Public Law 104-170 - Food Quality Protection Act of 1996

PUBLIC LAW 104–170—AUG. 3, 1996

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.

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Food Quality Protection Act
of 1996’’.

TITLE I—SUSPENSION-APPLICATORS
SEC. 101. REFERENCE.

Whenever in this title an amendment or repeal is expressed
in terms of an amendment to, or repeal of, a section or other
provision, the reference shall be considered to be made to a section
or other provision of the Federal Insecticide, Fungicide, and
Rodenticide Act.

Subtitle A—Suspension
SEC. 102. SUSPENSION.

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

Aug. 3, 1996
[H.R. 1627]
Food Quality
Protection Act of
1996.
7 USC 136 note.

110 STAT. 1490

PUBLIC LAW 104–170—AUG. 3, 1996

SEC. 103. TOLERANCE REEVALUATION AS PART OF REREGISTRATION.

Federal Register,
publication.

Section 4(g)(2) (7 U.S.C. 136a–1(g)(2)) is amended by adding
at the end the following:
‘‘(E) As soon as the Administrator has sufficient
information with respect to the dietary risk of a particular
active ingredient, but in any event no later than the time
the Administrator makes a determination under subparagraph (C) or (D) with respect to pesticides containing a
particular active ingredient, the Administrator shall—
‘‘(i) reassess each associated tolerance and exemption from the requirement for a tolerance issued under
section 408 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 346a);
‘‘(ii) determine whether such tolerance or exemption meets the requirements of that Act;
‘‘(iii) determine whether additional tolerances or
exemptions should be issued;
‘‘(iv) publish in the Federal Register a notice setting forth the determinations made under this subparagraph; and
‘‘(v) commence promptly such proceedings under
this Act and section 408 of the Federal Food, Drug,
and Cosmetic Act as are warranted by such determinations.’’.
SEC. 104. SCIENTIFIC ADVISORY PANEL.

Establishment.

Section 25(d) (7 U.S.C. 136w(d)) is amended—
(1) in the first sentence, by striking ‘‘The Administrator
shall’’ and inserting:
‘‘(1) IN GENERAL.—The Administrator shall’’; and
(2) by adding at the end the following:
‘‘(2) SCIENCE REVIEW BOARD.—There is established a
Science Review Board to consist of 60 scientists who shall
be available to the Scientific Advisory Panel to assist in reviews
conducted by the Panel. Members of the Board shall be selected
in the same manner as members of temporary subpanels created under paragraph (1). Members of the Board shall be compensated in the same manner as members of the Panel.’’.
SEC. 105. NITROGEN STABILIZER.

(a) SECTION 2.—Section 2 (7 U.S.C. 136) is amended—
(1) in subsection (a)—
(A) in paragraph (1) by striking ‘‘or’’ after ‘‘defoliant,’’
and inserting ‘‘, or nitrogen stabilizer’’ after ‘‘desiccant’’;
(B) at the end of paragraph (3) by striking ‘‘and’’;
(C) at the end of paragraph (4) by striking the period
and inserting ‘‘; and’’; and
(D) at the end by adding the following:
‘‘(5) in the case of a nitrogen stabilizer, an ingredient
which will prevent or hinder the process of nitrification,
denitrification, ammonia volatilization, or urease production
through action affecting soil bacteria.’’;
(2) in subsection (u), by striking ‘‘and’’ before ‘‘(2)’’ and
by inserting ‘‘and (3) any nitrogen stabilizer,’’ after ‘‘desiccant,’’;
and
(3) at the end by adding the following:

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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. The Administrator shall by regula-

Regulations.

110 STAT. 1492

PUBLIC LAW 104–170—AUG. 3, 1996
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.

7 USC 136x,
136y.

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

PUBLIC LAW 104–170—AUG. 3, 1996

110 STAT. 1493

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

‘‘Each State may establish minimum requirements for training
of maintenance applicators and service technicians. Such training
may include instruction in the safe and effective handling and
use of pesticides in accordance with the Environmental Protection
Agency approved labeling, and instruction in integrated pest
management techniques. The authority of the Administrator with
respect to minimum requirements for training of maintenance
applicators and service technicians shall be limited to ensuring
that each State understands the provisions of this section.’’.

TITLE II—MINOR USE CROP PROTECTION,
ANTIMICROBIAL
PESTICIDE
REGISTRATION REFORM, AND PUBLIC
HEALTH PESTICIDES
SEC. 201. REFERENCE.

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.’’.

7 USC 136w–5.

110 STAT. 1494

Effective date.

PUBLIC LAW 104–170—AUG. 3, 1996

(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) 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

PUBLIC LAW 104–170—AUG. 3, 1996

110 STAT. 1495

the period of 10 years following the date of submission
of such data. The applicant or registrant at the time
the new minor use is requested shall notify the
Administrator that to the best of their knowledge the
exclusive use period for the pesticide has expired and
that the data pertaining solely to the minor use of
a pesticide is eligible for the provisions of this paragraph. If the minor use registration which is supported
by data submitted pursuant to this subsection is voluntarily canceled or if such data are subsequently used
to support a nonminor use, the data shall no longer
be subject to the exclusive use provisions of this clause
but shall instead be considered by the Administrator
in accordance with the provisions of clause (i), as appropriate.’’.
(c) TIME EXTENSIONS FOR DEVELOPMENT OF MINOR USE DATA.—
(1)
DATA
CALL-IN.—Section
3(c)(2)(B)
(7
U.S.C.
136a(c)(2)(B)) is amended by adding at the end the following:
‘‘(vi) Upon the request of a registrant the Administrator
shall, in the case of a minor use, extend the deadline
for the production of residue chemistry data under this
subparagraph for data required solely to support that minor
use until the final deadline for submission of data under
section 4 for the other uses of the pesticide established
as of the date of enactment of the Food Quality Protection
Act of 1996, if—
‘‘(I) the data to support other uses of the pesticide
on a food are being provided;
‘‘(II) the registrant, in submitting a request for
such an extension, provides a schedule, including
interim dates to measure progress, to assure that the
data production will be completed before the expiration
of the extension period;
‘‘(III) the Administrator has determined that such
extension will not significantly delay the Administrator’s schedule for issuing a reregistration eligibility
determination required under section 4; and
‘‘(IV) the Administrator has determined that based
on existing data, such extension would not significantly
increase the risk of any unreasonable adverse effect
on the environment. If the Administrator grants an
extension under this clause, the Administrator shall
monitor the development of the data and shall ensure
that the registrant is meeting the schedule for the
production of the data. If the Administrator determines
that the registrant is not meeting or has not met
the schedule for the production of such data, the
Administrator may proceed in accordance with clause
(iv) regarding the continued registration of the affected
products with the minor use and shall inform the public
of such action. Notwithstanding the provisions of this
clause, the Administrator may take action to modify
or revoke the extension under this clause if the
Administrator determines that the extension for the
minor use may cause an unreasonable adverse effect
on the environment. In such circumstance, the
Administrator shall provide, in writing to the reg-

