[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1627 Introduced in House (IH)]
1st Session
H. R. 1627
To amend the Federal Insecticide, Fungicide, and Rodenticide Act and
the Federal Food, Drug, and Cosmetic Act, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 12, 1995
Mr. Bliley (for himself, Mr. Towns, Mr. Roberts, Mr. de la Garza, Mr.
Emerson, Mr. Condit, Mr. Bilirakis, Mr. Gunderson, Mr. Stenholm, 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 Tennessee, 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
_______________________________________________________________________
A BILL
To amend the Federal Insecticide, Fungicide, and Rodenticide Act and
the Federal Food, Drug, and Cosmetic Act, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food Quality Protection Act of
1995''.
TITLE I--CANCELLATION AND SUSPENSION
SEC. 101. 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 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 Classification or Other Terms or
Conditions of Registration.--
``(1) Authority.--Notwithstanding any other provision of
this Act, the Administrator may, by use of informal rulemaking
under this subsection, prescribe requirements regarding the
composition, packaging, and labeling of a pesticide (or a group
of pesticides 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 necessary to assure that the pesticide,
when used in accordance with widespread and commonly recognized
practice, does not generally cause unreasonable adverse 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 environment.
``(3) Prenotice of rulemaking procedures.--
``(A) The Administrator may not initiate a
rulemaking under paragraph (1) until the Administrator
has furnished to the registrant of each affected
pesticide a notice that includes a summary of the
validated test or other significant 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 Administrator
furnishes notice to registrants of the pesticide under
subparagraph (A), the Administrator shall also furnish
such notice to the Secretary 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 Administrator shall either--
``(i) issue a notice of proposed rulemaking
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 rulemaking under paragraph (5), of each timely
comment filed with the Administrator, of the report of the
Scientific Advisory Panel under paragraph (7), of a record of
each hearing held by the Administrator in connection with the
rulemaking of the decision 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 available 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 Administrator 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 purpose, 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
proposed rule is based;
``(ii) the major scientific assumptions,
legal interpretations, and policy
considerations underlying the proposed rule;
``(iii) a summary of available risk-benefit
information, including benefits and use
information as provided by the Secretary of
Agriculture; and
``(iv) the Administrator's analysis and
tentative conclusions regarding the balancing
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 rulemaking and were not included in the
bibliography included in the notice required in
subparagraph (A). If such person receives additional
scientific data or studies pertinent to the rulemaking
that were not included in such bibliography, the person
shall make a report of such scientific data and studies
to the Administrator promptly after receipt. If the
Administrator receives reports containing additional
data concerning 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 rulemaking. During such
period any person may submit comments, data, or
documentary information on the proposed rule. Promptly
upon receipt by the Administrator, all written comments
and documentary information on the proposed rule
received from any person for inclusion in the docket
during the comment period, shall be place in the
docket.
``(D) At the same time that the Administrator
publishes notice under subparagraph (A), the
Administrator shall provide the Secretary of
Agriculture and the Secretary of Health and Human
Services with a copy of the proposed rule. Not later
than 90 days after the publication of the notice of
proposed rulemaking, the Secretary of Agriculture and
the Secretary of Health and Human Services may provide
comments on such proposed rule. When an agricultural
commodity is affected, the Secretary of Agriculture
shall provide to the Administrator an analysis of the
impact of the proposed action on the domestic and
global availability, prices of agricultural commodities
and retail food prices, and any associated societal
impacts (including consumer nutrition and health and
low-income consumers).
``(6) Hearing.--
``(A) Any person who has submitted a comment may,
not later than 15 days after the close of the comment
period, request of the Administrator a hearing on
questions of fact, based on information submitted under
paragraph (5), and pertaining to the proposed rule 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
Register. 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 evidence, or evidence that should
have been submitted under subparagraph (5)(B).
``(C) The hearing examiner shall conduct the
hearing in a manner that encourages discussion and
debate on questions of fact regarding the docket, and
conforms with the deadlines set in this paragraph. The
Administrator shall designate one or more employees of
the Environmental Protection Agency to participate in
the hearing. Any person who submitted a comment on the
proposed rule may participate in the hearing and shall
be entitled to present evidence and argument to support
the participant's position or rebut a contrary position
and may choose to present materials in oral or written
form. The presentation of evidence and argument shall
not delay the conclusion of the hearing beyond 20 days
of its commencement.
``(D) Subject to subparagraph (B), an interested
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 hearing
examiner determines (I) to be appropriate, and
(II) to be required for a full and true disclosure with respect to such
issues.
``(E) As soon as practicable after completion 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 notice 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 Administrator if no
hearing is requested) 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
material 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 examiner (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 report. A copy of the
Panel's report and any comments 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 Administrator shall publish in the
Federal Register either 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 Administrator shall take into account the impact of the
action on production and prices of agricultural commodities,
retail food prices, and otherwise on agricultural 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 agricultural
commodities, retail food prices, and otherwise
on the agricultural economy; and
``(iii) explains any significant
disagreements the Administrator may
have with the comments, evaluations, or
recommendations 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 requirements,
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 registration to comply with the rule
or to request voluntary cancellation of the
registration. However, 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 submitted within such 30-day
period, the Administrator may issue and publish in the
Federal Register an order canceling the registration,
effective upon the date of publication of the order in
the Federal Register.
