Congressional Record, Volume 142 Issue 109 (Tuesday, July 23, 1996)

[Congressional Record Volume 142, Number 109 (Tuesday, July 23, 1996)]
[House]
[Pages H8127-H8147]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

FOOD QUALITY PROTECTION ACT OF 1996

Mr. ROBERTS. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 1627) to amend the Federal Insecticide, Fungicide, and
Rodenticide Act and the Federal Food, Drug, and Cosmetic Act, and for
other purposes, as amended.
The Clerk read as follows:

H.R. 1627

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 1996''.
TITLE I--SUSPENSION-APPLICATORS

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.
Subtitle A--Suspension

SEC. 102. SUSPENSION.

(a) Section 6(c)(1).--The second sentence of section
6(c)(1) (7 U.S.C. 136d(c)(1)) is amended to read: ``Except as
provided in paragraph (3), no order of suspension may be
issued under this subsection unless the Administrator has
issued, or at the same time issues, a notice of intention to
cancel the registration or change the classification of the
pesticide under subsection (b).''.
(b) Section 6(c)(3).--Section 6(c)(3) (7 U.S.C. 136d(c)(3))
is amended--
(1) by inserting after the first sentence the following new
sentence: ``The Administrator may issue an emergency order
under this paragraph before issuing a notice of intention to
cancel the registration or change the classification of the
pesticide under subsection (b) and the Administrator shall
proceed to issue the notice under subsection (b) within 90
days of issuing an emergency order. If the Administrator does
not issue a notice under subsection (b) within 90 days of
issuing an emergency order, the emergency order shall
expire.''; and
(2) by striking ``In that case'' and inserting ``In the
case of an emergency order''.

SEC. 103. 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.''.

[[Page H8128]]

SEC. 104. SCIENTIFIC ADVISORY PANEL.

Section 25(d) (7 U.S.C. 136w(d)) is amended--
(1) in the first sentence, 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. Members of the Board shall be
selected in the same manner as members of temporary subpanels
created under paragraph (1). Members of the Board shall be
compensated in the same manner as members of the Panel.''.

SEC. 105. NITROGEN STABILIZER.

(a) Section 2.--Section 2 (7 U.S.C. 136) is amended--
(1) in subsection (a)--
(A) in paragraph (1) by striking ``or'' after
``defoliant,'' and inserting ``, or nitrogen stabilizer''
after ``desiccant'';
(B) at the end of paragraph (3) by striking ``and'';
(C) at the end of paragraph (4) by striking the period and
inserting ``; and''; and
(D) at the end by adding the following:
``(5) in the case of a nitrogen stabilizer, an ingredient
which will prevent or hinder the process of nitrification,
denitrification, ammonia volatilization, or urease production
through action affecting soil bacteria.'';
(2) in subsection (u), by striking ``and'' before ``(2)''
and by inserting ``and (3) any nitrogen stabilizer,'' after
``desiccant,''; and
(3) at the end by adding the following:
``(hh) Nitrogen Stabilizer.--The term `nitrogen stabilizer'
means any substance or mixture of substances intended for
preventing or hindering the process of nitrification,
denitrification, ammonia volatilization, or urease production
through action upon soil bacteria. Such term shall not
include--
``(1) dicyandiamide;
``(2) ammonium thiosulfate; or
``(3) any substance or mixture of substances.--
``(A) that was not registered pursuant to section 3 prior
to January 1, 1992; and
``(B) that was in commercial agronomic use prior to January
1, 1992, with respect to which after January 1, 1992, the
distributor or seller of the substance or mixture has made no
specific claim of prevention or hindering of the process of
nitrification, denitrification, ammonia volatilization urease
production regardless of the actual use or purpose for, or
future use or purpose for, the substance or mixture.
Statements made in materials required to be submitted to any
State legislative or regulatory authority, or required by
such authority to be included in the labeling or other
literature accompanying any such substance or mixture shall
not be deemed a specific claim within the meaning of this
subsection.''.
(b) Section 3(f).--Section 3(f) (7 U.S.C. 136a(f)) is
amended by adding at the end the following:
``(4) Mixtures of nitrogen stabilizers and fertilizer
products.--Any mixture or other combination of--
``(A) 1 or more nitrogen stabilizers registered under this
Act; and
``(B) 1 or more fertilizer products,
shall not be subject to the provisions of this section or
sections 4, 5, 7, 15, and 17(a)(2) if the mixture or other
combination is accompanied by the labeling required under
this Act for the nitrogen stabilizer contained in the mixture
or other combination, the mixture or combination is mixed or
combined in accordance with such labeling, and the mixture or
combination does not contain any active ingredient other than
the nitrogen stabilizer.''.

SEC. 106. PERIODIC REGISTRATION REVIEW.

(a) Section 6.--Section 6 (7 U.S.C. 136d) is amended--
(1) in subsection (a), by striking the heading and
inserting the following:
``(a) Existing Stocks and Information.--''; and
(2) by amending paragraph (1) of subsection (a) to read as
follows:
``(1) Existing stocks.--The Administrator may permit the
continued sale and use of existing stocks of a pesticide
whose registration is suspended or canceled under this
section, or section 3 or 4, to such extent, under such
conditions, and for such uses as the Administrator determines
that such sale or use is not inconsistent with the purposes
of this Act.''.
(b) Section 3.--Section 3 (7 U.S.C. 136a) is amended by
adding at the end the following:
``(g) Registration Review.--
``(1)(A) General rule.--The registrations of pesticides are
to be periodically reviewed. The Administrator shall by
regulation establish a procedure for accomplishing the
periodic review of registrations. The goal of these
regulations shall be a review of a pesticide's registration
every 15 years. No registration shall be canceled as a result
of the registration review process unless the Administrator
follows the procedures and substantive requirements of
section 6.
``(B) Limitation.--Nothing in this subsection shall
prohibit the Administrator from undertaking any other review
of a pesticide pursuant to this Act.
``(2)(A) Data.--The Administrator shall use the authority
in subsection (c)(2)(B) to require the submission of data
when such data are necessary for a registration review.
``(B) Data submission, compensation, and exemption.--For
purposes of this subsection, the provisions of subsections
(c)(1), (c)(2)(B), and (c)(2)(D) shall be utilized for and be
applicable to any data required for registration review.''.
Subtitle B--Training for Maintenance Applicators and Service
Technicians

SEC. 120. MAINTENANCE APPLICATORS AND SERVICE TECHNICIANS
DEFINITIONS.

Section 2 (7 U.S.C. 136), as amended by section 106, is
amended by adding at the end the following:
``(jj) Maintenance Applicator.--The term `maintenance
applicator' means any individual who, in the principal course
of such individual's employment, uses, or supervises the use
of, a pesticide not classified for restricted use (other than
a ready to use consumer products pesticides); for the purpose
of providing structural pest control or lawn pest control
including janitors, general maintenance personnel, sanitation
personnel, and grounds maintenance personnel. The term
`maintenance applicator' does not include private applicators
as defined in section 2(e)(2); individuals who use
antimicrobial pesticides, sanitizers or disinfectants;
individuals employed by Federal, State, and local governments
or any political subdivisions thereof, or individuals who use
pesticides not classified for restricted use in or around
their homes, boats, sod farms, nurseries, greenhouses, or
other noncommercial property.
``(kk) Service Technician.--The term `service technician'
means any individual who uses or supervises the use of
pesticides (other than a ready to use consumer products
pesticide) for the purpose of providing structural pest
control or lawn pest control on the property of another for a
fee. The term `service technician' does not include
individuals who use antimicrobial pesticides, sanitizers or
disinfectants; or who otherwise apply ready to use consumer
products pesticides.''.

SEC. 121. MINIMUM REQUIREMENTS FOR TRAINING OF MAINTENANCE
APPLICATORS AND SERVICE TECHNICIANS.

The Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. 136 et seq.) is amended--
(1) by redesignating sections 30 and 31 as sections 33 and
34, respectively; and
(2) by adding after section 29 the following:

``SEC. 30. MINIMUM REQUIREMENTS FOR TRAINING OF MAINTENANCE
APPLICATORS AND SERVICE TECHNICIANS.

``Each State may establish minimum requirements for
training of maintenance applicators and service technicians.
Such training may include instruction in the safe and
effective handling and use of pesticides in accordance with
the Environmental Protection Agency approved labeling, and
instruction in integrated pest management techniques. The
authority of the Administrator with respect to minimum
requirements for training of maintenance applicators and
service technicians shall be limited to ensuring that each
State understands the provisions of this section.''.
TITLE II--MINOR USE CROP PROTECTION, ANTIMICROBIAL PESTICIDE
REGISTRATION REFORM, AND PUBLIC HEALTH PESTICIDES

SEC. 201. REFERENCE.

SEC. 210. MINOR CROP PROTECTION.

(a) Definition.--Section 2 (7 U.S.C. 136), as amended by
section 120, is further amended by adding at the end the
following:
``(ll) Minor Use.--The term `minor use' means the use of a
pesticide on an animal, on a commercial 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, as determined by the Secretary of
Agriculture; or
``(2) the Administrator, in consultation with the Secretary
of Agriculture, determines that, based on information
provided by an applicant for registration or a registrant,
the use does not provide sufficient 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;
``(B) the alternatives to the pesticide use pose greater
risks to the environment or human health;
``(C) the minor use pesticide plays or will play a
significant part in managing pest resistance; or
``(D) the minor use pesticide plays or will play a
significant part in an integrated pest management program.

The status as a minor use under this subsection shall
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--
(1) by redesignating clauses (ii) and (iii) as clauses
(iii) and (iv), respectively; and
(2) by inserting after clause (i) the following:

[[Page H8129]]

``(ii) The period of exclusive data use provided under
clause (i) shall be extended 1 additional year for each 3
minor uses registered after the date of enactment of this
clause and within 7 years of the commencement of the
exclusive use period, up to a total of 3 additional years for
all minor uses registered by the Administrator if the
Administrator, in consultation with the Secretary of
Agriculture, determines that, based on information provided
by an applicant for registration or a registrant, that--

``(I) there are insufficient efficacious alternative
registered pesticides available for the use;
``(II) the alternatives to the minor use pesticide pose
greater risks to the environment or human health;
``(III) the minor use pesticide plays or will play a
significant part in managing pest resistance; or
``(IV) the minor use pesticide plays or will play a
significant part in an integrated pest management 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 1 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.'';
(3) in clause (iv), as amended by paragraph (1), by
striking ``and (ii)'' and inserting ``, (ii), and (iii)'';
and
(4) at the end of the section, as amended by paragraph (1),
by adding the following:
``(v) The period of exclusive use provided under clause
(ii) shall not take into effect until 1 year after enactment
of this clause, except where an applicant or registrant is
applying for the registration of a pesticide containing an
active ingredient not previously registered.
``(vi) With respect to data submitted after the date of
enactment of this clause by an applicant or registrant to
support an amendment adding a new use to an existing
registration that does not retain any period of exclusive
use, if such data relates solely to a minor use of a
pesticide, such data shall not, without the written
permission of the original data submitter, be considered by
the Administrator to support an application for a minor use
by another person during the period of 10 years following the
date of submission of such data. The applicant or registrant
at the time the new minor use is requested shall notify the
Administrator that to the best of their knowledge the
exclusive use period for the pesticide has expired and that
the data pertaining solely to the minor use of a pesticide is
eligible for the provisions of this paragraph. If the minor
use registration which is supported by data submitted
pursuant to this subsection is voluntarily canceled or if
such data are subsequently used to support a nonminor use,
the data shall no longer be subject to the exclusive use
provisions of this clause but shall instead be considered by
the Administrator in accordance with the provisions of clause
(i), as appropriate.''.
(c) Time Extensions for Development of Minor Use Data.--
(1) Data call-in.--Section 3(c)(2)(B) (7 U.S.C.
136a(c)(2)(B)) is amended by adding at the end the following:
``(vi) Upon the request of a registrant the Administrator
shall, in the case of a minor use, extend the deadline for
the 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 uses of the pesticide established as
of the date of enactment of the Food Quality Protection Act
of 1996, if--
``(I) the data to support other uses of the pesticide on a
food are being provided;
``(II) the registrant, in submitting a request for such an
extension, provides a schedule, 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 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 application 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 Food Quality
Protection Act of 1996 if--
``(i) the data to support other uses of the pesticide on a
food are being provided;
``(ii) the registrant, in submitting a request for such an
extension provides a schedule, 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 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 affect on the environment.
In such circumstance, the Administrator shall provide written
notice to the registrant revoking the extension of time for
submission of data. Such data shall instead be due in
accordance with the date then 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 nonminor use, a minor use that
would, in the judgment of the Administrator, serve as a
replacement for any use which has been canceled in the 5
years preceding the receipt of the application, or a minor
use that in the opinion of the Administrator would avoid the
reissuance of an emergency exemption under section 18 for
that minor use.

``(D) Adequate time for submission of minor use data.--If a
registrant makes a request for a minor use waiver, regarding
data required by the Administrator, pursuant to

[[Page H8130]]

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 date of receipt
by the registrant of the Administrator's notice of denial.''.
(f) Temporary Extension of Registration for Unsupported
Minor Uses.--
(1) Reregistration.--
(A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C. 136a-1(d)(6) and
(f)(3)) are each amended by adding at the end the following:
``If the 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 Food Quality Protection Act
of 1996, 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 Food Quality Protection Act of 1996, for
the submission of data under this section for the supported
uses identified pursuant to this subparagraph unless the
Administrator 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)(1), is further amended by adding at
the end the following:
``(vii) If the registrant does not commit to support a
specific minor use of the 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 Food Quality
Protection Act of 1996, 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 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 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) Section 6(f) (7 U.S.C. 136d(f)) is amended--
(1) in paragraph (1)(C)(ii) by striking ``90-day'' each
place it appears and inserting ``180-day''; and
(2) in paragraph (3)(A) by striking ``90-day'' and
inserting ``180-day''.
(h) 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
pesticide.--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 subsection, the applicant must
certify that it agrees to satisfy any outstanding data
requirements necessary to support the reregistration of the
pesticide in accordance with the data submission schedule
established by the Administrator.''.
(i) Environmental Protection Agency Minor Use Program.--The
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136 et seq.), as amended by section 121, is amended by adding
after section 30 the following:

``SEC. 31. ENVIRONMENTAL PROTECTION AGENCY MINOR USE PROGRAM.

``(a) The Administrator shall assure coordination of minor
use issues through the establishment of a minor use program
within the Office of Pesticide Programs. Such 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.
``(b) The Office of Pesticide Programs shall prepare a
public report concerning the progress made on the
registration of minor uses, including implementation of the
exclusive use as an incentive for registering new minor uses,
within 3 years of the passage of the Food Quality Protection
Act of 1996.''.
(j) Department of Agriculture Minor Use Program.--The
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136 et seq.), as amended by subsection (i), is amended by
adding after section 31 the following:

``SEC. 32. DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM.

``(a) In General.--The Secretary of Agriculture
(hereinafter in this section referred

[[Page H8131]]

to as the `Secretary') shall assure 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 of Public Law 89-106 (7 U.S.C.
450i(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)(1) Minor Use Pesticide Data.--
``(A) Grant authority.--The Secretary, in consultation with
the Administrator, shall establish a program to make grants
for the development of data to support minor use pesticide
registrations and reregistrations. The amount of any such
grant shall not exceed \1/2\ of the cost of the project for
which the grant is made.
``(B) Applicants.--Any person who wants to develop data to
support minor use pesticide registrations and reregistrations
may apply for a grant under subparagraph (A). Priority shall
be given to an applicant for such a grant who does not
directly receive funds from the sale of pesticides registered
for minor uses.
``(C) Data ownership.--Any data that is developed under a
grant under subparagraph (A) shall be jointly owned by the
Department of Agriculture and the person who received the
grant. Such a person shall enter into an agreement with the
Secretary under which such person shall share any fee paid to
such person under section 3(c)(1)(F).
``(2) Minor use pesticide data revolving fund.--
``(A) Establishment.--There is established in the Treasury
of the United States a revolving fund to be known as the
Minor Use Pesticide Data Revolving Fund. The Fund shall be
available without fiscal year limitation to carry out the
authorized purposes of this subsection.
``(B) Contents of the fund.--There shall be deposited in
the Fund--
``(i) such amounts as may be appropriated to support the
purposes of this subsection; and
``(ii) fees collected by the Secretary for any data
developed under a grant under paragraph (1)(A).
``(C) Authorizations of appropriations.--There are
authorized to be appropriated for each fiscal year to carry
out the purposes of this subsection $10,000,000 to remain
available until expended.''.
Subtitle B--Antimicrobial Pesticide Registration Reform

SEC. 221. DEFINITIONS.