Notification.

Notice.

110 STAT. 1496

PUBLIC LAW 104–170—AUG. 3, 1996

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

PUBLIC LAW 104–170—AUG. 3, 1996

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) 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 ‘fulltime period’ means the time period originally established
by the Administrator for submission of such data, beginning

Review.

110 STAT. 1498

Federal Register,
publication.

Notice.

PUBLIC LAW 104–170—AUG. 3, 1996

with the date of receipt by the registrant of the Administrator’s notice of denial.’’.
(f) TEMPORARY EXTENSION OF REGISTRATION FOR UNSUPPORTED
MINOR USES.—
(1) REREGISTRATION.—
(A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C. 136a–1(d)(6)
and (f)(3)) are each amended by adding at the end the
following: ‘‘If the registrant does not commit to support
a specific minor use of the pesticide, but is supporting
and providing data in a timely and adequate fashion to
support uses of the pesticide on a food, or if all uses
of the pesticide are nonfood uses and the registrant does
not commit to support a specific minor use of the pesticide
but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide,
the Administrator, at the written request of the registrant,
shall not take any action pursuant to this paragraph in
regard to such unsupported minor use until the final deadline established as of the date of enactment of the Food
Quality Protection Act of 1996, for the submission of data
under this section for the supported uses identified pursuant to this paragraph unless the Administrator determines
that the absence of the data is significant enough to cause
human health or environmental concerns. On such a determination the Administrator may refuse the request for
extension by the registrant. Upon receipt of the request
from the registrant, the Administrator shall publish in
the Federal Register a notice of the receipt of the request
and the effective date upon which the uses not being supported will be voluntarily deleted from the registration
pursuant to section 6(f)(1). If the Administrator grants
an extension under this paragraph, the Administrator shall
monitor the development of the data for the uses being
supported and shall ensure that the registrant is meeting
the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or
has not met the schedule for the production of such data,
the Administrator may proceed in accordance with section
3(c)(2)(B)(iv) regarding the continued registration of the
affected products with the minor and other uses and shall
inform the public of such action in accordance with section
6(f)(2). Notwithstanding this subparagraph, the Administrator may deny, modify, or revoke the temporary extension
under this paragraph if the Administrator determines that
the continuation of the minor use may cause an unreasonable adverse effect on the environment. In the event of
modification or revocation, the Administrator shall provide,
in writing, to the registrant a notice revoking the temporary
extension and establish a new effective date by which the
minor use shall be deleted from the registration.’’.
(B) Section 4(e)(3)(A) (7 U.S.C. 136a–1(e)(3)(A)) is
amended by adding at the end the following: ‘‘If the registrant does not commit to support a specific minor use
of the pesticide, but is supporting and providing data in
a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood
uses and the registrant does not commit to support a

PUBLIC LAW 104–170—AUG. 3, 1996

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. Upon receipt of
the request from the registrant, the Administrator shall
publish in the Federal Register a notice of the receipt
of the request and the effective date upon which the uses
not being supported will be voluntarily deleted from the
registration pursuant to section 6(f)(1). If the Administrator
grants an extension under this subparagraph, the Administrator shall monitor the development of the data for the
uses being supported and shall ensure that the registrant
is meeting the schedule for the production of such data.
If the Administrator determines that the registrant is not
meeting or has not met the schedule for the production
of such data, the Administrator may proceed in accordance
with section 3(c)(2)(B)(iv) regarding the continued registration of the affected products with the minor and other
uses and shall inform the public of such action in accordance with section 6(f)(2). Notwithstanding this subparagraph, the Administrator may deny, modify, or revoke the
temporary extension under this subparagraph if the
Administrator determines that the continuation of the
minor use may cause an unreasonable adverse effect on
the environment. In the event of modification or revocation,
the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and
establish a new effective date by which the minor use
shall be deleted from the registration.’’.
(2) DATA.—Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as
amended by subsection (c)(1), is further amended by adding
at the end the following:
‘‘(vii) If the registrant does not commit to support
a specific minor use of the pesticide, but is supporting
and providing data in a timely and adequate fashion to
support uses of the pesticide on a food, or if all uses
of the pesticide are nonfood uses and the registrant does
not commit to support a specific minor use of the pesticide
but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide,
the Administrator, at the written request of the registrant,
shall not take any action pursuant to this clause in regard
to such unsupported minor use until the final deadline
established as of the date of enactment of the Food Quality
Protection Act of 1996, for the submission of data under
section 4 for the supported uses identified pursuant to
this clause unless the Administrator determines that the

Federal Register,
publication.

Notice.