``(10) Denial of applications.--Notwithstanding any other
provision of this Act, no application for initial or amended
registration of any pesticide 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 revocation of a rule that has
been issued under this subsection. The petition shall state the
factual material and argument that form the basis for the
petition. 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 evidence submitted by the
petitioner. If the Administrator proposes to amend or revoke
the rule, then the procedures established by paragraph (1) and
paragraphs (5) through (8) apply. A denial of a petition 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 published 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 proceeding 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 proceeding 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 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 proposed 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 sentence the following new
sentence: ``The Administrator may issue an emergency order under this
paragraph before issuing 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)(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 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);
``(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 proceedings
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 established a Science
Review Board to consist of 60 scientists who shall be available
to the Scientific Advisory 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 registration.--
``(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 notifies 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 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 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 judicial review under section 16(b)(1) of
this Act.
``(B) The Administrator may deny an application for
registration because it does not comply with the
requirements of a rule issued under section 6(b) of
this Act. The Administrator 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 Administrator shall
notify the registrant'' and all that follows through the end of
the paragraph, and inserting ``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 following: ``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 section 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 inserting the following:
``A hearing under this subsection shall be held in accordance
with the provisions of sections 554, 556, and 557 of title 5,
United States Code.''.
(g) Section 16(b).--Section 16(b) (17 U.S.C. 136n(b)) is amended--
(1) by striking ``(b) Review by Court of Appeals.--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 inserting
``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 leading
to the rule or decision may obtain judicial review by filing a
petition in the United States court of appeals for the circuit
wherein such person resides or has a place of business, within
60 days after the issuance 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 examiner under
section 6(b)(6), limiting such petitioner's cross-examination
or oral presentations, has precluded disclosure of disputed
material facts which was necessary to a full determination by
the Administrator 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 Administrator 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 section 706 of title 5, United States Code.
The judgment 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, operate 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 second
sentence; and
(2) by inserting at the end of the second sentence ``,
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 amendment 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 provision 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 agricultural 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
alternative 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
significant part in managing pest resistance; or
``(D) the pesticide plays or will play a
significant 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 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 by redesignating clauses (ii) and
(iii) as clauses (iii) and (iv), respectively, and by inserting after
clause (i) the following:
``(ii) The period of exclusive data use for
data submitted to support the application for
the original registration of a pesticide 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 Administrator if the Administrator in
consultation with the Secretary of Agriculture
determines that, based on information provided
by an applicant for registration or a
registrant, that--
``(I) there are insufficient
efficacious alternative registered
pesticides available for the use; or
``(II) the alternatives to the
pesticide pose greater risks to the
environment 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
integrated pest management program.
The registration of a pesticide for a minor use
on a crop grouping established by the
Administrator shall be considered for purposes
of this clause one minor use for each
representative crop for which data are provided
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 product 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
marketing 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 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 section 4 for the other use of the
pesticide established as of the date of
enactment of the Minor Use Crop Protection Act
of 1995, if--
``(I) the data to support other
uses of the pesticide on a food are
being provided;
``(II) the registrant, in
submitting a request for such an
extension, provides a schedule,
including 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
determined 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
determined in writing 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 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) regarding the continued
registration of the affected products with the minor use and shall
inform the public of such action. Notwithstanding the provisions of
this clause, the Administrator may take action 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 registrant, 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 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 submission of data under this section for the
other uses of the pesticide established as of the date of
enactment of the Minor Use Crop Protection Act of 1995 if--
``(i) the data to support other uses of the
pesticide on a food are being provided;
``(ii) the registrant, in submitting a request for
such an extension provides a schedule, including
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 determined that such
extension will not significantly delay the
Administrator's schedule for issuing a reregistration
eligibility determination required under this section;
and
``(iv) the Administrator has determined in writing
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 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 registration of the affected
products with the minor use and shall inform the public
of such action. Notwithstanding the provisions of this
subparagraph, the Administrator may take action to
modify or revoke the extension under this subparagraph
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 revoking the extension of time for
submission of data. Such data shall
instead be due in accordance with the date then
established by the Administrator 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 applicable data
requirements if the Administrator determines 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.--Section 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
expeditiously as possible, review and act on
any complete application--
``(I) that proposes the initial
registration of a new pesticide active
ingredient 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
registration amendment that proposes
significant 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 application, within 12
months after the submission of the
complete application, and the failure
of the Administrator to complete such a
review and evaluation under clause (i)
shall not be subject to judicial
review; 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
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 request for a minor use waiver,
regarding data required by the Administrator, pursuant to paragraph
(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
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 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 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 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
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 determines that the absence of
the data is significant enough to cause human health or
environmental concerns. On such a determination the
Administrator 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 section 6(f)(1). If the
Administrator grants an extension under this paragraph,
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 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 public 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 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 notice
revoking the temporary extension and establish 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 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 registrant, shall not take any action pursuant
to this subparagraph 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 support uses identified pursuant to this subparagraph
unless the Administrator 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 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 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 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
public 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 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 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), 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 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 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 Administrator
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 registrant.