Section 2 (7 U.S.C. 136), as amended by section 210(a) is
further amended--
(1) in subsection (u), by adding at the end the following:
``The term `pesticide' does not include liquid chemical
sterilant products (including any sterilant or subordinate
disinfectant claims on such products) for use on a critical
or semi-critical device, as defined in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). For
purposes of the preceding sentence, the term `critical
device' includes any device which is introduced directly into
the human body, either into or in contact with the
bloodstream or normally sterile areas of the body and the
term `semi-critical device' includes any device which
contacts intact mucous membranes but which does not
ordinarily penetrate the blood barrier or otherwise enter
normally sterile areas of the body.''; and
(2) by adding at the end the following:
``(mm) Antimicrobial Pesticide.--
``(1) In general.--The term `antimicrobial pesticide' means
a pesticide that--
``(A) is intended to--
``(i) disinfect, sanitize, reduce, or mitigate growth or
development of microbiological organisms; or
``(ii) protect inanimate objects, industrial processes or
systems, surfaces, water, or other chemical substances from
contamination, fouling, or deterioration caused by bacteria,
viruses, fungi, protozoa, algae, or slime; and
``(B) in the intended use is exempt from, or otherwise not
subject to, a tolerance under section 408 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 346a and 348) or a
food additive regulation under section 409 of such Act.
``(2) Excluded products.--The term `antimicrobial
pesticide' does not include --
``(A) a wood preservative or antifouling paint product for
which a claim of pesticidal activity other than or in
addition to an activity described in paragraph (1) is made;
``(B) an agricultural fungicide product; or
``(C) an aquatic herbicide product.
``(3) Included products.--The term `antimicrobial
pesticide' does include any other chemical sterilant product
(other than liquid chemical sterilant products exempt under
subsection (u)), any other disinfectant product, any other
industrial microbiocide product, and any other preservative
product that is not excluded by paragraph (2).''.

SEC. 222. FEDERAL AND STATE DATA COORDINATION.

Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as amended by
section 210(f)(2), is amended by adding at the end the
following:
``(viii)(I) If data required to support registration of a
pesticide under subparagraph (A) is requested by a Federal or
State regulatory authority, the Administrator shall, to the
extent practicable, coordinate data requirements, test
protocols, timetables, and standards of review and reduce
burdens and redundancy caused to the registrant by multiple
requirements on the registrant.
``(II) The Administrator may enter into a cooperative
agreement with a State to carry out subclause (I).
``(III) Not later than 1 year after the date of enactment
of this clause, the Administrator shall develop a process to
identify and assist in alleviating future disparities between
Federal and State data requirements.''.

SEC. 223. LABEL AND LABELING.

Section 3(c) (7 U.S.C. 136a(c)) is amended by adding at the
end the following:
``(9) Labeling.--
``(A) Additional statements.--Subject to subparagraphs (B)
and (C), it shall not be a violation of this Act for a
registrant to modify the labeling of an antimicrobial
pesticide product to include relevant information on product
efficacy, product composition, container composition or
design, or other characteristics that do not relate to any
pesticidal claim or pesticidal activity.
``(B) Requirements.--Proposed labeling information under
subparagraph (A) shall not be false or misleading, shall not
conflict with or detract from any statement required by law
or the Administrator as a condition of registration, and
shall be substantiated on the request of the Administrator.
``(C) Notification and disapproval.--
``(i) Notification.--A registration may be modified under
subparagraph (A) if --

``(I) the registrant notifies the Administrator in writing
not later than 60 days prior to distribution or sale of a
product bearing the modified labeling; and
``(II) the Administrator does not disapprove of the
modification under clause (ii).

``(ii) Disapproval.--Not later than 30 days after receipt
of a notification under clause (i), the Administrator may
disapprove the modification by sending the registrant
notification in writing stating that the proposed language is
not acceptable and stating the reasons why the Administrator
finds the proposed modification unacceptable.
``(iii) Restriction on sale.--A registrant may not sell or
distribute a product bearing a disapproved modification.
``(iv) Objection.--A registrant may file an objection in
writing to a disapproval under clause (ii) not later than 30
days after receipt of notification of the disapproval.
``(v) Final action.--A decision by the Administrator
following receipt and consideration of an objection filed
under clause (iv) shall be considered a final agency action.
``(D) Use dilution.--The label or labeling required under
this Act for an antimicrobial pesticide that is or may be
diluted for use may have a different statement of caution or
protective measures for use of the recommended diluted
solution of the pesticide than for use of a concentrate of
the pesticide if the Administrator determines that --
``(i) adequate data have been submitted to support the
statement proposed for the diluted solution uses; and
``(ii) the label or labeling provides adequate protection
for exposure to the diluted solution of the pesticide.''.

SEC. 224. REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL
PESTICIDES.

Section 3 (7 U.S.C. 136a), as amended by section 106(b), is
further amended by adding at the end the following:
``(h) Registration Requirements for Antimicrobial
Pesticides.--
``(1) Evaluation of process.--To the maximum extent
practicable consistent with the degrees of risk presented by
a antimicrobial pesticide and the type of review appropriate
to evaluate the risks, the Administrator shall identify and
evaluate reforms to the antimicrobial registration process
that would reduce review periods existing as of the date of
enactment of this subsection for antimicrobial pesticide
product registration applications and applications for
amended registration of antimicrobial pesticide products,
including--
``(A) new antimicrobial active ingredients;
``(B) new antimicrobial end-use products;
``(C) substantially similar or identical antimicrobial
pesticides; and
``(D) amendments to antimicrobial pesticide registrations.
``(2) Review time period reduction goal.--Each reform
identified under paragraph (1) shall be designed to achieve
the goal of reducing the review period following submission
of a complete application, consistent with the degree of
risk, to a period of not more than --
``(A) 540 days for a new antimicrobial active ingredient
pesticide registration;
``(B) 270 days for a new antimicrobial use of a registered
active ingredient;
``(C) 120 days for any other new antimicrobial product;
``(D) 90 days for a substantially similar or identical
antimicrobial product;
``(E) 90 days for an amendment to an antimicrobial
registration that does not require scientific review of data;
and
``(F) 90 to 180 days for an amendment to an antimicrobial
registration that requires scientific review of data and that
is not otherwise described in this paragraph.
``(3) Implementation.--
``(A) Proposed rulemaking.--
``(i) Issuance.--Not later than 270 days after the date of
enactment of this subsection, the Administrator shall publish
in the Federal Register proposed regulations to accelerate
and improve the review of

[[Page H8132]]

antimicrobial pesticide products designed to implement, to
the extent practicable, the goals set forth in paragraph (2).
``(ii) Requirements.--Proposed regulations issued under
clause (i) shall --

``(I) define the various classes of antimicrobial use
patterns, including household, industrial, and institutional
disinfectants and sanitizing pesticides, preservatives, water
treatment, and pulp and paper mill additives, and other such
products intended to disinfect, sanitize, reduce, or mitigate
growth or development of microbiological organisms, or
protect inanimate objects, industrial processes or systems,
surfaces, water, or other chemical substances from
contamination, fouling, or deterioration caused by bacteria,
viruses, fungi, protozoa, algae, or slime;
``(II) differentiate the types of review undertaken for
antimicrobial pesticides;
``(III) conform the degree and type of review to the risks
and benefits presented by antimicrobial pesticides and the
function of review under this Act, considering the use
patterns of the product, toxicity, expected exposure, and
product type;
``(IV) ensure that the registration process is sufficient
to maintain antimicrobial pesticide efficacy and that
antimicrobial pesticide products continue to meet product
performance standards and effectiveness levels for each type
of label claim made; and
``(V) implement effective and reliable deadlines for
process management.

``(iii) Comments.--In developing the proposed regulations,
the Administrator shall solicit the views from registrants
and other affected parties to maximize the effectiveness of
the rule development process.
``(B) Final regulations.--
``(i) Issuance.--The Administrator shall issue final
regulations not later than 240 days after the close of the
comment period for the proposed regulations.
``(ii) Failure to meet goal.--If a goal described in
paragraph (2) is not met by the final regulations, the
Administrator shall identify the goal, explain why the goal
was not attained, describe the element of the regulations
included instead, and identify future steps to attain the
goal.
``(iii) Requirements.--In issuing final regulations, the
Administrator shall--

``(I) consider the establishment of a certification process
for regulatory actions involving risks that can be
responsibly managed, consistent with the degree of risk, in
the most cost-efficient manner;
``(II) consider the establishment of a certification
process by approved laboratories as an adjunct to the review
process;
``(III) use all appropriate and cost-effective review
mechanisms, including--

``(aa) expanded use of notification and non-notification
procedures;
``(bb) revised procedures for application review; and
``(cc) allocation of appropriate resources to ensure
streamlined management of antimicrobial pesticide
registrations; and

``(IV) clarify criteria for determination of the
completeness of an application.

``(C) Expedited review.--This subsection does not affect
the requirements or extend the deadlines or review periods
contained in subsection (c)(3).
``(D) Alternative review periods.--If the final regulations
to carry out this paragraph are not effective 630 days after
the date of enactment of this subsection, until the final
regulations become effective, the review period, beginning on
the date of receipt by the Agency of a complete application,
shall be --
``(i) 2 years for a new antimicrobial active ingredient
pesticide registration;
``(ii) 1 year for a new antimicrobial use of a registered
active ingredient;
``(iii) 180 days for any other new antimicrobial product;
``(iv) 90 days for a substantially similar or identical
antimicrobial product;
``(v) 90 days for an amendment to an antimicrobial
registration that does not require scientific review of data;
and
``(vi) 240 days for an amendment to an antimicrobial
registration that requires scientific review of data and that
is not otherwise described in this subparagraph.
``(E) Wood preservatives.--An application for the
registration, or for an amendment to the registration, of a
wood preservative product for which a claim of pesticidal
activity listed in section 2(mm) is made (regardless of any
other pesticidal claim that is made with respect to the
product) shall be reviewed by the Administrator within the
same period as that established under this paragraph for an
antimicrobial pesticide product application, consistent with
the degree of risk posed by the use of the wood preservative
product, if the application requires the applicant to satisfy
the same data requirements as are required to support an
application for a wood preservative product that is an
antimicrobial pesticide.
``(F) Notification.--
``(i) In general.--Subject to clause (iii), the
Administrator shall notify an applicant whether an
application has been granted or denied not later than the
final day of the appropriate review period under this
paragraph, unless the applicant and the Administrator agree
to a later date.
``(ii) Final decision.--If the Administrator fails to
notify an applicant within the period of time required under
clause (i), the failure shall be considered an agency action
unlawfully withheld or unreasonably delayed for purposes of
judicial review under chapter 7 of title 5, United States
Code.
``(iii) Exemption.--This subparagraph does not apply to an
application for an antimicrobial pesticide that is filed
under subsection (c)(3)(B) prior to 90 days after the date of
enactment of this subsection.
``(4) Annual report.--
``(A) Submission.--Beginning on the date of enactment of
this subsection and ending on the date that the goals under
paragraph (2) are achieved, the Administrator shall, not
later than March 1 of each year, prepare and submit an annual
report to the Committee on Agriculture of the House of
Representatives and the Committee on Agriculture, Nutrition,
and Forestry of the Senate.
``(B) Requirements.--A report submitted under subparagraph
(A) shall include a description of--
``(i) measures taken to reduce the backlog of pending
registration applications;
``(ii) progress toward achieving reforms under this
subsection; and
``(iii) recommendations to improve the activities of the
Agency pertaining to antimicrobial registrations.''.

SEC. 225. DISPOSAL OF HOUSEHOLD, INDUSTRIAL, OR
INSTITUTIONAL ANTIMICROBIAL PRODUCTS.

Section 19(h) (7 U.S.C. 136q(h)) is amended--
(1) by striking ``Nothing in'' and inserting the following:
``(1) In general.--Nothing in''; and
(2) by adding at the end the following:
``(2) Antimicrobial products.--A household, industrial, or
institutional antimicrobial product that is not subject to
regulation under the Solid Waste Disposal Act (42 U.S.C. 6901
et seq.) shall not be subject to the provisions of
subsections (a), (e), and (f), unless the Administrator
determines that such product must be subject to such
provisions to prevent an unreasonable adverse effect on the
environment.''.
Subtitle C--Public Health Pesticides

SEC. 230. DEFINITIONS.

(a) Adverse Effects.--Section 2(bb) (7 U.S.C. 136(bb)) is
amended by adding at the end the following: ``The
Administrator shall consider the risks and benefits of public
health pesticides separate from the risks and benefits of
other pesticides. In weighing any regulatory action
concerning a public health pesticide under this Act, the
Administrator shall weigh any risks of the pesticide against
the health risks such as the diseases transmitted by the
vector to be controlled by the pesticide.''.
(b) New Definitions.--Section 2 (7 U.S.C. 136), as amended
by section 221, is amended by adding at the end the
following:
``(nn) Public Health Pesticide.--The term `public health
pesticide' means any minor use pesticide product registered
for use and used predominantly in public health programs for
vector control or for other recognized health protection
uses, including the prevention or mitigation of viruses,
bacteria, or other microorganisms (other than viruses,
bacteria, or other microorganisms on or in living man or
other living animal) that pose a threat to public health.
``(oo) Vector.--The term `vector' means any organism
capable of transmitting the causative agent of human disease
or capable of producing human discomfort or injury, including
mosquitoes, flies, fleas, cockroaches, or other insects and
ticks, mites, or rats.''.

SEC. 231. REGISTRATION.

Section 3(c)(2)(A) (7 U.S.C. 136a(c)(2)(A)) is amended--
(1) by inserting after ``pattern of use,'' the following:
``the public health and agricultural need for such minor
use,''; and
(2) by striking ``potential exposure of man and the
environment to the pesticide'' and inserting ``potential
beneficial or adverse effects on man and the environment''.

SEC. 232. REREGISTRATION.

Section 4 (7 U.S.C. 136a-1) is amended--
(1) in subsection (i)(4), by redesignating subparagraphs
(B) and (C) as subparagraphs (C) and (D), respectively, and
by adding after subparagraph (A) the following:
``(B) The Administrator shall exempt any public health
pesticide from the payment of the fee prescribed under
paragraph (3) if, in consultation with the Secretary of
Health and Human Services, the Administrator determines,
based on information supplied by the registrant, that the
economic return to the registrant from sales of the pesticide
does not support the registration or reregistration of the
pesticide.'';
(2) in subsection (i)(5), by redesignating subparagraphs
(F) and (G) as subparagraphs (G) and (H), respectively, and
by adding after subparagraph (E) the following:
``(F) The Administrator shall exempt any public health
pesticide from the payment of the fee prescribed under
paragraph (3) if, in consultation with the Secretary of
Health and Humans Services, the Administrator determines,
based on information supplied by the registrant, that the
economic return to the registrant from sales of the pesticide
does not support the registration or reregistration of the
pesticide.'';
(3) in subsection (i)(7)(B), by striking ``or to
determine'' and inserting ``, to determine'' and by inserting
before the period the following: ``, or to determine the
volume usage for public health pesticides''; and
(4) in subsection (k)(3)(A), by striking ``or'' at the end
of clause (i), by striking the period at the end of clause
(ii) and inserting thereof ``; or'', and by adding after
clause (ii) the following:
``(iii) proposes the initial or amended registration of an
end use pesticide that, if registered as proposed, would be
used for a public health pesticide.''.