110 STAT. 1500

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absence of the data is significant enough to cause human
health or environmental concerns. On the basis of such
determination, the Administrator may refuse the request
for extension by the registrant. Upon receipt of the request
from the registrant, the Administrator shall publish in
the Federal Register a notice of the receipt of the request
and the effective date upon which the uses not being supported will be voluntarily deleted from the registration
pursuant to section 6(f)(1). If the Administrator grants
an extension under this clause, the Administrator shall
monitor the development of the data for the uses being
supported and shall ensure that the registrant is meeting
the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or
has not met the schedule for the production of such data,
the Administrator may proceed in accordance with clause
(iv) of this subparagraph regarding the continued registration of the affected products with the minor and other
uses and shall inform the public of such action in accordance with section 6(f)(2). Notwithstanding the provisions
of this clause, the Administrator may deny, modify, or
revoke the temporary extension under this subparagraph
if the Administrator determines that the continuation of
the minor use may cause an unreasonable adverse effect
on the environment. In the event of modification or revocation, the Administrator shall provide, in writing, to the
registrant a notice revoking the temporary extension and
establish a new effective date by which the minor use
shall be deleted from the registration.’’.
(g) Section 6(f) (7 U.S.C. 136d(f)) is amended—
(1) in paragraph (1)(C)(ii) by striking ‘‘90-day’’ each place
it appears and inserting ‘‘180-day’’; and
(2) in paragraph (3)(A) by striking ‘‘90-day’’ and inserting
‘‘180-day’’.
(h) UTILIZATION OF DATA FOR VOLUNTARILY CANCELED CHEMICALS.—Section 6(f) (7 U.S.C. 136d(f)) is amended by adding at
the end the following:
‘‘(4) UTILIZATION OF DATA FOR VOLUNTARILY CANCELED PESTICIDE.—When an application is filed with the Administrator
for the registration of a pesticide for a minor use and another
registrant subsequently voluntarily cancels its registration for
an identical or substantially similar pesticide for an identical
or substantially similar use, the Administrator shall process,
review, and evaluate the pending application as if the voluntary
cancellation had not yet taken place except that the Administrator shall not take such action if the Administrator determines that such minor use may cause an unreasonable adverse
effect on the environment. In order to rely on this subsection,
the applicant must certify that it agrees to satisfy any outstanding data requirements necessary to support the reregistration
of the pesticide in accordance with the data submission schedule
established by the Administrator.’’.
(i) ENVIRONMENTAL PROTECTION AGENCY MINOR USE PROGRAM.—The Federal Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C. 136 et seq.), as amended by section 121, is amended
by adding after section 30 the following:

PUBLIC LAW 104–170—AUG. 3, 1996

110 STAT. 1501

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

7 USC 136w–6.

‘‘(a) The Administrator shall assure coordination of minor use
issues through the establishment of a minor use program within
the Office of Pesticide Programs. Such office shall be responsible
for coordinating the development of minor use programs and policies
and consulting with growers regarding minor use issues and registrations and amendments which are submitted to the Environmental Protection Agency.
‘‘(b) The Office of Pesticide Programs shall prepare a public
report concerning the progress made on the registration of minor
uses, including implementation of the exclusive use as an incentive
for registering new minor uses, within 3 years of the passage
of the Food Quality Protection Act of 1996.’’.
(j) DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM.—The
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136
et seq.), as amended by subsection (i), is amended by adding after
section 31 the following:

Public
information.
Reports.

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

7 USC 136w–7.

‘‘(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) ESTABLISHMENT.—There is established in the Treasury
of the United States a revolving fund to be known as the

Nomenclature.

110 STAT. 1502

PUBLIC LAW 104–170—AUG. 3, 1996
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

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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.

110 STAT. 1504

PUBLIC LAW 104–170—AUG. 3, 1996
‘‘(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;

PUBLIC LAW 104–170—AUG. 3, 1996

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) 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.

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110 STAT. 1506

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PUBLIC LAW 104–170—AUG. 3, 1996
‘‘(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 nonnotification procedures;
‘‘(bb) revised procedures for application
review; and
‘‘(cc) allocation of appropriate resources to
ensure
streamlined
management
of
antimicrobial pesticide registrations; and
‘‘(IV) clarify criteria for determination of the
completeness of an application.
‘‘(C) EXPEDITED REVIEW.—This subsection does not
affect the requirements or extend the deadlines or review
periods contained in subsection (c)(3).
‘‘(D) ALTERNATIVE REVIEW PERIODS.—If the final regulations to carry out this paragraph are not effective 630
days after the date of enactment of this subsection, until
the final regulations become effective, the review period,
beginning on the date of receipt by the Agency of a complete
application, shall be—
‘‘(i) 2 years for a new antimicrobial active ingredient pesticide registration;
‘‘(ii) 1 year for a new antimicrobial use of a registered active ingredient;
‘‘(iii) 180 days for any other new antimicrobial
product;
‘‘(iv) 90 days for a substantially similar or identical
antimicrobial product;
‘‘(v) 90 days for an amendment to an antimicrobial
registration that does not require scientific review of
data; and
‘‘(vi) 240 days for an amendment to an
antimicrobial registration that requires scientific
review of data and that is not otherwise described
in this subparagraph.
‘‘(E) WOOD PRESERVATIVES.—An application for the registration, or for an amendment to the registration, of a
wood preservative product for which a claim of pesticidal
activity listed in section 2(mm) is made (regardless of any
other pesticidal claim that is made with respect to the
product) shall be reviewed by the Administrator within

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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.’’.

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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

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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.—

110 STAT. 1510

Regulations.

Notification.

Notification.