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 deleted from the registration pursuant to section
6(f)(1). If the Administrator grants an extension 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 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 clause (iv) of this subparagraph 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). Notwithstanding the provisions of this clause,
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 environment. In the event of modification or revocation, 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.''.
(g) Utilization of Data for Voluntarily Canceled 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 Administrator 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
adverse effect on the environment. In order to rely on this
paragraph, 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 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 redesignating sections 30 and 31 as sections 32 and 33,
respectively, 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 office 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 pesticides, 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 Department 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 registrations,
tolerances, and reregistrations with the Environmental
Protection Agency.
``(b) Matching Fund Program.--
``(1) Establishment.--The Secretary of Agriculture, in
consultation with the Administrator, shall establish and
administer a minor use matching fund program. The matching fund
program shall be utilized to ensure the continued availability
of minor use crop protection chemicals, including the
development of data to support minor use pesticide
registrations and reregistrations. Access to the matching fund
program shall be available to any entity which desires to
develop data to support minor use registrations. 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
paragraph 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 developed 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 exceed $10,000,000.''.
TITLE III--DATA COLLECTION ACTIVITIES TO ASSURE THE HEALTH OF INFANTS
AND CHILDREN AND OTHER MEASURES
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 implementation 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 statistically valid sample of infants and
children.
(c) Residue Surveillance.--The Secretary of Agriculture shall
ensure that the residue surveillance activities conducted by the
Department of Agriculture provide for the improved surveillance of
pesticide residues, including guidelines for the use of comparable
analytical and standardized 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 vegetables.
(b) Collection.--The data shall be collected by surveys of farmers
or from other sources offering statistically reliable data.
(c) Coordination.--The Secretary 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
aggregate results of the surveys to assist the Administrator in
benefits determinations 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 sustainable approach to managing pests by
combining biological, 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 available to pesticide users,
including Federal agencies. Federal agencies shall use integrated pest
management techniques in carrying out pest management activities and
shall promote integrated pest management through procurement and
regulatory policies, and other activities.
TITLE IV--AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
SEC. 401. REFERENCE.
Whenever in this title an amendment is expressed in terms of an
amendment to a section or other provision, or refers to a section or
other provision, the reference shall be considered to be made to a
section or other provision of the Federal Food, Drug, and Cosmetic Act.
SEC. 402. DEFINITIONS.
(a) Section 201(q) (21 U.S.C. 321(q)) is amended to read as
follows:
``(q)(1) The term `pesticide chemical' means--
``(A) any substance that is a pesticide within the meaning
of the Federal Insecticide, Fungicide, and Rodenticide Act; or
``(B) any active ingredient of a pesticide within the
meaning of the Federal
Insecticide, Fungicide, and Rodenticide Act.
``(2) The term `pesticide chemical residue' means a residue in or
on raw agricultural commodity or processed food of--
``(A) a pesticide chemical; or
``(B) any other added substance that is present in the
commodity or food primarily as a result of the metabolism or
other degradation of a pesticide chemical.
``(3) Notwithstanding paragraphs (1) and (2), the Administrator may
by regulation except a substance from the definition of `pesticide
chemical' or `pesticide chemical residue' if--
``(A) its occurrence as a residue on a raw agricultural
commodity or processed 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 processed food; and
``(B) the Administrator, after consultation with the
Secretary, determines that the substance more appropriately
should be regulated under one or more provisions of this Act
other than sections 402(a)(2)(B) and 408.''.
(b) Paragraphs (1) and (2) of section 201(s) (21 U.S.C. 321(s)) are
amended to read as follows:
``(1) a pesticide chemical residue in or on a raw
agricultural commodity or processed food; or
``(2) a pesticide chemical; or''.
(c) Section 201 (21 U.S.C. 321) is amended by adding at the end the
following:
``(bb) The term `processed food' means any food other than a raw
agricultural commodity and includes any raw agricultural commodity that
has been subject to processing, such as canning, cooking, freezing,
dehydration, or milling.
``(cc) The term `Administrator' means the Administrator of the
United States Environmental Protection Agency.''.
SEC. 403. PROHIBITED ACTS.
Section 301(j) (21 U.S.C. 331(j)) is amended--
(1) by striking the period at the end; and
(2) by inserting at the end ``, or the violation of section
408(g)(2) or any regulation issued under that section.''.
SEC. 404. ADULTERATED FOOD.
Section 402(a)(2) (21 U.S.C. 342(a)(2)) is amended to read as
follows:
``(2)(A) if it bears or contains any added poisonous or
added deleterious substance (other than a substance that is a
pesticide chemical residue in or on a raw agricultural
commodity or processed food, a food additive, a color additive,
or a new animal drug) that is unsafe within the meaning of
section 406;
``(B) if it bears or contains a pesticide chemical residue
that is unsafe within the meaning of section 408(a); or
``(C) if it is or if it bears or contains--
``(i) any food additive that is unsafe within the
meaning of section 409; or
``(ii) a new animal drug (or conversion product
thereof) that is unsafe within the meaning of section
512; or''.
SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES.