[[Page H8133]]

SEC. 233. CANCELLATION.

Section 6(b) (7 U.S.C. 136d(b)) is amended by adding after
the eighth sentence the following: ``When a public health use
is affected, the Secretary of Health and Human Services
should provide available benefits and use information, or an
analysis thereof, in accordance with the procedures followed
and subject to the same conditions as the Secretary of
Agriculture in the case of agricultural pesticides.''.

SEC. 234. VIEWS OF THE SECRETARY OF HEALTH AND HUMAN
SERVICES.

Section 21 (7 U.S.C. 136s) is amended by redesignating
subsections (b) and (c) as subsections (c) and (d),
respectively, and by adding after subsection (a) the
following:
``(b) Secretary of Health and Human Services.--The
Administrator, before publishing regulations under this Act
for any public health pesticide, shall solicit the views of
the Secretary of Health and Human Services in the same manner
as the views of the Secretary of Agriculture are solicited
under section 25(a)(2).''.

SEC. 235. AUTHORITY OF ADMINISTRATOR.

Section 25(a)(1) (7 U.S.C. 136w(a)(1)) is amended--
(1) by inserting after ``various classes of pesticides''
the following: ``, including public health pesticides,''; and
(2) by striking ``and nonagricultural pesticides'' and
inserting ``, nonagricultural, and public health
pesticides''.

SEC. 236. IDENTIFICATION OF PESTS.

Section 28 (7 U.S.C. 136w-3) is amended by adding at the
end the following:
``(d) Public Health Pests.--The Administrator, in
coordination with the Secretary of Agriculture and the
Secretary of Health and Human Services, shall identify pests
of significant public health importance and, in coordination
with the Public Health Service, develop and implement
programs to improve and facilitate the safe and necessary use
of chemical, biological, and other methods to combat and
control such pests of public health importance.''.

SEC. 237. PUBLIC HEALTH DATA.

Section 4 (7 U.S.C. 136a-1) is amended by adding at the end
the following:
``(m) Authorization of Funds To Develop Public Health
Data.--
``(1) Definition.--For the purposes of this section,
`Secretary' means the Secretary of Health and Human Services,
acting through the Public Health Service.
``(2) Consultation.--In the case of a pesticide registered
for use in public health programs for vector control or for
other uses the Administrator determines to be human health
protection uses, the Administrator shall, upon timely request
by the registrant or any other interested person, or on the
Administrator's own initiative may, consult with the
Secretary prior to taking final action to suspend
registration under section 3(c)(2)(B)(iv), or cancel a
registration under section 4, 6(e), or 6(f). In consultation
with the Secretary, the Administrator shall prescribe the
form and content of requests under this section.
``(3) Benefits to support family.--The Administrator, after
consulting with the Secretary, shall make a determination
whether the potential benefits of continued use of the
pesticide for public health or health protection purposes are
of such significance as to warrant a commitment by the
Secretary to conduct or to arrange for the conduct of the
studies required by the Administrator to support continued
registration under section 3 or reregistration under section
4.
``(4) Additional time.--If the Administrator determines
that such a commitment is warranted and in the public
interest, the Administrator shall notify the Secretary and
shall, to the extent necessary, amend a notice issued under
section 3(c)(2)(B) to specify additional reasonable time
periods for submission of the data.
``(5) Arrangements.--The Secretary shall make such
arrangements for the conduct of required studies as the
Secretary finds necessary and appropriate to permit
submission of data in accordance with the time periods
prescribed by the Administrator. Such arrangements may
include Public Health Service intramural research activities,
grants, contracts, or cooperative agreements with academic,
public health, or other organizations qualified by experience
and training to conduct such studies.
``(6) Support.--The Secretary may provide for support of
the required studies using funds authorized to be
appropriated under this section, the Public Health Service
Act, or other appropriate authorities. After a determination
is made under subsection (d), the Secretary shall notify the
Committees on Appropriations of the House Representatives and
the Senate of the sums required to conduct the necessary
studies.
``(7) Authorization of appropriations.--There is authorized
to be appropriated to carry out the purposes of this section
$12,000,000 for fiscal year 1997, and such sums as may be
necessary for succeeding fiscal years.''.
Subtitle D--Expedited Registration of Reduced Risk Pesticides

SEC. 250. EXPEDITED REGISTRATION OF PESTICIDES .

Section 3(c) (7 U.S.C. 136a(c)), as amended by section 223,
is amended--
(1) by adding at the end of paragraph (1) the following:
``(G) If the applicant is requesting that the registration
or amendment to the registration of a pesticide be expedited,
an explanation of the basis for the request must be
submitted, in accordance with paragraph (10) of this
subsection.''; and
(2) by adding at the end the following:
``(10) Expedited registration of pesticides.--
``(A) Not later than 1 year after the date of enactment of
this paragraph, the Administrator shall, utilizing public
comment, develop procedures and guidelines, and expedite the
review of an application for registration of a pesticide or
an amendment to a registration that satisfies such
guidelines.
``(B) Any application for registration or an amendment,
including biological and conventional pesticides, will be
considered for expedited review under this paragraph. An
application for registration or an amendment shall qualify
for expedited review if use of the pesticide proposed by the
application may reasonably be expected to accomplish 1 or
more of the following:
``(i) Reduce the risks of pesticides to human health.
``(ii) Reduce the risks of pesticides to nontarget
organisms.
``(iii) Reduce the potential for contamination of
groundwater, surface water, or other valued environmental
resources.
``(iv) Broaden the adoption of integrated pest management
strategies, or make such strategies more available or more
effective.
``(C) The Administrator, not later than 30 days after
receipt of an application for expedited review, shall notify
the applicant whether the application is complete. If it is
found to be incomplete, the Administrator may either reject
the request for expedited review or ask the applicant for
additional information to satisfy the guidelines developed
under subparagraph (A).''.
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 Data Collection.--The Secretary of Agriculture
shall ensure that the residue data collection activities
conducted by the Department of Agriculture in cooperation
with the Environmental Protection Agency and the Department
of Health and Human Services, provide for the improved data
collection of pesticide residues, including guidelines for
the use of comparable analytical and 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 of Agriculture shall, as
appropriate, coordinate with the Administrator of the
Environmental Protection Agency in the design of the surveys
and make available to the Administrator the aggregate results
of the surveys to assist the Administrator.

SEC. 303. INTEGRATED PEST MANAGEMENT.

The Secretary of Agriculture, in cooperation with the
Administrator, shall implement research, demonstration, and
education programs to support adoption of Integrated Pest
Management. Integrated Pest Management is a 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.

SEC. 304. COORDINATION OF CANCELLATION.

Section 2(bb) (7 U.S.C. 136(bb)) is amended--
(1) by inserting ``(1)'' after ``means''; and
(2) by striking the period at the end of the first sentence
and inserting ``, or (2) a human dietary risk from residues
that result from a use of a pesticide in or on any food
inconsistent with the standard under section 408 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a).''.

SEC. 305. PESTICIDE USE INFORMATION STUDY.

(a) The Secretary of Agriculture shall, in consultation
with the Administrator of the Environmental Protection
Agency, prepare a

[[Page H8134]]

report to Congress evaluating the current status and
potential improvements in Federal pesticide use information
gathering activities. This report shall at least include--
(1) an analysis of the quality and reliability of the
information collected by the Department of Agriculture, the
Environmental Protection Agency, and other Federal agencies
regarding the agricultural use of pesticides; and
(2) an analysis of options to increase the effectiveness of
national pesticide use information collection, including an
analysis of costs, burdens placed on agricultural producers
and other pesticide users, and effectiveness in tracking risk
reduction by those options.
(b) The Secretary shall submit this report to Congress not
later than 1 year following the date of enactment of this
section.
TITLE IV--AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

SEC 401. SHORT TITLE AND REFERENCE.

(a) Short Title.--This title may be cited as the ``Food
Quality Protection Act of 1996''.
(b) Reference.--Whenever in this title an amendment or
repeal is expressed in terms of an amendment to, or repeal
of, a section or other provision, the reference shall be
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).--Section 201(q) (21 U.S.C. 321(q)) is
amended to read as follows:
``(q)(1) The term `pesticide chemical' means any substance
that is a pesticide within the meaning of the Federal
Insecticide, Fungicide, and Rodenticide Act, including all
active and inert ingredients of such pesticide.
``(2) The term `pesticide chemical residue' means a residue
in or on raw agricultural commodity or processed food of--
``(A) a pesticide chemical; or
``(B) any other added substance that is present on or in
the commodity or food primarily as a result of the metabolism
or other degradation of a pesticide 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 or in 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) Section 201(s).--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.--Section 201 (21 U.S.C. 321) is amended by
adding at the end the following:
``(gg) The term `processed food' means any food other than
a raw agricultural commodity and includes any raw
agricultural commodity that has been subject to processing,
such as canning, cooking, freezing, dehydration, or milling.
``(hh) The term `Administrator' means the Administrator of
the United States Environmental Protection Agency.''.

SEC. 403. PROHIBITED ACTS.

Section 301(j) (21 U.S.C. 331(j)) is amended in the first
sentence by inserting before the period the following: ``; or
the violating of section 408(i)(2) or any regulation issued
under that section.''.

SEC. 404. ADULTERATED FOOD.

Section 402(a) (21 U.S.C. 342(a)) is amended by striking
``(2)(A) if it bears'' and all that follows through ``(3) if
it consists'' and inserting the following: ``(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; or (B) if it bears or contains a pesticide chemical
residue that is unsafe within the meaning of section 408(a);
or (C) if it is or if it bears or contains (i) any food
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 (3) if it
consists''.

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.--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 quantity
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.
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.
``(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 pesticide chemical has been used in or
on the raw agricultural commodity in conformity with a
tolerance under this section, such residue in or on the raw
agricultural commodity has been removed to the extent
possible in good manufacturing practice, and the
concentration of the pesticide chemical residue in the
processed food is not greater than the tolerance prescribed
for the pesticide chemical residue in the raw agricultural
commodity; or
``(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;
``(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 and does not state 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 Tolerance.--
``(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 own initiative under
subsection (e).

As used in this section, the term `modify' shall not mean
expanding the tolerance to cover additional foods.
``(2) Standard.--
``(A) General rule.--
``(i) Standard.--The Administrator may establish or leave
in effect a tolerance for a pesticide chemical residue in or
on a food only if the Administrator determines that the
tolerance is safe. The Administrator shall modify or revoke a
tolerance if the Administrator determines it is not safe.
``(ii) Determination of safety.--As used in this section,
the term `safe', with respect to a tolerance for a pesticide
chemical residue', means that the Administrator has
determined that there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all
other exposures for which there is reliable information.
``(iii) Rule of construction.--With respect to a tolerance,
a pesticide chemical residue meeting the standard under
clause (i) is not an eligible pesticide chemical residue for
purposes of subparagraph (B).
``(B) Tolerances for eligible pesticide chemical
residues.--
``(i) Definition.--As used in this subparagraph, the term
`eligible pesticide chemical residue' means a pesticide
chemical residue as to which--

[[Page H8135]]

``(I) the Administrator is not able to identify a level of
exposure to the residue at which the residue will not cause
or contribute to a known or anticipated harm to human health
(referred to in this section as a `nonthreshold effect');
``(II) the lifetime risk of experiencing the nonthreshold
effect is appropriately assessed by quantitative risk
assessment; and
``(III) with regard to any known or anticipated harm to
human health for which the Administrator is able to identify
a level at which the residue will not cause such harm
(referred to in this section as a `threshold effect'), the
Administrator determines that the level of aggregate exposure
is safe.

``(ii) Determination of tolerance.--Notwithstanding
subparagraph (A)(i), a tolerance for an eligible pesticide
chemical residue may be left in effect or modified under this
subparagraph if--

``(I) at least one of the conditions described in clause
(iii) is met; and
``(II) both of the conditions described in clause (iv) are
met.

``(iii) Conditions regarding use.--For purposes of clause
(ii), the conditions described in this clause with respect to
a tolerance for an eligible pesticide chemical residue are
the following:

``(I) Use of the pesticide chemical that produces the
residue protects consumers from adverse effects on health
that would pose a greater risk than the dietary risk from the
residue.
``(II) Use of the pesticide chemical that produces the
residue is necessary to avoid a significant disruption in
domestic production of an adequate, wholesome, and economical
food supply.

``(iv) Conditions regarding risk.--For purposes of clause
(ii), the conditions described in this clause with respect to
a tolerance for an eligible pesticide chemical residue are
the following:

``(I) The yearly risk associated with the nonthreshold
effect from aggregate exposure to the residue does not exceed
10 times the yearly risk that would be allowed under
subparagraph (A) for such effect.
``(II) The tolerance is limited so as to ensure that the
risk over a lifetime associated with the nonthreshold effect
from aggregate exposure to the residue is not greater than
twice the lifetime risk that would be allowed under
subparagraph (A) for such effect.

``(v) Review.--Five years after the date on which the
Administrator makes a determination to leave in effect or
modify a tolerance under this subparagraph, and thereafter as
the Administrator deems appropriate, the Administrator shall
determine, after notice and opportunity for comment, whether
it has been demonstrated to the Administrator that a
condition described in clause (iii)(I) or clause (iii)(II)
continues to exist with respect to the tolerance and that the
yearly and lifetime risks from aggregate exposure to such
residue continue to comply with the limits specified in
clause (iv). If the Administrator determines by such date
that such demonstration has not been made, the Administrator
shall, not later than 180 days after the date of such
determination, issue a regulation under subsection (e)(1) to
modify or revoke the tolerance.
``(vi) Infants and children.--Any tolerance under this
subparagraph shall meet the requirements of subparagraph (C).
``(C) Exposure of infants and children.--In establishing,
modifying, leaving in effect, or revoking a tolerance or
exemption for a pesticide chemical residue, the
Administrator--
``(i) shall assess the risk of the pesticide chemical
residue based on--

``(I) available information about consumption patterns
among infants and children that are likely to result in
disproportionately high consumption of foods containing or
bearing such residue among infants and children in comparison
to the general population;
``(II) available information concerning the special
susceptibility of infants and children to the pesticide
chemical residues, including neurological differences between
infants and children and adults, and effects of in utero
exposure to pesticide chemicals; and
``(III) available information concerning the cumulative
effects on infants and children of such residues and other
substances that have a common mechanism of toxicity; and

``(ii) shall--

``(I) ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate
exposure to the pesticide chemical residue; and
``(II) publish a specific determination regarding the
safety of the pesticide chemical residue for infants and
children.