PUBLIC LAW 104–170—AUG. 3, 1996
‘‘(1) DEFINITION.—For the purposes of this section, ‘Secretary’ means the Secretary of Health and Human Services,
acting through the Public Health Service.
‘‘(2) CONSULTATION.—In the case of a pesticide registered
for use in public health programs for vector control or for
other uses the Administrator determines to be human health
protection uses, the Administrator shall, upon timely request
by the registrant or any other interested person, or on the
Administrator’s own initiative may, consult with the Secretary
prior to taking final action to suspend registration under section
3(c)(2)(B)(iv), or cancel a registration under section 4, 6(e),
or 6(f). In consultation with the Secretary, the Administrator
shall prescribe the form and content of requests under this
section.
‘‘(3) BENEFITS TO SUPPORT FAMILY.—The Administrator,
after consulting with the Secretary, shall make a determination
whether the potential benefits of continued use of the pesticide
for public health or health protection purposes are of such
significance as to warrant a commitment by the Secretary
to conduct or to arrange for the conduct of the studies required
by the Administrator to support continued registration under
section 3 or reregistration under section 4.
‘‘(4) ADDITIONAL TIME.—If the Administrator determines
that such a commitment is warranted and in the public interest,
the Administrator shall notify the Secretary and shall, to the
extent necessary, amend a notice issued under section 3(c)(2)(B)
to specify additional reasonable time periods for submission
of the data.
‘‘(5) ARRANGEMENTS.—The Secretary shall make such
arrangements for the conduct of required studies as the Secretary finds necessary and appropriate to permit submission
of data in accordance with the time periods prescribed by
the Administrator. Such arrangements may include Public
Health Service intramural research activities, grants, contracts,
or cooperative agreements with academic, public health, or
other organizations qualified by experience and training to
conduct such studies.
‘‘(6) SUPPORT.—The Secretary may provide for support of
the required studies using funds authorized to be appropriated
under this section, the Public Health Service Act, or other
appropriate authorities. After a determination is made under
subsection (d), the Secretary shall notify the Committees on
Appropriations of the House 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:

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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) Not later than 1 year after the date of enactment
of this paragraph, the Administrator shall, utilizing public
comment, develop procedures and guidelines, and expedite
the review of an application for registration of a pesticide
or an amendment to a registration that satisfies such guidelines.
‘‘(B) Any application for registration or an amendment,
including biological and conventional pesticides, will be
considered for expedited review under this paragraph. An
application for registration or an amendment shall qualify
for expedited review if use of the pesticide proposed by
the application may reasonably be expected to accomplish
1 or more of the following:
‘‘(i) Reduce the risks of pesticides to human health.
‘‘(ii) Reduce the risks of pesticides to nontarget
organisms.
‘‘(iii) Reduce the potential for contamination of
groundwater, surface water, or other valued environmental resources.
‘‘(iv) Broaden the adoption of integrated pest
management strategies, or make such strategies more
available or more effective.
‘‘(C) The Administrator, not later than 30 days after
receipt of an application for expedited review, shall notify
the applicant whether the application is complete. If it
is found to be incomplete, the Administrator may either
reject the request for expedited review or ask the applicant
for additional information to satisfy the guidelines developed under subparagraph (A).’’.

Guidelines.

Notification.

TITLE III—DATA COLLECTION ACTIVITIES TO ASSURE THE HEALTH OF INFANTS AND CHILDREN AND OTHER
MEASURES
SEC. 301. DATA COLLECTION ACTIVITIES TO ASSURE THE HEALTH
OF INFANTS AND CHILDREN.

(a) IN GENERAL.—The Secretary of Agriculture, in consultation
with the Administrator of the Environmental Protection Agency
and the Secretary of Health and Human Services, shall coordinate
the development and implementation of survey procedures to ensure
that adequate data on food consumption patterns of infants and
children are collected.
(b) PROCEDURES.—To the extent practicable, the procedures
referred to in subsection (a) shall include the collection of data
on food consumption patterns of a statistically valid sample of
infants and children.

21 USC 346a
note.

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(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.
7 USC 136i–2.

SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION.

(a) IN GENERAL.—The Secretary of Agriculture shall collect
data of statewide or regional significance on the use of pesticides
to control pests and diseases of major crops and crops of dietary
significance, including fruits and vegetables.
(b) COLLECTION.—The data shall be collected by surveys of
farmers or from other sources offering statistically reliable data.
(c) COORDINATION.—The Secretary of Agriculture shall, as
appropriate, coordinate with the Administrator of the Environmental Protection Agency in the design of the surveys and make
available to the Administrator the aggregate results of the surveys
to assist the Administrator.
7 USC 136r–1.

SEC. 303. INTEGRATED PEST MANAGEMENT.

The Secretary of Agriculture, in cooperation with the Administrator, shall implement research, demonstration, and education programs to support adoption of Integrated Pest Management.
Integrated Pest Management is a sustainable approach to managing
pests by combining biological, cultural, physical, and chemical tools
in a way that minimizes economic, health, and environmental risks.
The Secretary of Agriculture and the Administrator shall make
information on Integrated Pest Management widely available to
pesticide users, including Federal agencies. Federal agencies shall
use Integrated Pest Management techniques in carrying out pest
management activities and shall promote Integrated Pest Management through procurement and regulatory policies, and other activities.
SEC. 304. COORDINATION OF CANCELLATION.

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

SEC. 305. PESTICIDE USE INFORMATION STUDY.

(a) The Secretary of Agriculture shall, in consultation with
the Administrator of the Environmental Protection Agency, prepare
a report to Congress evaluating the current status and potential
improvements in Federal pesticide use information gathering activities. This report shall at least include—
(1) an analysis of the quality and reliability of the information collected by the Department of 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

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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—AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC
ACT

Food Quality
Protection Act of
1996.

SEC 401. SHORT TITLE AND REFERENCE.

(a) SHORT TITLE.—This title may be cited as the ‘‘Food Quality
Protection Act of 1996 ’’.
(b) REFERENCE.—Whenever in this title an amendment or
repeal is expressed in terms of an amendment to, or repeal of,
a section or other provision, the reference shall be considered to
be made to a section or other provision of the Federal Food, Drug,
and Cosmetic Act.
SEC. 402. DEFINITIONS.