Section 408 (21 U.S.C. 346a) is amended to read as follows:
``TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
``Sec. 408. (a) Requirement for Tolerance or Exemption.--
``(1) General rule.--For the purposes of this section, the
term `food,' when used as a noun 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 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 concentration of the residue is within
the limits of the tolerance; or
``(B) an exemption from the requirement of a
tolerance is in effect under this section for the
pesticide chemical residue.
``(2) Processed food.--Notwithstanding paragraph (1)--
``(A) if a tolerance is in effect under this
section for a pesticide chemical residue in or on a raw
agricultural commodity, a pesticide chemical 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 processed 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
commodity.
``(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 agricultural
commodity, a pesticide chemical 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).
``(3) Residues of degradation products.--If a pesticide
chemical residue is present in or on a food because it is a
metabolite or other degradation product of a precursor
substance that itself is a 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--
``(A) the Administrator has not determined that the
degradation product is likely to pose any potential
health risk from dietary exposure that is of a
different type than, or of a greater significance than,
any risk posed by dietary exposure to the precursor
substance; and
``(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 substance in or on the food is at or
below the stoichiometrically equivalent level
that would be permitted by the tolerance if the
residue consisted only of the
precursor substance rather than the
degradation product; or
``(ii) an exemption from the need for a
tolerance is in effect under this section for
residues of the precursor substance in or on
the food; and
``(C) the tolerance or exemption for residues of
the precursor substance does not state that it applies
only to particular named substances or states that it
does not apply to residues of the degradation product.
``(4) Effect of tolerance or exemption.--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 bearing 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 Tolerances.--
``(1) Authority.--The Administrator may issue regulations
establishing, modifying, or revoking a tolerance for a
pesticide chemical residue in or on a food--
``(A) in response to a petition filed under
subsection (d); or
``(B) on the Administrator's initiative under
subsection (e).
``(2) Standard.--(A) A tolerance may not be established for
a pesticide chemical residue in or on a food at a level that is
higher than a level that the Administrator determines is
adequate to protect the public health.
``(B) The Administrator shall modify or revoke a tolerance
if it is at a level higher than the level that the
Administrator determines is adequate to protect the public
health.
``(C) In making a determination under this paragraph the
Administrator shall take into account, among other relevant
factors, the validity, completeness, and reliability of the
available data from studies 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, available information
and reasonable assumptions concerning the dietary exposure
levels of food consumers (and major identifiable subgroups of
food consumers, including infants and children) to the
pesticide chemical residue, and available information and
reasonable assumptions concerning the variability of the
sensitivities of major identifiable groups, including infants
and children, and shall consider other factors to the extent
required by subparagraph (F).
``(D) For purposes of subparagraph (A), a tolerance 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 consumers by such level of the
pesticide chemical residue is negligible. The Administrator
shall by regulation set forth the factors and methods,
including tests which are appropriate for the determination of
dietary risk and most likely dietary exposure, for the
determination of negligible dietary risk.
``(E) Procedures shall be developed and implemented that
ensure that pesticide tolerances adequately safeguard the
health of infants and children.
``(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 particular, the
Administrator shall take into account aggregate pesticide use and
residue data collected by the Department of Agriculture.
``(G) For purposes of subparagraph (A), a level of a
pesticide chemical residue in or on a food that poses a greater
than negligible dietary risk to consumers of the food shall be
deemed to be adequate to protect the public health if the
Administrator determines that such risk is not unreasonable
because--
``(i) use of the pesticide that produces the
residue protects humans or the environment from adverse
effects on public health or welfare that would,
directly or indirectly, result in greater risk to the
public or the environment than the dietary risk from
the pesticide chemical residue; or
``(ii) use of the pesticide avoids risks to
workers, the public, or the environment that would be
expected to result from the use of another pesticide or
pest control method on the same food that are
considered to be greater than the risks that result
from dietary exposure to the pesticide chemical
residue; or
``(iii) the availability of the pesticide would
enable domestic growers to maintain the availability of
an adequate, wholesome, and economical food supply for
consumers, taking into account national and regional
effects.
In making the determination under this subparagraph, the
Administrator shall not consider the effects on any pesticide
registrant, manufacturer, or marketer of a pesticide.
``(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 alternative method of pest control or an alternative
pesticide chemical for use on such commodity or food that would
meet the requirements of paragraph (2)(D).
``(B) A tolerance for a pesticide chemical residue in or on
a food shall not be established by the Administrator unless the
Administrator determines, after consultation with the
Secretary, that there is a practical method for detecting and
measuring the levels of the pesticide chemical residue in or on
the food, or that a practical method is unavailable or not
feasible.
``(C) A tolerance for a pesticide chemical residue in or on
a food shall not be established at a level lower than the limit
of detection of the method for detecting and measuring the
pesticide chemical residue specified by the Administrator under
subparagraph (B).
``(4) International standards.--In establishing 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 Administrator 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 determination 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 tolerance on the
availability to consumers of an adequate, wholesome and economical food
supply, does not outweigh the risk posed by the pesticide residue.
``(c) Authority and Standard for Exemptions.--
``(1) Authority.--The Administrator may issue a regulation
establishing, modifying, or revoking an exemption from the
requirement for a tolerance for a pesticide chemical residue in
or on a food--
``(A) in response to a petition filed under
subsection (d); or
``(B) on the Administrator's initiative under
subsection (e).
