Public Law 104-170

104th Congress

An Act

To amend the Federal Insecticide, Fungicide, and Rodenticide Act and the

Federal Food, Drug, and Cosmetic Act, and for other purposes. << NOTE:

Aug. 3, 1996 - [H.R. 1627]>>

Be it enacted by the Senate and House of Representatives of the

United States of America in Congress assembled, <<NOTE: Food Qu ality

Protection Act of 1996.>>

SECTION 1. <<NOTE: 7 USC 136 note.>> SHORT TITLE

This Act may be cited as the ``Food Quality Protection Act of

1996''.

TITLE I--SUSPENSION-APPLICATORS

SEC. 101. REFERENCE.

Whenever in this title an amendment or repeal is expressed in terms

of an amendment to, or repeal of, a section or other provision, the

reference shall be considered to be made to a section or other provision

of the Federal Insecticide, Fungicide, and Rodenticide Act.

Subtitle A--Suspension

SEC. 102. SUSPENSION.

(a) Section 6(c)(1).--The second sentence of section 6(c)(1) (7

U.S.C. 136d(c)(1)) is amended to read: ``Except as provided in paragraph

(3), no order of suspension may be issued under this subsection unless

the Administrator has issued, or at the same time issues, a notice of

intention to cancel the registration or change the classification of the

pesticide under subsection (b).''.

(b) Section 6(c)(3).--Section 6(c)(3) (7 U.S.C. 136d(c)(3)) is

amended--

(1) by inserting after the first sentence the following new

sentence: ``The Administrator may issue an emergency order under

this paragraph before issuing a notice of intention to cancel

the registration or change the classification of the pesticide

under subsection (b) and the Administrator shall proceed to

issue the notice under subsection (b) within 90 days of issuing

an emergency order. If the Administrator does not issue a notice

under subsection (b) within 90 days of issuing an emergency

order, the emergency order shall expire.''; and

(2) by striking ``In that case'' and inserting ``In the case

of an emergency order''.

[[Page 110 STAT. 1490||

SEC. 103. TOLERANCE REEVALUATION AS PART OF REREGISTRATION.

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

end the following:

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

information with respect to the dietary risk of a

particular active ingredient, but in any event no later

than the time the Administrator makes a determination

under subparagraph (C) or (D) with respect to pesticides

containing a particular active ingredient, the

Administrator shall--

``(i) reassess each associated tolerance and

exemption from the requirement for a tolerance

issued under section 408 of the Federal Food,

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

``(ii) determine whether such tolerance or

exemption meets the requirements of that Act;

``(iii) determine whether additional

tolerances or exemptions should be issued;

``(iv) <<NOTE: Federal Register,

publication.>> publish in the Federal Re gister a

notice setting forth the determinations made under

this subparagraph; and

``(v) commence promptly such proceedings under

this Act and section 408 of the Federal Food,

Drug, and Cosmetic Act as are warranted by such

determinations.''.

SEC. 104. SCIENTIFIC ADVISORY PANEL.

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

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

shall'' and inserting:

``(1) In general.--The Administrator shall''; and

(2) by adding at the end the following:

``(2) <<NOTE: Establishment.>> Scien ce 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'';

period and inserting ``; and''; and

(D) at the end by adding the following:

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

which will prevent or hinder the process of nitrification,

denitrification, ammonia volatilization, or urease production

through action affecting soil bacteria.'';

(2) in subsection (u), by striking ``and'' before ``(2)''

and by inserting ``and (3) any nitrogen stabilizer,'' after

``desiccant,''; and

(3) at the end by adding the following:

[[Page 110 STAT. 1491||

``(hh) Nitrogen Stabilizer.--The term `nitrogen stabilizer' means

any substance or mixture of substances intended for preventing or

hindering the process of nitrification, denitrification, ammonia

volatilization, or urease production through action upon soil bacteria.

Such term shall not include--

``(1) dicyandiamide;

``(2) ammonium thiosulfate; or

``(3) any substance or mixture of substances.--

``(A) that was not registered pursuant to section 3

prior to January 1, 1992; and

``(B) that was in commercial agronomic use prior to

January 1, 1992, with respect to which after January 1,

1992, the distributor or seller of the substance or

mixture has made no specific claim of prevention or

hindering of the process of nitrification,

denitrification, ammonia volatilization urease

production regardless of the actual use or purpose for,

or future use or purpose for, the substance or mixture.

Statements made in materials required to be submitted to any State

legislative or regulatory authority, or required by such authority to be

included in the labeling or other literature accompanying any such

substance or mixture shall not be deemed a specific claim within the

meaning of this subsection.''.

(b) Section 3(f).--Section 3(f) (7 U.S.C. 136a(f)) is amended by

adding at the end the following:

``(4) Mixtures of nitrogen stabilizers and fertilizer

products.--Any mixture or other combination of--

``(A) 1 or more nitrogen stabilizers registered

under this Act; and

``(B) 1 or more fertilizer products,

shall not be subject to the provisions of this section or

sections 4, 5, 7, 15, and 17(a)(2) if the mixture or other

combination is accompanied by the labeling required under this

Act for the nitrogen stabilizer contained in the mixture or

other combination, the mixture or combination is mixed or

combined in accordance with such labeling, and the mixture or

combination does not contain any active ingredient other than

the nitrogen stabilizer.''.

SEC. 106. PERIODIC REGISTRATION REVIEW.

(a) Section 6.--Section 6 (7 U.S.C. 136d) is amended--

(1) in subsection (a), by striking the heading and inserting

the following:

``(a) Existing Stocks and Information.--''; and

(2) by amending paragraph (1) of subsection (a) to read as

follows:

``(1) Existing stocks.--The Administrator may permit the

continued sale and use of existing stocks of a pesticide whose

registration is suspended or canceled under this section, or

section 3 or 4, to such extent, under such conditions, and for

such uses as the Administrator determines that such sale or use

is not inconsistent with the purposes of this Act.''.

(b) Section 3.--Section 3 (7 U.S.C. 136a) is amended by adding at

the end the following:

``(g) Registration Review.--

``(1)(A) General rule.--The registrations of pesticides are

to be periodically reviewed. <<NOTE: Regulations.&g t;> The

Administrator shall by regula

[[Page 110 STAT. 1492||

tion establish a procedure for accomplishing the periodic review

of registrations. The goal of these regulations shall be a

review of a pesticide's registration every 15 years. No

registration shall be canceled as a result of the registration

review process unless the Administrator follows the procedures

and substantive requirements of section 6.

``(B) Limitation.--Nothing in this subsection shall prohibit

the Administrator from undertaking any other review of a

pesticide pursuant to this Act.

``(2)(A) Data.--The Administrator shall use the authority in

subsection (c)(2)(B) to require the submission of data when such

data are necessary for a registration review.

``(B) Data submission, compensation, and exemption.--For

purposes of this subsection, the provisions of subsections

(c)(1), (c)(2)(B), and (c)(2)(D) shall be utilized for and be

applicable to any data required for registration review.''.

Subtitle B--Training for Maintenance Applicators and Service Technicians

SEC. 120. MAINTENANCE APPLICATORS AND SERVICE TECHNICIANS DEFINITIONS.

Section 2 (7 U.S.C. 136), as amended by section 106, is amended by

adding at the end the following:

``(jj) Maintenance Applicator.--The term `maintenance applicator'

means any individual who, in the principal course of such individual's

employment, uses, or supervises the use of, a pesticide not classified

for restricted use (other than a ready to use consumer products

pesticide); for the purpose of providing structural pest control or lawn

pest control including janitors, general maintenance personnel,

sanitation personnel, and grounds maintenance personnel. The term

`maintenance applicator' does not include private applicators as defined

in section 2(e)(2); individuals who use antimicrobial pesticides,

sanitizers or disinfectants; individuals employed by Federal, State, and

local governments or any political subdivisions thereof, or individuals

who use pesticides not classified for restricted use in or around their

homes, boats, sod farms, nurseries, greenhouses, or other noncommercial

property.

``(kk) Service Technician.--The term `service technician' means any

individual who uses or supervises the use of pesticides (other than a

ready to use consumer products pesticide) for the purpose of providing

structural pest control or lawn pest control on the property of another

for a fee. The term `service technician' does not include individuals

who use antimicrobial pesticides, sanitizers or disinfectants; or who

otherwise apply ready to use consumer products pesticides.''.

SEC. 121. MINIMUM REQUIREMENTS FOR TRAINING OF MAINTENANCE APPLICATORS

AND SERVICE TECHNICIANS.

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

136 et seq.) is amended--

(1) by redesignating sections 30 and 31 <<NOTE: 7 U SC 136x,

136y.>> as sections 33 and 34, respectively; and

(2) by adding after section 29 the following:

[[Page 110 STAT. 1493||

``SEC. 30. <<NOTE: 7 USC 136w-5.>> MINIMUM REQUI REMENTS FOR TRAINING OF

MAINTENANCE APPLICATORS AND SERVICE TECHNICIANS.

``Each State may establish minimum requirements for training of

maintenance applicators and service technicians. Such training may

include instruction in the safe and effective handling and use of

pesticides in accordance with the Environmental Protection Agency

approved labeling, and instruction in integrated pest management

techniques. The authority of the Administrator with respect to minimum

requirements for training of maintenance applicators and service

technicians shall be limited to ensuring that each State understands the

provisions of this section.''.

TITLE II--MINOR USE CROP PROTECTION, ANTIMICROBIAL PESTICIDE

REGISTRATION REFORM, AND PUBLIC HEALTH PESTICIDES

SEC. 201. REFERENCE.

Whenever in this title an amendment or repeal is expressed in terms

of an amendment to, or repeal of, a section or other provision, the

reference shall be considered to be made to a section or other provision

of the Federal Insecticide, Fungicide, and Rodenticide Act.

Subtitle A--Minor Use Crop Protection

SEC. 210. MINOR CROP PROTECTION.

(a) Definition.--Section 2 (7 U.S.C. 136), as amended by section

120, is further amended by adding at the end the following:

``(ll) Minor Use.--The term `minor use' means the use of a pesticide

on an animal, on a commercial agricultural crop or site, or for the

protection of public health where--

``(1) the total United States acreage for the crop is less

than 300,000 acres, as determined by the Secretary of

Agriculture; or

``(2) the Administrator, in consultation with the Secretary

of Agriculture, determines that, based on information provided

by an applicant for registration or a registrant, the use does

not provide sufficient economic incentive to support the initial

registration or continuing registration of a pesticide for such

use and--

``(A) there are insufficient efficacious alternative

registered pesticides available for the use;

``(B) the alternatives to the pesticide use pose

greater risks to the environment or human health;

``(C) the minor use pesticide plays or will play a

significant part in managing pest resistance; or

``(D) the minor use pesticide plays or will play a

significant part in an integrated pest management

program.

The status as a minor use under this subsection shall continue as long

as the Administrator has not determined that, based on existing data,

such use may cause an unreasonable adverse effect on the environment and

the use otherwise qualifies for such status.''.

[[Page 110 STAT. 1494||

(b) Exclusive Use of Minor Use Pesticides.--Section 3(c)(1)(F) (7

U.S.C. 136a(c)(1)(F)) is amended--

(1) by redesignating clauses (ii) and (iii) as clauses (iii)

and (iv), respectively; and

(2) by inserting after clause (i) the following:

``(ii) The period of exclusive data use

provided under clause (i) shall be extended 1

additional year for each 3 minor uses registered

after the date of enactment of this clause and

within 7 years of the commencement of the

exclusive use period, up to a total of 3

additional years for all minor uses registered by

the Administrator if the Administrator, in

consultation with the Secretary of Agriculture,

determines that, based on information provided by

an applicant for registration or a registrant,

that--

``(I) there are insufficient

efficacious alternative registered

pesticides available for the use;

``(II) the alternatives to the minor

use pesticide pose greater risks to the

environment or human health;

``(III) the minor use pesticide

plays or will play a significant part in

managing pest resistance; or

``(IV) the minor use pesticide plays

or will play a significant part in an

integrated pest management program.

The registration of a pesticide for a minor use on

a crop grouping established by the Administrator

shall be considered for purposes of this clause 1

minor use for each representative crop for which

data are provided in the crop grouping. Any

additional exclusive use period under this clause

shall be modified as appropriate or terminated if

the registrant voluntarily cancels the product or

deletes from the registration the minor uses which

formed the basis for the extension of the

additional exclusive use period or if the

Administrator determines that the registrant is

not actually marketing the product for such minor

uses.'';

(3) in clause (iv), as amended by paragraph (1), by striking

``and (ii)'' and inserting ``, (ii), and (iii)''; and

(4) at the end of the section, as amended by paragraph (1),

by adding the following:

``(v) <<NOTE: Effective date.> > The period of

exclusive use provided under clause (ii) shall not

take effect until 1 year after enactment of this

clause, except where an applicant or registrant is

applying for the registration of a pesticide

containing an active ingredient not previously

registered.

``(vi) With respect to data submitted after

the date of enactment of this clause by an

applicant or registrant to support an amendment

adding a new use to an existing registration that

does not retain any period of exclusive use, if

such data relates solely to a minor use of a

pesticide, such data shall not, without the

written permission of the original data submitter,

be considered by the Administrator to support an

application for a minor use by another person

during

[[Page 110 STAT. 1495||

the period of 10 years following the date of

submission of such data. <<NOTE: Notifica tion.>>

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.''.