(a) SECTION 201(q).—Section 201(q) (21 U.S.C. 321(q)) is
amended to read as follows:
‘‘(q)(1) The term ‘pesticide chemical’ means any substance that
is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and inert ingredients of such pesticide.
‘‘(2) The term ‘pesticide chemical residue’ means a residue
in or on raw agricultural commodity or processed food of—
‘‘(A) a pesticide chemical; or
‘‘(B) any other added substance that is present on or in
the commodity or food primarily as a result of the metabolism
or other degradation of a pesticide chemical.
‘‘(3) Notwithstanding paragraphs (1) and (2), the Administrator
may by regulation except a substance from the definition of ‘pesticide chemical’ or ‘pesticide chemical residue’ if—
‘‘(A) its occurrence as a residue on or in a raw agricultural
commodity or processed food is attributable primarily to natural
causes or to human activities not involving the use of any
substances for a pesticidal purpose in the production, storage,
processing, or transportation of any raw agricultural commodity
or processed food; and
‘‘(B) the Administrator, after consultation with the Secretary, determines that the substance more appropriately
should be regulated under one or more provisions of this Act
other than sections 402(a)(2)(B) and 408.’’.
(b) SECTION 201(s).—Paragraphs (1) and (2) of section 201(s)
(21 U.S.C. 321(s)) are amended to read as follows:
‘‘(1) a pesticide chemical residue in or on a raw agricultural
commodity or processed food; or
‘‘(2) a pesticide chemical; or’’.
(c) SECTION 201.—Section 201 (21 U.S.C. 321) is amended by
adding at the end the following:
‘‘(gg) The term ‘processed food’ means any food other than
a raw agricultural commodity and includes any raw agricultural

21 USC 301 note.

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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

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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.

110 STAT. 1516

PUBLIC LAW 104–170—AUG. 3, 1996
‘‘(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

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disruption in domestic production of an adequate,
wholesome, and economical food supply.
‘‘(iv) CONDITIONS REGARDING RISK.—For purposes
of clause (ii), the conditions described in this clause
with respect to a tolerance for an eligible pesticide
chemical residue are the following:
‘‘(I) The yearly risk associated with the nonthreshold effect from aggregate exposure to the
residue does not exceed 10 times the yearly risk
that would be allowed under subparagraph (A)
for such effect.
‘‘(II) The tolerance is limited so as to ensure
that the risk over a lifetime associated with the
nonthreshold effect from aggregate exposure to the
residue is not greater than twice the lifetime risk
that would be allowed under subparagraph (A)
for such effect.
‘‘(v) REVIEW.—Five years after the date on which
the Administrator makes a determination to leave in
effect or modify a tolerance under this subparagraph,
and thereafter as the Administrator deems appropriate, the Administrator shall determine, after notice
and opportunity for comment, whether it has been
demonstrated to the Administrator that a condition
described in clause (iii)(I) or clause (iii)(II) continues
to exist with respect to the tolerance and that the
yearly and lifetime risks from aggregate exposure to
such residue continue to comply with the limits specified in clause (iv). If the Administrator determines
by such date that such demonstration has not been
made, the Administrator shall, not later than 180 days
after the date of such determination, issue a regulation
under subsection (e)(1) to modify or revoke the tolerance.
‘‘(vi) INFANTS AND CHILDREN.—Any tolerance under
this subparagraph shall meet the requirements of
subparagraph (C).
‘‘(C) EXPOSURE OF INFANTS AND CHILDREN.—In
establishing, modifying, leaving in effect, or revoking a
tolerance or exemption for a pesticide chemical residue,
the Administrator—
‘‘(i) shall assess the risk of the pesticide chemical
residue based on—
‘‘(I) available information about consumption
patterns among infants and children that are likely
to result in disproportionately high consumption
of foods containing or bearing such residue among
infants and children in comparison to the general
population;
‘‘(II) available information concerning the special susceptibility of infants and children to the
pesticide chemical residues, including neurological
differences between infants and children and
adults, and effects of in utero exposure to pesticide
chemicals; and
‘‘(III) available information concerning the
cumulative effects on infants and children of such

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110 STAT. 1518

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PUBLIC LAW 104–170—AUG. 3, 1996
residues and other substances that have a common
mechanism of toxicity; and
‘‘(ii) shall—
‘‘(I) ensure that there is a reasonable certainty
that no harm will result to infants and children
from aggregate exposure to the pesticide chemical
residue; and
‘‘(II) publish a specific determination regarding
the safety of the pesticide chemical residue for
infants and children.
The Secretary of Health and Human Services and the
Secretary of Agriculture, in consultation with the Administrator, shall conduct surveys to document dietary exposure
to pesticides among infants and children. In the case of
threshold effects, for purposes of clause (ii)(I) an additional
tenfold margin of safety for the pesticide chemical residue
and other sources of exposure shall be applied for infants
and children to take into account potential pre- and postnatal 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-

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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. 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

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110 STAT. 1520

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modified by the Administrator unless the Administrator
determines, after consultation with the Secretary, that
there is a practical method for detecting and measuring
the levels of the pesticide chemical residue in or on the
food.
‘‘(B) DETECTION LIMIT.—A tolerance for a pesticide
chemical residue in or on a food shall not be established
at or modified to a level lower than the limit of detection
of the method for detecting and measuring the pesticide
chemical residue specified by the Administrator under
subparagraph (A).
‘‘(4) INTERNATIONAL STANDARDS.—In establishing a tolerance for a pesticide chemical residue in or on a food, the
Administrator shall determine whether a maximum residue
level for the pesticide chemical has been established by the
Codex Alimentarius Commission. If a Codex maximum residue
level has been established for the pesticide chemical and the
Administrator does not propose to adopt the Codex level, the
Administrator shall publish for public comment a notice
explaining the reasons for departing from the Codex level.
‘‘(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—

