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’’.

7 USC 136 note.

Food Quality

Protection Act of

1996.

Aug. 3, 1996

[H.R. 1627]
110 STAT. 1490 PUBLIC LAW 104–170—AUG. 3, 1996

SEC. 103. TOLERANCE REEVALUATION AS PART OF REREGISTRATION.

Section 4(g)(2) (7 U.S.C. 136a–1(g)(2)) is amended by adding

at the end the following:

‘‘(E) As soon as the Administrator has sufficient

information with respect to the dietary risk of a particular

active ingredient, but in any event no later than the time

the Administrator makes a determination under subparagraph (C) or (D) with respect to pesticides containing a

particular active ingredient, the Administrator shall—

‘‘(i) reassess each associated tolerance and exemption from the requirement for a tolerance issued under

section 408 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 346a);

‘‘(ii) determine whether such tolerance or exemption meets the requirements of that Act;

‘‘(iii) determine whether additional tolerances or

exemptions should be issued;

‘‘(iv) publish in the Federal Register a notice setting forth the determinations made under this subparagraph; and

‘‘(v) commence promptly such proceedings under

this Act and section 408 of the Federal Food, Drug,

and Cosmetic Act as are warranted by such determinations.’’.

SEC. 104. SCIENTIFIC ADVISORY PANEL.

Section 25(d) (7 U.S.C. 136w(d)) is amended—

(1) in the first sentence, by striking ‘‘The Administrator

shall’’ and inserting:

‘‘(1) IN GENERAL.—The Administrator shall’’; and

(2) by adding at the end the following:

‘‘(2) SCIENCE REVIEW BOARD.—There is established a

Science Review Board to consist of 60 scientists who shall

be available to the Scientific Advisory Panel to assist in reviews

conducted by the Panel. Members of the Board shall be selected

in the same manner as members of temporary subpanels created under paragraph (1). Members of the Board shall be compensated in the same manner as members of the Panel.’’.

SEC. 105. NITROGEN STABILIZER.

(a) SECTION 2.—Section 2 (7 U.S.C. 136) is amended—

(1) in subsection (a)—

(A) in paragraph (1) by striking ‘‘or’’ after ‘‘defoliant,’’

and inserting ‘‘, or nitrogen stabilizer’’ after ‘‘desiccant’’;

(B) at the end of paragraph (3) by striking ‘‘and’’;

(C) at the end of paragraph (4) by striking the period

and inserting ‘‘; and’’; and

(D) at the end by adding the following:

‘‘(5) in the case of a nitrogen stabilizer, an ingredient

which will prevent or hinder the process of nitrification,

denitrification, ammonia volatilization, or urease production

through action affecting soil bacteria.’’;

(2) in subsection (u), by striking ‘‘and’’ before ‘‘(2)’’ and

by inserting ‘‘and (3) any nitrogen stabilizer,’’ after ‘‘desiccant,’’;

and

(3) at the end by adding the following:

Establishment.

Federal Register,

publication.
PUBLIC LAW 104–170—AUG. 3, 1996 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.

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:

7 USC 136x,

136y.
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 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

Effective date.
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 regNotice.

Notification.
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 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

Notice.

Federal Register,

publication.
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

Notice.

Federal Register,

publication.
110 STAT. 1500 PUBLIC LAW 104–170—AUG. 3, 1996

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:

Notice.

Federal Register,

publication.
PUBLIC LAW 104–170—AUG. 3, 1996 110 STAT. 1501

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

‘‘(a) The Administrator shall assure coordination of minor use

issues through the establishment of a minor use program within

the Office of Pesticide Programs. Such office shall be responsible

for coordinating the development of minor use programs and policies

and consulting with growers regarding minor use issues and registrations and amendments which are submitted to the Environmental Protection Agency.

‘‘(b) The Office of Pesticide Programs shall prepare a public

report concerning the progress made on the registration of minor

uses, including implementation of the exclusive use as an incentive

for registering new minor uses, within 3 years of the passage

of the Food Quality Protection Act of 1996.’’.

(j) DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM.—The

Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136

et seq.), as amended by subsection (i), is amended by adding after

section 31 the following:

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

‘‘(a) IN GENERAL.—The Secretary of Agriculture (hereinafter

in this section referred 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.

7 USC 136w–7.

Public

information.

Reports.

7 USC 136w–6.
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
PUBLIC LAW 104–170—AUG. 3, 1996 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.

Federal Register,

publication.
110 STAT. 1506 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

Review.
PUBLIC LAW 104–170—AUG. 3, 1996 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.’’.
110 STAT. 1508 PUBLIC LAW 104–170—AUG. 3, 1996

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
PUBLIC LAW 104–170—AUG. 3, 1996 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 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:

Notification.