(1) Data call-in.--Section 3(c)(2)(B) (7 U.S.C.

136a(c)(2)(B)) is amended by adding at the end the following:

``(vi) Upon the request of a registrant the

Administrator shall, in the case of a minor use, extend

the deadline for the production of residue chemistry

data under this subparagraph for data required solely to

support that minor use until the final deadline for

submission of data under section 4 for the other uses of

the pesticide established as of the date of enactment of

the Food Quality Protection Act of 1996, if--

``(I) the data to support other uses of the

pesticide on a food are being provided;

``(II) the registrant, in submitting a request

for such an extension, provides a schedule,

including interim dates to measure progress, to

assure that the data production will be completed

before the expiration of the extension period;

``(III) the Administrator has determined that

such extension will not significantly delay the

Administrator's schedule for issuing a

reregistration eligibility determination required

under section 4; and

``(IV) the Administrator has determined that

based on existing data, such extension would not

significantly increase the risk of any

unreasonable adverse effect on the environment. If

the Administrator grants an extension under this

clause, the Administrator shall monitor the

development of the data and shall ensure that the

registrant is meeting the schedule for the

production of the data. If the Administrator

determines that the registrant is not meeting or

has not met the schedule for the production of

such data, the Administrator may proceed in

accordance with clause (iv) regarding the

continued registration of the affected products

with the minor use and shall inform the public of

such action. Notwithstanding the provisions of

this clause, the Administrator may take action to

modify or revoke the extension under this clause

if the Administrator determines that the extension

for the minor use may cause an unreasonable

adverse effect on the

environment. <<NOTE: Notice.>& gt; In such

circumstance, the Administrator shall provide, in

writing to the reg

[[Page 110 STAT. 1496||

istrant, a notice revoking the extension of time

for submission of data. Such data shall instead be

due in accordance with the date established by the

Administrator for the submission of the data.''.

(2) Reregistration.--Sections 4(d)(4)(B), 4(e)(2)(B), and

4(f)(2)(B) (7 U.S.C. 136a-1(d)(4)(B), (e)(2)(B), and (f)(2)(B))

are each amended by adding at the end the following: ``Upon

application of a registrant, the Administrator shall, in the

case of a minor use, extend the deadline for the production of

residue chemistry data under this subparagraph for data required

solely to support that minor use until the final deadline for

submission of data under this section for the other uses of the

pesticide established as of the date of enactment of the Food

Quality Protection Act of 1996 if--

``(i) the data to support other uses of the

pesticide on a food are being provided;

``(ii) the registrant, in submitting a request

for such an extension provides a schedule,

including interim dates to measure progress, to

assure that the data production will be completed

before the expiration of the extension period;

``(iii) the Administrator has determined that

such extension will not significantly delay the

Administrator's schedule for issuing a

reregistration eligibility determination required

under this section; and

``(iv) the Administrator has determined that

based on existing data, such extension would not

significantly increase the risk of any

unreasonable adverse effect on the environment. If

the Administrator grants an extension under this

subparagraph, the Administrator shall monitor the

development of the data and shall ensure that the

registrant is meeting the schedule for the

production of the data. If the Administrator

determines that the registrant is not meeting or

has not met the schedule for the production of

such data, the Administrator may proceed in

accordance with clause (iv) of section 3(c)(2)(B)

or other provisions of this section, as

appropriate, regarding the continued registration

of the affected products with the minor use and

shall inform the public of such action.

Notwithstanding the provisions of this

subparagraph, the Administrator may take action to

modify or revoke the extension under this

subparagraph if the Administrator determines that

the extension for the minor use may cause an

unreasonable adverse effect on the environment. In

such circumstance, the Administrator shall provide

written notice to the registrant revoking the

extension of time for submission of data. Such

data shall instead be due in accordance with the

date then established by the Administrator for

submission of the data.''.

(d) Minor Use Waiver.--Section 3(c)(2) (7 U.S.C. 136a(c)(2)) is

amended--

(1) by inserting ``In general.--'' after ``(A)'';

(2) by inserting ``Additional data.--'' after ``(B)'';

(3) by inserting ``Simplified procedures.--'' after ``(C)'';

and

[[Page 110 STAT. 1497||

(4) by adding at the end the following:

``(E) Minor use waiver.--In handling the

registration of a pesticide for a minor use, the

Administrator may waive otherwise applicable data

requirements if the Administrator determines that the

absence of such data will not prevent the Administrator

from determining--

``(i) the incremental risk presented by the

minor use of the pesticide; and

``(ii) that such risk, if any, would not be an

unreasonable adverse effect on the environment.''.

(e) Expediting Minor Use Registrations.--Section 3(c)(3) (7 U.S.C.

136a(c)(3)) is amended--

(1) by inserting after ``(A)'' the following: ``In

general.--'';

(2) by inserting after ``(B)'' the following: ``Identical or

substantially similar.--''; and

(3) by adding at the end the following:

``(C) Minor use registration.--

``(i) <<NOTE: Review.>> The Administrator

shall, as expeditiously as possible, review and

act on any complete application--

``(I) that proposes the initial

registration of a new pesticide active

ingredient if the active ingredient is

proposed to be registered solely for

minor uses, or proposes a registration

amendment solely for minor uses to an

existing registration; or

``(II) for a registration or a

registration amendment that proposes

significant minor uses.

``(ii) For the purposes of clause (i)--

``(I) the term `as expeditiously as

possible' means that the Administrator

shall, to the greatest extent

practicable, complete a review and

evaluation of all data, submitted with a

complete application, within 12 months

after the submission of the complete

application, and the failure of the

Administrator to complete such a review

and evaluation under clause (i) shall

not be subject to judicial review; and

``(II) the term `significant minor

uses' means 3 or more minor uses

proposed for every nonminor use, a minor

use that would, in the judgment of the

Administrator, serve as a replacement

for any use which has been canceled in

the 5 years preceding the receipt of the

application, or a minor use that in the

opinion of the Administrator would avoid

the reissuance of an emergency exemption

under section 18 for that minor use.

``(D) Adequate time for submission of minor use

data.--If a registrant makes a request for a minor use

waiver, regarding data required by the Administrator,

pursuant to paragraph (2)(E), and if the Administrator

denies in whole or in part such data waiver request, the

registrant shall have a full-time period for providing

such data. For purposes of this subparagraph, the term

`full-time period' means the time period originally

established by the Administrator for submission of such

data, beginning

[[Page 110 STAT. 1498||

with the date of receipt by the registrant of the

Administrator's notice of denial.''.

(f) Temporary Extension of Registration for Unsupported Minor

Uses.--

(1) Reregistration.--

(A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C. 136a-

1(d)(6) and (f)(3)) are each amended by adding at the

end the following: ``If the registrant does not commit

to support a specific minor use of the pesticide, but is

supporting and providing data in a timely and adequate

fashion to support uses of the pesticide on a food, or

if all uses of the pesticide are nonfood uses and the

registrant does not commit to support a specific minor

use of the pesticide but is supporting and providing

data in a timely and adequate fashion to support other

nonfood uses of the pesticide, the Administrator, at the

written request of the registrant, shall not take any

action pursuant to this paragraph in regard to such

unsupported minor use until the final deadline

established as of the date of enactment of the Food

Quality Protection Act of 1996, for the submission of

data under this section for the supported uses

identified pursuant to this paragraph unless the

Administrator determines that the absence of the data is

significant enough to cause human health or

environmental concerns. On such a determination the

Administrator may refuse the request for extension by

the registrant. <<NOTE: Federal Register,

publication.>> Upon receipt of the request fro m the

registrant, the Administrator shall publish in the

Federal Register a notice of the receipt of the request

and the effective date upon which the uses not being

supported will be voluntarily deleted from the

registration pursuant to section 6(f)(1). If the

Administrator grants an extension under this paragraph,

the Administrator shall monitor the development of the

data for the uses being supported and shall ensure that

the registrant is meeting the schedule for the

production of such data. If the Administrator determines

that the registrant is not meeting or has not met the

schedule for the production of such data, the

Administrator may proceed in accordance with section

3(c)(2)(B)(iv) regarding the continued registration of

the affected products with the minor and other uses and

shall inform the public of such action in accordance

with section 6(f)(2). Notwithstanding this subparagraph,

the Administrator may deny, modify, or revoke the

temporary extension under this paragraph if the

Administrator determines that the continuation of the

minor use may cause an unreasonable adverse effect on

the environment. <<NOTE: Notice.>&gt ; In the event of

modification or revocation, the Administrator shall

provide, in writing, to the registrant a notice revoking

the temporary extension and establish a new effective

date by which the minor use shall be deleted from the

registration.''.

(B) Section 4(e)(3)(A) (7 U.S.C. 136a-1(e)(3)(A)) is

amended by adding at the end the following: ``If the

registrant does not commit to support a specific minor

use of the pesticide, but is supporting and providing

data in a timely and adequate fashion to support uses of

the pesticide on a food, or if all uses of the pesticide

are nonfood uses and the registrant does not commit to

support a

[[Page 110 STAT. 1499||

specific minor use of the pesticide but is supporting

and providing data in a timely and adequate fashion to

support other nonfood uses of the pesticide, the

Administrator, at the written request of the registrant,

shall not take any action pursuant to this subparagraph

in regard to such unsupported minor use until the final

deadline established as of the date of enactment of the

Food Quality Protection Act of 1996, for the submission

of data under this section for the supported uses

identified pursuant to this subparagraph unless the

Administrator determines that the absence of the data is

significant enough to cause human health or

environmental concerns. On the basis of such

determination, the Administrator may refuse the request

for extension by the registrant. <<NOTE: Federa l

from the registrant, the Administrator shall publish in

the Federal Register a notice of the receipt of the

request and the effective date upon which the uses not

being supported will be voluntarily deleted from the

registration pursuant to section 6(f)(1). If the

Administrator grants an extension under this

subparagraph, the Administrator shall monitor the

development of the data for the uses being supported and

shall ensure that the registrant is meeting the schedule

for the production of such data. If the Administrator

determines that the registrant is not meeting or has not

met the schedule for the production of such data, the

Administrator may proceed in accordance with section

3(c)(2)(B)(iv) regarding the continued registration of

the affected products with the minor and other uses and

shall inform the public of such action in accordance

with section 6(f)(2). Notwithstanding this subparagraph,

the Administrator may deny, modify, or revoke the

temporary extension under this subparagraph if the

Administrator determines that the continuation of the

minor use may cause an unreasonable adverse effect on

the environment. <<NOTE: Notice.>&gt ; In the event of

modification or revocation, the Administrator shall

provide, in writing, to the registrant a notice revoking

the temporary extension and establish a new effective

date by which the minor use shall be deleted from the

registration.''.

(2) Data.--Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as

amended by subsection (c)(1), is further amended by adding at

the end the following:

``(vii) If the registrant does not commit to support

a specific minor use of the pesticide, but is supporting

and providing data in a timely and adequate fashion to

support uses of the pesticide on a food, or if all uses

of the pesticide are nonfood uses and the registrant

does not commit to support a specific minor use of the

pesticide but is supporting and providing data in a

timely and adequate fashion to support other nonfood

uses of the pesticide, the Administrator, at the written

request of the registrant, shall not take any action

pursuant to this clause in regard to such unsupported

minor use until the final deadline established as of the

date of enactment of the Food Quality Protection Act of

1996, for the submission of data under section 4 for the

supported uses identified pursuant to this clause unless

the Administrator determines that the

[[Page 110 STAT. 1500||

absence of the data is significant enough to cause human

health or environmental concerns. On the basis of such

determination, the Administrator may refuse the request

for extension by the registrant. <<NOTE: Federa l

from the registrant, the Administrator shall publish in

the Federal Register a notice of the receipt of the

request and the effective date upon which the uses not

being supported will be voluntarily deleted from the

registration pursuant to section 6(f)(1). If the

Administrator grants an extension under this clause, the

Administrator shall monitor the development of the data

for the uses being supported and shall ensure that the

registrant is meeting the schedule for the production of

such data. If the Administrator determines that the

registrant is not meeting or has not met the schedule

for the production of such data, the Administrator may

proceed in accordance with clause (iv) of this

subparagraph regarding the continued registration of the

affected products with the minor and other uses and

shall inform the public of such action in accordance

with section 6(f)(2). Notwithstanding the provisions of

this clause, the Administrator may deny, modify, or

revoke the temporary extension under this subparagraph

if the Administrator determines that the continuation of

the minor use may cause an unreasonable adverse effect

on the environment. <<NOTE: Notice.>& ;gt; In the event of

modification or revocation, the Administrator shall

provide, in writing, to the registrant a notice revoking

the temporary extension and establish a new effective

date by which the minor use shall be deleted from the

registration.''.

(g) Section 6(f) (7 U.S.C. 136d(f)) is amended--

(1) in paragraph (1)(C)(ii) by striking ``90-day'' each

place it appears and inserting ``180-day''; and

(2) in paragraph (3)(A) by striking ``90-day'' and inserting

``180-day''.