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‘‘(A) that there is a practical method for detecting
and measuring the levels of such pesticide chemical residue
in or on food; or
‘‘(B) that there is no need for such a method, and
states the reasons for such determination in issuing the
regulation establishing or modifying the exemption.
‘‘(d) PETITION FOR TOLERANCE OR EXEMPTION.—
‘‘(1) PETITIONS AND PETITIONERS.—Any person may file with
the Administrator a petition proposing the issuance of a regulation—
‘‘(A) establishing, modifying, or revoking a tolerance
for a pesticide chemical residue in or on a food; or
‘‘(B) establishing, modifying, or revoking an exemption
from the requirement of a tolerance for such a residue.
‘‘(2) PETITION CONTENTS.—
‘‘(A) ESTABLISHMENT.—A petition under paragraph (1)
to establish a tolerance or exemption for a pesticide chemical residue shall be supported by such data and information
as are specified in regulations issued by the Administrator,
including—
‘‘(i)(I) an informative summary of the petition and
of the data, information, and arguments submitted
or cited in support of the petition; and
‘‘(II) a statement that the petitioner agrees that
such summary or any information it contains may
be published as a part of the notice of filing of the
petition to be published under this subsection and as
part of a proposed or final regulation issued under
this section;
‘‘(ii) the name, chemical identity, and composition
of the pesticide chemical residue and of the pesticide
chemical that produces the residue;
‘‘(iii) data showing the recommended amount, frequency, method, and time of application of that pesticide chemical;
‘‘(iv) full reports of tests and investigations made
with respect to the safety of the pesticide chemical,
including full information as to the methods and controls used in conducting those tests and investigations;
‘‘(v) full reports of tests and investigations made
with respect to the nature and amount of the pesticide
chemical residue that is likely to remain in or on
the food, including a description of the analytical methods used;
‘‘(vi) a practical method for detecting and measuring the levels of the pesticide chemical residue in or
on the food, or for exemptions, a statement why such
a method is not needed;
‘‘(vii) a proposed tolerance for the pesticide chemical residue, if a tolerance is proposed;
‘‘(viii) if the petition relates to a tolerance for a
processed food, reports of investigations conducted
using the processing method(s) used to produce that
food;
‘‘(ix) such information as the Administrator may
require to make the determination under subsection
(b)(2)(C);

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‘‘(x) such information as the Administrator may
require on whether the pesticide chemical may have
an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects;
‘‘(xi) information regarding exposure to the pesticide chemical residue due to any tolerance or exemption already granted for such residue;
‘‘(xii) practical methods for removing any amount
of the residue that would exceed any proposed tolerance; and
‘‘(xiii) such other data and information as the
Administrator requires by regulation to support the
petition.
If information or data required by this subparagraph is
available to the Administrator, the person submitting the
petition may cite the availability of the information or
data in lieu of submitting it. The Administrator may
require a petition to be accompanied by samples of the
pesticide chemical with respect to which the petition is
filed.
‘‘(B) MODIFICATION OR REVOCATION.—The Administrator may by regulation establish the requirements for
information and data to support a petition to modify or
revoke a tolerance or to modify or revoke an exemption
from the requirement for a tolerance.
‘‘(3) NOTICE.—A notice of the filing of a petition that the
Administrator determines has met the requirements of paragraph (2) shall be published by the Administrator within 30
days after such determination. The notice shall announce the
availability of a description of the analytical methods available
to the Administrator for the detection and measurement of
the pesticide chemical residue with respect to which the petition
is filed or shall set forth the petitioner’s statement of why
such a method is not needed. The notice shall include the
summary required by paragraph (2)(A)(i)(I).
‘‘(4) ACTIONS BY THE ADMINISTRATOR.—
‘‘(A) IN GENERAL.—The Administrator shall, after giving due consideration to a petition filed under paragraph
(1) and any other information available to the Administrator—
‘‘(i) issue a final regulation (which may vary from
that sought by the petition) establishing, modifying,
or revoking a tolerance for the pesticide chemical residue or an exemption of the pesticide chemical residue
from the requirement of a tolerance (which final regulation shall be issued without further notice and without
further period for public comment);
‘‘(ii) issue a proposed regulation under subsection
(e), and thereafter issue a final regulation under such
subsection; or
‘‘(iii) issue an order denying the petition.
‘‘(B) PRIORITIES.—The Administrator shall give priority
to petitions for the establishment or modification of a tolerance or exemption for a pesticide chemical residue that
appears to pose a significantly lower risk to human health

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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 not continue to exist, the
Administrator shall, not later than 180 days after the
date on which the determination under the preceding
sentence is made, issue a regulation under subsection
(e)(1) to modify or revoke the tolerance.
‘‘(e) ACTION ON ADMINISTRATOR’S OWN INITIATIVE.—
‘‘(1) GENERAL RULE.—The Administrator may issue a regulation—
‘‘(A) establishing, modifying, suspending under subsection (l)(3), or revoking a tolerance for a pesticide chemical or a pesticide chemical residue;
‘‘(B) establishing, modifying, suspending under subsection (l)(3), or revoking an exemption of a pesticide chemical residue from the requirement of a tolerance; or
‘‘(C) establishing general procedures and requirements
to implement this section.
‘‘(2) NOTICE.—Before issuing a final regulation under paragraph (1), the Administrator shall issue a notice of proposed
rulemaking and provide a period of not less than 60 days
for public comment on the proposed regulation, except that
a shorter period for comment may be provided if the Administrator for good cause finds that it would be in the public
interest to do so and states the reasons for the finding in
the notice of proposed rulemaking.
‘‘(f) SPECIAL DATA REQUIREMENTS.—
‘‘(1) REQUIRING SUBMISSION OF ADDITIONAL DATA.—If the
Administrator determines that additional data or information
are reasonably required to support the continuation of a tolerance or exemption that is in effect under this section for a
pesticide chemical residue on a food, the Administrator shall—
‘‘(A) issue a notice requiring the person holding the
pesticide registrations associated with such tolerance or
exemption to submit the data or information under section
3(c)(2)(B) of the Federal Insecticide, Fungicide, and
Rodenticide Act;