The Secretary of Health and Human Services and the Secretary
of Agriculture, in consultation with the Administrator, shall
conduct surveys to document dietary exposure to pesticides
among infants and children. In the case of threshold effects,
for purposes of clause (ii)(I) an additional tenfold margin
of safety for the pesticide chemical residue and other
sources of exposure shall be applied for infants and children
to take into account potential pre- and post-natal toxicity
and completeness of the data with respect to exposure and
toxicity to infants and children. Notwithstanding such
requirement for an additional margin of safety, the
Administrator may use a different margin of safety for the
pesticide chemical residue only if, on the basis of reliable
data, such margin will be safe for infants and children.
``(D) Factors.--In establishing, modifying, leaving in
effect, or revoking a tolerance or exemption for a pesticide
chemical residue, the Administrator shall consider, among
other relevant factors--
``(i) the validity, completeness, and reliability of the
available data from studies of the pesticide chemical and
pesticide chemical residue;
``(ii) the nature of any toxic effect shown to be caused by
the pesticide chemical or pesticide chemical residue in such
studies;
``(iii) available information concerning the relationship
of the results of such studies to human risk;
``(iv) available information concerning the dietary
consumption patterns of consumers (and major identifiable
subgroups of consumers);
``(v) available information concerning the cumulative
effects of such residues and other substances that have a
common mechanism of toxicity;
``(vi) available information concerning the aggregate
exposure levels of consumers (and major identifiable
subgroups of consumers) to the pesticide chemical residue and
to other related substances, including dietary exposure under
the tolerance and all other tolerances in effect for the
pesticide chemical residue, and exposure from other non-
occupational sources;
``(vii) available information concerning the variability of
the sensitivities of major identifiable subgroups of
consumers;
``(viii) such information as the Administrator may require
on whether the pesticide chemical may have an effect in
humans that is similar to an effect produced by a naturally
occurring estrogen or other endocrine effects; and
``(ix) safety factors which in the opinion of experts
qualified by scientific training and experience to evaluate
the safety of food additives are generally recognized as
appropriate for the use of animal experimentation data.
``(E) Data and information regarding anticipated and actual
residue levels.--
``(i) Authority.--In establishing, modifying, leaving in
effect, or revoking a tolerance for a pesticide chemical
residue, the Administrator may consider available data and
information on the anticipated residue levels of the
pesticide chemical in or on food and the actual residue
levels of the pesticide chemical that have been measured in
food, including residue data collected by the Food and Drug
Administration.
``(ii) Requirement.--If the Administrator relies on
anticipated or actual residue levels in establishing,
modifying, or leaving in effect a tolerance, the
Administrator shall pursuant to subsection (f)(1) require
that data be provided five years after the date on which the
tolerance is established, modified, or left in effect, and
thereafter as the Administrator deems appropriate,
demonstrating that such residue levels are not above the
levels so relied on. If such data are not so provided, or if
the data do not demonstrate that the residue levels are not
above the levels so relied on, the Administrator shall, not
later than 180 days after the date on which the data were
required to be provided, issue a regulation under subsection
(e)(1), or an order under subsection (f)(2), as appropriate,
to modify or revoke the tolerance.
``(F) Percent of food actually treated.--In establishing,
modifying, leaving in effect, or revoking a tolerance for a
pesticide chemical residue, the Administrator may, when
assessing chronic dietary risk, consider available data and
information on the percent of food actually treated with the
pesticide chemical (including aggregate pesticide use data
collected by the Department of Agriculture) only if the
Administrator--
``(i) finds that the data are reliable and provide a valid
basis to show what percentage of the food derived from such
crop is likely to contain such pesticide chemical residue;
``(ii) finds that the exposure estimate does not understate
exposure for any significant subpopulation group;
``(iii) finds that, if data are available on pesticide use
and consumption of food in a particular area, the population
in such area is not dietarily exposed to residues above those
estimated by the Administrator; and
``(iv) provides for the periodic reevaluation of the
estimate of anticipated dietary exposure.
``(3) Detection methods.--
``(A) General rule.--A tolerance for a pesticide chemical
residue in or on a food shall not be established or modified
by the Administrator unless the Administrator determines,
after consultation with the Secretary, that there is a
practical method for detecting and measuring the levels of
the pesticide chemical residue in or on the food.
``(B) Detection limit.--A tolerance for a pesticide
chemical residue in or on a food shall not be established at
or modified to 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
(A).
``(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 pesticide chemical has been established by the Codex
Alimentarius Commission. If a Codex maximum residue level has
been established for the pesticide chemical and the
Administrator does not propose to adopt the Codex level, the
Administrator shall publish for public comment a notice
explaining the reasons for departing from the Codex level.

[[Page H8136]]

``(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 food--
``(A) in response to a petition filed under subsection (d);
or
``(B) on the Administrator's initiative under subsection
(e).
``(2) Standard.--
``(A) General rule.--
``(i) Standard.--The Administrator may establish or leave
in effect an exemption from the requirement for a tolerance
for a pesticide chemical residue in or on food only if the
Administrator determines that the exemption is safe. The
Administrator shall modify or revoke an exemption if the
Administrator determines it is not safe.
``(ii) Determination of safety.--The term `safe', with
respect to an exemption for a pesticide chemical residue,
means that the Administrator has determined that there is a
reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, including all
anticipated dietary exposures and all other exposures for
which there is reliable information.
``(B) Factors.--In making a determination under this
paragraph, the Administrator shall take into account, among
other relevant considerations, the considerations set forth
in subparagraphs (C) and (D) of subsection (b)(2).
``(3) Limitation.--An exemption from the requirement for a
tolerance for a pesticide chemical residue in or on food
shall not be established or modified 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 food; or
``(B) that there is no need for such a method, and states
the reasons for such determination in issuing the regulation
establishing or modifying the exemption.
``(d) Petition for Tolerance or 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, modifying, 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; and
``(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 for exemptions, a statement why such a method is not
needed;
``(vii) a proposed tolerance for the pesticide chemical
residue, if a tolerance is proposed;
``(viii) if the petition relates to a tolerance for a
processed food, reports of investigations conducted using the
processing method(s) used to produce that food;
``(ix) such information as the Administrator may require to
make the determination under subsection (b)(2)(C);
``(x) such information as the Administrator may require on
whether the pesticide chemical may have an effect in humans
that is similar to an effect produced by a naturally
occurring estrogen or other endocrine effects;
``(xi) information regarding exposure to the pesticide
chemical residue due to any tolerance or exemption already
granted for such residue;
``(xii) practical methods for removing any amount of the
residue that would exceed any proposed tolerance; and
``(xiii) 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 modify or 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)(I).
``(4) Actions by the administrator.--
``(A) In general.--The Administrator shall, after giving
due consideration to a petition filed under paragraph (1) and
any other information available to the Administrator--
``(i) issue a final regulation (which may vary from that
sought by the petition) establishing, modifying, or revoking
a tolerance for the pesticide chemical residue or an
exemption of the pesticide chemical residue from the
requirement of a tolerance (which final regulation shall be
issued without further notice and without further period for
public comment);
``(ii) issue a proposed regulation under subsection (e),
and thereafter issue a final regulation under such
subsection; or
``(iii) issue an order denying the petition.
``(B) Priorities.--The Administrator shall give priority to
petitions for the establishment or modification of a
tolerance or exemption for a pesticide chemical residue that
appears to pose a significantly lower risk to human health
from dietary exposure than pesticide chemical residues that
have tolerances in effect for the same or similar uses.
``(C) Expedited review of certain petitions.--
``(i) Date certain for review.--If a person files a
complete petition with the Administrator proposing the
issuance of a regulation establishing a tolerance or
exemption for a pesticide chemical residue that presents a
lower risk to human health than a pesticide chemical residue
for which a tolerance has been left in effect or modified
under subsection (b)(2)(B), the Administrator shall complete
action on such petition under this paragraph within 1 year.
``(ii) Required determinations.--If the Administrator
issues a final regulation establishing a tolerance or
exemption for a safer pesticide chemical residue under clause
(i), the Administrator shall, not later than 180 days after
the date on which the regulation is issued, determine whether
a condition described in subclause (I) or (II) of subsection
(b)(2)(B)(iii) continues to exist with respect to a tolerance
that has been left in effect or modified under subsection
(b)(2)(B). If such condition does not continue to exist, the
Administrator shall, not later than 180 days after the date
on which the determination under the preceding sentence is
made, issue a regulation under subsection (e)(1) to modify or
revoke the tolerance.
``(e) Action on Administrator's Own Initiative.--
``(1) General rule.--The Administrator may issue a
regulation--
``(A) establishing, modifying, suspending under subsection
(l)(3), or revoking a tolerance for a pesticide chemical or a
pesticide chemical residue;
``(B) establishing, modifying, suspending under subsection
(l)(3), 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.
``(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 in the
public interest to do so and states the reasons for the
finding in the notice of proposed rulemaking.
``(f) Special Data Requirements.--
``(1) Requiring submission of 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 person 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 60 days' duration, an order--
``(i) requiring the submission to the Administrator by one
or more interested persons of a notice identifying the person
or

[[Page H8137]]

persons who will submit the required data and information;
``(ii) describing the type of data and information required
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 under subparagraph (C) revise any such
order to correct an error. The Administrator may under this
paragraph require data or information pertaining to whether
the pesticide chemical may have an effect in humans that is
similar to an effect produced by a naturally occurring
estrogen or other endocrine effects.
``(2) Noncompliance.--If a submission required by a notice
issued in accordance with paragraph (1)(A), a rule issued
under paragraph (1)(B), or an order issued under paragraph
(1)(C) is not made by the time specified in such notice,
rule, or order, the Administrator may by order published in
the Federal Register modify or revoke the tolerance or
exemption in question. In any review of such an order under
subsection (g)(2), the only material issue shall be whether a
submission required under paragraph (1) was not made by the
time specified.
``(g) Effective Date, Objections, Hearings, and
Administrative Review.--
``(1) Effective date.--A regulation or order issued under
subsection (d)(4), (e)(1), or (f)(2) shall take effect upon
publication unless the regulation or order specifies
otherwise. The Administrator may stay the effectiveness of
the regulation or order if, after issuance of such regulation
or order, objections are filed with respect to such
regulation or order pursuant to paragraph (2).
``(2) Further proceedings.--
``(A) Objections.--Within 60 days after a regulation or
order is issued under subsection (d)(4), (e)(1)(A),
(e)(1)(B), (f)(2), (n)(3), or (n)(5)(C), any person may file
objections thereto with the Administrator, specifying with
particularity the provisions of the regulation or order
deemed objectionable and stating reasonable grounds therefor.
If the regulation or order was issued in response to a
petition under subsection (d)(1), a copy of each objection
filed by a person other than the petitioner shall be served
by the Administrator on the petitioner.
``(B) Hearing.--An objection may include a request for a
public 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) Final decision.--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.
``(h) Judicial Review.--
``(1) Petition.--In a case of actual controversy as to the
validity of any regulation issued under subsection (e)(1)(C),
or any order issued under subsection (f)(1)(C) or (g)(2)(C),
or any regulation that is the subject of such an order, any
person who will be adversely affected by such order or
regulation may obtain 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 or
regulation, a petition praying that the order or regulation
be set aside in whole or in part.
``(2) Record and jurisdiction.--A copy of the petition
under paragraph (1) shall be forthwith transmitted by the
clerk of the court to the Administrator, or any officer
designated by the 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. As to orders issued following a public evidentiary
hearing, 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.
``(3) Additional evidence.--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.
``(4) Final judgment; supreme court review.--The judgment
of the court affirming or setting aside, in whole or in part,
any regulation or any order and any regulation which is the
subject of such an order shall be final, subject to review by
the Supreme Court of the United States as provided in section
1254 of title 28 of the United States Code. The commencement
of proceedings under this subsection shall not, unless
specifically ordered by the court to the contrary, operate as
a stay of a regulation or order.
``(5) Application.--Any issue as to which review is or was
obtainable under this subsection shall not be the subject of
judicial review under any other provision of law.
``(i) Confidentiality and Use of Data.--
``(1) General rule.--Data and information that are or have
been submitted to the Administrator under this section or
section 409 in support of a tolerance or an exemption from a
tolerance shall be entitled to confidential treatment for
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.--
``(A) In general.--Data and information that are entitled
to confidential treatment under paragraph (1) may be
disclosed, under such security requirements as the
Administrator may provide by regulation, to--
``(i) employees of the United States authorized by the
Administrator to examine such data and information in the
carrying out of their official duties under this Act or other
Federal statutes intended to protect the public health; or
``(ii) contractors with the United States authorized by the
Administrator to examine such data and information in the
carrying out of contracts under this Act or such statutes.
``(B) Congress.--This subsection does not authorize the
withholding of data or information from either House of
Congress or from, to the extent of matter within its
jurisdiction, any committee or subcommittee of such committee
or any joint committee of Congress or any subcommittee of
such joint committee.
``(3) Summaries.--Notwithstanding any provision of this
subsection or other law, the Administrator may publish the
informative summary required by 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.
``(j) 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), and shall be subject to review under subsection
(q).
``(2) Regulations under section 409.--Regulations that
established tolerances for substances that are pesticide
chemical residues in or on 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), and shall be subject to review under
subsection (q).
``(3) Regulations under section 408.--Regulations that
established tolerances or exemptions under this section that
were issued on or before the date of the enactment of this
paragraph shall remain in effect unless modified or revoked
under subsection (d) or (e), and shall be subject to review
under subsection (q).
``(k) Transitional Provision.--If, on the day before the
date of the enactment of this subsection, a substance that is
a pesticide chemical was, with respect to a particular
pesticidal use of the substance and any resulting pesticide
chemical residue in or on a particular food--

[[Page H8138]]

``(1) regarded by the Administrator or the Secretary as
generally recognized as safe for use within the meaning of
the provisions of subsection (a) or section 201(s) as then in
effect; or
``(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. Any exemption under this subsection may be
modified or revoked as if it had been issued under subsection
(c).
``(l) Harmonization With Action Under Other Laws.--
``(1) Coordination with fifra.--To the extent practicable
and consistent with the review deadlines in subsection (q),
in issuing a final rule under this subsection that suspends
or revokes a tolerance or exemption for a pesticide chemical
residue in or on food, the Administrator shall coordinate
such action with any related necessary action under the
Federal Insecticide, Fungicide, and Rodenticide Act.
``(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. Subsection (e)
shall apply to actions taken 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. Subsection (e) shall apply to actions
taken 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 suspended or canceled
prior to the date of the enactment of this paragraph under
the Federal Insecticide, Fungicide, and Rodenticide Act, if
the Administrator determines that a residue of the canceled
or suspended pesticide chemical will 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. In establishing such a tolerance, the
Administrator shall take into account both the factors set
forth in subsection (b)(2) and the unavoidability of the
residue. Subsection (e) shall apply to the establishment of
such tolerance. The Administrator shall review any such
tolerance periodically and modify it as necessary so that it
allows no greater level of the pesticide chemical residue
than 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.
``(6) Tolerance for use of pesticides under an emergency
exemption.--If the Administrator grants an exemption under
section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136p) for a pesticide chemical, the
Administrator shall establish a tolerance or exemption from
the requirement for a tolerance for the pesticide chemical
residue. Such a tolerance or exemption from a tolerance shall
have an expiration date. The Administrator may establish such
a tolerance or exemption without providing notice or a period
for comment on the tolerance or exemption. The Administrator
shall promulgate regulations within 365 days after the date
of the enactment of this paragraph governing the
establishment of tolerances and exemptions under this
paragraph. Such regulations shall be consistent with the
safety standard under subsections (b)(2) and (c)(2) and with
section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act.
``(m) Fees.--
``(1) Amount.--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--
``(A) the acceptance for filing of a petition submitted
under subsection (d);
``(B) establishing, modifying, leaving in effect, or
revoking a tolerance or establishing, modifying, leaving in
effect, or revoking an exemption from the requirement for a
tolerance under this section;
``(C) the acceptance for filing of objections under
subsection (g); or
``(D) the certification and filing in court of a transcript
of the proceedings and the record under subsection (h);

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.
``(2) Deposit.--All fees collected under paragraph (1)
shall be deposited in the Reregistration and Expedited
Processing Fund created by section 4(k) of the Federal
Insecticide, Fungicide, and Rodenticide Act. Such fees shall
be available to the Administrator, without fiscal year
limitation, for the performance of the Administrator's
services or functions as specified in paragraph (1).
``(n) 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 this subsection.
``(2) Qualifying federal determination.--For purposes of
this subsection, the term `qualifying Federal determination'
means a tolerance or exemption from the requirement for a
tolerance for a qualifying pesticide chemical residue that--
``(A) is issued under this section after the date of the
enactment of this subsection and determined by the
Administrator to meet the standard under subsection (b)(2)(A)
(in the case of a tolerance) or (c)(2) (in the case of an
exemption); or
``(B)(i) pursuant to subsection (j) is remaining in effect
or is deemed to have been issued under this section, or is
regarded under subsection (k) as exempt from the requirement
for a tolerance; and
``(ii) is determined by the Administrator to meet the
standard under subsection (b)(2)(A) (in the case of a
tolerance) or (c)(2) (in the case of an exemption).
``(3) Limitation.--The Administrator may make the
determination described in paragraph (2)(B)(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 (g) and (h).
``(4) State authority.--Except as provided in paragraphs
(5), (6), and (8) no State or political subdivision may
establish or enforce

