I
103D CONGRESS
1ST SESSION
H. R. 1627
To amend the Federal Insecticide, Fungicide, and Rodenticide Act and the
Federal Food, Drug, and Cosmetic Act, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
APRIL 1, 1993
Mr. LEHMAN (for himself, Mr. BLILEY, Mr. ROWLAND, Mr. SMITH of Oregon,
Mr. ROBERTS, Mr. PENNY, Mr. ENGLISH of Oklahoma, Mr. HOLDEN,
Mr. EMERSON, Mr. KINGSTON, Mr. SARPALIUS, Mr. EWING, Mr.
DOOLEY, Mr. JOHNSON of South Dakota, Mr. BARRETT of Nebraska,
Mr. BOEHNER, Mr. COMBEST, Mr. DOOLITTLE, Mr. CONDIT, Mr. BISH-
OP, Mr. GUNDERSON, Mr. POMEROY, Mr. ALLARD, Mr. TOWNS, Mr.
COOPER, Mr. HALL of Texas, Mr. MCMILLAN, Mr. HASTERT, Mr.
UPTON, Mr. PAXON, Mr. KLUG, Mr. FRANKS of Connecticut, Mr. MAN-
TON, Mr. BOUCHER, Mr. CRAPO, Mr. BARTON of Texas, Mr. GILLMOR,
Mr. OXLEY, Mr. TAUZIN, and Mr. MOOREHEAD) introduced the following
bill; which was referred jointly to the Committees on Agriculture and En-
ergy and Commerce
AUGUST 18, 1993
Additional sponsors: Mr. JOHNSON of Georgia, Mr. PARKER, Mr. DARDEN,
Mr. LIPINSKI, Mr. STUMP, Mr. HANCOCK, Mr. BEREUTER, Mr. WALSH,
Mr. DORNAN, Mr. BATEMAN, Mr. HUGHES, Mr. SMITH of Michigan, Mr.
HERGER, Mr. BAKER of Louisiana, Mr. PAYNE of Virginia, Mr. INHOFE,
Mr. COBLE, Mr. SUNDQUIST, Mr. RAVENEL, Mr. POMBO, Mr. SISISKY,
Mr. WISE, Mr. LAROCCO, Mr. CAMP, Mr. CANADY, Mr. WALKER, Mr.
ROTH, Mr. HOUGHTON, Mr. COLEMAN, Mr. STEARNS, Mr. THOMAS of
Wyoming, Mr. HEFNER, Mr. MCCRERY, Ms. DANNER, Mr. GOODLING,
Mr. MCDADE, Mr. VALENTINE, Mr. BURTON of Indiana, Mr. DREIER,
Mr. LEWIS of Florida, Mr. CLYBURN, Mr. GEKAS, Mr. DEAL, Mr. KAN-
JORSKI, Mr. GINGRICH, Mr. SHUSTER, Mr. GRAMS, Mr. TAYLOR of North
Carolina, Mr. TRAFICANT, Mr. SCHAEFER, Mr. GALLEGLY, Mr. HUTCH-
INSON, Mr. ANDREWS of New Jersey, Mr. PETERSON of Minnesota, Ms.
DUNN, Mr. GALLO, Mr. BALLENGER, Mr. ZELIFF, Mr. GOODLATTE, Mr.
BAKER of California, Mr. ARMEY, Mr. BREWSTER, Mr. PETERSON of
Florida, Mr. HANSEN, Mrs. LLOYD, Mr. SOLOMON, Mr. NEAL of North
Carolina, Mr. BONILLA, Mr. GONZALEZ, Mr. GUTIERREZ, Mr. COLLINS
of Georgia, Mr. DUNCAN, Mr. COX, Mr. LIGHTFOOT, Ms. KAPTUR, Mr.
YOUNG of Alaska, Mr. GILCHREST, and Mr. FAZIO
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 1993’’.
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 or inert ingredi-
ent), or may classify any such pesticide, or may pro-
hibit the registration or continued registration of
any such pesticide for some or all purposes, to the
extent necessary to assure that the pesticide, when
used in accordance with widespread and commonly
recognized practice, does not generally cause unrea-
sonable adverse effects on the environment.