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110 STAT. 1524
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‘‘(B) issue a rule requiring that testing be conducted
on a substance or mixture under section 4 of the Toxic
Substances Control Act; or
‘‘(C) publish in the Federal Register, after first providing notice and an opportunity for comment of not less
than 60 days’ duration, an order—
‘‘(i) requiring the submission to the Administrator
by one or more interested persons of a notice identifying the person or 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

PUBLIC LAW 104–170—AUG. 3, 1996

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) 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

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110 STAT. 1526

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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

PUBLIC LAW 104–170—AUG. 3, 1996

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. 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

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110 STAT. 1528

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contains a particular pesticide chemical and that is labeled
for use on a particular food, or requires that the registration
of each such pesticide be modified to prohibit its use in connection with the production, storage, or transportation of such
food, due in whole or in part to dietary risks to humans posed
by residues of that pesticide chemical on that food, the Administrator shall revoke any tolerance or exemption that allows
the presence of the pesticide chemical, or any pesticide chemical
residue that results from its use, in or on that food. Subsection
(e) shall apply to actions taken under this paragraph. A revocation under this paragraph shall become effective not later than
180 days after—
‘‘(A) the date by which each such cancellation of a
registration has become effective; or
‘‘(B) the date on which the use of the canceled pesticide
becomes unlawful under the terms of the cancellation,
whichever is later.
‘‘(3) SUSPENSION OF TOLERANCE OR EXEMPTION FOLLOWING
SUSPENSION OF ASSOCIATED REGISTRATIONS.—
‘‘(A) SUSPENSION.—If the Administrator, acting under
the Federal Insecticide, Fungicide, and Rodenticide Act,
suspends the use of each registered pesticide that contains
a particular pesticide chemical and that is labeled for use
on a particular food, due in whole or in part to dietary
risks to humans posed by residues of that pesticide chemical on that food, the Administrator shall suspend any tolerance or exemption that allows the presence of the pesticide
chemical, or any pesticide chemical residue that results
from its use, in or on that food. Subsection (e) shall apply
to actions taken under this paragraph. A suspension under
this paragraph shall become effective not later than 60
days after the date by which each such suspension of
use has become effective.
‘‘(B) EFFECT OF SUSPENSION.—The suspension of a
tolerance or exemption under subparagraph (A) shall be
effective as long as the use of each associated registration
of a pesticide is suspended under the Federal Insecticide,
Fungicide, and Rodenticide Act. While a suspension of a
tolerance or exemption is effective the tolerance or exemption shall not be considered to be in effect. If the suspension
of use of the pesticide under that Act is terminated, leaving
the registration of the pesticide for such use in effect under
that Act, the Administrator shall rescind any associated
suspension of tolerance or exemption.
‘‘(4) TOLERANCES FOR UNAVOIDABLE RESIDUES.—In connection with action taken under paragraph (2) or (3), or with
respect to pesticides whose registrations were suspended or
canceled prior to the date of the enactment of this paragraph
under the Federal Insecticide, Fungicide, and Rodenticide Act,
if the Administrator determines that a residue of the canceled
or suspended pesticide chemical will unavoidably persist in
the environment and thereby be present in or on a food, the
Administrator may establish a tolerance for the pesticide chemical residue. In establishing such a tolerance, the Administrator
shall take into account both the factors set forth in subsection
(b)(2) and the unavoidability of the residue. Subsection (e)
shall apply to the establishment of such tolerance. The Adminis-

PUBLIC LAW 104–170—AUG. 3, 1996

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. The Administrator
shall promulgate regulations within 365 days after the date
of the enactment of this paragraph governing the establishment
of tolerances and exemptions under this paragraph. Such regulations shall be consistent with the safety standard under subsections (b)(2) and (c)(2) and with section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act.
‘‘(m) FEES.—
‘‘(1) AMOUNT.—The Administrator shall by regulation
require the payment of such fees as will in the aggregate,
in the judgment of the Administrator, be sufficient over a
reasonable term to provide, equip, and maintain an adequate
service for the performance of the Administrator’s functions
under this section. Under the regulations, the performance
of the Administrator’s services or other functions under this
section, including—
‘‘(A) the acceptance for filing of a petition submitted
under subsection (d);
‘‘(B) establishing, modifying, leaving in effect, or revoking a tolerance or establishing, modifying, leaving in effect,
or revoking an exemption from the requirement for a tolerance under this section;

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110 STAT. 1530

PUBLIC LAW 104–170—AUG. 3, 1996
‘‘(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

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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