[[Page H8139]]

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 a 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).
``(5) Petition procedure.--
``(A) In general.--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) Petition requirements.--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) Authorization.--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; and
``(ii) would not cause any food to be a violation of
Federal law.
``(D) Treatment.--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
modify or revoke a tolerance or 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) Review.--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
(g) and (h).
``(6) Urgent petition procedure.--Any State petition to the
Administrator pursuant to paragraph (5) that demonstrates
that consumption of a food containing such pesticide residue
level during the period of the food's likely availability in
the State will pose a significant public health threat from
acute exposure shall be considered an urgent petition. If an
order by the Administrator to grant or deny the requested
authorization in an urgent petition is not made within 30
days of receipt of the petition, the petitioning State may
establish and enforce a temporary regulatory limit on a
qualifying pesticide chemical residue in or on the food. The
temporary regulatory limit shall be validated or terminated
by the Administrator's final order on the petition.
``(7) 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 section
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.
``(8) Savings.--Nothing in this Act preempts the authority
of any State or political subdivision to require that a food
containing a pesticide chemical residue bear or be the
subject of a warning or other statement relating to the
presence of the pesticide chemical residue in or on such
food.
``(o) Consumer Right to Know.--Not later than 2 years after
the date of the enactment of the Food Quality Protection Act
of 1996, and annually thereafter, the Administrator shall, in
consultation with the Secretary of Agriculture and the
Secretary of Health and Human Services, publish in a format
understandable to a lay person, and distribute to large
retail grocers for public display (in a manner determined by
the grocer), the following information, at a minimum:
``(1) A discussion of the risks and benefits of pesticide
chemical residues in or on food purchased by consumers.
``(2) A listing of actions taken under subparagraph (B) of
subsection (b)(2) that may result in pesticide chemical
residues in or on food that present a yearly or lifetime risk
above the risk allowed under subparagraph (A) of such
subsection, and the food on which the pesticide chemicals
producing the residues are used.
``(3) Recommendations to consumers for reducing dietary
exposure to pesticide chemical residues in a manner
consistent with maintaining a healthy diet, including a list
of food that may reasonably substitute for food listed under
paragraph (2).
Nothing in this subsection shall prevent retail grocers
from providing additional information.
``(p) Estrogenic substances screening program.--
``(1) Development.--Not later than 2 years after the date
of enactment of this section, the Administrator shall in
consultation with the Secretary of Health and Human Services
develop a screening program, using appropriate validated test
systems and other scientifically relevant information, to
determine whether certain substances may have an effect in
humans that is similar to an effect produced by a naturally
occurring estrogen, or such other endocrine effect as the
Administrator may designate.
``(2) Implementation.--Not later than 3 years after the
date of enactment of this section, after obtaining public
comment and review of the screening program described in
paragraph (1) by the scientific advisory panel established
under section 25(d) of the Federal Insecticide, Fungicide,
and Rodenticide Act or the science advisory board established
by section 8 of the Environmental Research, Development, and
Demonstration Act of 1978 (42 U.S.C. 4365), the Administrator
shall implement the program.
``(3) Substances.--In carrying out the screening program
described in paragraph (1), the Administrator--
``(A) shall provide for the testing of all pesticide
chemicals; and
``(B) may provide for the testing of any other substance
that may have an effect that is cumulative to an effect of a
pesticide chemical if the Administrator determines that a
substantial population may be exposed to such substance.
``(4) Exemption.--Notwithstanding paragraph (3), the
Administrator may, by order, exempt from the requirements of
this section a biologic substance or other substance if the
Administrator determines that the substance is anticipated
not to produce any effect in humans similar to an effect
produced by a naturally occurring estrogen.
``(5) Collection of information.--
``(A) In general.--The Administrator shall issue an order
to a registrant of a substance for which testing is required
under this subsection, or to a person who manufactures or
imports a substance for which testing is required under this
subsection, to conduct testing in accordance with the
screening program described in paragraph (1), and submit
information obtained from the testing to the Administrator,
within a reasonable time period that the Administrator
determines is sufficient for the generation of the
information.
``(B) Procedures.--To the extent practicable the
Administrator shall minimize duplicative testing of the same
substance for the same endocrine effect, develop, as
appropriate, procedures for fair and equitable sharing of
test costs, and develop, as necessary, procedures for
handling of confidential business information.
``(C) Failure of registrants to submit information.--
``(i) Suspension.--If a registrant of a substance referred
to in paragraph (3)(A) fails to comply with an order under
subparagraph (A) of this paragraph, the Administrator shall
issue a notice of intent to suspend the sale or distribution
of the substance by the registrant. Any suspension proposed
under this paragraph shall become final at the end of the 30-
day period beginning on the date that the registrant receives
the notice of intent to suspend, unless during that period a
person adversely affected by the notice requests a hearing or
the Administrator determines that the registrant has complied
fully with this paragraph.
``(ii) Hearing.--If a person requests a hearing under
clause (i), the hearing shall be conducted in accordance with
section 554 of title 5, United States Code. The only matter
for resolution at the hearing shall be whether the registrant
has failed to comply with an order under subparagraph (A) of
this paragraph. A decision by the Administrator after
completion of a hearing shall be considered to be a final
agency action.
``(iii) Termination of suspensions.--The Administrator
shall terminate a suspension under this subparagraph issued
with respect to a registrant if the Administrator determines
that the registrant has complied fully with this paragraph.
``(D) Noncompliance by other persons.--Any person (other
than a registrant) who fails to comply with an order under
subparagraph (A) shall be liable for the same penalties and
sanctions as are provided under section 16 of the Toxic
Substances Control Act (15 U.S.C. 2601 and following) in the
case of a violation referred to in that section. Such
penalties and sanctions shall be assessed and imposed in the
same manner as provided in such section 16.
``(6) Agency action.--In the case of any substance that is
found, as a result of testing and evaluation under this
section, to have an endocrine effect on humans, the
Administrator shall, as appropriate, take action under such
statutory authority as is available to the Administrator,
including consideration under other sections of this Act, as
is necessary to ensure the protection of public health.
``(7) Report to congress.--Not later than 4 years after the
date of enactment of this section, the Administrator shall
prepare and submit to Congress a report containing--
``(A) the findings of the Administrator resulting from the
screening program described in paragraph (1);
``(B) recommendations for further testing needed to
evaluate the impact on human health of the substances tested
under the screening program; and
``(C) recommendations for any further actions (including
any action described in

[[Page H8140]]

paragraph (6)) that the Administrator determines are
appropriate based on the findings.
``(q) Schedule for Review.--
``(1) In general.--The Administrator shall review
tolerances and exemptions for pesticide chemical residues in
effect on the day before the date of the enactment of the
Food Quality Protection Act of 1996, as expeditiously as
practicable, assuring that--
``(A) 33 percent of such tolerances and exemptions are
reviewed within 3 years of the date of enactment of such Act;
``(B) 66 percent of such tolerances and exemptions are
reviewed within 6 years of the date of enactment of such Act;
and
``(C) 100 percent of such tolerances and exemptions are
reviewed within 10 years of the date of enactment of such
Act.

In conducting a review of a tolerance or exemption, the
Administrator shall determine whether the tolerance or
exemption meets the requirements of subsections (b)(2) or
(c)(2) and shall, by the deadline for the review of the
tolerance or exemption, issue a regulation under subsection
(d)(4) or (e)(1) to modify or revoke the tolerance or
exemption if the tolerance or exemption does not meet such
requirements.
``(2) Priorities.--In determining priorities for reviewing
tolerances and exemptions under paragraph (1), the
Administrator shall give priority to the review of the
tolerances or exemptions that appear to pose the greatest
risk to public health.
``(3) Publication of schedule.--Not later than 12 months
after the date of the enactment of the Food Quality
Protection Act of 1996, the Administrator shall publish a
schedule for review of tolerances and exemptions established
prior to the date of the enactment of the Food Quality
Protection Act of 1996. The determination of priorities for
the review of tolerances and exemptions pursuant to this
subsection is not a rulemaking and shall not be subject to
judicial review, except that failure to take final action
pursuant to the schedule established by this paragraph shall
be subject to judicial review.
``(r) Temporary tolerance or exemption.--The Administrator
may, upon the request of any person who has obtained an
experimental permit for a pesticide chemical under the
Federal Insecticide, Fungicide, and Rodenticide Act or upon
the Administrator's own initiative, establish a temporary
tolerance or exemption for the pesticide chemical residue for
the uses covered by the permit. Subsections (b)(2), (c)(2),
(d), and (e) shall apply to actions taken under this
subsection.
``(s) Savings Clause.--Nothing in this section shall be
construed to amend or modify the provisions of the Toxic
Substances Control Act or the Federal Insecticide, Fungicide,
and Rodenticide Act.''.

SEC. 406. AUTHORIZATION FOR INCREASED MONITORING.

For the fiscal years 1997 through 1999, there is authorized
to be appropriated in the aggregate an additional $12,000,000
for increased monitoring by the Secretary of Health and Human
Services of pesticide residues in imported and domestic food.

SEC. 407. ALTERNATIVE ENFORCEMENT.

Section 303(g) (21 U.S.C. 333(f)) is amended--
(1) by redesignating paragraphs (2), (3), and (4) as
paragraphs (3), (4), and (5), respectively,
(2) by inserting after paragraph (1) the following:
``(2)(A) Any person who introduces into interstate commerce
or delivers for introduction into interstate commerce an
article of food that is adulterated within the meaning of
section 402(a)(2)(B) shall be subject to a civil money
penalty of not more than $50,000 in the case of an individual
and $250,000 in the case of any other person for such
introduction or delivery, not to exceed $500,000 for all such
violations adjudicated in a single proceeding.
``(B) This paragraph shall not apply to any person who grew
the article of food that is adulterated. If the Secretary
assesses a civil penalty against any person under this
paragraph, the Secretary may not use the criminal authorities
under this section to sanction such person for the
introduction or delivery for introduction into interstate
commerce of the article of food that is adulterated. If the
Secretary assesses a civil penalty against any person under
this paragraph, the Secretary may not use the seizure
authorities of section 304 or the injunction authorities of
section 302 with respect to the article of food that is
adulterated.
``(C) In a hearing to assess a civil penalty under this
paragraph, the presiding officer shall have the same
authority with regard to compelling testimony or production
of documents as a presiding officer has under section
408(g)(2)(B). The third sentence of paragraph (3)(A) shall
not apply to any investigation under this paragraph.'';
(3) in paragraph (3), as so redesignated, by striking
``paragraph (1)'' each place it occurs and inserting
``paragraph (1) or (2)'';
(4) in paragraph (4), as so redesignated, by striking
``(2)(A)'' and inserting ``(3)(A)''; and
(5) in paragraph (5), as so redesignated, by striking
``(3)'' each place it occurs and inserting ``(4)''.
TITLE V--FEES

SEC. 501. REREGISTRATION FEES.

(a) Section 4(i).--Section 4(i) (7 U.S.C. 136a-1(i)), as
amended by section 232(2), is amended--
(1) in paragraphs (5)(H) and (6), by striking ``1997'' and
inserting ``2001''; and
(2) in paragraph (5)(C), by inserting ``(i)'' after ``(C)''
and by adding at the end the following:
``(ii) in each of the fiscal years 1998, 1999, and 2000,
the Administrator is authorized to collect up to an
additional $2,000,000 in a manner consistent with subsection
(k)(5) and the recommendations of the Inspector General of
the Environmental Protection Agency. The total fees that may
be collected under this clause shall not exceed
$6,000,000.''.
(b) Section 4(k)(1).--Section 4(k)(1) (7 U.S.C. 136a-
1(k)(1) is amended by inserting before the period the
following: ``which shall be known as the Reregistration and
Expedited Processing Fund''.
(c) Section 4(k)(2).--Section 4(k)(2) (7 136a-1(k)(2)) is
amended to read as follows:
``(2) Source and use.--
``(A) All moneys derived from fees collected by the
Administrator under subsection (i) shall be deposited in the
fund and shall be available to the Administrator, without
fiscal year limitation, specifically to offset the costs of
reregistration and expedited processing of the applications
specified in paragraph (3). Such moneys derived from fees may
not be expended in any fiscal year to the extent such moneys
derived from fees would exceed money appropriated for use by
the Administrator and expended in such year for such costs of
reregistration and expedited processing of such applications.
The Administrator shall, prior to expending any such moneys
derived from fees--
``(i) effective October 1, 1997, adopt specific and cost
accounting rules and procedures as approved by the General
Accounting Office and the Inspector General of the
Environmental Protection Agency to ensure that moneys derived
from fees are allocated solely to the costs of reregistration
and expedited processing of the applications specified in
paragraph (3) in the same portion as appropriated funds;
``(ii) prohibit the use of such moneys derived from fees to
pay for any costs other than those necessary to achieve
reregistration and expedited processing of the applications
specified in paragraph (3); and
``(iii) ensure that personnel and facility costs associated
with the functions to be carried out under this paragraph do
not exceed agency averages for comparable personnel and
facility costs.
``(B) The Administrator shall also--
``(i) complete the review of unreviewed reregistration
studies required to support the reregistration eligibility
decisions scheduled for completion in accordance with
subsection (l)(2); and
``(ii) contract for such outside assistance as may be
necessary for review of required studies, using a generally
accepted competitive process for the selection of vendors of
such assistance.''.
(d) Section 4(k)(3).--Section 4(k)(3) (7 U.S.C. 136a-
1(k)(3)) is amended--
(1) in subparagraph (A), by striking out ``for each of the
fiscal years 1992, 1993, and 1994, \1/7\th of the maintenance
fees collected, up to 2 million each year'' and inserting in
lieu thereof ``for each of the fiscal years 1997 through
2001, not more than \1/7\ of the maintenance fees collected
in such fiscal year''; and
(2) by adding a new subparagraph (C) to read as follows:
``(C) So long as the Administrator has not met the time
frames specified in clause (ii) of section 3(c)(3)(B) with
respect to any application subject to section 3(c)(3)(B) that
was received prior to the date of enactment of the Food
Quality Protection Act of 1996, the Administrator shall use
the full amount of the fees specified in subparagraph (A) for
the purposes specified therein. Once all applications subject
to section 3(c)(3)(B) that were received prior to such date
of enactment have been acted upon, no limitation shall be
imposed by the preceding sentence of this subparagraph so
long as the Administrator meets the time frames specified in
clause (ii) of section 3(c)(3)(B) on 90 percent of affected
applications in a fiscal year. Should the Administrator not
meet such time frames in a fiscal year, the limitations
imposed by the first sentence of this subparagraph shall
apply until all overdue applications subject to section
3(c)(3)(B) have been acted upon.''.
(e) Section 4(k)(5).--Section 4(k)(5) (7 U.S.C. 136a-
1(k)(5)) is amended to read as follows:
``(5) Accounting and performance.--The Administrator shall
take all steps necessary to ensure that expenditures from
fees authorized by subsection (i)(5)(C)(ii) are used only to
carry out the goals established under subsection (l). The
Reregistration and Expedited Processing Fund shall be
designated as an Environmental Protection Agency component
for purposes of section 3515(c) of title 31, United States
Code. The annual audit required under section 3521 of such
title of the financial statements of activities under this
Act under section 3515(b) of such title shall include an
audit of the fees collected under subsection (i)(5)(C) and
disbursed, of the amount appropriated to match such fees, and
of the Administrator's attainment of performance measure and
goals established under subsection (l). Such an audit shall
also include a review of the reasonableness of the overhead
allocation and adequacy of disclosures of direct and indirect
costs associated with carrying out the reregistration and
expedited processing of the applications specified in
paragraph (3), and the basis for and accuracy of all costs
paid with moneys derived from such fees. The Inspector
General shall conduct the annual audit and report

[[Page H8141]]

the findings and recommendations of such audit to the
Administrator and to the Committees on Agriculture of the
House of Representatives and the Senate. The cost of such
audit shall be paid for out of the fees collected under
subsection (i)(5)(C).''.
(f) Goals.--Subsections (l) and (m) of section 4 (7 U.S.C.
136a-1), as amended by section 237, are redesignated as
subsections (m) and (n) respectively and the following is
inserted after subsection (k):
``(l) Performance Measures and Goal.--The Administrator
shall establish and publish annually in the Federal Register
performance measures and goals. Such measures and goals shall
include--
``(1) the number of products reregistered, canceled, or
amended, the status of reregistration, the number and type of
data requests under section 3(c)(2)(B) issued to support
product reregistration by active ingredient, the progress in
reducing the number of unreviewed, required reregistration
studies, the aggregate status of tolerances reassessed, and
the number of applications for registration submitted under
subsection (k)(3) that were approved or disapproved;
``(2) the future schedule for reregistrations, including
the projection for such schedules that will be issued under
subsection (g)(2)(A) and (B) in the current fiscal year and
the succeeding fiscal year; and
``(3) the projected year of completion of the
reregistrations under this section.''.