(h) Utilization of Data for Voluntarily Canceled Chemicals.--Section

6(f) (7 U.S.C. 136d(f)) is amended by adding at the end the following:

``(4) Utilization of data for voluntarily canceled

pesticide.--When an application is filed with the Administrator

for the registration of a pesticide for a minor use and another

registrant subsequently voluntarily cancels its registration for

an identical or substantially similar pesticide for an identical

or substantially similar use, the Administrator shall process,

review, and evaluate the pending application as if the voluntary

cancellation had not yet taken place except that the

Administrator shall not take such action if the Administrator

determines that such minor use may cause an unreasonable adverse

effect on the environment. In order to rely on this subsection,

the applicant must certify that it agrees to satisfy any

outstanding data requirements necessary to support the

reregistration of the pesticide in accordance with the data

submission schedule established by the Administrator.''.

(i) Environmental Protection Agency Minor Use Program.--The Federal

Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), as

amended by section 121, is amended by adding after section 30 the

following:

[[Page 110 STAT. 1501||

``SEC. 31. <<NOTE: 7 USC 136w-6.>> ENVIRONMENTAL PROTECTION AGENCY

MINOR USE PROGRAM.

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

issues through the establishment of a minor use program within the

Office of Pesticide Programs. Such office shall be responsible for

coordinating the development of minor use programs and policies and

consulting with growers regarding minor use issues and registrations and

amendments which are submitted to the Environmental Protection Agency.

``(b) <<NOTE: Public information. Reports.>> The Office of

Pesticide Programs shall prepare a public report concerning the progress

made on the registration of minor uses, including implementation of the

exclusive use as an incentive for registering new minor uses, within 3

years of the passage of the Food Quality Protection Act of 1996.''.

(j) Department of Agriculture Minor Use Program.--The Federal

Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), as

amended by subsection (i), is amended by adding after section 31 the

following:

``SEC. 32. <<NOTE: 7 USC 136w-7.>> DEPARTMENT OF AGRICULTURE MINOR USE

PROGRAM.

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

section referred to as the `Secretary') shall assure the coordination of

the responsibilities of the Department of Agriculture related to minor

uses of pesticides, including--

``(1) carrying out the Inter-Regional Project Number 4 (IR-

4) as described in section 2 of Public Law 89-106 (7 U.S.C.

450i(e)) and the national pesticide resistance monitoring

program established under section 1651 of the Food, Agriculture,

Conservation, and Trade Act of 1990 (7 U.S.C. 5882);

``(2) supporting integrated pest management research;

``(3) consulting with growers to develop data for minor

uses; and

``(4) providing assistance for minor use registrations,

tolerances, and reregistrations with the Environmental

Protection Agency.

``(b)(1) Minor Use Pesticide Data.--

``(A) Grant authority.--The Secretary, in consultation with

the Administrator, shall establish a program to make grants for

the development of data to support minor use pesticide

registrations and reregistrations. The amount of any such grant

shall not exceed \1/2\ of the cost of the project for which the

grant is made.

``(B) Applicants.--Any person who wants to develop data to

support minor use pesticide registrations and reregistrations

may apply for a grant under subparagraph (A). Priority shall be

given to an applicant for such a grant who does not directly

receive funds from the sale of pesticides registered for minor

uses.

``(C) Data ownership.--Any data that is developed under a

grant under subparagraph (A) shall be jointly owned by the

Department of Agriculture and the person who received the grant.

Such a person shall enter into an agreement with the Secretary

under which such person shall share any fee paid to such person

under section 3(c)(1)(F).

``(2) Minor Use Pesticide Data Revolving Fund.--

``(A) <<NOTE: Nomenclature.>> Establ ishment.--There is

established in the Treasury of the United States a revolving

fund to be known as the

[[Page 110 STAT. 1502||

Minor Use Pesticide Data Revolving Fund. The Fund shall be

available without fiscal year limitation to carry out the

authorized purposes of this subsection.

``(B) Contents of the fund.--There shall be deposited in the

Fund--

``(i) such amounts as may be appropriated to support

the purposes of this subsection; and

``(ii) fees collected by the Secretary for any data

developed under a grant under paragraph (1)(A).

``(C) Authorizations of appropriations.--There are

authorized to be appropriated for each fiscal year to carry out

the purposes of this subsection $10,000,000 to remain available

until expended.''.

Subtitle B--Antimicrobial Pesticide Registration Reform

SEC. 221. DEFINITIONS.

Section 2 (7 U.S.C. 136), as amended by section 210(a) is further

amended--

(1) in subsection (u), by adding at the end the following:

``The term `pesticide' does not include liquid chemical

sterilant products (including any sterilant or subordinate

disinfectant claims on such products) for use on a critical or

semi-critical device, as defined in section 201 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 321). For purposes of

the preceding sentence, the term `critical device' includes any

device which is introduced directly into the human body, either

into or in contact with the bloodstream or normally sterile

areas of the body and the term `semi-critical device' includes

any device which contacts intact mucous membranes but which does

not ordinarily penetrate the blood barrier or otherwise enter

normally sterile areas of the body.''; and

(2) by adding at the end the following:

``(mm) Antimicrobial Pesticide.--

``(1) In general.--The term `antimicrobial pesticide' means

a pesticide that--

``(A) is intended to--

``(i) disinfect, sanitize, reduce, or mitigate

growth or development of microbiological

organisms; or

``(ii) protect inanimate objects, industrial

processes or systems, surfaces, water, or other

chemical substances from contamination, fouling,

or deterioration caused by bacteria, viruses,

fungi, protozoa, algae, or slime; and

``(B) in the intended use is exempt from, or

otherwise not subject to, a tolerance under section 408

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

346a and 348) or a food additive regulation under

section 409 of such Act.

``(2) Excluded products.--The term `antimicrobial pesticide'

does not include --

``(A) a wood preservative or antifouling paint

product for which a claim of pesticidal activity other

than or in addition to an activity described in

paragraph (1) is made;

``(B) an agricultural fungicide product; or

[[Page 110 STAT. 1503||

``(C) an aquatic herbicide product.

``(3) Included products.--The term `antimicrobial pesticide'

does include any other chemical sterilant product (other than

liquid chemical sterilant products exempt under subsection (u)),

any other disinfectant product, any other industrial

microbiocide product, and any other preservative product that is

not excluded by paragraph (2).''.

SEC. 222. FEDERAL AND STATE DATA COORDINATION.

Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as amended by section

210(f)(2), is amended by adding at the end the following:

``(viii)(I) If data required to support registration

of a pesticide under subparagraph (A) is requested by a

Federal or State regulatory authority, the Administrator

shall, to the extent practicable, coordinate data

requirements, test protocols, timetables, and standards

of review and reduce burdens and redundancy caused to

the registrant by multiple requirements on the

registrant.

``(II) The Administrator may enter into a

cooperative agreement with a State to carry out

subclause (I).

``(III) Not later than 1 year after the date of

enactment of this clause, the Administrator shall

develop a process to identify and assist in alleviating

future disparities between Federal and State data

requirements.''.

SEC. 223. LABEL AND LABELING.

Section 3(c) (7 U.S.C. 136a(c)) is amended by adding at the end the

following:

``(9) Labeling.--

``(A) Additional statements.--Subject to

subparagraphs (B) and (C), it shall not be a violation

of this Act for a registrant to modify the labeling of

an antimicrobial pesticide product to include relevant

information on product efficacy, product composition,

container composition or design, or other

characteristics that do not relate to any pesticidal

claim or pesticidal activity.

``(B) Requirements.--Proposed labeling information

under subparagraph (A) shall not be false or misleading,

shall not conflict with or detract from any statement

required by law or the Administrator as a condition of

registration, and shall be substantiated on the request

of the Administrator.

``(C) Notification and disapproval.--

``(i) Notification.--A registration may be

modified under subparagraph (A) if --

``(I) the registrant notifies the

Administrator in writing not later than

60 days prior to distribution or sale of

a product bearing the modified labeling;

and

``(II) the Administrator does not

disapprove of the modification under

clause (ii).

``(ii) Disapproval.--Not later than 30 days

after receipt of a notification under clause (i),

the Administrator may disapprove the modification

by sending the registrant notification in writing

stating that the proposed language is not

acceptable and stating the reasons why the

Administrator finds the proposed modification

unacceptable.

[[Page 110 STAT. 1504||

``(iii) Restriction on sale.--A registrant may

not sell or distribute a product bearing a

disapproved modification.

``(iv) Objection.--A registrant may file an

objection in writing to a disapproval under clause

(ii) not later than 30 days after receipt of

notification of the disapproval.

``(v) Final action.--A decision by the

Administrator following receipt and consideration

of an objection filed under clause (iv) shall be

considered a final agency action.

``(D) Use dilution.--The label or labeling required

under this Act for an antimicrobial pesticide that is or

may be diluted for use may have a different statement of

caution or protective measures for use of the

recommended diluted solution of the pesticide than for

use of a concentrate of the pesticide if the

Administrator determines that --

``(i) adequate data have been submitted to

support the statement proposed for the diluted

solution uses; and

``(ii) the label or labeling provides adequate

protection for exposure to the diluted solution of

the pesticide.''.

SEC. 224. REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES.

Section 3 (7 U.S.C. 136a), as amended by section 106(b), is further

amended by adding at the end the following:

``(h) Registration Requirements for Antimicrobial Pesticides.--

``(1) Evaluation of process.--To the maximum extent

practicable consistent with the degrees of risk presented by an

antimicrobial pesticide and the type of review appropriate to

evaluate the risks, the Administrator shall identify and

evaluate reforms to the antimicrobial registration process that

would reduce review periods existing as of the date of enactment

of this subsection for antimicrobial pesticide product

registration applications and applications for amended

registration of antimicrobial pesticide products, including--

``(A) new antimicrobial active ingredients;

``(B) new antimicrobial end-use products;

``(C) substantially similar or identical

antimicrobial pesticides; and

``(D) amendments to antimicrobial pesticide

registrations.

``(2) Review time period reduction goal.--Each reform

identified under paragraph (1) shall be designed to achieve the

goal of reducing the review period following submission of a

complete application, consistent with the degree of risk, to a

period of not more than--

``(A) 540 days for a new antimicrobial active

ingredient pesticide registration;

``(B) 270 days for a new antimicrobial use of a

registered active ingredient;

``(C) 120 days for any other new antimicrobial

product;

[[Page 110 STAT. 1505||

``(D) 90 days for a substantially similar or

identical antimicrobial product;

``(E) 90 days for an amendment to an antimicrobial

registration that does not require scientific review of

data; and

``(F) 90 to 180 days for an amendment to an

antimicrobial registration that requires scientific

review of data and that is not otherwise described in

this paragraph.

``(3) Implementation.--

``(A) Proposed rulemaking.--

``(i) <<NOTE: Federal Register,

publication.>> Issuance.--Not later than 270 days

after the date of enactment of this subsection,

the Administrator shall publish in the Federal

improve the review of antimicrobial pesticide

products designed to implement, to the extent

practicable, the goals set forth in paragraph (2).

``(ii) Requirements.--Proposed regulations

issued under clause (i) shall--

``(I) define the various classes of

antimicrobial use patterns, including

household, industrial, and institutional

disinfectants and sanitizing pesticides,

preservatives, water treatment, and pulp

and paper mill additives, and other such

products intended to disinfect,

sanitize, reduce, or mitigate growth or

development of microbiological

organisms, or protect inanimate objects,

industrial processes or systems,

surfaces, water, or other chemical

substances from contamination, fouling,

or deterioration caused by bacteria,

viruses, fungi, protozoa, algae, or

slime;

``(II) differentiate the types of

review undertaken for antimicrobial

pesticides;

``(III) conform the degree and type

of review to the risks and benefits

presented by antimicrobial pesticides

and the function of review under this

Act, considering the use patterns of the

product, toxicity, expected exposure,

and product type;

``(IV) ensure that the registration

process is sufficient to maintain

antimicrobial pesticide efficacy and

that antimicrobial pesticide products

continue to meet product performance

standards and effectiveness levels for

each type of label claim made; and

``(V) implement effective and

reliable deadlines for process

management.

``(iii) Comments.--In developing the proposed

regulations, the Administrator shall solicit the

views from registrants and other affected parties

to maximize the effectiveness of the rule

development process.

``(B) Final regulations.--

``(i) Issuance.--The Administrator shall issue

final regulations not later than 240 days after

the close of the comment period for the proposed

regulations.

[[Page 110 STAT. 1506||

``(ii) Failure to meet goal.--If a goal

described in paragraph (2) is not met by the final

regulations, the Administrator shall identify the

goal, explain why the goal was not attained,

describe the element of the regulations included

instead, and identify future steps to attain the

goal.

``(iii) Requirements.--In issuing final

regulations, the Administrator shall--

``(I) consider the establishment of

a certification process for regulatory

actions involving risks that can be

responsibly managed, consistent with the

degree of risk, in the most cost-

efficient manner;

``(II) consider the establishment of

a certification process by approved

laboratories as an adjunct to the review

process;

``(III) use all appropriate and

cost-effective review mechanisms,

including--

``(aa) expanded use of

notification and non-

notification procedures;

``(bb) revised procedures

for application review; and

``(cc) allocation of

appropriate resources to ensure

streamlined management of

antimicrobial pesticide

registrations; and

``(IV) clarify criteria for

determination of the completeness of an

application.

