order and any
revision to the regulation or prior
order shall, with respect to questions
of fact at issue in the hearing, be
based only on substantial evidence of
record at such hearing, and shall set
forth in detail the findings of facts
and the conclusions of law or policy
upon which the order or regulation is
based.
‘‘(h) JUDICIAL REVIEW.—
‘‘(1) PETITION.—In a case of actual
controversy as to the validity of any reg-
200
ulation issued under subsection (e)(1)(C),
or any order issued under subsection
(f)(1)(C) or (g)(2)(C), or any regulation
that is the subject of such an order, any
person who will be adversely affected by
such order or regulation may obtain judi-
cial 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 Co-
lumbia Circuit, within 60 days after pub-
lication of such order or regulation, a pe-
tition praying that the order or regula-
tion be set aside in whole or in part.
‘‘(2) 
RECORD
AND
JURISDICTION.—A
copy of the petition under paragraph (1)
shall be forthwith transmitted by the
clerk of the court to the Administrator,
or any officer designated by the Adminis-
trator for that purpose, and thereupon
the Administrator shall file in the court
the record of the proceedings on which
the Administrator based the order or reg-
ulation, as provided in section 2112 of