110 STAT. 1532

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residue in or on the food. The temporary regulatory limit shall
be validated or terminated by the Administrator’s final order
on the petition.
‘‘(7) RESIDUES FROM LAWFUL APPLICATION.—No State or
political subdivision may enforce any regulatory limit on the
level of a pesticide chemical residue that may appear in or
on any food if, at the time of the application of the pesticide
that resulted in such residue, the sale of such food with such
residue level was lawful under this section and under the
law of such State, unless the State demonstrates that consumption of the food containing such pesticide residue level during
the period of the food’s likely availability in the State will
pose an unreasonable dietary risk to the health of persons
within such State.
‘‘(8) SAVINGS.—Nothing in this Act preempts the authority
of any State or political subdivision to require that a food
containing a pesticide chemical residue bear or be the subject
of a warning or other statement relating to the presence of
the pesticide chemical residue in or on such food.
‘‘(o) CONSUMER RIGHT TO KNOW.—Not later than 2 years after
the date of the enactment of the Food Quality Protection Act of
1996, and annually thereafter, the Administrator shall, in consultation with the Secretary of Agriculture and the Secretary of Health
and Human Services, publish in a format understandable to a
lay person, and distribute to large retail grocers for public display
(in a manner determined by the grocer), the following information,
at a minimum:
‘‘(1) A discussion of the risks and benefits of pesticide
chemical residues in or on food purchased by consumers.
‘‘(2) A listing of actions taken under subparagraph (B)
of subsection (b)(2) that may result in pesticide chemical residues in or on food that present a yearly or lifetime risk above
the risk allowed under subparagraph (A) of such subsection,
and the food on which the pesticide chemicals producing the
residues are used.
‘‘(3) Recommendations to consumers for reducing dietary
exposure to pesticide chemical residues in a manner consistent
with maintaining a healthy diet, including a list of food that
may reasonably substitute for food listed under paragraph (2).
Nothing in this subsection shall prevent retail grocers from
providing additional information.
‘‘(p) ESTROGENIC SUBSTANCES SCREENING PROGRAM.—
‘‘(1) DEVELOPMENT.—Not later than 2 years after the date
of enactment of this section, the Administrator shall in consultation with the Secretary of Health and Human Services
develop a screening program, using appropriate validated test
systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans
that is similar to an effect produced by a naturally occurring
estrogen, or such other endocrine effect as the Administrator
may designate.
‘‘(2) IMPLEMENTATION.—Not later than 3 years after the
date of enactment of this section, after obtaining public comment and review of the screening program described in paragraph (1) by the scientific advisory panel established under
section 25(d) of the Federal Insecticide, Fungicide, and
Rodenticide Act or the science advisory board established by

PUBLIC LAW 104–170—AUG. 3, 1996

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 Administrator shall issue an
order to a registrant of a substance for which testing is
required under this subsection, or to a person who manufactures or imports a substance for which testing is required
under this subsection, to conduct testing in accordance
with the screening program described in paragraph (1),
and submit information obtained from the testing to the
Administrator, within a reasonable time period that the
Administrator determines is sufficient for the generation
of the information.
‘‘(B) PROCEDURES.—To the extent practicable the
Administrator shall minimize duplicative testing of the
same substance for the same endocrine effect, develop,
as appropriate, procedures for fair and equitable sharing
of test costs, and develop, as necessary, procedures for
handling of confidential business information.
‘‘(C) FAILURE OF REGISTRANTS TO SUBMIT INFORMATION.—
‘‘(i) SUSPENSION.—If a registrant of a substance
referred to in paragraph (3)(A) fails to comply with
an order under subparagraph (A) of this paragraph,
the Administrator shall issue a notice of intent to
suspend the sale or distribution of the substance by
the registrant. Any suspension proposed under this
paragraph shall become final at the end of the 30day 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-

Orders.

Notice.

110 STAT. 1534

Regulations.

PUBLIC LAW 104–170—AUG. 3, 1996
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.
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.

PUBLIC LAW 104–170—AUG. 3, 1996

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

110 STAT. 1536

PUBLIC LAW 104–170—AUG. 3, 1996

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.

Effective date.
Rules and
procedures.

(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) 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;

PUBLIC LAW 104–170—AUG. 3, 1996

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) complete the review of unreviewed reregistration studies required to support the reregistration eligibility decisions scheduled for completion in accordance
with subsection (l)(2); and
‘‘(ii) contract for such outside assistance as may
be necessary for review of required studies, using a
generally accepted competitive process for the selection
of vendors of such assistance.’’.
(d) SECTION 4(k)(3).—Section 4(k)(3) (7 U.S.C. 136a–1(k)(3))
is amended—
(1) in subparagraph (A), by striking out ‘‘for each of the
fiscal years 1992, 1993, and 1994, 1⁄7th of the maintenance
fees collected, up to 2 million each year’’ and inserting in
lieu thereof ‘‘for each of the fiscal years 1997 through 2001,
not more than 1⁄7 of the maintenance fees collected in such
fiscal year’’; and
(2) by adding a new subparagraph (C) to read as follows:
‘‘(C) So long as the Administrator has not met the
time frames specified in clause (ii) of section 3(c)(3)(B)
with respect to any application subject to section 3(c)(3)(B)
that was received prior to the date of enactment of the
Food Quality Protection Act of 1996, the Administrator
shall use the full amount of the fees specified in subparagraph (A) for the purposes specified therein. Once all
applications subject to section 3(c)(3)(B) that were received
prior to such date of enactment have been acted upon,
no limitation shall be imposed by the preceding sentence
of this subparagraph so long as the Administrator meets
the time frames specified in clause (ii) of section 3(c)(3)(B)
on 90 percent of affected applications in a fiscal year.
Should the Administrator not meet such time frames in
a fiscal year, the limitations imposed by the first sentence
of this subparagraph shall apply until all overdue applications subject to section 3(c)(3)(B) have been acted upon.’’.
(e) SECTION 4(k)(5).—Section 4(k)(5) (7 U.S.C. 136a–1(k)(5))
is amended to read as follows:
‘‘(5) ACCOUNTING AND PERFORMANCE.—The Administrator
shall take all steps necessary to ensure that expenditures from
fees authorized by subsection (i)(5)(C)(ii) are used only to carry
out the goals established under subsection (l). The Reregistration and Expedited Processing Fund shall be designated as
an Environmental Protection Agency component for purposes
of section 3515(c) of title 31, United States Code. The annual
audit required under section 3521 of such title of the financial
statements of activities under this Act under section 3515(b)
of such title shall include an audit of the fees collected under
subsection (i)(5)(C) and disbursed, of the amount appropriated
to match such fees, and of the Administrator’s attainment

Review.

Contracts.

Applicability.

110 STAT. 1538

Reports.

Federal Register,
publication.

PUBLIC LAW 104–170—AUG. 3, 1996

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. 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) 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:
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.

Æ