``(C) Expedited review.--This subsection does not

affect the requirements or extend the deadlines or

review periods contained in subsection (c)(3).

``(D) Alternative review periods.--If the final

regulations to carry out this paragraph are not

effective 630 days after the date of enactment of this

subsection, until the final regulations become

effective, the review period, beginning on the date of

receipt by the Agency of a complete application, shall

be--

``(i) 2 years for a new antimicrobial active

ingredient pesticide registration;

``(ii) 1 year for a new antimicrobial use of a

registered active ingredient;

``(iii) 180 days for any other new

antimicrobial product;

``(iv) 90 days for a substantially similar or

identical antimicrobial product;

``(v) 90 days for an amendment to an

antimicrobial registration that does not require

scientific review of data; and

``(vi) 240 days for an amendment to an

antimicrobial registration that requires

scientific review of data and that is not

otherwise described in this subparagraph.

``(E) <<NOTE: Review.>> Wood preservatives.--An

application for the registration, or for an amendment to

the registration, of a wood preservative product for

which a claim of pesticidal activity listed in section

2(mm) is made (regardless of any other pesticidal claim

that is made with respect to the product) shall be

reviewed by the Administrator within

[[Page 110 STAT. 1507||

the same period as that established under this paragraph

for an antimicrobial pesticide product application,

consistent with the degree of risk posed by the use of

the wood preservative product, if the application

requires the applicant to satisfy the same data

requirements as are required to support an application

for a wood preservative product that is an antimicrobial

pesticide.

``(F) Notification.--

``(i) In general.--Subject to clause (iii),

the Administrator shall notify an applicant

whether an application has been granted or denied

not later than the final day of the appropriate

review period under this paragraph, unless the

applicant and the Administrator agree to a later

date.

``(ii) Final decision.--If the Administrator

fails to notify an applicant within the period of

time required under clause (i), the failure shall

be considered an agency action unlawfully withheld

or unreasonably delayed for purposes of judicial

review under chapter 7 of title 5, United States

Code.

``(iii) Exemption.--This subparagraph does not

apply to an application for an antimicrobial

pesticide that is filed under subsection (c)(3)(B)

prior to 90 days after the date of enactment of

this subsection.

``(4) Annual report.--

``(A) Submission.--Beginning on the date of

enactment of this subsection and ending on the date that

the goals under paragraph (2) are achieved, the

Administrator shall, not later than March 1 of each

year, prepare and submit an annual report to the

Committee on Agriculture of the House of Representatives

and the Committee on Agriculture, Nutrition, and

Forestry of the Senate.

``(B) Requirements.--A report submitted under

subparagraph (A) shall include a description of--

``(i) measures taken to reduce the backlog of

pending registration applications;

``(ii) progress toward achieving reforms under

this subsection; and

``(iii) recommendations to improve the

activities of the Agency pertaining to

antimicrobial registrations.''.

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

ANTIMICROBIAL PRODUCTS.

Section 19(h) (7 U.S.C. 136q(h)) is amended--

(1) by striking ``Nothing in'' and inserting the following:

``(1) In general.--Nothing in''; and

(2) by adding at the end the following:

``(2) Antimicrobial products.--A household, industrial, or

institutional antimicrobial product that is not subject to

regulation under the Solid Waste Disposal Act (42 U.S.C. 6901 et

seq.) shall not be subject to the provisions of subsections (a),

(e), and (f), unless the Administrator determines that such

product must be subject to such provisions to prevent an

unreasonable adverse effect on the environment.''.

[[Page 110 STAT. 1508||

Subtitle C--Public Health Pesticides

SEC. 230. DEFINITIONS.

(a) Adverse Effects.--Section 2(bb) (7 U.S.C. 136(bb)) is amended by

adding at the end the following: ``The Administrator shall consider the

risks and benefits of public health pesticides separate from the risks

and benefits of other pesticides. In weighing any regulatory action

concerning a public health pesticide under this Act, the Administrator

shall weigh any risks of the pesticide against the health risks such as

the diseases transmitted by the vector to be controlled by the

pesticide.''.

(b) New Definitions.--Section 2 (7 U.S.C. 136), as amended by

section 221, is amended by adding at the end the following:

``(nn) Public Health Pesticide.--The term `public health pesticide'

means any minor use pesticide product registered for use and used

predominantly in public health programs for vector control or for other

recognized health protection uses, including the prevention or

mitigation of viruses, bacteria, or other microorganisms (other than

viruses, bacteria, or other microorganisms on or in living man or other

living animal) that pose a threat to public health.

``(oo) Vector.--The term `vector' means any organism capable of

transmitting the causative agent of human disease or capable of

producing human discomfort or injury, including mosquitoes, flies,

fleas, cockroaches, or other insects and ticks, mites, or rats.''.

SEC. 231. REGISTRATION.

Section 3(c)(2)(A) (7 U.S.C. 136a(c)(2)(A)) is amended--

(1) by inserting after ``pattern of use,'' the following:

``the public health and agricultural need for such minor use,'';

and

(2) by striking ``potential exposure of man and the

environment to the pesticide'' and inserting ``potential

beneficial or adverse effects on man and the environment''.

SEC. 232. REREGISTRATION.

Section 4 (7 U.S.C. 136a-1) is amended--

(1) in subsection (i)(4), by redesignating subparagraphs (B)

and (C) as subparagraphs (C) and (D), respectively, and by

adding after subparagraph (A) the following:

``(B) The Administrator shall exempt any public

health pesticide from the payment of the fee prescribed

under paragraph (3) if, in consultation with the

Secretary of Health and Human Services, the

Administrator determines, based on information supplied

by the registrant, that the economic return to the

registrant from sales of the pesticide does not support

the registration or reregistration of the pesticide.'';

(2) in subsection (i)(5), by redesignating subparagraphs (F)

and (G) as subparagraphs (G) and (H), respectively, and by

adding after subparagraph (E) the following:

``(F) The Administrator shall exempt any public

health pesticide from the payment of the fee prescribed

under paragraph (3) if, in consultation with the

Secretary of Health and Humans Services, the

Administrator determines, based on information supplied

by the registrant, that the economic return to the

registrant from sales of

[[Page 110 STAT. 1509||

the pesticide does not support the registration or

reregistration of the pesticide.'';

(3) in subsection (i)(7)(B), by striking ``or to determine''

and inserting ``, to determine'' and by inserting before the

period the following: ``, or to determine the volume usage for

public health pesticides''; and

(4) in subsection (k)(3)(A), by striking ``or'' at the end

of clause (i), by striking the period at the end of clause (ii)

and inserting thereof ``; or'', and by adding after clause (ii)

the following:

``(iii) proposes the initial or amended

registration of an end use pesticide that, if

registered as proposed, would be used for a public

health pesticide.''.

SEC. 233. CANCELLATION.

Section 6(b) (7 U.S.C. 136d(b)) is amended by adding after the

eighth sentence the following: ``When a public health use is affected,

the Secretary of Health and Human Services should provide available

benefits and use information, or an analysis thereof, in accordance with

the procedures followed and subject to the same conditions as the

Secretary of Agriculture in the case of agricultural pesticides.''.

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

Section 21 (7 U.S.C. 136s) is amended by redesignating subsections

(b) and (c) as subsections (c) and (d), respectively, and by adding

after subsection (a) the following:

``(b) Secretary of Health and Human Services.--The Administrator,

before publishing regulations under this Act for any public health

pesticide, shall solicit the views of the Secretary of Health and Human

Services in the same manner as the views of the Secretary of Agriculture

are solicited under section 25(a)(2).''.

SEC. 235. AUTHORITY OF ADMINISTRATOR.

Section 25(a)(1) (7 U.S.C. 136w(a)(1)) is amended--

(1) by inserting after ``various classes of pesticides'' the

following: ``, including public health pesticides,''; and

(2) by striking ``and nonagricultural pesticides'' and

inserting ``, nonagricultural, and public health pesticides''.

SEC. 236. IDENTIFICATION OF PESTS.

Section 28 (7 U.S.C. 136w-3) is amended by adding at the end the

following:

``(d) Public Health Pests.--The Administrator, in coordination with

the Secretary of Agriculture and the Secretary of Health and Human

Services, shall identify pests of significant public health importance

and, in coordination with the Public Health Service, develop and

implement programs to improve and facilitate the safe and necessary use

of chemical, biological, and other methods to combat and control such

pests of public health importance.''.

SEC. 237. PUBLIC HEALTH DATA.

Section 4 (7 U.S.C. 136a-1) is amended by adding at the end the

following:

``(m) Authorization of Funds To Develop Public Health Data.--

[[Page 110 STAT. 1510||

``(1) Definition.--For the purposes of this section,

`Secretary' means the Secretary of Health and Human Services,

acting through the Public Health Service.

``(2) Consultation.--In the case of a pesticide registered

for use in public health programs for vector control or for

other uses the Administrator determines to be human health

protection uses, the Administrator shall, upon timely request by

the registrant or any other interested person, or on the

Administrator's own initiative may, consult with the Secretary

prior to taking final action to suspend registration under

section 3(c)(2)(B)(iv), or cancel a registration under section

4, 6(e), or 6(f). <<NOTE: Regulations.>> In consultation with

the Secretary, the Administrator shall prescribe the form and

content of requests under this section.

``(3) Benefits to support family.--The Administrator, after

consulting with the Secretary, shall make a determination

whether the potential benefits of continued use of the pesticide

for public health or health protection purposes are of such

significance as to warrant a commitment by the Secretary to

conduct or to arrange for the conduct of the studies required by

the Administrator to support continued registration under

section 3 or reregistration under section 4.

``(4) <<NOTE: Notification.>> Additio nal time.--If the

Administrator determines that such a commitment is warranted and

in the public interest, the Administrator shall notify the

Secretary and shall, to the extent necessary, amend a notice

issued under section 3(c)(2)(B) to specify additional reasonable

time periods for submission of the data.

``(5) Arrangements.--The Secretary shall make such

arrangements for the conduct of required studies as the

Secretary finds necessary and appropriate to permit submission

of data in accordance with the time periods prescribed by the

Administrator. Such arrangements may include Public Health

Service intramural research activities, grants, contracts, or

cooperative agreements with academic, public health, or other

organizations qualified by experience and training to conduct

such studies.

``(6) Support.--The Secretary may provide for support of the

required studies using funds authorized to be appropriated under

this section, the Public Health Service Act, or other

appropriate authorities. <<NOTE: Notification.>& amp;gt; After a

determination is made under subsection (d), the Secretary shall

notify the Committees on Appropriations of the House of

Representatives and the Senate of the sums required to conduct

the necessary studies.

``(7) Authorization of appropriations.--There is authorized

to be appropriated to carry out the purposes of this section

$12,000,000 for fiscal year 1997, and such sums as may be

necessary for succeeding fiscal years.''.

Subtitle D--Expedited Registration of Reduced Risk Pesticides

SEC. 250. EXPEDITED REGISTRATION OF PESTICIDES .

Section 3(c) (7 U.S.C. 136a(c)), as amended by section 223, is

amended--

(1) by adding at the end of paragraph (1) the following:

[[Page 110 STAT. 1511||

``(G) If the applicant is requesting that the

registration or amendment to the registration of a

pesticide be expedited, an explanation of the basis for

the request must be submitted, in accordance with

paragraph (10) of this subsection.''; and

(2) by adding at the end the following:

``(10) Expedited registration of pesticides.--

``(A) <<NOTE: Guidelines.>> Not later than 1 year

after the date of enactment of this paragraph, the

Administrator shall, utilizing public comment, develop

procedures and guidelines, and expedite the review of an

application for registration of a pesticide or an

amendment to a registration that satisfies such

guidelines.

``(B) Any application for registration or an

amendment, including biological and conventional

pesticides, will be considered for expedited review

under this paragraph. An application for registration or

an amendment shall qualify for expedited review if use

of the pesticide proposed by the application may

reasonably be expected to accomplish 1 or more of the

following:

``(i) Reduce the risks of pesticides to human

health.

``(ii) Reduce the risks of pesticides to

nontarget organisms.

``(iii) Reduce the potential for contamination

of groundwater, surface water, or other valued

environmental resources.

``(iv) Broaden the adoption of integrated pest

management strategies, or make such strategies

more available or more effective.

``(C) <<NOTE: Notification.>> The Administrator,

not later than 30 days after receipt of an application

for expedited review, shall notify the applicant whether

the application is complete. If it is found to be

incomplete, the Administrator may either reject the

request for expedited review or ask the applicant for

additional information to satisfy the guidelines

developed under subparagraph (A).''.

TITLE III--DATA COLLECTION ACTIVITIES TO ASSURE THE HEALTH OF INFANTS

AND CHILDREN AND OTHER MEASURES

SEC. 301. <<NOTE: 21 USC 346a note.>> DATA COLL ECTION ACTIVITIES TO

ASSURE THE HEALTH OF INFANTS AND CHILDREN.

(a) In General.--The Secretary of Agriculture, in consultation with

the Administrator of the Environmental Protection Agency and the

Secretary of Health and Human Services, shall coordinate the development

and implementation of survey procedures to ensure that adequate data on

food consumption patterns of infants and children are collected.

(b) Procedures.--To the extent practicable, the procedures referred

to in subsection (a) shall include the collection of data on food

consumption patterns of a statistically valid sample of infants and

children.