The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Kansas [Mr. Roberts] and the gentleman from Texas [Mr. de la Garza]
will each control 20 minutes.
Mr. Chair recognizes the gentleman from Kansas [Mr. Roberts].
Mr. ROBERTS. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, H.R. 1627, the Food Quality Protection Act, represents
nearly a decade of effort to modernize the Federal pesticide regulatory
system. Today the Committee on Agriculture and the Committee on
Commerce will accomplish what many thought simply could not be done;
that is, successful consideration on the floor of a pesticide reform
bill.
Mr. Speaker, this bill has been cosponsored by over 240 Members. This
bill was made possible by a recognition from all sides of the debate
that the proper use of safe pesticides is a critical element in
protecting public health and ensuring a safe, abundant, and affordable
food supply for our American consumers. To that end, H.R. 1627 does
provide wide latitude for the Environmental Protection Agency to adapt
its regulatory system to meet the constantly improving scientific
information that is available.
H.R. 1627 reforms the outdated Delaney clause to allow modern
science, rather than arbitrary rules, to be used in evaluating
pesticide risks and benefits. Just as important, because the new
standard will be narrative rather than specific, this legislation will
allow the regulatory process to be adjusted as scientific risks and
benefit assessments simply progress.
H.R. 1627 also provides additional incentives to register new, safer
pesticides through new authorities that allow the EPA to streamline the
pesticide registration procedures, including antimicrobial pesticides.
In addition, the bill provides several incentives for interested
parties who wish to pursue the registration of so-called ``minor use''
pesticides to ensure their availability in critical public health and
agricultural use situations.
This bill requires the Federal Government to fully consider any
special risk to infants and children in regulatory actions.
Specifically, when there is not enough reliable data on the risks to
infants and children submitted to support the setting of a food
tolerance, the bill provides the EPA administrator the flexibility to
adjust a pesticide food tolerance to ensure that infants and children
are indeed safe.
In the National Academy of Sciences report, Pesticides in the Diets
of Infants and Children, the NAS highlighted the EPA's current practice
of applying an additional tenfold safety factor to the established
thousandfold safety margin in order to ensure safety for fetal
development. In addition, the bill does provide the EPA the additional
flexibility to apply a safety factor of less than ten-fold if the
administrator determines such a level will be safe for infants and for
children.
To further protect infants and children, the bill requires the EPA,
the Department of Agriculture, and the FDA to coordinate their efforts
to collect accurate dietary information on the eating patterns of U.S.
consumers of all ages to ensure the EPA has reliable data from which to
make rational science-based regulatory decisions.
H.R. 1627 also provides the EPA the resources necessary to continue
the long-delayed reregistration of existing pesticides. Over the next 5
years the EPA administrator is authorized to collect up to $76 million
in reregistration fees from the pesticide industry to help the agency
meet the task of completing the reviewing of the data of pesticides
registered prior to 1985. To ensure these funds are used only for the
reregistration program and to enable Congress to meet its oversight
responsibilities relative to the program goals, this legislation
requires a stringent annual financial and performance audit of the
monies collected and appropriated for the reregistration program.

Everyone involved in this legislation had made significant
compromises to reach the goal of passing a valuable reform, a critical
reform of pesticide law. As we near the finish line, it is important to
commend everyone involved on both committees in Congress and many
others for the hard work that certainly brings us to this point.
I personally would like to mention the contributions of our former
colleague and the former Secretary of Agriculture, the late Edward
Madigan; our former colleague, the late Mr. Bill Emerson of Missouri;
the chairman emeritus of the House Committee on Agriculture, the
gentleman from Texas Mr. Kika de la Garza, the godfather of this entire
effort; the gentleman from Texas, Mr. George Brown; the gentleman from
Texas, Mr. Stenhom, who has been a valuable help to us down through the
years; the gentleman from California, Mr. Condit; the distinguished
chairman of the Committee on Commerce, the gentleman from Virginia, Mr.
Bliley; Mr. Bruce, a former colleague from Illinois; Mr. Lehman, a
former colleague from California, and Mr. Rowland, a former colleague
from Georgia.
The ultimate success of this reform will rest with the
professionalism and the common sense of the Environmental Protection
Agency. Congress will be watching closely as we try to implement these
reforms. We will, to ensure that science, not emotion, is the basis of
the pesticide regulation.
Mr. Speaker, I reserve the balance of my time.
Mr. de la GARZA. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, it has been a long time in coming. I am speaking of the
amendment to FIFRA and the food and drug law. Today we have a package
before this House that makes amendment to how we regulate pesticides,
and it is on the suspension calendar. It is hard to believe that we
have come all this way.
Mr. Speaker, let me echo appreciation to all of those Chairman
Roberts has mentioned as having worked on this effort. I would like to
add only our former colleague from Iowa, Mr. Berkley Bedell, who
diligently worked on this issue and had it almost to the brink of
passage at one time.
Mr. Speaker, I have no objections to the present bill. However, I
have concerns about how it will be implemented. One of the biggest
hurdles, if not the biggest, to getting where we are today has been the
infamous or famous Delaney clause.
Whatever one's perspective might be, the Delaney clause was a
political outgrowth of the public's fear in the 1950's of the disease
that was being increasingly diagnosed: cancer. Americans were facing
this mysterious killer more frequently. Interestingly, at the same time
medicine was improving and physicians were diagnosing more cancer.
Today we have the capability to measure to parts per trillion. There is
no justifiable reason for a test based on zero tolerance like we have
with the Delaney clause.
Mr. Speaker, I would like to mention that all of the areas that have
been covered by the chairman of the committee, minor use crop
protection, antimicrobial pesticide registration reform, and public
health pesticides, were all very diligently and studiously worked on by
members of the Committee on Agriculture.
I would like to commend our friends from the Committee on Commerce,
the chairman, the ranking member, and the ranking member of the
Subcommittee on Health and Environment, for all the work they have
done, and for their diligence in seeing that the needs of society are
met to the extent that it is possible.

[[Page H8142]]

I have always maintained, Mr. Speaker, that Americans enjoy the
safest, least expensive, and most abundant food supply in the world and
that legislation is the art of the possible. We are here with that,
with what is possible. It is not perfect. This is what could be agreed
upon. Probably in the future it might be further looked at, but for now
it is the extent of what is possible, considering all of the areas of
concern. To all of those from the Committee on Commerce, we commend
them and appreciate their work and cooperation.
Mr. Speaker, commending my colleagues from the Commerce Committee on
the work that they have done, I yield half of my time, 10 minutes, to
the gentleman from California [Mr. Waxman], and I ask unanimous consent
he be permitted to control that time. He was chairman of the
subcommittee and did tremendous work, and now is the ranking member of
that committee.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Texas?
There was no objection.
Mr. WAXMAN. Mr. Speaker, I reserve the balance of my time.
Mr. ROBERTS. Mr. Speaker, it is with great pleasure that I yield 6
minutes to the distinguished gentleman from Virginia [Mr. Bliley],
chairman of the Committee on Commerce, without whose effective
leadership we would not be here today passing a critical reform on the
Suspension Calendar.
Mr. BLILEY. Mr. Speaker, I thank the gentleman for his kind remarks
and for yielding me the time.
Mr. Speaker, today this House has a great opportunity to strengthen
America's food safety laws and improve the safety and quality of its
food supply. H.R. 1627, the Food Quality Protection Act of 1996, is a
landmark bipartisan agreement that will bring Federal regulations of
the Nation's food producers into the 21st century.
As everyone knows, reforming America's food safety laws has been an
issue in Congress for more than a decade. For as long as I can recall,
Republicans and Democrats alike have tried to replace the outdated
Delaney clause with a modern, workable safety standard. The Delaney
clause is a holdover that reflects the science of the 1950's.
In fact, the Delaney clause has been criticized almost since its
inception in 1958. How long was that? Well, consider in 1958 ``At the
Hop'' by Danny and the Juniors, was one of America's favorite songs;
``Gunsmoke'' riveted millions of families to their black and white TV
sets; and a gallon of gasoline cost 30 cents.
Perhaps more telling of all, 1958 was the year Fidel Castro came to
power in Cuba. Like Castro, the Delaney clause has cast a long and dark
shadow over the years. By establishing a counterproductive standard for
food safety, the clause has frozen science for 40 years.
In 1958 our knowledge of carcinogens was in its infancy. Our ability
to identify trace amounts of pesticide residues was primitive by
comparison to today. We had not even begun to think about risk
assessment. Where before we could detect pesticide residues in
measurements of parts per million, today we do so in parts per billion,
and in some cases, parts per trillion.

{time} 1230

We know more about cancer today than we did then and about the
relative risks of trace amounts of carcinogens. In fact only one thing
has remained constant since 1958, the Delaney clause itself. But
despite bipartisan consensus that the Delaney clause needed reform,
Congress was never able to achieve agreement on how best to do so until
now.
After weeks of bipartisan negotiations, the Committee on Commerce
reported out a strong bill that makes much-needed improvements to the
regulation of pesticides. Under the legislation before us today, the
Delaney clause will be replaced with a unified safety standard. The
standard will protect our food quality standards by allowing for the
approval of pesticide tolerances when there is a reasonable certainty
no harm will come to the consuming public.
For the first time, we will be able to address the issue of food
safety comprehensively, taking into account the safety of the consuming
public, preservation of the food supply and economic benefits as well.
The legislation establishes strong protections for infants and
children, adopting the recommendations of the National Research
Council's report.
I would like to thank particularly the staff on the minority side,
Kay Holcombe and Phil Schiliro, to the administration's Dr. Goldman,
Jim Adolia and Bill Schultz, and my staff, Howard Cohen and Eric
Berger.
This legislation before us today contains amendments to the Food,
Drug and Cosmetic Act exactly as reported by the House Committee on
Commerce. I feel confident that our efforts today will improve the
safety, abundance and affordability of the Nation's food supply.
We would not be here without the cooperation of everyone,
particularly my friends, the gentleman from Michigan [Mr. Dingell], the
ranking member of the full committee, and the gentleman from Hollywood,
CA [Mr. Waxman], the ranking member of the subcommittee, whom I
sometimes have a slight disagreement with, and to the gentleman from
Florida [Mr. Bilirakis], the chairman of the Subcommittee on Health and
Environment of the Committee on Commerce, who has worked long and hard
on this issue.
Mr. de la GARZA. Mr. Speaker, I yield 2 minutes to the distinguished
gentleman from California [Mr. Brown].
(Mr. BROWN of California asked and was given permission to revise and
extend his remarks.)
Mr. BROWN of California. Mr. Speaker, I thank the distinguished
gentleman from Texas [Mr. de la Garza] for yielding me this time.
Mr. Speaker, it seems like some of the best decades of my life have
been spent working on FIFRA, and I am very happy to see this day arrive
today. I can remember quite well when the gentleman from Texas [Mr. de
la Garza], who had been wrestling with this problem as chairman of the
appropriate subcommittee, turned that subcommittee over to me and to
the gentleman from Kansas [Mr. Roberts], our ranking member, and we
worked diligently for many years in an effort to reach the position
where we are today. We had the support of Presidents of both parties,
and yet we were never able to succeed.
I recite this because I think we should appreciate that this bill,
along with a few others such as the telecommunications bill, have come
to fruition only after generations. This may be an example--these two
bills, telecommunications and this--of the benefits and the
productivity of working together on a bipartisan basis to solve real
problems in the most constructive possible way. I think we have done
that here.
I have to pay particular tribute to the gentleman from Kansas [Mr.
Roberts], my good friend, who never gave up, who continued to
persevere. While he has praised my role, it is his role that is really
the one that is most significant. I gave up years ago, and he kept on
working until we have reached this day of success.
Of course I must also praise our colleagues on the Committee on
Commerce, the gentleman from Michigan [Mr. Dingell] and the gentleman
from California [Mr. Waxman]. The Committee on Commerce will be
recognized as the source of the most important and productive
legislation we have passed in this Congress and, despite my occasional
arguments with the gentleman from Michigan [Mr. Dingell], I praise him
for this.
This is a day that many people thought we were not going to see. But
today, we are going to pass a bipartisan bill to reform our pesticide
laws. H.R. 1627 replaces the Delaney clause with a commonsense
alternative that is not only scientifically defensible, but will result
in comprehensive protection of public health.
H.R. 1627, is a good bill. Each of the diverse array of interest
groups who have followed this legislation would probably wish to have
something included in, or excluded from it. So, from each of their
perspectives. H.R. 1627 would not be considered a perfect bill, but
they believe H.R. 1627 represents a significant improvement over
current law. The bill is the result of a great deal of hard work by the
Agriculture and Commerce Committees and the administration to fashion
these compromises and achieve consensus.
Chairman Roberts and I have worked on pesticide legislation together
for many years. I would like to commend him for his efforts and for
conducting an inclusive, bipartisan process