``(2) Standard.--(A) An exemption from the requirement for
a tolerance for a pesticide chemical residue in or on a food
may be established only if the Administrator determines that a
tolerance is not needed to protect the public health, in view
of the levels of dietary exposure to the pesticide chemical
residue that could reasonably be expected to occur.
``(B) An exemption from the requirement for a tolerance for
a pesticide chemical residue in or on a food shall be revoked
if the Administrator, in response to a petition for the
revocation of the exemption or at the Administrator's own
initiative determines that the exemption does not satisfy the
criterion of subparagraph (A).
``(C) In making a determination under this paragraph, the
Administrator shall take into account, among other relevant
factors, the factors set forth in subsection (b)(2)(C).
``(3) Limitation.--An exemption from the requirement for a
tolerance for a pesticide chemical residue in or on a food
shall not be established by the Administrator unless the
Administrator 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 such food; or
``(B) that there is no need for such a method, and
states the reasons for such determination in the order
issuing the regulation establishing or modifying the
regulation.
``(d) Petition for Tolerance or Exemption.--
``(1) Petitions and petitioners.--Any person may file with
the Administrator a petition proposing the issuance of a
regulation--
``(A) establishing, modifying, or revoking a
tolerance for a pesticide chemical residue in or on a
food; or
``(B) establishing or revoking an exemption from
the requirement of a tolerance for such a residue.
``(2) Petition contents.--
``(A) Establishment.--A petition under paragraph
(1) to establish a tolerance or exemption for a
pesticide chemical residue shall be supported by such
data and information as are specified in regulations
issued by the Administrator, including--
``(i)(I) an informative summary of the
petition and of the data, information, and
arguments submitted or cited in support of the
petition;
``(II) a statement that the petitioner
agrees that such summary or any
information 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 issued under
this section;
``(ii) the name, chemical identity, and
composition of the pesticide chemical residue
and of the pesticide chemical that produces the
residue;
``(iii) data showing the recommended
amount, frequency, method, and time of
application of that pesticide chemical;
``(iv) full reports of tests and
investigations made with respect to the safety
of the pesticide chemical, including full
information as to the methods and controls 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 analytical
methods used;
``(vi) a practical method for detecting and
measuring the levels of the pesticide chemical
residue in or on the food, or a statement why
such a method is not needed;
``(vii) practical methods for removing any
amount of the residue that would exceed any
proposed tolerance;
``(viii) a proposed tolerance for the
pesticide chemical residue, if a tolerance is
proposed;
``(ix) all relevant data bearing on the
physical or other technical effect that the
pesticide chemical is intended to have and the
quantity of the pesticide chemical that is
required to produce the effect;
``(x) if the petition relates to a
tolerance for a processed food, reports of
investigations conducted using the processing
method(s) used to produce that food;
``(xi) such information as the
Administrator may require to make the
determination under subsection (b)(2)(E); and
``(xii) such other data and information as
the Administrator requires by regulation to
support the petition.
If information or data required by this 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 revocation.--The
Administrator may by regulation establish the
requirements for information and data to support a
petition to modify or revoke a tolerance or to revoke
an exemption from the requirement for a tolerance.
``(3) Notice.--A notice of the filing of a petition that
the Administrator determines has met the requirements of
paragraph (2) shall be published by the Administrator within 30
days after such determination. The notice shall announce the
availability of a description of the analytical methods
available to the Administrator for the detection
and measurement of the pesticide chemical residue with respect
to which the petition is filed or shall set forth the petitioner's
statement of why such a method is not needed. The notice shall include
the summary required by paragraph (2)(A)(i).
``(4) Actions by the administrator.--The Administrator
shall, after giving due consideration to a petition filed under
paragraph (1) and any other information available to the
Administrator--
``(A) issue a final regulation (which may vary from
that sought by the petition) establishing, modifying,
or revoking a tolerance for the pesticide chemical
residue or an exemption of the pesticide chemical
residue from the requirement of a tolerance;
``(B) issue a proposed regulation under subsection
(e), and thereafter either issue a final regulation
under subsection (e) or an order denying the petition;
or
``(C) issue an order denying the petition.
``(5) Effective date.--A regulation issued under paragraph
(4) shall take effect upon publication.
``(6) Further proceedings.--
``(A) Within 60 days after a regulation or order is
issued under paragraph (4), subsection (e)(1), or
subsection (f)(1), any person may file objections
thereto with the Administrator, specifying with
particularity the provisions of the regulation or order
deemed objectionable and stating reasonable grounds
therefor. If the regulation or order was issued in
response to a petition under paragraph (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) An objection may include a request for a
public evidentiary hearing upon the objection. The
Administrator shall, upon the initiative 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 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 production of documents from any person.
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 reasonable
fees and expenses as a condition to requiring testimony
of the witness. On contest, such a subpoena may be
enforced by a Federal district court.
``(C) As soon as practicable after receiving the
arguments of the parties, the Administrator shall issue
an order stating the action taken upon each such
objection and setting forth any revision to the
regulation or prior order that the Administrator has
found to be warranted. If a hearing was held under
subparagraph (B), such order and any revision to the
regulation or prior order shall, with respect to
questions of fact at issue in the hearing, be based
only on 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.