[[Page 110 STAT. 1512||

ensure that the residue data collection activities conducted by the

Department of Agriculture in cooperation with the Environmental

Protection Agency and the Department of Health and Human Services,

provide for the improved data collection of pesticide residues,

including guidelines for the use of comparable analytical and

standardized reporting methods, and the increased sampling of foods most

likely consumed by infants and children.

SEC. 302. <<NOTE: 7 USC 136i-2.>> COLLECTION OF PESTICIDE USE

INFORMATION.

(a) In General.--The Secretary of Agriculture shall collect data of

statewide or regional significance on the use of pesticides to control

pests and diseases of major crops and crops of dietary significance,

including fruits and vegetables.

(b) Collection.--The data shall be collected by surveys of farmers

or from other sources offering statistically reliable data.

appropriate, coordinate with the Administrator of the Environmental

Protection Agency in the design of the surveys and make available to the

Administrator the aggregate results of the surveys to assist the

Administrator.

SEC. 303. <<NOTE: 7 USC 136r-1.>> INTEGRATED PES T MANAGEMENT.

The Secretary of Agriculture, in cooperation with the Administrator,

shall implement research, demonstration, and education programs to

support adoption of Integrated Pest Management. Integrated Pest

Management is a sustainable approach to managing pests by combining

biological, cultural, physical, and chemical tools in a way that

minimizes economic, health, and environmental risks. The Secretary of

Agriculture and the Administrator shall make information on Integrated

Pest Management widely available to pesticide users, including Federal

agencies. Federal agencies shall use Integrated Pest Management

techniques in carrying out pest management activities and shall promote

Integrated Pest Management through procurement and regulatory policies,

and other activities.

SEC. 304. COORDINATION OF CANCELLATION.

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

(1) by inserting ``(1)'' after ``means''; and

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

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

result from a use of a pesticide in or on any food inconsistent

with the standard under section 408 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 346a).''.

SEC. 305. <<NOTE: 7 USC 136i-2 note.>> PESTICID E USE INFORMATION

STUDY.

(a) <<NOTE: Reports.>> The Secretary of Agri culture shall, in

consultation with the Administrator of the Environmental Protection

Agency, prepare a report to Congress evaluating the current status and

potential improvements in Federal pesticide use information gathering

activities. This report shall at least include--

(1) an analysis of the quality and reliability of the

information collected by the Department of Agriculture, the

Environmental Protection Agency, and other Federal agencies

regarding the agricultural use of pesticides; and

(2) an analysis of options to increase the effectiveness of

national pesticide use information collection, including an

[[Page 110 STAT. 1513||

analysis of costs, burdens placed on agricultural producers and

other pesticide users, and effectiveness in tracking risk

reduction by those options.

(b) The Secretary shall submit this report to Congress not later

than 1 year following the date of enactment of this section.

TITLE IV-- <<NOTE: Food Quality Protection Act of 1996.> > AMENDMENTS TO

THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

SEC 401. SHORT TITLE AND REFERENCE.

(a) <<NOTE: 21 USC 301 note.>> Short Title.- -This title may be

cited as the ``Food Quality Protection Act of 1996 ''.

(b) Reference.--Whenever in this title an amendment or repeal is

expressed in terms of an amendment to, or repeal of, a section or other

provision, the reference shall be considered to be made to a section or

other provision of the Federal Food, Drug, and Cosmetic Act.

SEC. 402. DEFINITIONS.

(a) Section 201(q).--Section 201(q) (21 U.S.C. 321(q)) is amended to

read as follows:

``(q)(1) The term `pesticide chemical' means any substance that is a

pesticide within the meaning of the Federal Insecticide, Fungicide, and

Rodenticide Act, including all active and inert ingredients of such

pesticide.

``(2) The term `pesticide chemical residue' means a residue in or on

raw agricultural commodity or processed food of--

``(A) a pesticide chemical; or

``(B) any other added substance that is present on or in the

commodity or food primarily as a result of the metabolism or

other degradation of a pesticide chemical.

``(3) Notwithstanding paragraphs (1) and (2), the Administrator may

by regulation except a substance from the definition of `pesticide

chemical' or `pesticide chemical residue' if--

``(A) its occurrence as a residue on or in a raw

agricultural commodity or processed food is attributable

primarily to natural causes or to human activities not involving

the use of any substances for a pesticidal purpose in the

production, storage, processing, or transportation of any raw

agricultural commodity or processed food; and

``(B) the Administrator, after consultation with the

Secretary, determines that the substance more appropriately

should be regulated under one or more provisions of this Act

other than sections 402(a)(2)(B) and 408.''.

(b) Section 201(s).--Paragraphs (1) and (2) of section 201(s) (21

U.S.C. 321(s)) are amended to read as follows:

``(1) a pesticide chemical residue in or on a raw

agricultural commodity or processed food; or

``(2) a pesticide chemical; or''.

at the end the following:

``(gg) The term `processed food' means any food other than a raw

agricultural commodity and includes any raw agricultural

[[Page 110 STAT. 1514||

commodity that has been subject to processing, such as canning, cooking,

freezing, dehydration, or milling.

``(hh) The term `Administrator' means the Administrator of the

United States Environmental Protection Agency.''.

SEC. 403. PROHIBITED ACTS.

Section 301(j) (21 U.S.C. 331(j)) is amended in the first sentence

by inserting before the period the following: ``; or the violating of

section 408(i)(2) or any regulation issued under that section.''.

SEC. 404. ADULTERATED FOOD.

Section 402(a) (21 U.S.C. 342(a)) is amended by striking ``(2)(A) if

it bears'' and all that follows through ``(3) if it consists'' and

inserting the following: ``(2)(A) if it bears or contains any added

poisonous or added deleterious substance (other than a substance that is

a pesticide chemical residue in or on a raw agricultural commodity or

processed food, a food additive, a color additive, or a new animal drug)

that is unsafe within the meaning of section 406; or (B) if it bears or

contains a pesticide chemical residue that is unsafe within the meaning

of section 408(a); or (C) if it is or if it bears or contains (i) any

food additive that is unsafe within the meaning of section 409; or (ii)

a new animal drug (or conversion product thereof) that is unsafe within

the meaning of section 512; or (3) if it consists''.

SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES.

Section 408 (21 U.S.C. 346a) is amended to read as follows:

``Sec. 408. (a) Requirement for Tolerance or Exemption.--

``(1) General rule.--Except as provided in paragraph (2) or

(3), any pesticide chemical residue in or on a food shall be

deemed unsafe for the purpose of section 402(a)(2)(B) unless--

``(A) a tolerance for such pesticide chemical

residue in or on such food is in effect under this

section and the quantity of the residue is within the

limits of the tolerance; or

``(B) an exemption from the requirement of a

tolerance is in effect under this section for the

pesticide chemical residue.

For the purposes of this section, the term `food', when used as

a noun without modification, shall mean a raw agricultural

commodity or processed food.

``(2) Processed food.--Notwithstanding paragraph (1)--

``(A) if a tolerance is in effect under this section

for a pesticide chemical residue in or on a raw

agricultural commodity, a pesticide chemical residue

that is present in or on a processed food because the

food is made from that raw agricultural commodity shall

not be considered unsafe within the meaning of section

402(a)(2)(B) despite the lack of a tolerance for the

pesticide chemical residue in or on the processed food

if the pesticide chemical has been used in or on the raw

agricultural commodity in conformity with a tolerance

under this section, such residue in or on the raw

agricultural commodity has been removed

[[Page 110 STAT. 1515||

to the extent possible in good manufacturing practice,

and the concentration of the pesticide chemical residue

in the processed food is not greater than the tolerance

prescribed for the pesticide chemical residue in the raw

agricultural commodity; or

``(B) if an exemption for the requirement for a

tolerance is in effect under this section for a

pesticide chemical residue in or on a raw agricultural

commodity, a pesticide chemical residue that is present

in or on a processed food because the food is made from

that raw agricultural commodity shall not be considered

unsafe within the meaning of section 402(a)(2)(B).

``(3) Residues of degradation products.--If a pesticide

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

metabolite or other degradation product of a precursor substance

that itself is a pesticide chemical or pesticide chemical

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

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

tolerance or exemption from the need for a tolerance for such

residue in or on such food if--

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

degradation product is likely to pose any potential

health risk from dietary exposure that is of a different

type than, or of a greater significance than, any risk

posed by dietary exposure to the precursor substance;

``(B) either--

``(i) a tolerance is in effect under this

section for residues of the precursor substance in

or on the food, and the combined level of residues

of the degradation product and the precursor

substance in or on the food is at or below the

stoichiometrically equivalent level that would be

permitted by the tolerance if the residue

consisted only of the precursor substance rather

than the degradation product; or

``(ii) an exemption from the need for a

tolerance is in effect under this section for

residues of the precursor substance in or on the

food; and

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

precursor substance does not state that it applies only

to particular named substances and does not state that

it does not apply to residues of the degradation

product.

``(4) Effect of tolerance or exemption.--While a tolerance

or exemption from the requirement for a tolerance is in effect

under this section for a pesticide chemical residue with respect

to any food, the food shall not by reason of bearing or

containing any amount of such a residue be considered to be

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

``(b) Authority and Standard for Tolerance.--

``(1) Authority.--The Administrator may issue regulations

establishing, modifying, or revoking a tolerance for a pesticide

chemical residue in or on a food--

``(A) in response to a petition filed under

subsection (d); or

``(B) on the Administrator's own initiative under

subsection (e).

As used in this section, the term `modify' shall not mean

expanding the tolerance to cover additional foods.

[[Page 110 STAT. 1516||

``(2) Standard.--

``(A) General rule.--

``(i) Standard.--The Administrator may

establish or leave in effect a tolerance for a

pesticide chemical residue in or on a food only if

the Administrator determines that the tolerance is

safe. The Administrator shall modify or revoke a

tolerance if the Administrator determines it is

not safe.

``(ii) Determination of safety.--As used in

this section, the term `safe', with respect to a

tolerance for a pesticide chemical residue, means

that the Administrator has determined that there

is a reasonable certainty that no harm will result

from aggregate exposure to the pesticide chemical

residue, including all anticipated dietary

exposures and all other exposures for which there

is reliable information.

``(iii) Rule of construction.--With respect to

a tolerance, a pesticide chemical residue meeting

the standard under clause (i) is not an eligible

pesticide chemical residue for purposes of

subparagraph (B).

``(B) Tolerances for eligible pesticide chemical

residues.--

``(i) Definition.--As used in this

subparagraph, the term `eligible pesticide

chemical residue' means a pesticide chemical

residue as to which--

``(I) the Administrator is not able

to identify a level of exposure to the

residue at which the residue will not

cause or contribute to a known or

anticipated harm to human health

(referred to in this section as a

`nonthreshold effect');

``(II) the lifetime risk of

experiencing the nonthreshold effect is

appropriately assessed by quantitative

risk assessment; and

``(III) with regard to any known or

anticipated harm to human health for

which the Administrator is able to

identify a level at which the residue

will not cause such harm (referred to in

this section as a `threshold effect'),

the Administrator determines that the

level of aggregate exposure is safe.

``(ii) Determination of tolerance.--

Notwithstanding subparagraph (A)(i), a tolerance

for an eligible pesticide chemical residue may be

left in effect or modified under this subparagraph

if--

``(I) at least one of the conditions

described in clause (iii) is met; and

``(II) both of the conditions

described in clause (iv) are met.

``(iii) Conditions regarding use.--For

purposes of clause (ii), the conditions described

in this clause with respect to a tolerance for an

eligible pesticide chemical residue are the

following:

``(I) Use of the pesticide chemical

that produces the residue protects

consumers from adverse effects on health

that would pose a greater risk than the

dietary risk from the residue.

``(II) Use of the pesticide chemical

that produces the residue is necessary

to avoid a significant

[[Page 110 STAT. 1517||

disruption in domestic production of an

adequate, wholesome, and economical food

supply.

``(iv) Conditions regarding risk.--For

purposes of clause (ii), the conditions described

in this clause with respect to a tolerance for an

eligible pesticide chemical residue are the

following:

``(I) The yearly risk associated

with the nonthreshold effect from

aggregate exposure to the residue does

not exceed 10 times the yearly risk that

would be allowed under subparagraph (A)

for such effect.

``(II) The tolerance is limited so

as to ensure that the risk over a

lifetime associated with the

nonthreshold effect from aggregate

exposure to the residue is not greater

than twice the lifetime risk that would

be allowed under subparagraph (A) for

such effect.

``(v) Review.--Five years after the date on

which the Administrator makes a determination to

leave in effect or modify a tolerance under this

subparagraph, and thereafter as the Administrator

deems appropriate, the Administrator shall

determine, after notice and opportunity for

comment, whether it has been demonstrated to the

Administrator that a condition described in clause

(iii)(I) or clause (iii)(II) continues to exist

with respect to the tolerance and that the yearly

and lifetime risks from aggregate exposure to such

residue continue to comply with the limits

specified in clause (iv). <<NOTE: Regulat ions.>>

If the Administrator determines by such date that

such demonstration has not been made, the

Administrator shall, not later than 180 days after

the date of such determination, issue a regulation

under subsection (e)(1) to modify or revoke the

tolerance.

