[104th Congress Public Law 170]
[From the U.S. Government Printing Office]
<DOC>
[DOCID: f:publ170.104]
[[Page 110 STAT. 1489]]
Public Law 104-170
104th Congress
An Act
To amend the Federal Insecticide, Fungicide, and Rodenticide Act and the
Federal Food, Drug, and Cosmetic Act, and for other purposes. <<NOTE:
Aug. 3, 1996 - [H.R. 1627]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Food Quality
Protection Act of 1996.>>
SECTION 1. <<NOTE: 7 USC 136 note.>> 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''.
[[Page 110 STAT. 1490]]
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) <<NOTE: Federal Register,
publication.>> publish in the Federal Register a
notice setting forth the determinations made under
this subparagraph; and
``(v) commence promptly such proceedings under
this Act and section 408 of the Federal Food,
Drug, and Cosmetic Act as are warranted by such
determinations.''.
SEC. 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) <<NOTE: Establishment.>> 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:
[[Page 110 STAT. 1491]]
``(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. <<NOTE: Regulations.>> The
Administrator shall by regula
[[Page 110 STAT. 1492]]
tion 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
pesticide); 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 <<NOTE: 7 USC 136x,
136y.>> as sections 33 and 34, respectively; and
(2) by adding after section 29 the following:
[[Page 110 STAT. 1493]]
``SEC. 30. <<NOTE: 7 USC 136w-5.>> 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.
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--Minor Use Crop Protection
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.''.
[[Page 110 STAT. 1494]]
(b) Exclusive Use of Minor Use Pesticides.--Section 3(c)(1)(F) (7
U.S.C. 136a(c)(1)(F)) is amended--
(1) by redesignating clauses (ii) and (iii) as clauses (iii)
and (iv), respectively; and
(2) by inserting after clause (i) the following:
``(ii) The period of exclusive data use
provided under clause (i) shall be extended 1
additional year for each 3 minor uses 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) <<NOTE: Effective date.>> The period of
exclusive use provided under clause (ii) shall not
take 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
[[Page 110 STAT. 1495]]
the period of 10 years following the date of
submission of such data. <<NOTE: Notification.>>
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. <<NOTE: Notice.>> In such
circumstance, the Administrator shall provide, in
writing to the reg
[[Page 110 STAT. 1496]]
istrant, a notice revoking the extension of time
for submission of data. Such data shall instead be
due in accordance with the date established by the
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 effect 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
[[Page 110 STAT. 1497]]
(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) <<NOTE: Review.>> 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 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
[[Page 110 STAT. 1498]]
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. <<NOTE: Federal Register,
publication.>> 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. <<NOTE: Notice.>> 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
[[Page 110 STAT. 1499]]
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. <<NOTE: Federal
Register, publication.>> 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. <<NOTE: Notice.>> 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
[[Page 110 STAT. 1500]]
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. <<NOTE: Federal
Register, publication.>> 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. <<NOTE: Notice.>> 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:
[[Page 110 STAT. 1501]]
``SEC. 31. <<NOTE: 7 USC 136w-6.>> 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) <<NOTE: Public information. Reports.>> 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. <<NOTE: 7 USC 136w-7.>> DEPARTMENT OF AGRICULTURE MINOR USE
PROGRAM.
``(a) In General.--The Secretary of Agriculture (hereinafter in this
section referred to as the `Secretary') shall assure the coordination of
the responsibilities of the Department of Agriculture related to minor
uses of 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) <<NOTE: Nomenclature.>> Establishment.--There is
established in the Treasury of the United States a revolving
fund to be known as the
[[Page 110 STAT. 1502]]
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
[[Page 110 STAT. 1503]]
``(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.
[[Page 110 STAT. 1504]]
``(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 an
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;
[[Page 110 STAT. 1505]]
``(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) <<NOTE: Federal Register,
publication.>> 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 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.
[[Page 110 STAT. 1506]]
``(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) <<NOTE: Review.>> 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
[[Page 110 STAT. 1507]]
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.''.
[[Page 110 STAT. 1508]]
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
[[Page 110 STAT. 1509]]
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.''.
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.--
[[Page 110 STAT. 1510]]
``(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). <<NOTE: Regulations.>> 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) <<NOTE: Notification.>> 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. <<NOTE: Notification.>> After a
determination is made under subsection (d), the Secretary shall
notify the Committees on Appropriations of the House of
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:
[[Page 110 STAT. 1511]]
``(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) <<NOTE: Guidelines.>> 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) <<NOTE: Notification.>> 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. <<NOTE: 21 USC 346a note.>> 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.