``(D) An order issued under this paragraph ruling
on an objection shall not take effect 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 findings as to such conditions.
``(7) Judicial review.--(A) In a case of actual controversy
as to the validity of any order issued under paragraph (6) or
any regulation that is the subject of such an order, any person
who will be adversely affected by such order or regulation may
obtain judicial review by filing in the United States Court of
Appeals for the circuit wherein that person resides or has its
principal place of business, or in the United States Court of
Appeals for the District of Columbia Circuit, within 60 days
after publication of such order, a petition praying that the
order or regulation be set aside in whole or in part.
``(B) A copy of the petition shall be forthwith transmitted
by the clerk of the court to the Administrator, or any officer
designated by the Administrator 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
regulation, as provided in section 2112 of title 28, United
States Code. Upon the filing of such a petition, the court
shall have exclusive jurisdiction to affirm or set aside the
order or regulation complained of in whole or in part. The
findings of the Administrator with respect to questions of fact
shall be sustained only if supported by substantial evidence
when considered on the record as a whole.
``(C) If a party applies to the court for leave to adduce
additional evidence, and shows to the satisfaction 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 additional 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.
``(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 subject of such an order shall be
final, subject to review by the Supreme Court of the United
States as provided in section 1254 of title 28 of the United
States Code. The commencement of proceedings under this
paragraph shall not, unless specifically ordered by the court
to the contrary, operate as a stay of a regulation or order.
``(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.
``(e) Action on Administrator's Own Initiative.--
``(1) General rule.--The Administrator may issue a
regulation--
``(A) establishing, modifying, or revoking a
tolerance for a pesticide chemical
or a pesticide chemical residue;
``(B) establishing or revoking an exemption of a
pesticide chemical residue from the requirement of a
tolerance; or
``(C) establishing general procedures and
requirements to implement this section.
A regulation issued under this paragraph shall become effective
upon its publication.
``(2) Notice.--Before issuing a final regulation under
paragraph (1), the Administrator shall issue a notice of
proposed rulemaking and provide a period of not less than 60
days for public comment on the proposed regulation, except that
a shorter period for comment may be provided if the
Administrator for good cause finds that it would be contrary to
the public interest to do so and states the reasons for the
finding in the notice of proposed rulemaking. The Administrator
shall provide an opportunity for a public hearing during the
rulemaking under procedures provided in subsection (d)(6)(B).
``(f) Special Data Requirements.--
``(1) Requiring submission of additional data.--If the
Administrator determines 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--
``(A) issue a notice requiring the persons holding
the pesticide registrations associated with such
tolerance or exemption to submit the data or
information under section 3(c)(2)(B) of the Federal
Insecticide, Fungicide, and Rodenticide Act;
``(B) issue a rule requiring that testing be
conducted on a substance or mixture under section 4 of
the Toxic Substances Control Act; or
``(C) publish in the Federal Register, after first
providing notice and an opportunity for comment of not
less than 90 days' duration, an order--
``(i) requiring the submission to the
Administrator by one or more interested persons
of a notice identifying the person or persons
who will submit the required data and
information;
``(ii) describing the type of data and
information requiring to be submitted to the
Administrator and stating why the data and
information could not be obtained under the
authority of section 3(c)(2)(B) of the Federal
Insecticide, Fungicide, and Rodenticide Act or
section 4 of the Toxic Substances Control Act;
``(iii) describing the reports of the
Administrator required to be prepared during
and after the collection of the data and
information;
``(iv) requiring the submission to the
Administrator of the data, information, and
reports referred to in clauses (ii) and (iii);
and
``(v) establishing dates by which the
submissions described in clauses (i) and (iv)
must be made.
The Administrator may revise any such order to correct
an error.
``(2) Noncompliance.--If a submission required by a notice
issued in accordance with paragraph (1)(A) or an order issued
under paragraph (1)(B) is not made by the time
specified in such notice or order, the Administrator may by
order published in the Federal Register modify or revoke the tolerance
or exemption in question.
``(3) Review.--An order issued under this subsection shall be
effective upon publication and shall be subject to review in accordance
with paragraphs (6) and (7) of subsection (d).
``(g) Confidentiality and Use of Data.--
``(1) General rule.--Data and information that are
submitted to the Administrator under this section in support of
a tolerance or an exemption from a tolerance shall be entitled
to confidential treatment for reasons of business
confidentiality and to exclusive use and data compensation, to
the same extent provided by sections 3 and 10 of the Federal
Insecticide, Fungicide, and Rodenticide Act.
``(2) Exceptions.--Data that are entitled to confidential
treatment under paragraph (1) may nonetheless be disclosed to
the Congress of the United States, and may be disclosed, under
such security requirements as the Administrator may provide by
regulation, to--
``(A) employees of the United States authorized by
the Administrator to examine such data in the carrying
out of their official duties under this Act or other
Federal statutes intended to protect the public health;
or
``(B) contractors with the United States authorized
by the Administrator to examine such data in the
carrying out of contracts under such statutes.