``(vi) Infants and children.--Any tolerance

under this subparagraph shall meet the

requirements of subparagraph (C).

``(C) Exposure of infants and children.--In

establishing, modifying, leaving in effect, or revoking

a tolerance or exemption for a pesticide chemical

residue, the Administrator--

``(i) shall assess the risk of the pesticide

chemical residue based on--

``(I) available information about

consumption patterns among infants and

children that are likely to result in

disproportionately high consumption of

foods containing or bearing such residue

among infants and children in comparison

to the general population;

``(II) available information

concerning the special susceptibility of

infants and children to the pesticide

chemical residues, including

neurological differences between infants

and children and adults, and effects of

in utero exposure to pesticide

chemicals; and

``(III) available information

concerning the cumulative effects on

infants and children of such

[[Page 110 STAT. 1518||

residues and other substances that have

a common mechanism of toxicity; and

``(ii) shall--

``(I) ensure that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to the pesticide

chemical residue; and

``(II) <<NOTE: Publication.& ;gt;> publish a

specific determination regarding the

safety of the pesticide chemical residue

for infants and children.

<<NOTE: Surveys.>> The Secretary of Health and Human

Services and the Secretary of Agriculture, in

consultation with the Administrator, shall conduct

surveys to document dietary exposure to pesticides among

infants and children. In the case of threshold effects,

for purposes of clause (ii)(I) an additional tenfold

margin of safety for the pesticide chemical residue and

other sources of exposure shall be applied for infants

and children to take into account potential pre- and

post-natal toxicity and completeness of the data with

respect to exposure and toxicity to infants and

children. Notwithstanding such requirement for an

additional margin of safety, the Administrator may use a

different margin of safety for the pesticide chemical

residue only if, on the basis of reliable data, such

margin will be safe for infants and children.

``(D) Factors.--In establishing, modifying, leaving

in effect, or revoking a tolerance or exemption for a

pesticide chemical residue, the Administrator shall

consider, among other relevant factors--

``(i) the validity, completeness, and

reliability of the available data from studies of

the pesticide chemical and pesticide chemical

residue;

``(ii) the nature of any toxic effect shown to

be caused by the pesticide chemical or pesticide

chemical residue in such studies;

``(iii) available information concerning the

relationship of the results of such studies to

human risk;

``(iv) available information concerning the

dietary consumption patterns of consumers (and

major identifiable subgroups of consumers);

``(v) available information concerning the

cumulative effects of such residues and other

substances that have a common mechanism of

toxicity;

``(vi) available information concerning the

aggregate exposure levels of consumers (and major

identifiable subgroups of consumers) to the

pesticide chemical residue and to other related

substances, including dietary exposure under the

tolerance and all other tolerances in effect for

the pesticide chemical residue, and exposure from

other non-occupational sources;

``(vii) available information concerning the

variability of the sensitivities of major

identifiable subgroups of consumers;

``(viii) such information as the Administrator

may require on whether the pesticide chemical may

have an effect in humans that is similar to an

effect pro

[[Page 110 STAT. 1519||

duced by a naturally occurring estrogen or other

endocrine effects; and

``(ix) safety factors which in the opinion of

experts qualified by scientific training and

experience to evaluate the safety of food

additives are generally recognized as appropriate

for the use of animal experimentation data.

``(E) Data and information regarding anticipated and

actual residue levels.--

``(i) Authority.--In establishing, modifying,

leaving in effect, or revoking a tolerance for a

pesticide chemical residue, the Administrator may

consider available data and information on the

anticipated residue levels of the pesticide chemical in

or on food and the actual residue levels of the

pesticide chemical that have been measured in food,

including residue data collected by the Food and Drug

Administration.

``(ii) Requirement.--If the Administrator relies on

anticipated or actual residue levels in establishing,

modifying, or leaving in effect a tolerance, the

Administrator shall pursuant to subsection (f)(1)

require that data be provided five years after the date

on which the tolerance is established, modified, or left

in effect, and thereafter as the Administrator deems

appropriate, demonstrating that such residue levels are

not above the levels so relied

on. <<NOTE: Regulations.>> If su ch data are not so

provided, or if the data do not demonstrate that the

residue levels are not above the levels so relied on,

the Administrator shall, not later than 180 days after

the date on which the data were required to be provided,

issue a regulation under subsection (e)(1), or an order

under subsection (f)(2), as appropriate, to modify or

revoke the tolerance.

``(F) Percent of food actually treated.--In

establishing, modifying, leaving in effect, or revoking

a tolerance for a pesticide chemical residue, the

Administrator may, when assessing chronic dietary risk,

consider available data and information on the percent

of food actually treated with the pesticide chemical

(including aggregate pesticide use data collected by the

Department of Agriculture) only if the Administrator--

``(i) finds that the data are reliable and

provide a valid basis to show what percentage of

the food derived from such crop is likely to

contain such pesticide chemical residue;

``(ii) finds that the exposure estimate does

not understate exposure for any significant

subpopulation group;

``(iii) finds that, if data are available on

pesticide use and consumption of food in a

particular area, the population in such area is

not dietarily exposed to residues above those

estimated by the Administrator; and

``(iv) provides for the periodic reevaluation

of the estimate of anticipated dietary exposure.

``(3) Detection methods.--

``(A) General rule.--A tolerance for a pesticide

chemical residue in or on a food shall not be

established or

[[Page 110 STAT. 1520||

modified by the Administrator unless the Administrator

determines, after consultation with the Secretary, that

there is a practical method for detecting and measuring

the levels of the pesticide chemical residue in or on

the food.

``(B) Detection limit.--A tolerance for a pesticide

chemical residue in or on a food shall not be

established at or modified to a level lower than the

limit of detection of the method for detecting and

measuring the pesticide chemical residue specified by

the Administrator under subparagraph (A).

``(4) International standards.--In establishing a tolerance

for a pesticide chemical residue in or on a food, the

Administrator shall determine whether a maximum residue level

for the pesticide chemical has been established by the Codex

Alimentarius Commission. <<NOTE: Publication.>&a mp;gt; If a Codex

maximum residue level has been established for the pesticide

chemical and the Administrator does not propose to adopt the

Codex level, the Administrator shall publish for public comment

a notice explaining the reasons for departing from the Codex

level.

``(c) Authority and Standard for Exemptions.--

``(1) Authority.--The Administrator may issue a regulation

establishing, modifying, or revoking an exemption from the

requirement for a tolerance for a pesticide chemical residue in

or on food--

``(A) in response to a petition filed under

subsection (d); or

``(B) on the Administrator's initiative under

subsection (e).

``(2) Standard.--

``(A) General rule.--

``(i) Standard.--The Administrator may

establish or leave in effect an exemption from the

requirement for a tolerance for a pesticide

chemical residue in or on food only if the

Administrator determines that the exemption is

safe. The Administrator shall modify or revoke an

exemption if the Administrator determines it is

not safe.

``(ii) Determination of safety.--The term

`safe', with respect to an exemption for a

pesticide chemical residue, means that the

Administrator has determined that there is a

reasonable certainty that no harm will result from

aggregate exposure to the pesticide chemical

residue, including all anticipated dietary

exposures and all other exposures for which there

is reliable information.

``(B) Factors.--In making a determination under this

paragraph, the Administrator shall take into account,

among other relevant considerations, the considerations

set forth in subparagraphs (C) and (D) of subsection

(b)(2).

``(3) Limitation.--An exemption from the requirement for a

tolerance for a pesticide chemical residue in or on food shall

not be established or modified by the Administrator unless the

Administrator determines, after consultation with the

Secretary--

[[Page 110 STAT. 1521||

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

and measuring the levels of such pesticide chemical

residue in or on food; or

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

states the reasons for such determination in issuing the

regulation establishing or modifying the exemption.

``(d) Petition for Tolerance or Exemption.--

``(1) Petitions and petitioners.--Any person may file with

the Administrator a petition proposing the issuance of a

regulation--

``(A) establishing, modifying, or revoking a

tolerance for a pesticide chemical residue in or on a

food; or

``(B) establishing, modifying, or revoking an

exemption from the requirement of a tolerance for such a

residue.

``(2) Petition contents.--

``(A) <<NOTE: Regulations.>> Establishment.--A

petition under paragraph (1) to establish a tolerance or

exemption for a pesticide chemical residue shall be

supported by such data and information as are specified

in regulations issued by the Administrator, including--

``(i)(I) an informative summary of the

petition and of the data, information, and

arguments submitted or cited in support of the

petition; and

``(II) a statement that the petitioner agrees

that such summary or any information it contains

may be published as a part of the notice of filing

of the petition to be published under this

subsection and as part of a proposed or final

regulation issued under this section;

``(ii) the name, chemical identity, and

composition of the pesticide chemical residue and

of the pesticide chemical that produces the

residue;

``(iii) data showing the recommended amount,

frequency, method, and time of application of that

pesticide chemical;

``(iv) full reports of tests and

investigations made with respect to the safety of

the pesticide chemical, including full information

as to the methods and controls used in conducting

those tests and investigations;

``(v) full reports of tests and investigations

made with respect to the nature and amount of the

pesticide chemical residue that is likely to

remain in or on the food, including a description

of the analytical methods used;

``(vi) a practical method for detecting and

measuring the levels of the pesticide chemical

residue in or on the food, or for exemptions, a

statement why such a method is not needed;

``(vii) a proposed tolerance for the pesticide

chemical residue, if a tolerance is proposed;

``(viii) if the petition relates to a

tolerance for a processed food, reports of

investigations conducted using the processing

method(s) used to produce that food;

``(ix) such information as the Administrator

may require to make the determination under

subsection (b)(2)(C);

[[Page 110 STAT. 1522||

``(x) such information as the Administrator

may require on whether the pesticide chemical may

have an effect in humans that is similar to an

effect produced by a naturally occurring estrogen

or other endocrine effects;

``(xi) information regarding exposure to the

pesticide chemical residue due to any tolerance or

exemption already granted for such residue;

``(xii) practical methods for removing any

amount of the residue that would exceed any

proposed tolerance; and

``(xiii) such other data and information as

the Administrator requires by regulation to

support the petition.

If information or data required by this subparagraph is

available to the Administrator, the person submitting

the petition may cite the availability of the

information or data in lieu of submitting it. The

Administrator may require a petition to be accompanied

by samples of the pesticide chemical with respect to

which the petition is filed.

``(B) Modification or revocation.--The Administrator

may by regulation establish the requirements for

information and data to support a petition to modify or

revoke a tolerance or to modify or revoke an exemption

from the requirement for a tolerance.

``(3) <<NOTE: Publication.>> Notice. --A notice of the

filing of a petition that the Administrator determines has met

the requirements of paragraph (2) shall be published by the

Administrator within 30 days after such determination. The

notice shall announce the availability of a description of the

analytical methods available to the Administrator for the

detection and measurement of the pesticide chemical residue with

respect to which the petition is filed or shall set forth the

petitioner's statement of why such a method is not needed. The

notice shall include the summary required by paragraph

(2)(A)(i)(I).

``(4) Actions by the administrator.--

``(A) <<NOTE: Regulations.>> In general.--The

Administrator shall, after giving due consideration to a

petition filed under paragraph (1) and any other

information available to the Administrator--

``(i) issue a final regulation (which may vary

from that sought by the petition) establishing,

modifying, or revoking a tolerance for the

pesticide chemical residue or an exemption of the

pesticide chemical residue from the requirement of

a tolerance (which final regulation shall be

issued without further notice and without further

period for public comment);

``(ii) issue a proposed regulation under

subsection (e), and thereafter issue a final

regulation under such subsection; or

``(iii) issue an order denying the petition.

``(B) Priorities.--The Administrator shall give

priority to petitions for the establishment or

modification of a tolerance or exemption for a pesticide

chemical residue that appears to pose a significantly

lower risk to human health

[[Page 110 STAT. 1523||

from dietary exposure than pesticide chemical residues

that have tolerances in effect for the same or similar

uses.

``(C) Expedited review of certain petitions.--

``(i) Date certain for review.--If a person

files a complete petition with the Administrator

proposing the issuance of a regulation

establishing a tolerance or exemption for a

pesticide chemical residue that presents a lower

risk to human health than a pesticide chemical

residue for which a tolerance has been left in

effect or modified under subsection (b)(2)(B), the

Administrator shall complete action on such

petition under this paragraph within 1 year.

``(ii) Required determinations.--If the

Administrator issues a final regulation

establishing a tolerance or exemption for a safer

pesticide chemical residue under clause (i), the

Administrator shall, not later than 180 days after

the date on which the regulation is issued,

determine whether a condition described in

subclause (I) or (II) of subsection (b)(2)(B)(iii)

continues to exist with respect to a tolerance

that has been left in effect or modified under

subsection (b)(2)(B). If such condition

does <<NOTE: Regulations.>> not continue to exist,

the Administrator shall, not later than 180 days

after the date on which the determination under

the preceding sentence is made, issue a regulation

under subsection (e)(1) to modify or revoke the

tolerance.

``(e) Action on Administrator's Own Initiative.--

``(1) General rule.--The Administrator may issue a

regulation--

``(A) establishing, modifying, suspending under

subsection (l)(3), or revoking a tolerance for a

pesticide chemical or a pesticide chemical residue;

``(B) establishing, modifying, suspending under

subsection (l)(3), or revoking an exemption of a

pesticide chemical residue from the requirement of a

tolerance; or

``(C) establishing general procedures and

requirements to implement this section.