[[Page 110 STAT. 1512]]
(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. <<NOTE: 7 USC 136i-2.>> 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. <<NOTE: 7 USC 136r-1.>> 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. <<NOTE: 7 USC 136i-2 note.>> PESTICIDE USE INFORMATION
STUDY.
(a) <<NOTE: Reports.>> The Secretary of Agriculture shall, in
consultation with the Administrator of the Environmental Protection
Agency, prepare a report to Congress evaluating the current status and
potential improvements in Federal pesticide use information gathering
activities. This report shall at least include--
(1) an analysis of the quality and reliability of the
information collected by the Department of 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
[[Page 110 STAT. 1513]]
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-- <<NOTE: Food Quality Protection Act of 1996.>> AMENDMENTS TO
THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
SEC 401. SHORT TITLE AND REFERENCE.
(a) <<NOTE: 21 USC 301 note.>> 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
[[Page 110 STAT. 1514]]
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
[[Page 110 STAT. 1515]]
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.
[[Page 110 STAT. 1516]]
``(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--
``(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
[[Page 110 STAT. 1517]]
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). <<NOTE: Regulations.>>
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
[[Page 110 STAT. 1518]]
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) <<NOTE: Publication.>> publish a
specific determination regarding the
safety of the pesticide chemical residue
for infants and children.
<<NOTE: Surveys.>> 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 pro
[[Page 110 STAT. 1519]]
duced 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. <<NOTE: Regulations.>> 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
[[Page 110 STAT. 1520]]
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. <<NOTE: Publication.>> 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.
``(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--
[[Page 110 STAT. 1521]]
``(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) <<NOTE: Regulations.>> 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);
[[Page 110 STAT. 1522]]
``(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) <<NOTE: Publication.>> 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) <<NOTE: Regulations.>> 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
[[Page 110 STAT. 1523]]
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 <<NOTE: Regulations.>> 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) <<NOTE: Notice.>> 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;
[[Page 110 STAT. 1524]]
``(B) <<NOTE: Rules.>> issue a rule requiring that
testing be conducted on a substance or mixture under
section 4 of the Toxic Substances Control Act; or
``(C) <<NOTE: Federal Register,
publication.>> 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 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
[[Page 110 STAT. 1525]]
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 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) <<NOTE: Orders.>> 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
[[Page 110 STAT. 1526]]
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
[[Page 110 STAT. 1527]]
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--
``(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. <<NOTE: Regulations.>> 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
[[Page 110 STAT. 1528]]
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. <<NOTE: Effective date.>> 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. <<NOTE: Applicability.>>
Subsection (e) shall apply to actions taken under this
paragraph. <<NOTE: Effective date.>> 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. <<NOTE: Applicability.>> Subsection (e) shall apply to
the establishment of such tolerance. <<NOTE: Review.>> The
Adminis
[[Page 110 STAT. 1529]]
trator 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. <<NOTE: Regulations.>>
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) <<NOTE: Regulations.>> 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;
[[Page 110 STAT. 1530]]
``(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, and 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
[[Page 110 STAT. 1531]]
or enforce any regulatory limit on a qualifying pesticide
chemical residue in or on any food if a qualifying Federal
determination applies to the presence of such pesticide chemical
residue in or on such food, unless such State regulatory limit
is identical to such qualifying Federal determination. A State
or political subdivision shall be deemed to establish or enforce
a regulatory limit on a pesticide chemical residue in or on 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
[[Page 110 STAT. 1532]]
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.
<<NOTE: Publication. Public information.>> ``(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
[[Page 110 STAT. 1533]]
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 <<NOTE: Orders.>> 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) <<NOTE: Notice.>> 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 comple
[[Page 110 STAT. 1534]]
tion 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 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.
<<NOTE: Regulations.>> 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.
[[Page 110 STAT. 1535]]
``(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
[[Page 110 STAT. 1536]]
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 U.S.C. 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) <<NOTE: Effective date. Rules and
procedures.>> 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;
[[Page 110 STAT. 1537]]
``(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) <<NOTE: Review.>> 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) <<NOTE: Contracts.>> 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 <<NOTE: Applicability.>> 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
[[Page 110 STAT. 1538]]
of performance measures 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. <<NOTE: Reports.>> The Inspector General shall conduct the
annual audit and report 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) <<NOTE: Federal Register, publication.>> 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.''.
Approved August 3, 1996.
LEGISLATIVE HISTORY--H.R. 1627:
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HOUSE REPORTS: No. 104-669, Pt. 1 (Comm. on Agriculture) and Pt. 2
(Comm. on Commerce).
CONGRESSIONAL RECORD, Vol. 142 (1996):
July 23, considered and passed House.
July 24, considered and passed Senate.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 32 (1996):
Aug. 3, Presidential remarks and statement.
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