Notification.

Regulations.
PUBLIC LAW 104–170—AUG. 3, 1996 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).’’.

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.

Notification.

Guidelines.
110 STAT. 1512 PUBLIC LAW 104–170—AUG. 3, 1996

(c) RESIDUE DATA COLLECTION.—The Secretary of Agriculture

shall ensure that the residue data collection activities conducted

by the Department of Agriculture in cooperation with the Environmental Protection Agency and the Department of Health and

Human Services, provide for the improved data collection of pesticide residues, including guidelines for the use of comparable

analytical and standardized reporting methods, and the increased

sampling of foods most likely consumed by infants and children.

SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION.

(a) IN GENERAL.—The Secretary of Agriculture shall collect

data of statewide or regional significance on the use of pesticides

to control pests and diseases of major crops and crops of dietary

significance, including fruits and vegetables.

(b) COLLECTION.—The data shall be collected by surveys of

farmers or from other sources offering statistically reliable data.

(c) COORDINATION.—The Secretary of Agriculture shall, as

appropriate, coordinate with the Administrator of the Environmental Protection Agency in the design of the surveys and make

available to the Administrator the aggregate results of the surveys

to assist the Administrator.

SEC. 303. INTEGRATED PEST MANAGEMENT.

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

Integrated Pest Management is a sustainable approach to managing

pests by combining biological, cultural, physical, and chemical tools

in a way that minimizes economic, health, and environmental risks.

The Secretary of Agriculture and the Administrator shall make

information on Integrated Pest Management widely available to

pesticide users, including Federal agencies. Federal agencies shall

use Integrated Pest Management techniques in carrying out pest

management activities and shall promote Integrated Pest Management through procurement and regulatory policies, and other activities.

SEC. 304. COORDINATION OF CANCELLATION.

Section 2(bb) (7 U.S.C. 136(bb)) is amended—

(1) by inserting ‘‘(1)’’ after ‘‘means’’; and

(2) by striking the period at the end of the first sentence

and inserting ‘‘, or (2) a human dietary risk from residues

that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 346a).’’.

SEC. 305. PESTICIDE USE INFORMATION STUDY.

(a) The Secretary of Agriculture shall, in consultation with

the Administrator of the Environmental Protection Agency, prepare

a 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

Reports.

7 USC 136i–2

note.

7 USC 136r–1.

7 USC 136i–2.
PUBLIC LAW 104–170—AUG. 3, 1996 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

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.

Food Quality

Protection Act of

1996.
110 STAT. 1514 PUBLIC LAW 104–170—AUG. 3, 1996

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
PUBLIC LAW 104–170—AUG. 3, 1996 110 STAT. 1515

to the extent possible in good manufacturing practice, and

the concentration of the pesticide chemical residue in the

processed food is not greater than the tolerance prescribed

for the pesticide chemical residue in the raw agricultural

commodity; or

‘‘(B) if an exemption for the requirement for a tolerance

is in effect under this section for a pesticide chemical

residue in or on a raw agricultural commodity, a pesticide

chemical residue that is present in or on a processed food

because the food is made from that raw agricultural

commodity shall not be considered unsafe within the meaning of section 402(a)(2)(B).

‘‘(3) RESIDUES OF DEGRADATION PRODUCTS.—If a pesticide

chemical residue is present in or on a food because it is a

metabolite or other degradation product of a precursor substance that itself is a pesticide chemical or pesticide chemical

residue, such a residue shall not be considered to be unsafe

within the meaning of section 402(a)(2)(B) despite the lack

of a tolerance or exemption from the need for a tolerance

for such residue in or on such food if—

‘‘(A) the Administrator has not determined that the

degradation product is likely to pose any potential health

risk from dietary exposure that is of a different type than,

or of a greater significance than, any risk posed by dietary

exposure to the precursor substance;

‘‘(B) either—

‘‘(i) a tolerance is in effect under this section for

residues of the precursor substance in or on the food,

and the combined level of residues of the degradation

product and the precursor substance in or on the food

is at or below the stoichiometrically equivalent level

that would be permitted by the tolerance if the residue

consisted only of the precursor substance rather than

the degradation product; or

‘‘(ii) an exemption from the need for a tolerance

is in effect under this section for residues of the precursor substance in or on the food; and

‘‘(C) the tolerance or exemption for residues of the

precursor substance does not state that it applies only

to particular named substances and does not state that

it does not apply to residues of the degradation product.

‘‘(4) EFFECT OF TOLERANCE OR EXEMPTION.—While a tolerance or exemption from the requirement for a tolerance is

in effect under this section for a pesticide chemical residue

with respect to any food, the food shall not by reason of bearing

or containing any amount of such a residue be considered

to be adulterated within the meaning of section 402(a)(1).