``(3) Summaries.--Notwithstanding any provision of this
subsection or other law, the Administrator may publish the
informative summary required by subsection (d)(2)(A)(i) and
may, in issuing a proposed or final regulation or order under
this section, publish an informative summary of the data
relating to the regulation or order.
``(h) Status of Previously Issued Regulations.--
``(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 subsections (d) and (e).
``(2) Regulations under section 409.--Regulations that
established tolerances for substances that are pesticide
chemical residues on or in processed food, or that otherwise
stated the conditions under which such pesticide chemicals
could be safely used, and that were issued under section 409 on
or before the date of the enactment of this paragraph, shall be
deemed to be regulations issued under this section and shall be
subject to modification or revocation under subsection (d) or
(e).
``(3) Regulations under section 408.--Regulations that
established tolerances or exemptions under this section that
were issued on or before the date of the enactment of this
paragraph shall remain in effect unless modified or revoked
under subsection (d) or (e).
``(i) Transitional Provision.--If, on the day before the date of
the enactment of this subsection, a substance that is a pesticide
chemical was, with respect to a particular pesticidal use of the
substance and any resulting pesticide chemical residue in or on a
particular food--
``(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
``(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 enactment of this subsection. The Administrator
shall by regulation indicate which substances are described by
this subsection. All exemption under this subsection may be
revoked or modified as if it had been issued under subsection
(c).
``(j) Harmonization With Action Under Other Laws.--
``(1) Limitation.--Notwithstanding any other provision of
this Act, a final rule under this section that revokes,
modifies, or suspends a tolerance or exemption for a pesticide
chemical residue in or on a food may be issued only if the
Administrator has first taken any necessary action under the
Federal Insecticide, Fungicide, and Rodenticide Act with
respect to the registration of the pesticide(s) whose use
results in such residue to ensure that any authorized 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
subsection (a).
``(2) Revocation of tolerance or exemption 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 residues of that pesticide chemical on
that food, the Administrator shall revoke any tolerance or
exemption that allows the presence of the pesticide chemical,
or any pesticide chemical residue that results from its use, in
or on that food. The Administrator shall use the procedures set
forth in subsection (e) in taking action under this paragraph.
A revocation under this paragraph shall become effective not
later than 180 days after--
``(A) the date by which each such cancellation of a
registration has become effective; or
``(B) the date on which the use of the canceled
pesticide becomes unlawful under the terms of the
cancellation, whichever is later.
``(3) Suspension of tolerance or exemption following
suspension of associated registrations.--
``(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 dietary risks to humans posed by
residues of that pesticide chemical on that food, the
Administrator shall suspend any tolerance or exemption
that allows the presence of the pesticide chemical, or
any pesticide chemical residue that results from its
use, in or on that food.
The Administrator shall use the procedures set forth
in subsection (e) in taking action under this paragraph. A suspension
under this paragraph shall become effective not later than 60 days
after the date by which each such suspension of use has become
effective.
``(B) Effect of suspension.--The suspension of a
tolerance or exemption under subparagraph (A) shall be
effective as long as the use of each associated
registration of a pesticide is suspended under the
Federal Insecticide, Fungicide, and Rodenticide Act.
While a suspension of a tolerance or exemption is
effective the tolerance or exemption shall not be
considered to be in effect. If the suspension of use of
the pesticide under that Act is terminated, leaving the
registration of the pesticide for such use in effect
under that Act, the Administrator shall rescind any
associated suspension of tolerance or exemption.
``(4) Tolerances for unavoidable residues.--In connection
with action taken under paragraph (2) or (3), or with respect
to pesticides whose registrations were canceled prior to the
effective date of this paragraph, if the Administrator
determines that a residue of the canceled or suspended
pesticide chemical will unavoidably persist in the environment
and thereby be present in or on a food, the Administrator may
establish a tolerance for the pesticide chemical residue at a
level that permits such unavoidable residue to remain in such
food. In establishing 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 necessary so that it
allows only that level of the pesticide chemical residue that
is unavoidable.
``(5) Pesticide residues resulting from lawful application
of pesticide.--Notwithstanding any other provision of this Act,
if a tolerance or exemption for a pesticide chemical residue in
or on a food has been revoked, suspended, or modified under
this section, an article of that food shall not be deemed
unsafe solely because of the presence of such pesticide
chemical residue in or on such food if it is shown to the
satisfaction of the Secretary that--
``(A) the residue is present as the result of an
application or use of a pesticide at a time and in a
manner that was lawful under the Federal Insecticide,
Fungicide, and Rodenticide Act; and
``(B) the residue does not exceed a level that was
authorized at the time of that application 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 revoked,
suspended, or modified under this subsection or subsection (d)
or (e), the Administrator has issued a determination that
consumption of the legally treated food during the period of
its likely availability in commerce will pose an unreasonable
dietary risk.