[[Page H8143]]

during the consideration of this legislation by the Agriculture
Committee. This is the way the legislative process should work.
I am pleased to support H.R. 1627, and I urge my colleagues to do the
same.
Mr. WAXMAN. Mr. Speaker, I yield 3 minutes to the gentleman from
Michigan [Mr. Dingell], the ranking member of the Committee on
Commerce.
(Mr. DINGELL asked and was given permission to revise and extend his
remarks.)
Mr. DINGELL. Mr. Speaker, this is quite a historic moment, for today
we consider in the House a piece of legislation that literally has been
pending before Congress for over a decade. This bill overhauls the way
the Government regulates pesticides, and at long last deals with the
thorny issue of differing standards for different kinds of food
products, and with the scientifically outdated application of the
Delaney clause.
It is an amazing compromise that has been reached, which has brought
together some of the most staunch and bitter rivals in this debate--
consumer and environmental groups, the food industry, American
agriculture, and the Federal Government agencies who oversee pesticide
use and safety--the Environmental Protection Agency and the Food and
Drug Administration.
This bill represents the product of that successful negotiation. It
meets the need of the agriculture and food industries for proper,
consistent regulation of pesticides, without arbitrary standards such
as the outdated and inappropriate Delaney clause.
In accomplishing that goal, the bill delicately strikes the essential
balance between this legitimate need and consumer desire to continue
the already high level of safety of American food.
Specifically, the legislation adopts the widely held view that
special attention must be paid to dietary habits and health needs of
special populations, such as children. At the same time, it provides
flexibility to use methods and numbers that are appropriate and
supported by valid information.
Significantly, the bill recognizes the importance of pesticides to
the food supply, and builds this benefit into the evaluation of how
pesticides are used.
No one group or individual will consider this to be perfect
legislation, nor does it fulfill the full agenda of any one party. Its
development required significant concessions from every quarter; it
demonstrates that worthy goals are achievable through compromise. We
are pleased that bipartisan negotiation produced good legislation.
I want to express my appreciation to my colleagues from California,
Michigan, Texas, and New York--Mr. Waxman, Mr. Stupak, Mr. Hall, and
Mr. Towns.
Mr. Speaker, I commend the gentleman from Virginia [Mr. Bliley], the
chairman of the Committee on Commerce, and also the gentleman from
Florida [Mr. Bilirakis], the chairman of the subcommittee. I also want
to commend the gentleman from Kansas [Mr. Roberts], the gentleman from
California [Mr. Condit], and the gentleman from Texas [Mr. de la
Garza]. The gentleman from Texas [Mr. de la Garza] is the valuable
ranking member of the Committee on Agriculture and has long been
interested in this. Those gentlemen and many others, along with the
staff, have made an outstanding contribution to the solution of the
problems before us today. I commend them and I thank them for the
outstanding job which they have done.
Mr. ROBERTS. Mr. Speaker, I yield 3 minutes to the distinguished
gentleman from Florida [Mr. Bilirakis], the chairman of the
Subcommittee on Health and Environment of the Committee on Commerce.
Mr. BILIRAKIS. Mr. Speaker, I appreciate the gentleman yielding this
time to me. I, too, would like to make a few brief points concerning
the legislation before us today.
The Food Quality Protection Act is more than just an important reform
initiative. It is, as others have already said, the culmination of
intensive bipartisan negotiations and, as we have heard here today, has
the strong support of Members on both sides of the aisle.
The high level of support for this bill is actually not very
surprising when we stop to think about it. Food safety reform has been
a primary focus of Congress for more than a decade. That is because for
farmers, for processors, manufacturers and of course for consumers the
zero risk standard of the Delaney clause has served to freeze 1950
science into law.
When the Delaney clause was enacted in 1958, the body of scientific
knowledge on cancer was very limited. Of course we have made tremendous
strides, thank God, in detecting and fighting cancer but our pesticide
regulations have not been allowed to keep pace with scientific
advances.
As a result, it is essential that we adopt a modern consistent
standard for determining the safety of our food supply. H.R. 1627 has
the support of the Food Chain Coalition which includes the American
Farm Bureau Federation, the American Meat Institute, Grocery
Manufacturers of America, the Independent Bakers Association, the
National Cattlemen's Beef Association, the National Farmers Union, the
United Fresh Fruit and Vegetable Association, and, of course, so many
others that I have not mentioned.

The legislation before us is a long-overdue step forward in the
Nation's efforts to produce the best food supply possible. It
establishes a unified general risk-setting standard for pesticides
based on a standard of safety which is defined as a reasonable
certainty of no harm.
It contains requirements for tolerance setting which are directly
responsible to the recommendations of the National Research Council's
report on ``Pesticides in the Diets of Infants and Children.''
It allows the use of benefits in specific situations, such as where
the risk of not using the pesticide is greater than the risk of using
it, and where the pesticide is needed to avoid a significant disruption
in the domestic production of an adequate, wholesome, and economic food
supply.
It retains the national uniformity for Federal pesticide residue
tolerance except in limited cases.
It gives the administrator the authority to require data or
information to determine whether a pesticide chemical may have an
effect similar to an effect produced by a naturally occurring estrogen
or other endocrine effect.
It provides for a consumer information booklet to be distributed by
EPA to large retail grocers.
It establishes limited civil penalties as an alternate to the current
heavy-handed enforcement tools of seizure, injunctions, and criminal
action.
I am very pleased, as my colleagues might imagine, Mr. Speaker, with
the bipartisan spirit that has helped craft this legislation. I want to
commend the gentleman from Virginia [Mr. Bliley], the chairman, the
gentleman from Michigan [Mr. Dingell], and the gentleman from
California [Mr. Waxman] for their great contributions to this effort
and, most important, the staffs who worked long and late hours to get
us to this point. This is a reform measure of which we all have reason
to be proud.
Mr. WAXMAN. Mr. Speaker, I yield myself 3 minutes.
Mr. Speaker, I rise in strong support of H.R. 1627 and want to
commend Chairmen Bliley and Roberts, subcommittee Chairman Bilirakis,
and John Dingell for their efforts to resolve this issue and bring this
important legislation to the floor.
In the last 2 weeks, we have worked together to resolve a problem
that has frustrated Congress for nearly two decades. And in reaching
this agreement, we have found a way to reconcile fundamentally
different positions into a strong bill that will benefit all Americans.
The starting point for this compromise is the repeal of the Delaney
Clause and the creation of a single health-based standard that will
apply to all foods. This reform gives industry needed regulatory
flexibility while providing important health protections to American
families.
In passing this legislation we are ensuring that pesticides will
present no danger to our children. H.R. 1627 requires the Environmental
Protection Agency--when establishing safety tolerances that apply to
all Americans--to consider any special impacts a pesticide may have on
infants and children and ensure that any aggregate exposure to a
pesticide chemical residue present a reasonable certainty of no harm to
them. This provision cannot be waived for eligible pesticide chemical
residues.

[[Page H8144]]

H.R. 1627 also establishes an estrogen screening program and a right-
to-know initiative that will provide vital information to consumers.
I am pleased to announce to my colleagues that H.R. 1627 is supported
by a number of environmental and public health groups, including: the
American Preventative Medical Association; the American Public Health
Association; Center for Science in the Public Interest; Citizen Action;
Citizen Health; Consumers Union; the Environmental Defense Fund; the
Environmental Working Group; the National Audobon Society; the National
PTA; the National Wildlife Federation; the National Resources Defense
Council; Physicians for Social Responsibility; Public Voice; and World
Wildlife Fund.
This is not a bill of winners and losers. It is a bill of winners.
Industry wins because it receives regulatory relief and health and
environmental public interest groups win because important health
safeguards are guaranteed. Most importantly, H.R. 1627 is a major
victory for common sense and for all Americans.
This compromise is only possible because a lot of hard work has been
done by congressional staff and administration officials. And I want to
commend both industry and environmental groups for their willingness to
put aside long-held positions and find common ground in this proposal.
Mr. Speaker, I do want to mention that while this bill is originating
in the House, there has been an enormous amount of work that has been
done on this legislation in the other body, and I particularly want to
single out the work that has been done by Senators Kennedy, Leahy,
Lugar, and Kassebaum. They have struggled with this issue and we hope
they will now, after we pass this bill, join with us in putting the
finishing touches on the work for which they have endeavored for so
many years.
Our colleagues deserve commendation, particularly Chairman Bliley,
Mr. Bilirakis, Mr. Dingell and others who will be addressing us.
Mr. Speaker, I reserve the balance of my time.

{time} 1245

Mr. de la GARZA. Mr. Speaker, I yield 2 minutes to the distinguished
gentleman from California [Mr. Condit], the ranking member of the
subcommittee.
(Mr. CONDIT asked and was given permission to revise and extend his
remarks.)
Mr. CONDIT. Mr. Speaker, this culminates over a decade of work by
many Members of Congress, and without their leadership this would not
be happening today. I want to single out a few people: the gentleman
from Kansas, Chairman Roberts, the gentleman from Virginia, Chairman
Bliley, the gentleman from Texas, Mr. de la Garza, the gentleman from
Michigan, Mr. Dingell, the gentleman from California, Mr. Waxman, and
the gentleman from Florida, Mr. Bilirakis. Without their hard work, we
could not have accomplished what we are accomplishing here today.
I strongly believe that the resulting legislation represents the best
approach for needed reform in food safety. This action sends a strong
message that many Members of Congress are serious about this essential
reform and we must not miss this opportunity to move forward.
The Delaney Clause, while well-intended 34 years ago, has become a
problem that must be replaced by sound science and negligible risk.
H.R. 1627 will finally replace the inconsistent standard that now
governs pesticide residue with a single modern standard applied
uniformly to pesticide residue in all foods. We cannot tell farmers
that a minimum level of certain pesticide residue is safe on fresh
market produce but not safe enough on such products sent to be
processed.
This is an historical day. A lot of people have worked very hard, and
I am delighted and honored to be a part of this solution.
Mr. ROBERTS. Mr. Speaker, I yield 1 minute to the gentleman from New
York [Mr. Walsh], a former member of the House Committee on
Agriculture, a distinguished member of the Committee on Appropriations,
and a gentleman who has worked long and hard on the Delaney Clause.
(Mr. WALSH asked and was given permission to revise and extend his
remarks.)
Mr. WALSH. Mr. Speaker, I would like to just take a moment to
congratulate everyone, both sides of the aisle, Republicans and
Democrats, chairmen and ranking members, who worked to find a
reasonable solution to this problem. This is a problem that the
country, our producers, our processors, our consumers, it has bedeviled
them for a long, long time, and this approach to legislation is
remarkable. The result is remarkable. It is good for everyone.
I carried the rider last year on the Delaney Clause that would have
prevented the EPA from delicensing chemicals that did not meet the
standard that the court required them to meet. That was a strong
measure. We backed away from that to provide some pressure to the
legislative process. The Committee on Commerce responded, and I think
it is a terrific solution, and I congratulate all of you.
Mr. WAXMAN. Mr. Speaker, I yield 1 minute to the gentleman from New
Mexico [Mr. Richardson].
(Mr. RICHARDSON asked and was given permission to revise and extend
his remarks.)
Mr. RICHARDSON. Mr. Speaker, we do a lot of bills around here that
never are signed into law, but let me say that here is one that will be
because it is a compromise.
Mr. Speaker, let me just say that, as a member of the Commerce
Committee, this is the second major bill from the Commerce Committee--I
know Agriculture has a major role--the first one being
telecommunications and now this one, that is going to be signed into
law. Credit goes to the gentleman from Virginia, Chairman Bliley, the
gentleman from Texas, Mr. de la Garza, the gentleman from Kansas, Mr.
Roberts, the gentleman from California, Mr. Waxman, and the gentleman
from Michigan, Mr. Dingell.
I have been in Congress 14 years. We started working on this bill,
someone said 10 years ago, I think the gentleman from California [Mr.
Condit]. It seems to me the first year I was here we started working,
never could come together, always major divisions. The Delaney Clause
is like an institution. It is like a building that you cannot take
down.
It has been modified. It is a good compromise and, Mr. Chairman, I
commend those that worked hard on this. It shows that we can get
something done if we just work together and compromise and forget that
there is an election and a presidential election, which I know is very
difficult to do these days. I do want to commend the authors of this
bill.
Mr. WAXMAN. Mr. Speaker, I yield 2 minutes to the gentleman from New
York [Mr. Towns].
Mr. TOWNS. Mr. Speaker, I would like to begin by thanking the
gentleman from Virginia [Mr. Bliley], the gentleman from Michigan [Mr.
Dingell], the gentleman from Florida [Mr. Bilirakis], and of course the
gentleman from California [Mr. Waxman], and the majority and minority
staff, as well as the gentleman from Kansas [Mr. Roberts], and of
course the gentleman from Texas [Mr. de la Garza], for their
outstanding job in bringing us to where we are today.
If we do not change the Delaney Clause, fruits and vegetables will
become less abundant and poorer in quality. Consumers, particularly
low-income consumers, will not have access to fruits and vegetables
that are affordable and readily available. If we urge Americans to
improve their health by changing their diets, then we must ensure that
the elements of a healthy diet, like fresh fruits and vegetables, are
both economical and available.
The measures before us today will ensure continued access by all
Americans to safe, abundant, and affordable foods. The bipartisan
support of H.R. 1627 has resulted in a balanced approach to reform of
the Delaney Clause in a very positive way.
Mr. Speaker, I urge all my colleagues to vote for this bill. Failure
to do so only harms the American consumers, and I think that we do not
want to harm them, we want to help them. This bill is help for them.
Mr. ROBERTS. Mr. Speaker, I yield myself such time as I may consume.
We have no further request for time on this side.

[[Page H8145]]

(Mr. ROBERTS asked and was given permission to revise and extend his
remarks and to include extraneous material.)
Mr. ROBERTS. Mr. Speaker, I would like to observe this: I would like
to thank the gentleman from California [Mr. Brown] very much for his
very kind comments. George Brown has provided more expertise on FIFRA
than perhaps any other Member.
The gentleman from Texas [Mr. de la Garza] mentioned the gentleman
from Iowa, Mr. Berkley Bedell. I can remember well when we passed a
FIFRA reform on the House side. It did not pass the Senate. We had
adjourned, and Berkley Bedell had me in tow over on the Senate side
trying to find real live Senators to try to get this done. So this one
is for Berkley.
I would like to also thank my staff. There are no self-made men or
women in public office. It is your friends and staff who make you what
you are, more especially Mr. Bill O'Conner, who worked long and hard
for Mr. Madigan both when he was the ranking member of the committee
and the Secretary of Agriculture.
I would like to mention Mr. Gary Mitchell, who is our staff director,
who had the FIFRA responsibilities when I was the ranking member of the
subcommittee.
And, more especially, Mr. Dale Moore. Dale is a former rodeo rider,
and every time we let the FIFRA horse out of the chute, we could not
even saddle him, let alone ride the full 10 seconds to finally get
something done. So in this particular case where it is a rodeo of
achievement, if you will, I especially want to thank Dale.
It is rare during an even-numbered year when we have had great
controversy and strong differences of opinion in this Congress, that we
have a situation where the gentleman from Virginia, Tom Bliley, the
gentleman from Florida, Mike Bilirakis, and the gentleman from Kansas,
Pat Roberts, stood with the gentleman from Texas, Kika de la Garza, the
gentleman from Michigan, John Dingell, and the gentleman from
California, Henry Waxman, representing the environmental community, the
agriculture community, industry, and the administration.
We have done something and we are proud of it. We have 55 different
organizations who have signed on with this reform. It is good reform.
It is the kind of thing that we should do more of.
Mr. Speaker, I include for the Record report language to accompany
H.R. 1627 regarding the use of registered pesticides to protect public
health and safety, and a letter from the Environmental Protection
Agency on the same matter; as well as report language developed to
address a concern related to the Endangered Species Act:

Report Language to Accompany H.R. 1627

Use of Registered Pesticides to Protect Public Health and Safety

The Committee is aware of the potential for situations in
which public health and safety may be compromised by efforts
to protect endangered species. There are commercial
facilities which are part of this nation's food production
and distribution system, such as processing plants,
warehouses, grocery stores, restaurants, etc., which are
located in critical habitat areas where the use of pest
control tools may be prohibited or severely restricted. While
the Committee recognizes the importance of preventing the
destruction of endangered species, it is concerned that
unwarranted actions to protect a species could result in the
unchecked spread of rodent-, insect-, or other pest vector-
borne diseases that could pose serious threats to consumer
and food safety.
The Committee strongly believes that preserving the safety
and wholesomeness of this nation's food supply is paramount.
Managers of food processing and handling facilities, and
public health officials, must be able to take the steps
necessary to control pests that may pose a threat to public
health. The managers of these facilities generally rely on
certified commercial applicators or persons under their
direct supervision who are trained to apply rodenticides and
other pesticides in safe manner, which helps ensure that
these products are only used when and where necessary.
One of the overriding goals of H.R. 1627 is to eliminate
the statutory and regulatory paradoxes that inhibit the
efficient, science-based administration of FIFRA and the
Federal Food, Drug, and Cosmetic Act. The Committee believes
this goal should be considered when reforms to other
statutes, such as the Endangered Species Act, are undertaken
to make certain that the safety and wholesomeness of a
consumer's food supply, especially for infants and children,
is adequately protected.
The Committee recognizes this concern can be addressed
rationally in many cases through the cooperative efforts of
federal and state regulatory officials, and is encouraged
that federal and state agencies are examining this issue. For
example, the California Environmental Protection Agency's
Department of Pesticide Regulation states, ``A categorical
exemption for food processing plants and other industrial and
institutional use could probably be made with little, if any,
impact on listed species. In particular, the use of toxicant
inside of buildings or immediately adjacent to buildings does
not seem to pose a hazard to listed species.''
The Committee expects the EPA to investigate this issue and
any related situations where competing regulatory actions by
the Agency, other federal agencies, or state agencies pose a
threat to consumers or the U.S. food supply, and to act
quickly to remedy these situations. In addition, if the EPA
is unable to address the situation in an efficient and fair
manner, the Agency should promptly notify this and any other
committee of appropriate jurisdiction. If resolution is
prohibited because of competing or inconsistent provisions of
law, the Committee also expects the Agency to provide
legislative proposals that may be needed to ensure that the
Administrator has sufficient statutory authority to address
these situations in a common sense, science-based manner.
____