‘‘(b) AUTHORITY AND STANDARD FOR TOLERANCE.—

‘‘(1) AUTHORITY.—The Administrator may issue regulations

establishing, modifying, or revoking a tolerance for a pesticide

chemical residue in or on a food—

‘‘(A) in response to a petition filed under subsection

(d); or

‘‘(B) on the Administrator’s own initiative under subsection (e).

As used in this section, the term ‘modify’ shall not mean

expanding the tolerance to cover additional foods.
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
PUBLIC LAW 104–170—AUG. 3, 1996 110 STAT. 1517

disruption in domestic production of an adequate,

wholesome, and economical food supply.

‘‘(iv) CONDITIONS REGARDING RISK.—For purposes

of clause (ii), the conditions described in this clause

with respect to a tolerance for an eligible pesticide

chemical residue are the following:

‘‘(I) The yearly risk associated with the nonthreshold effect from aggregate exposure to the

residue does not exceed 10 times the yearly risk

that would be allowed under subparagraph (A)

for such effect.

‘‘(II) The tolerance is limited so as to ensure

that the risk over a lifetime associated with the

nonthreshold effect from aggregate exposure to the

residue is not greater than twice the lifetime risk

that would be allowed under subparagraph (A)

for such effect.

‘‘(v) REVIEW.—Five years after the date on which

the Administrator makes a determination to leave in

effect or modify a tolerance under this subparagraph,

and thereafter as the Administrator deems appropriate, the Administrator shall determine, after notice

and opportunity for comment, whether it has been

demonstrated to the Administrator that a condition

described in clause (iii)(I) or clause (iii)(II) continues

to exist with respect to the tolerance and that the

yearly and lifetime risks from aggregate exposure to

such residue continue to comply with the limits specified in clause (iv). 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

Regulations.
110 STAT. 1518 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 proSurveys.

Publication.
PUBLIC LAW 104–170—AUG. 3, 1996 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

Regulations.
110 STAT. 1520 PUBLIC LAW 104–170—AUG. 3, 1996

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—

Publication.
PUBLIC LAW 104–170—AUG. 3, 1996 110 STAT. 1521

‘‘(A) that there is a practical method for detecting

and measuring the levels of such pesticide chemical residue

in or on food; or

‘‘(B) that there is no need for such a method, and

states the reasons for such determination in issuing the

regulation establishing or modifying the exemption.

‘‘(d) PETITION FOR TOLERANCE OR EXEMPTION.—

‘‘(1) PETITIONS AND PETITIONERS.—Any person may file with

the Administrator a petition proposing the issuance of a regulation—

‘‘(A) establishing, modifying, or revoking a tolerance

for a pesticide chemical residue in or on a food; or

‘‘(B) establishing, modifying, or revoking an exemption

from the requirement of a tolerance for such a residue.

‘‘(2) PETITION CONTENTS.—

‘‘(A) 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);

Regulations.
110 STAT. 1522 PUBLIC LAW 104–170—AUG. 3, 1996

‘‘(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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Publication.
PUBLIC LAW 104–170—AUG. 3, 1996 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;

Notice.

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110 STAT. 1524 PUBLIC LAW 104–170—AUG. 3, 1996

‘‘(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

Federal Register,

publication.

Rules.
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

Orders.
110 STAT. 1526 PUBLIC LAW 104–170—AUG. 3, 1996

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 PUBLIC LAW 104–170—AUG. 3, 1996

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)

Review. shall apply to the establishment of such tolerance. The AdminisApplicability.

Effective date.

Applicability.

Effective date.
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
PUBLIC LAW 104–170—AUG. 3, 1996 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 PUBLIC LAW 104–170—AUG. 3, 1996

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

Publication.

Public

information.
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 30-

day period beginning on the date that the registrant

receives the notice of intent to suspend, unless during

that period a person adversely affected by the notice

requests a hearing or the Administrator determines

that the registrant has complied fully with this paragraph.

‘‘(ii) HEARING.—If a person requests a hearing

under clause (i), the hearing shall be conducted in

accordance with section 554 of title 5, United States

Code. The only matter for resolution at the hearing

shall be whether the registrant has failed to comply

with an order under subparagraph (A) of this paragraph. A decision by the Administrator after compleNotice.

Orders.
110 STAT. 1534 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.

Regulations.
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.

(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;

Effective date.

Rules and

procedures.
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

Applicability.

Contracts.

Review.
110 STAT. 1538 PUBLIC LAW 104–170—AUG. 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

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.

Federal Register,

publication.

Reports.