‘‘(2) BASIS FOR RULE.—
‘‘(A) 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
environment.
‘‘(B)(i) The Administrator shall submit to
a scientific peer review committee established
by the Administrator the validated test or other
significant evidence upon which the Adminis-
trator proposes to base a rulemaking under
paragraph (1).
‘‘(ii) The scientific peer review committee
shall provide written recommendations to the
Administrator as to whether the test or evi-
dence reviewed satisfies the criteria under para-
graph (1) for initiating a rulemaking under
paragraph (1).
‘‘(iii) The scientific peer review committee
shall consist of employees of or consultants to
the Environmental Protection Agency who have
not been involved in any previous analysis of
the validated test or significant evidence pre-
sented to the committee and who are expert in
the physical or biological disciplines involved in
the proposed rulemaking.
‘‘(3) PRENOTICE PROCEDURES.—
‘‘(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.
‘‘(4) ADVANCE NOTICE TO PUBLIC.—
‘‘(A) The Administrator after receiving the
recommendation of the peer review committee
established under paragraph (2)(B) together
with any comments submitted by the Secretary
of Agriculture, the Secretary of Health and
Human Services, and any registrant shall ei-
ther—
‘‘(i) issue an advance notice of pro-
posed rulemaking, or
‘‘(ii) issue a notice of a proposed deci-
sion not to initiate a rulemaking under
paragraph (1).
‘‘(B) The Administrator shall publish such
notice in the Federal Register and provide a pe-
riod of not less than 60 days for comment
thereon. The notice shall contain a statement of
its basis and purpose, which shall include a
summary of—
‘‘(i) the factual data on which the no-
tice is based,
‘‘(ii) the major scientific assumptions
underlying the notice, and
‘‘(iii) a summary of the notice under
paragraph (3) and any significant com-
ments received from any registrant, the
Secretary of Agriculture, and the Secretary
of Health and Human Services.
‘‘(C) If the Administrator, after consider-
ing any comments received, decides not to issue
a notice of proposed rulemaking, the Adminis-
‘‘(A) Not less than 60 days after an ad-
vance notice of proposed rulemaking, except as
provided in paragraph (14), the Administrator
may issue a notice of proposed rulemaking. The
notice of proposed rulemaking shall include a
statement of its basis and purpose, a request
for any additional data needed, and a bibliog-
raphy of all significant scientific data and stud-
ies 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
ministrator an informal hearing on questions of
fact pertaining to the proposed rule or com-
ments thereon. Upon such request, the Admin-
istrator shall schedule an informal hearing not
to exceed 20 days duration, and to conduct not
later than 60 days after the close of the com-
ment period. The Administrator shall announce
the time, place, and purpose of the hearing in
the Federal Register. The informal hearing
shall be limited to addressing questions of fact
raised by materials in the docket. A transcript
shall be made of any oral presentation, discus-
sion, or debate and included in the docket.
‘‘(B) The Administrator shall appoint a
presiding officer who shall have the authority to
administer oaths, regulate the course of the
hearing, conduct prehearing conferences, sched-
ule presentations, and exclude irrelevant, imma-
terial, or unduly repetitious evidence.
‘‘(C) The presiding officer shall conduct
the informal hearing in a manner that encour-
ages discussion and debate on questions of fact
regarding the docket. 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.
‘‘(8) 
REVIEW
BY
SCIENTIFIC
ADVISORY
PANEL.—At the time the Administrator issues a no-
tice of proposed rulemaking under paragraph (6),
the Administrator shall provide a copy of such notice
to the Scientific Advisory Panel established under
section 25(d). If any person submits comments
under paragraph (6) in opposition to the proposed
rule, the Administrator shall request the comments,
evaluations, and recommendations of the Panel as to
the impact on health and the environment of the
proposed rule and on any disputed issues of fact or
scientific policy that appear to be of significance in
the rulemaking. The Panel may hold a public hear-
ing to discuss the proposed rule. The Panel shall
provide a report to the Administrator not later than
30 days after the close of comment period (or, if a
hearing has been requested under paragraph (7), not
later than 30 days after the end of such hearing).