``(2) Notice.--Before issuing a final regulation under

paragraph (1), the Administrator shall issue a notice of

proposed rulemaking and provide a period of not less than 60

days for public comment on the proposed regulation, except that

a shorter period for comment may be provided if the

Administrator for good cause finds that it would be in the

public interest to do so and states the reasons for the finding

in the notice of proposed rulemaking.

``(f) Special Data Requirements.--

``(1) Requiring submission of additional data.--If the

Administrator determines that additional data or information are

reasonably required to support the continuation of a tolerance

or exemption that is in effect under this section for a

pesticide chemical residue on a food, the Administrator shall--

``(A) <<NOTE: Notice.>> issue a notice requiring the

person holding the pesticide registrations associated

with such tolerance or exemption to submit the data or

information under section 3(c)(2)(B) of the Federal

Insecticide, Fungicide, and Rodenticide Act;

[[Page 110 STAT. 1524||

``(B) <<NOTE: Rules.>> issue a rule requiring that

testing be conducted on a substance or mixture under

section 4 of the Toxic Substances Control Act; or

``(C) <<NOTE: Federal Register,

publication.>> publish in the Federal Register, after

first providing notice and an opportunity for comment of

not less than 60 days' duration, an order--

``(i) requiring the submission to the

Administrator by one or more interested persons of

a notice identifying the person or persons who

will submit the required data and information;

``(ii) describing the type of data and

information required to be submitted to the

Administrator and stating why the data and

information could not be obtained under the

authority of section 3(c)(2)(B) of the Federal

Insecticide, Fungicide, and Rodenticide Act or

section 4 of the Toxic Substances Control Act;

``(iii) describing the reports of the

Administrator required to be prepared during and

after the collection of the data and information;

``(iv) requiring the submission to the

Administrator of the data, information, and

reports referred to in clauses (ii) and (iii); and

``(v) establishing dates by which the

submissions described in clauses (i) and (iv) must

be made.

The Administrator may under subparagraph (C) revise any

such order to correct an error. The Administrator may

under this paragraph require data or information

pertaining to whether the pesticide chemical may have an

effect in humans that is similar to an effect produced

by a naturally occurring estrogen or other endocrine

effects.

``(2) Noncompliance.--If a submission required by a notice

issued in accordance with paragraph (1)(A), a rule issued under

paragraph (1)(B), or an order issued under paragraph (1)(C) is

not made by the time specified in such notice, rule, or order,

the Administrator may by order published in the Federal Register

modify or revoke the tolerance or exemption in question. In any

review of such an order under subsection (g)(2), the only

material issue shall be whether a submission required under

paragraph (1) was not made by the time specified.

``(g) Effective Date, Objections, Hearings, and Administrative

Review.--

``(1) Effective date.--A regulation or order issued under

subsection (d)(4), (e)(1), or (f)(2) shall take effect upon

publication unless the regulation or order specifies otherwise.

The Administrator may stay the effectiveness of the regulation

or order if, after issuance of such regulation or order,

objections are filed with respect to such regulation or order

pursuant to paragraph (2).

``(2) Further proceedings.--

``(A) Objections.--Within 60 days after a regulation

or order is issued under subsection (d)(4), (e)(1)(A),

(e)(1)(B), (f)(2), (n)(3), or (n)(5)(C), any person may

file objections thereto with the Administrator,

specifying with particularity the provisions of the

regulation or order deemed objectionable and stating

reasonable grounds therefor. If the regulation or order

was issued in response to a petition under subsection

(d)(1), a copy of each objection filed by

[[Page 110 STAT. 1525||

a person other than the petitioner shall be served by

the Administrator on the petitioner.

``(B) Hearing.--An objection may include a request

for a public evidentiary hearing upon the objection. The

Administrator shall, upon the initiative of the

Administrator or upon the request of an interested

person and after due notice, hold a public evidentiary

hearing if and to the extent the Administrator

determines that such a public hearing is necessary to

receive factual evidence relevant to material issues of

fact raised by the objections. The presiding officer in

such a hearing may authorize a party to obtain discovery

from other persons and may upon a showing of good cause

made by a party issue a subpoena to compel testimony or

production of documents from any person. The presiding

officer shall be governed by the Federal Rules of Civil

Procedure in making any order for the protection of the

witness or the content of documents produced and shall

order the payment of reasonable fees and expenses as a

condition to requiring testimony of the witness. On

contest, such a subpoena may be enforced by a Federal

district court.

``(C) <<NOTE: Orders.>> Final decision.--As soon as

practicable after receiving the arguments of the

parties, the Administrator shall issue an order stating

the action taken upon each such objection and setting

forth any revision to the regulation or prior order that

the Administrator has found to be warranted. If a

hearing was held under subparagraph (B), such order and

any revision to the regulation or prior order shall,

with respect to questions of fact at issue in the

hearing, be based only on substantial evidence of record

at such hearing, and shall set forth in detail the

findings of facts and the conclusions of law or policy

upon which the order or regulation is based.

``(h) Judicial Review.--

``(1) Petition.--In a case of actual controversy as to the

validity of any regulation issued under subsection (e)(1)(C), or

any order issued under subsection (f)(1)(C) or (g)(2)(C), or any

regulation that is the subject of such an order, any person who

will be adversely affected by such order or regulation may

obtain judicial review by filing in the United States Court of

Appeals for the circuit wherein that person resides or has its

principal place of business, or in the United States Court of

Appeals for the District of Columbia Circuit, within 60 days

after publication of such order or regulation, a petition

praying that the order or regulation be set aside in whole or in

part.

``(2) Record and jurisdiction.--A copy of the petition under

paragraph (1) shall be forthwith transmitted by the clerk of the

court to the Administrator, or any officer designated by the

Administrator for that purpose, and thereupon the Administrator

shall file in the court the record of the proceedings on which

the Administrator based the order or regulation, as provided in

section 2112 of title 28, United States Code. Upon the filing of

such a petition, the court shall have exclusive jurisdiction to

affirm or set aside the order or regulation complained of in

whole or in part. As to orders issued following a public

evidentiary hearing, the findings of the Administrator with

respect to questions of fact shall be sustained only if

[[Page 110 STAT. 1526||

supported by substantial evidence when considered on the record

as a whole.

``(3) Additional evidence.--If a party applies to the court

for leave to adduce additional evidence and shows to the

satisfaction of the court that the additional evidence is

material and that there were reasonable grounds for the failure

to adduce the evidence in the proceeding before the

Administrator, the court may order that the additional evidence

(and evidence in rebuttal thereof) shall be taken before the

Administrator in the manner and upon the terms and conditions

the court deems proper. The Administrator may modify prior

findings as to the facts by reason of the additional evidence so

taken and may modify the order or regulation accordingly. The

Administrator shall file with the court any such modified

finding, order, or regulation.

``(4) Final judgment; supreme court review.--The judgment of

the court affirming or setting aside, in whole or in part, any

regulation or any order and any regulation which is the subject

of such an order shall be final, subject to review by the

Supreme Court of the United States as provided in section 1254

of title 28 of the United States Code. The commencement of

proceedings under this subsection shall not, unless specifically

ordered by the court to the contrary, operate as a stay of a

regulation or order.

``(5) Application.--Any issue as to which review is or was

obtainable under this subsection shall not be the subject of

judicial review under any other provision of law.

``(i) Confidentiality and Use of Data.--

``(1) General rule.--Data and information that are or have

been submitted to the Administrator under this section or

section 409 in support of a tolerance or an exemption from a

tolerance shall be entitled to confidential treatment for

reasons of business confidentiality and to exclusive use and

data compensation to the same extent provided by sections 3 and

10 of the Federal Insecticide, Fungicide, and Rodenticide Act.

``(2) Exceptions.--

``(A) In general.--Data and information that are

entitled to confidential treatment under paragraph (1)

may be disclosed, under such security requirements as

the Administrator may provide by regulation, to--

``(i) employees of the United States

authorized by the Administrator to examine such

data and information in the carrying out of their

official duties under this Act or other Federal

statutes intended to protect the public health; or

``(ii) contractors with the United States

authorized by the Administrator to examine such

data and information in the carrying out of

contracts under this Act or such statutes.

``(B) Congress.--This subsection does not authorize

the withholding of data or information from either House

of Congress or from, to the extent of matter within its

jurisdiction, any committee or subcommittee of such

committee or any joint committee of Congress or any

subcommittee of such joint committee.

``(3) Summaries.--Notwithstanding any provision of this

subsection or other law, the Administrator may publish the

[[Page 110 STAT. 1527||

informative summary required by subsection (d)(2)(A)(i) and may,

in issuing a proposed or final regulation or order under this

section, publish an informative summary of the data relating to

the regulation or order.

``(j) Status of Previously Issued Regulations.--

``(1) Regulations under section 406.--Regulations affecting

pesticide chemical residues in or on raw agricultural

commodities promulgated, in accordance with section 701(e),

under the authority of section 406(a) upon the basis of public

hearings instituted before January 1, 1953, shall be deemed to

be regulations issued under this section and shall be subject to

modification or revocation under subsections (d) and (e), and

shall be subject to review under subsection (q).

``(2) Regulations under section 409.--Regulations that

established tolerances for substances that are pesticide

chemical residues in or on processed food, or that otherwise

stated the conditions under which such pesticide chemicals could

be safely used, and that were issued under section 409 on or

before the date of the enactment of this paragraph, shall be

deemed to be regulations issued under this section and shall be

subject to modification or revocation under subsection (d) or

(e), and shall be subject to review under subsection (q).

``(3) Regulations under section 408.--Regulations that

established tolerances or exemptions under this section that

were issued on or before the date of the enactment of this

paragraph shall remain in effect unless modified or revoked

under subsection (d) or (e), and shall be subject to review

under subsection (q).

``(k) Transitional Provision.--If, on the day before the date of the

enactment of this subsection, a substance that is a pesticide chemical

was, with respect to a particular pesticidal use of the substance and

any resulting pesticide chemical residue in or on a particular food--

``(1) regarded by the Administrator or the Secretary as

generally recognized as safe for use within the meaning of the

provisions of subsection (a) or section 201(s) as then in

effect; or

``(2) regarded by the Secretary as a substance described by

section 201(s)(4);

such a pesticide chemical residue shall be regarded as exempt from the

requirement for a tolerance, as of the date of enactment of this

subsection. <<NOTE: Regulations.>> The Administr ator shall by

regulation indicate which substances are described by this subsection.

Any exemption under this subsection may be modified or revoked as if it

had been issued under subsection (c).

``(l) Harmonization With Action Under Other Laws.--

``(1) Coordination with fifra.--To the extent practicable

and consistent with the review deadlines in subsection (q), in

issuing a final rule under this subsection that suspends or

revokes a tolerance or exemption for a pesticide chemical

residue in or on food, the Administrator shall coordinate such

action with any related necessary action under the Federal

Insecticide, Fungicide, and Rodenticide Act.

``(2) Revocation of tolerance or exemption following

cancellation of associated registrations.--If the Administrator,

acting under the Federal Insecticide, Fungicide, and Rodenticide

Act, cancels the registration of each pesticide that

[[Page 110 STAT. 1528||

contains a particular pesticide chemical and that is labeled for

use on a particular food, or requires that the registration of

each such pesticide be modified to prohibit its use in

connection with the production, storage, or transportation of

such food, due in whole or in part to dietary risks to humans

posed by residues of that pesticide chemical on that food, the

Administrator shall revoke any tolerance or exemption that

allows the presence of the pesticide chemical, or any pesticide

chemical residue that results from its use, in or on that food.

Subsection (e) shall apply to actions taken under this

paragraph. <<NOTE: Effective date.>> A r evocation under this

paragraph shall become effective not later than 180 days after--

``(A) the date by which each such cancellation of a

registration has become effective; or

``(B) the date on which the use of the canceled

pesticide becomes unlawful under the terms of the

cancellation, whichever is later.

``(3) Suspension of tolerance or exemption following

suspension of associated registrations.--

``(A) Suspension.--If the Administrator, acting

under the Federal Insecticide, Fungicide, and

Rodenticide Act, suspends the use of each registered

pesticide that contains a particular pesticide chemical

and that is labeled for use on a particular food, due in

whole or in part to dietary risks to humans posed by

residues of that pesticide chemical on that food, the

Administrator shall suspend any tolerance or exemption

that allows the presence of the pesticide chemical, or

any pesticide chemical residue that results from its

use, in or on that food. <<NOTE: Applicability. >>

Subsection (e) shall apply to actions taken under this

paragraph. <<NOTE: Effective date.>& gt; A suspension under

this paragraph shall become effective not later than 60

days after the date by which each such suspension of use

has become effective.

``(B) Effect of suspension.--The suspension of a

tolerance or exemption under subparagraph (A) shall be

effective as long as the use of each associated

registration of a pesticide is suspended under the

Federal Insecticide, Fungicide, and Rodenticide Act.

While a suspension of a tolerance or exemption is

effective the tolerance or exemption shall not be

considered to be in effect. If the suspension of use of

the pesticide under that Act is terminated, leaving the

registration of the pesticide for such use in effect

under that Act, the Administrator shall rescind any

associated suspension of tolerance or exemption.