``(k) Fees.--The Administrator shall by regulation require the
payment of such fees as will in the aggregate, in the judgment of the
Administrator, be sufficient over a reasonable term to provide, equip,
and maintain an adequate service for the performance of the
Administrator's functions under this section. Under the regulations,
the performance of the
Administrator's services or other functions under this section,
including--
``(1) the acceptance for filing of a petition submitted
under subsection (d);
``(2) the promulgation of a regulation establishing,
modifying, or revoking a tolerance or establishing or revoking
an exemption from the requirement of a tolerance under this
section;
``(3) the acceptance for filing of objections under
subsection (d)(6); or
``(4) the certification and filing in court of a transcript
of the proceedings and the record under subsection (d)(7);
may be conditioned upon the payment of such fees. The regulations may
further provide for waiver or refund of fees in whole or in part when
in the judgment of the Administrator such a waiver or refund is
equitable and not contrary to the purposes of this subsection.
``(l) National Uniformity of Tolerances.--
``(1) Qualifying pesticide chemical residue.--For purposes
of this subsection, the term `qualifying pesticide chemical
residue' means a pesticide chemical residue resulting from the
use, in production, processing, or storage of a food, of a
pesticide chemical that is an active ingredient and that--
``(A) was first approved for such use in a
registration of a pesticide issued under section
3(c)(5) of the Federal Insecticide, Fungicide,
Rodenticide Act on or after April 25, 1985, on the
basis of data determined by the Administrator to meet
all applicable requirements for data prescribed by
regulations in effect under that Act on April 25, 1985;
or
``(B) was approved for such use in a reregistration
eligibility determination issued under section 4(g) of
that Act on or after the date of enactment of the Food
Quality Protection Act of 1995.
``(2) Qualifying federal determination.--For purposes of
this subsection, the term `qualifying Federal determination'
means--
``(A) a tolerance or exemption from the requirement
for a tolerance for a qualifying pesticide chemical
residue that was--
``(i) issued under this section after the
date of enactment of the Food Quality
Protection Act of 1995; (or)
``(ii) issued (or, pursuant to subsection
(h) or (i), deemed to have been issued) under
this section, and determined by the
Administrator to meet the standard under
subsection (b)(2) (in the case of a tolerance)
or (c)(2) (in the case of an exemption); and
``(B) any statement, issued by the Secretary, of
the residue level below which enforcement action will
not be taken under this Act with respect to any
qualifying pesticide chemical residue, if the Secretary
finds that such pesticide chemical residue level
permitted by such statement during the period to which
such statement applies protects human health.
``(3) Limitation.--The Administrator may make the
determination described in paragraph (2)(A)(ii) only by issuing
a rule in accordance with the procedure set forth in subsection
(d) or (e) and only if the Administrator issues a proposed rule
and allows a period of not less than 30 days for comment on the
proposed rule. Any such rule shall be reviewable in accordance
with subsections (d)(6) and (d)(7).
``(4) State authority.--Except as provided in paragraph
(5), no State or political subdivision may establish or enforce
any regulatory limit on a qualifying pesticide chemical residue
in or on any food if a qualifying Federal determination applies
to the presence of such pesticide chemical residue in or on
such food, unless such State regulatory limit is identical to
such qualifying Federal determination. A State or political
subdivision shall be deemed to establish or enforce a
regulatory limit on a pesticide chemical residue in or on food
if it purports to prohibit or penalize the production,
processing, shipping, 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 pesticide residue in the food.
``(5) Petition procedure.--
``(A) Any State may petition the Administrator for
authorization to establish in such State a regulatory
limit on a qualifying pesticide chemical residue in or
on any food that is not identical to the qualifying
Federal determination applicable to such qualifying
pesticide chemical residue.
``(B) Any petition under subparagraph (A) shall--
``(i) satisfy any requirements prescribed,
by rule, by the Administrator; and
``(ii) be supported by scientific data
about the pesticide chemical residue that is
the subject of the petition or about chemically
related pesticide chemical residues, data on
the consumption within such State of food
bearing the pesticide chemical residue, and
data on exposure of humans within such State to
the pesticide chemical residue.
``(C) Subject to paragraph (6), the Administrator
may, by order, grant the authorization described in
subparagraph (A) if the Administrator determines that
the proposed State regulatory limit--
``(i) is justified by compelling local
conditions;
``(ii) would not unduly burden interstate
commerce; and
``(iii) would not cause any food to be in
violation of Federal law.
``(D) In lieu of any action authorized under
subparagraph (C), the Administrator may treat a
petition under this paragraph as a petition under
subsection (d) to revoke or modify a tolerance or to
revoke an exemption. If the Administrator determines to
treat a petition under this paragraph as a petition
under subsection (d), the Administrator shall
thereafter act on the petition pursuant to subsection
(d).
``(E) Any order of the Administrator granting or
denying the authorization described in subparagraph (A)
shall be subject to review in the manner described in
subsections (d)(6) and (d)(7).
``(6) Residues from lawful application.--No State or
political subdivision may enforce any regulatory limit on the
level of a pesticide chemical residue that may appear in or on
any food if, at the time of the application of the pesticide
that resulted in such residue, the sale of such food with such
residue level was lawful under this Act and under the law of
such State, unless the State demonstrates 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 unreasonable dietary risk to the health of persons within
such State.''.
SEC. 406. AUTHORIZATION FOR INCREASE MONITORING.
There is authorized to be appropriated an additional $12,000,000
for increased monitoring by the Secretary of Health and Human Services
of pesticide residues in imported and domestic food.
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