The Administrator shall allow a reasonable time for
written public comment on the Panel’s report. A
copy of the Panel’s report and any comments shall
be included in the rulemaking docket.
‘‘(9) FINAL ACTION.—After considering all ma-
terial in the docket, the Administrator shall publish
in the Federal Register either a final rule or a with-
drawal of the proposed rule. The Administrator may
not prohibit a use of a pesticide if alternative re-
quirements will assure that the pesticide, when used
in accordance with widespread and commonly recog-
nized practice, will not generally cause unreasonable
adverse effects on the environment. In taking any
final action, the Administrator shall take into ac-
count the impact of the action on production and
prices of agricultural commodities, retail food prices,
and otherwise on agricultural economy. The final
rule or withdrawal of the proposal shall be accom-
panied 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 differences 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 (8) or the benefits and
use information described in paragraph
(6)(A)(iii) and analysis in paragraph
(6)(D) as it bears on the final rule.
A final rule issued under this subsection shall be ef-
fective upon the date of its publication in the Fed-
eral Register.
‘‘(10) 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. The
final rule may prohibit or limit distribution or
sale by the registrant of the affected pesticide
to any other person in any State during such
30-day period.
‘‘(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.
‘‘(11) 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.
‘‘(12) 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 (6) through (9) apply. A denial of a peti-
tion shall be judicially reviewable as provided in
paragraph (13).
‘‘(13) JUDICIAL
REVIEW.—A decision not to
initiate a rulemaking published under paragraph (4),
a final rule or a withdrawal of a proposed rule pub-
lished under paragraph (9) or a denial of a petition
under paragraph (12) shall be judicially reviewable
in the manner specified by section 16(b)(2).
‘‘(14) EXCEPTION TO REQUIREMENTS.—If the
Administrator finds it necessary to issue a suspen-
sion order under subsection (c), the Administrator
may waive the requirements of paragraphs (3) and
(4) of this subsection.’’.
SEC. 103. PESTICIDES IN REVIEW.
If the Administrator, on or before January 1, 1993,
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 Pro-
tection Act of 1993, elect to continue such review proceed-
ing 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 enact-
ment of the Food Quality Protection Act of 1993.
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 revised to read: ‘‘Ex-
cept as provided in paragraph (3), no order of suspension
may be issued under this subsection unless the Adminis-
trator has issued, or at the same time issues, a proposed
rule under subsection (b).’’.
(b) SECTION 6(c)(3).—Section 6(c)(3) (7 U.S.C.
136d(c)(1)) 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
REREGISTRATION.
Section 4(g) (7 U.S.C. 136b(g)) is amended in para-
graph (2) 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 by striking out ‘‘The Administrator
shall’’ and inserting in lieu thereof ‘‘(1) IN GENERAL.—
The Administrator shall’’ and such section is amended 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 during
that time the applicant submits a request for a
hearing, the Administrator may issue an order
denying the application. If during that time the
Administrator does not receive such corrections
to the application or such a request for hearing,
the Administrator may issue an order denying
the application. Such an order shall be pub-
lished in the Federal Register and shall not be
subject to judicial review. If during that time
the Administrator receives a request for a hear-
ing, a hearing shall be conducted under section
6(d) of the Act. If such a hearing is held, a de-
cision after completion of such hearing shall be
final and shall be subject to judicial 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(dd))
is amended—
(1) in paragraph (1)(A), by striking out ‘‘on the
initial classification and registered pesticides’’ and
inserting in lieu thereof ‘‘under section 6(b) of this
Act. Registered pesticides’’; and
(2) in paragraph (2), by striking out all that
follows ‘‘on the environment,’’ and inserting in lieu
thereof ‘‘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. 136b(e)(3)(B)(iii)(III)) is amended—
(1) by striking out ‘‘section 6(d), except that
the’’ and inserting in lieu thereof ‘‘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.’’;