U.S. Environmental

Protection Agency,

Washington, DC, July 18, 1996.
Hon. Pat Roberts,
Chairman, Committee on Agriculture, House of Representatives,
Washington, DC.
Dear Mr. Chairman: Thank you for your request regarding
clarification of the effect that endangered species
protection measures may have on the use of pesticides to
control pests in food processing or handling warehouses. We
understand that some are concerned that endangered species
protection measures could inappropriately restrict, within
areas designated for the protection of endangered species,
use of certain pesticides. Specifically, a concern was raised
that use of pesticides that are important to control pests
which may damage or contaminate food items may be unduly
limited by endangered species protection measures in the
State of California.
We believe that the federal, state and local agencies in
California responsible for endangered species protection
recognized this concern and have worked with all stakeholders
to appropriately resolve this situation. Furthermore, the
information available to us indicates that pesticide labels
and the state-initiated endangered species plans do not
unnecessarily restrict responsible pesticide use and do
provide for both safe and effective use of pesticides in
these situations.
Obviously, we understand that controlling pests in food
storage and processing facilities can be a significant public
health concern, and we will continue to work with the
appropriate state and federal officials to make sure that
important public health protection measures are not
unnecessarily restricted.
In addition, we stand ready to work with you, members of
your committee, and the state, local and Federal authorities
to resolve legitimate concerns that may arise regarding this
issue. Please let me know if I may be of further assistance.
Sincerely,
Lynn R. Goldman, M.D.,
Assistant Administrator.
____

Food Chain Coalition,

July 23, 1996.
Hon. Thomas J. Bliley, Jr.,
House of Representatives, Rayburn House Office Building,
Washington, DC.
Dear Congressman Bliley: Last week, representatives of the
Administration, industry and the environmental community
reached compromise agreement on H.R. 1627, ``The Food Quality
Protection Act,'' after several weeks of negotiations. This
bill represents the best opportunity in a decade to modernize
the Delaney Clause and strengthen our nation's food laws.
The House of Representatives is expected today to consider
H.R. 1627, and the Senate has indicated the intention to
quickly follow suit. As Americans working to produce, process
and market our nation's food supply, we urge your support for
this critically important bill.
There is virtually unanimous agreement that an overhaul of
the outdated Delaney clause for pesticide residues is long
overdue. With the very limited number of legislative days
remaining this year, the need for action to accomplish that
objective is now more urgent than ever.
EPA recently proposed disallowing the use of five
pesticides on a number of crops under the Delaney Clause,
even though the agency has repeatedly stated its belief that
those pesticides pose no significant health risk to
consumers. By April 1997, EPA is due to determine whether to
disallow up to 40 additional uses; without corrective action,
farmers could lose the use of a number of safe and effective
crop protection tools that keep the American food supply
abundant and affordable.
The compromise version of ``The Food Quality Protection
Act'' has received bipartisan praise from both the House and
Senate, with key Republican and Democratic leaders stating
that it is their goal to see this legislation signed into law
by the President this

[[Page H8146]]

year. We urge its prompt adoption by the House.
Sincerely,
Agricultural Council of California; Agri Bank; Agri-Mark,
Inc.; Agway, Inc.; American Bakers Association; American
Crystal Sugar Company; American Farm Bureau Federation;
American Meat Institute; American Feed Industry
Association; Apricot Producers of California; and Atlantic
Dairy Cooperative.
Biscuit & Cracker Manufacturers Association; Blue Diamond
Growers; California Tomato Growers Association, Inc.;
California Pear Growers; Chemical Specialties Manufacturers
Association; Chocolate Manufacturers Association; Gold Kist,
Inc.; Grocery Manufacturers of America; and Growmark.
Harvest States; Independent Bakers Association;
International Apple Institute; International Dairy Foods
Association; Kansas Grain and Feed Association; Kraft Foods,
Incorporated; Land O'Lakes; Michigan Agribusiness
Association; Milk Marketing Inc.; National Agricultural
Aviation Association; and National Cattlemen's Beef
Association.
National Confectioners Association; National Council of
Farmer Cooperatives; National Farmers Union; National Food
Processors Association; National Grain and Feed Association;
National Grain Trade Council; National Grange; National Grape
Co-operative Association, Inc; National Pasta Association;
and Nebraska Cooperative Council.
North American Export Grain Association; Oklahoma Grain and
Feed Association; Produce Marketing Association; Pro-Fac
Cooperative; SF Services, Inc.; Snack Food Association; South
Dakota Association of Cooperatives; and Southern States
Cooperative.
Tortilla Industry Association; USA Rice Federation; United
Fresh Fruit and Vegetable Association; Upstate Milk
Cooperatives, Inc.; Utah Council of Farmer Cooperatives; and
Wisconsin Agri-Service Association.

Mr. WAXMAN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, in closing I want to point out that what we are doing
here today is what the American people expect of us, to work out
compromises, not to go to any extreme but to look for a middle ground.
I want to particularly thank the chairman of our committee, the
gentleman from Virginia [Mr. Bliley], for this leadership, and the
gentleman from Florida [Mr. Bilirakis], as the chairman of the
subcommittee.
We do have on occasion, a difference of opinion. We have a different
starting point as we look at the role of government; but they were good
enough to look at this as a practical matter, to try to think through
how we could make a constructive proposal work so that we could get an
idea passed into law.
I want to thank all the staff of our committee, Howard Cohen, Eric
Berger, Kay Holcombe; Greg Dotson, and Phil Schilirop; and the people
in the administration, as well, Lynn Goldman, Jim Aidala, Larry
Elsworth, Bill Schultz, and Phil Barnett.
I would point out that President Clinton put this issue on the agenda
when he proposed that we do something on this very matter. The bill we
are sending to the Senate and then hopefully on to him in many ways
tracks what he proposed and in many ways improves and changes it.
Mr. Speaker, we have a good bill. It is a good compromise. The
American people should look upon this with favor. I ask our colleagues,
as well, to give their support to it.
Mr. Speaker, I yield back the balance of my time.
Mr. de la GARZA. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, let me add my commendation to all of the staffs from the
committees, including the hard work done by the members' staff of the
Agriculture Committee.
Mr. Speaker, when I became a subcommittee chairman three decades ago,
the first major bill that was referred to our subcommittee was FIFRA. I
did not know what the word stood for at that time, and I have worked
with FIFRA since then. As Members know, I will not be returning the
next session of Congress, and I think probably with this unanimity and
all this good will, that it may well be the crown of my retirement that
we hopefully go through the Senate and finish with a FIFRA bill as I
leave this Congress.
We worked diligently. There have been many, many long hours of hard
work. There have been discussions, heated and otherwise, but to arrive
at this point on a suspension calendar is something worthy to be
remembered. It is historic, and I am so proud to have been a small part
of this endeavor. It will be something that I can go home with and
point to with pride.
With that, I ask all of the Members to give us their support and
their vote on this legislation.
Mr. BUYER. Mr. Speaker, the bill before us today is long overdue. I
am delighted that this legislation has not only passed two House
committees but will pass the full House of Representatives today. There
have been times that I never thought we would be able to get to this
point. Those in the agribusiness industry know first hand what a truly
historic agreement this is. I applaud the Agriculture Committee and the
Commerce Committee for completing action on this legislation and
bringing it to the floor of the House.
Mr. Speaker, almost 4 years ago, I formed the Fifth District
Agricultural and Rural Advisory Committee. Made of those who daily work
in their agribusiness and farm communities, this committee listed
reforms of the Delany clause as one of their top concerns. The efforts
of the 104th Congress to bring common sense to this matter without
endangering the supply of food in the United States is to be commended.
H.R. 1627, the Federal Insecticide, Fungicide, and Rodenticide Act
[FIFRA], reforms the outdated Delaney clause and allows sound science
to prevail. It offers a framework of standards that allows the EPA the
flexibility to consider pertinent public health factors when setting
pesticide residue levels.
Mr. Speaker, most would agree that the United States enjoys the
safest food supply in the world. The abundance and affordability is in
large part due to the prudent use of pest control. Pesticides are
necessary tools that when used in a responsible manner contribute
significantly to the health of individuals and the environment. It is
this bill, H.R. 1627, that takes into consideration both the individual
and the environment.
Mr. Speaker, technology today makes zero risk a much outdated policy.
This legislation provides a commonsense answer to ensuring consumer
access to a healthy, abundant, affordable, and most importantly--a safe
food supply. I congratulate Mr. Roberts and Mr. Bliley on this historic
agreement.
Mr. ROEMER. Mr. Speaker, I rise in support of H.R. 1627, the
Pesticide Regulation Reform Act. I want to congratulate my colleagues
who have worked so hard to produce a bill that helps our farmers while
protecting public safety, and has considered the concerns of consumer
and environmental groups as well.
Fixing the provision known as the Delaney clause is important. When
this provision was written, only the largest percentages of carcinogens
could be detected in the food supply. With modern technology now being
able to detect trace quantities in the range of parts per trillion and
beyond, updating this law is critical. EPA itself has tried to use a
more workable, scientific standard, but the courts have ruled
otherwise.
This legislation will help our farmers by using less intrusive,
modern standards. In using more common-sense tolerance standards, we
not only protect consumers, but may reduce the cost to farmers of
getting their goods to market. This is also good for consumers. In
addition, the bill observes the special needs of infants and children
who may be more susceptible to the presence of pesticides in food.
Finally, the legislation achieves balance in considering the benefits
of risk analysis and recognition of the public's right of access to
information on Government policy. Informed consumers are happy
consumers, and this bill gives badly needed aid to our farmers while
helping to keep consumers aware of changes in agricultural regulations.
Mr. Speaker, America's farmers have made great sacrifices this year,
not only in sharing budget cuts but in widely accepting the recently
passed farm bill. This legislation is a small step in recognizing the
farmer's contribution to a balanced budget and fiscal stability for our
country.
Mr. BEREUTER. Mr. Speaker, this Member is concerned that H.R. 1627
did not include even a modified version of a provision that was
included in the original House Agriculture Committee bill per this
Member's request, which was subsequently deleted from this bill.
This Member has severe reservations and regrets and faults the
administration--specifically Environmental Protection Agency
Administrator Carol Browner, Department of Agriculture Secretary Dan
Glickman, and Department of the Interior Secretary Bruce Babbitt--which
in a letter to the House Agriculture Committee chairman, the
distinguished gentleman from Kansas [Mr. Roberts], attempted to
intimidate the committee into deleting this Member's modified
provision. This Member protested this deletion strenuously and by all
legitimate means.
Specifically, this Member's provision would have allowed Indian
tribes to enforce FIFRA regulations for the entire area of a
reservation only if at least 50 percent of the lands in the reservation
are owned by the tribe or Indians. This provision is needed to address
legitimate

[[Page H8147]]

concerns raised by non-Indian landowners who own land within
reservation boundaries. Non-Indians own more than one-half of the land
in two Indian reservations within this Member's congressional district.
In fact on one reservation in this Member's district, non-Indians won
about 84 percent of the land. This provision is very important to
constituents in this Member's district to assure that the relations
between members of Indian tribes and non-Indians owning land within
reservation boundaries are not further exacerbated.
Where we have more than one-half of the reservation owned by non-
Indians--and the one case mentioned previously where about 84 percent
is owned by non-Indians--it is reasonable that non-Indian lands have
FIFRA enforcement by State government just as States enforce FIFRA for
the rest of the State. That is what the language suggested by this
Member would have done. The way it is now, non-Indian property owners
will have enforcement conducted by a governmental body--the tribal
council--for which they have absolutely no role in electing. Many of
the Member's constituents have made it absolutely clear that this
regulation of private property by officials employed by a tribal
government will exacerbate Indian/non-Indian relations. This Member's
language would have avoided that problem by preserving the tribal
council's role in enforcing FIFRA regulation on Indian owned or tribal
lands on reservations if they own more than 50 percent of the
reservation land.

Mr. Speaker, nevertheless, the critical advances in this legislation,
especially as they relate to the Delaney clause, argue overwhelmingly
for the support of this legislation.
Mr. GUTKNECHT. Mr. Speaker, today's long-overdue passage of H.R.
1627, the Food Quality Protection Act, is further evidence that this
Congress not only talks about regulatory reform, but acts on it.
Food processors and farmers in my district want to preserve the
safety of our Nation's food supply. They also recognize that our
technology has outgrown the regulatory demands of the Delaney Clause.
For decades, they have urged Congress to update this law. I am pleased
that today we have.
I hope passage of H.R. 1627 will allow the House to move forward in
passing another reform bill that enjoys bipartisan support--H.R. 3338,
the Antimicrobial Pesticide Registration Reform Act.
This bill allows for a separate regulatory definition for
antimicrobial pesticides. Under current conditions, the EPA treats
antimicrobials--substances like bleaches and cleansers that limit the
growth of microogranisms--like more traditional pesticides, even though
their uses differ significantly. This has caused unreasonable and
unnecessary delays in getting improved products to market.
I urge the House to continue to demonstrate its commitment to
commonsense regulatory reform by acting on H.R. 3338.
Mr. CAMP. Mr. Speaker, I rise in support of H.R. 1627, a commonsense
environmental measure that is good for American consumers and American
farmers. The bill reforms the out-of-date Delaney clause that was
passed in the 1950's to protect the food supply from cancer-causing
products.
The bill before us actually strengthens the objectives of the 1950's
law. It strengthens regulations of raw food, while bringing balance to
current standards for processed food. Why do we need the changes in
this bill? Well, in the 1950's, testing equipment could detect cancer-
causing residues to the range of one part per million. With today's
testing equipment, we can detect parts per trillion. What does all that
mean? That means with today's testing equipment, we can detect a glass
of beer in Lake Michigan. And since the 1950's Delaney clause says that
no traces of cancer-causing residues can exist in the food supply, and
traces can be found in parts per trillion now, the EPA simply cannot
enforce this impossibly high standard.
Now that we can detect residues to such minute levels, we have to
give the EPA enforceable standards to protect our food supply. And our
bill does just that. We tell the EPA to establish a reasonable
certainty standard so that it can take advantage of the latest
scientific advances to maintain our food safety, while not being bound
by those very advances to impossible-to-enforce laws.
What will our bill result in? Safer and newer pesticides for our
farmers. Better harvests, because farmers will not be limited to, and
be forced to overuse, fewer pesticides to protect their crops. Safer
food for Americans, because the EPA will finally have an enforceable
food safety law. I urge support for H.R. 1627.
Mr. de la GARZA. Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore (Mr. Hayworth). The question is on the motion
of the gentleman from Kansas [Mr. Roberts] that the House suspend the
rules and pass the bill, H.R. 1627, as amended.
The question was taken.
Mr. BLILEY. Mr. Speaker, on that, I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 5, rule I, and the
Chair's prior announcement, further proceedings on this motion will be
postponed.

____________________