``(4) Tolerances for unavoidable residues.--In connection

with action taken under paragraph (2) or (3), or with respect to

pesticides whose registrations were suspended or canceled prior

to the date of the enactment of this paragraph under the Federal

Insecticide, Fungicide, and Rodenticide Act, if the

Administrator determines that a residue of the canceled or

suspended pesticide chemical will unavoidably persist in the

environment and thereby be present in or on a food, the

Administrator may establish a tolerance for the pesticide

chemical residue. In establishing such a tolerance, the

Administrator shall take into account both the factors set forth

in subsection (b)(2) and the unavoidability of the

residue. <<NOTE: Applicability.>> Subsect ion (e) shall apply to

the establishment of such tolerance. <<NOTE: Review.&am p;gt;> The

Adminis

[[Page 110 STAT. 1529||

trator shall review any such tolerance periodically and modify

it as necessary so that it allows no greater level of the

pesticide chemical residue than is unavoidable.

``(5) Pesticide residues resulting from lawful application

of pesticide.--Notwithstanding any other provision of this Act,

if a tolerance or exemption for a pesticide chemical residue in

or on a food has been revoked, suspended, or modified under this

section, an article of that food shall not be deemed unsafe

solely because of the presence of such pesticide chemical

residue in or on such food if it is shown to the satisfaction of

the Secretary that--

``(A) the residue is present as the result of an

application or use of a pesticide at a time and in a

manner that was lawful under the Federal Insecticide,

Fungicide, and Rodenticide Act; and

``(B) the residue does not exceed a level that was

authorized at the time of that application or use to be

present on the food under a tolerance, exemption, food

additive regulation, or other sanction then in effect

under this Act;

unless, in the case of any tolerance or exemption revoked,

suspended, or modified under this subsection or subsection (d)

or (e), the Administrator has issued a determination that

consumption of the legally treated food during the period of its

likely availability in commerce will pose an unreasonable

dietary risk.

``(6) Tolerance for use of pesticides under an emergency

exemption.--If the Administrator grants an exemption under

section 18 of the Federal Insecticide, Fungicide, and

Rodenticide Act (7 U.S.C. 136p) for a pesticide chemical, the

Administrator shall establish a tolerance or exemption from the

requirement for a tolerance for the pesticide chemical residue.

Such a tolerance or exemption from a tolerance shall have an

expiration date. The Administrator may establish such a

tolerance or exemption without providing notice or a period for

comment on the tolerance or exemption. <<NOTE: Regulati ons.>>

The Administrator shall promulgate regulations within 365 days

after the date of the enactment of this paragraph governing the

establishment of tolerances and exemptions under this paragraph.

Such regulations shall be consistent with the safety standard

under subsections (b)(2) and (c)(2) and with section 18 of the

Federal Insecticide, Fungicide, and Rodenticide Act.

``(m) Fees.--

``(1) <<NOTE: Regulations.>> Amount.- -The Administrator

shall by regulation require the payment of such fees as will in

the aggregate, in the judgment of the Administrator, be

sufficient over a reasonable term to provide, equip, and

maintain an adequate service for the performance of the

Administrator's functions under this section. Under the

regulations, the performance of the Administrator's services or

other functions under this section, including--

``(A) the acceptance for filing of a petition

submitted under subsection (d);

``(B) establishing, modifying, leaving in effect, or

revoking a tolerance or establishing, modifying, leaving

in effect, or revoking an exemption from the requirement

for a tolerance under this section;

[[Page 110 STAT. 1530||

``(C) the acceptance for filing of objections under

subsection (g); or

``(D) the certification and filing in court of a

transcript of the proceedings and the record under

subsection (h);

may be conditioned upon the payment of such fees. The

regulations may further provide for waiver or refund of fees in

whole or in part when in the judgment of the Administrator such

a waiver or refund is equitable and not contrary to the purposes

of this subsection.

``(2) Deposit.--All fees collected under paragraph (1) shall

be deposited in the Reregistration and Expedited Processing Fund

created by section 4(k) of the Federal Insecticide, Fungicide,

and Rodenticide Act. Such fees shall be available to the

Administrator, without fiscal year limitation, for the

performance of the Administrator's services or functions as

specified in paragraph (1).

``(n) National Uniformity of Tolerances.--

``(1) Qualifying pesticide chemical residue.--For purposes

of this subsection, the term `qualifying pesticide chemical

residue' means a pesticide chemical residue resulting from the

use, in production, processing, or storage of a food, of a

pesticide chemical that is an active ingredient and that--

``(A) was first approved for such use in a

registration of a pesticide issued under section 3(c)(5)

of the Federal Insecticide, Fungicide, and Rodenticide

Act on or after April 25, 1985, on the basis of data

determined by the Administrator to meet all applicable

requirements for data prescribed by regulations in

effect under that Act on April 25, 1985; or

``(B) was approved for such use in a reregistration

eligibility determination issued under section 4(g) of

that Act on or after the date of enactment of this

subsection.

``(2) Qualifying federal determination.--For purposes of

this subsection, the term `qualifying Federal determination'

means a tolerance or exemption from the requirement for a

tolerance for a qualifying pesticide chemical residue that--

``(A) is issued under this section after the date of

the enactment of this subsection and determined by the

Administrator to meet the standard under subsection

(b)(2)(A) (in the case of a tolerance) or (c)(2) (in the

case of an exemption); or

``(B)(i) pursuant to subsection (j) is remaining in

effect or is deemed to have been issued under this

section, or is regarded under subsection (k) as exempt

from the requirement for a tolerance; and

``(ii) is determined by the Administrator to meet

the standard under subsection (b)(2)(A) (in the case of

a tolerance) or (c)(2) (in the case of an exemption).

``(3) Limitation.--The Administrator may make the

determination described in paragraph (2)(B)(ii) only by issuing

a rule in accordance with the procedure set forth in subsection

(d) or (e) and only if the Administrator issues a proposed rule

and allows a period of not less than 30 days for comment on the

proposed rule. Any such rule shall be reviewable in accordance

with subsections (g) and (h).

``(4) State authority.--Except as provided in paragraphs

(5), (6), and (8) no State or political subdivision may

establish

[[Page 110 STAT. 1531||

or enforce any regulatory limit on a qualifying pesticide

chemical residue in or on any food if a qualifying Federal

determination applies to the presence of such pesticide chemical

residue in or on such food, unless such State regulatory limit

is identical to such qualifying Federal determination. A State

or political subdivision shall be deemed to establish or enforce

a regulatory limit on a pesticide chemical residue in or on a

food if it purports to prohibit or penalize the production,

processing, shipping, or other handling of a food because it

contains a pesticide residue (in excess of a prescribed limit).

``(5) Petition procedure.--

``(A) In general.--Any State may petition the

Administrator for authorization to establish in such

State a regulatory limit on a qualifying pesticide

chemical residue in or on any food that is not identical

to the qualifying Federal determination applicable to

such qualifying pesticide chemical residue.

``(B) Petition requirements.--Any petition under

subparagraph (A) shall--

``(i) satisfy any requirements prescribed, by

rule, by the Administrator; and

``(ii) be supported by scientific data about

the pesticide chemical residue that is the subject

of the petition or about chemically related

pesticide chemical residues, data on the

consumption within such State of food bearing the

pesticide chemical residue, and data on exposure

of humans within such State to the pesticide

chemical residue.

``(C) Authorization.--The Administrator may, by

order, grant the authorization described in subparagraph

(A) if the Administrator determines that the proposed

State regulatory limit--

``(i) is justified by compelling local

conditions; and

``(ii) would not cause any food to be a

violation of Federal law.

``(D) Treatment.--In lieu of any action authorized

under subparagraph (C), the Administrator may treat a

petition under this paragraph as a petition under

subsection (d) to modify or revoke a tolerance or an

exemption. If the Administrator determines to treat a

petition under this paragraph as a petition under

subsection (d), the Administrator shall thereafter act

on the petition pursuant to subsection (d).

``(E) Review.--Any order of the Administrator

granting or denying the authorization described in

subparagraph (A) shall be subject to review in the

manner described in subsections (g) and (h).

``(6) Urgent petition procedure.--Any State petition to the

Administrator pursuant to paragraph (5) that demonstrates that

consumption of a food containing such pesticide residue level

during the period of the food's likely availability in the State

will pose a significant public health threat from acute exposure

shall be considered an urgent petition. If an order by the

Administrator to grant or deny the requested authorization in an

urgent petition is not made within 30 days of receipt of the

petition, the petitioning State may establish and enforce a

temporary regulatory limit on a qualifying pesticide chemical

[[Page 110 STAT. 1532||

residue in or on the food. The temporary regulatory limit shall

be validated or terminated by the Administrator's final order on

the petition.

``(7) Residues from lawful application.--No State or

political subdivision may enforce any regulatory limit on the

level of a pesticide chemical residue that may appear in or on

any food if, at the time of the application of the pesticide

that resulted in such residue, the sale of such food with such

residue level was lawful under this section and under the law of

such State, unless the State demonstrates that consumption of

the food containing such pesticide residue level during the

period of the food's likely availability in the State will pose

an unreasonable dietary risk to the health of persons within

such State.

``(8) Savings.--Nothing in this Act preempts the authority

of any State or political subdivision to require that a food

containing a pesticide chemical residue bear or be the subject

of a warning or other statement relating to the presence of the

pesticide chemical residue in or on such food.

<<NOTE: Publication. Public information.>> `` (o) Consumer Right To

Know.--Not later than 2 years after the date of the enactment of the

Food Quality Protection Act of 1996, and annually thereafter, the

Administrator shall, in consultation with the Secretary of Agriculture

and the Secretary of Health and Human Services, publish in a format

understandable to a lay person, and distribute to large retail grocers

for public display (in a manner determined by the grocer), the following

information, at a minimum:

``(1) A discussion of the risks and benefits of pesticide

chemical residues in or on food purchased by consumers.

``(2) A listing of actions taken under subparagraph (B) of

subsection (b)(2) that may result in pesticide chemical residues

in or on food that present a yearly or lifetime risk above the

risk allowed under subparagraph (A) of such subsection, and the

food on which the pesticide chemicals producing the residues are

used.

``(3) Recommendations to consumers for reducing dietary

exposure to pesticide chemical residues in a manner consistent

with maintaining a healthy diet, including a list of food that

may reasonably substitute for food listed under paragraph (2).

Nothing in this subsection shall prevent retail grocers from

providing additional information.

``(p) Estrogenic substances screening program.--

``(1) Development.--Not later than 2 years after the date of

enactment of this section, the Administrator shall in

consultation with the Secretary of Health and Human Services

develop a screening program, using appropriate validated test

systems and other scientifically relevant information, to

determine whether certain substances may have an effect in

humans that is similar to an effect produced by a naturally

occurring estrogen, or such other endocrine effect as the

Administrator may designate.

``(2) Implementation.--Not later than 3 years after the date

of enactment of this section, after obtaining public comment and

review of the screening program described in paragraph (1) by

the scientific advisory panel established under section 25(d) of

the Federal Insecticide, Fungicide, and Rodenticide Act or the

science advisory board established by

[[Page 110 STAT. 1533||

section 8 of the Environmental Research, Development, and

Demonstration Act of 1978 (42 U.S.C. 4365), the Administrator

shall implement the program.

``(3) Substances.--In carrying out the screening program

described in paragraph (1), the Administrator--

``(A) shall provide for the testing of all pesticide

chemicals; and

``(B) may provide for the testing of any other

substance that may have an effect that is cumulative to

an effect of a pesticide chemical if the Administrator

determines that a substantial population may be exposed

to such substance.

``(4) Exemption.--Notwithstanding paragraph (3), the

Administrator may, by order, exempt from the requirements of

this section a biologic substance or other substance if the

Administrator determines that the substance is anticipated not

to produce any effect in humans similar to an effect produced by

a naturally occurring estrogen.

``(5) Collection of information.--

``(A) In general.--

The <<NOTE: Orders.>> Administrat or shall issue an order

to a registrant of a substance for which testing is

required under this subsection, or to a person who

manufactures or imports a substance for which testing is

required under this subsection, to conduct testing in

accordance with the screening program described in

paragraph (1), and submit information obtained from the

testing to the Administrator, within a reasonable time

period that the Administrator determines is sufficient

for the generation of the information.

``(B) Procedures.--To the extent practicable the

Administrator shall minimize duplicative testing of the

same substance for the same endocrine effect, develop,

as appropriate, procedures for fair and equitable

sharing of test costs, and develop, as necessary,

procedures for handling of confidential business

information.

``(C) Failure of registrants to submit

information.--

``(i) <<NOTE: Notice.>> Suspension.--If a

registrant of a substance referred to in paragraph

(3)(A) fails to comply with an order under

subparagraph (A) of this paragraph, the

Administrator shall issue a notice of intent to

suspend the sale or distribution of the substance

by the registrant. Any suspension proposed under

this paragraph shall become final at the end of

the 30-day period beginning on the date that the

registrant receives the notice of intent to

suspend, unless during that period a person

adversely affected by the notice requests a

hearing or the Administrator determines that the

registrant has complied fully with this paragraph.

``(ii) Hearing.--If a person requests a

hearing under clause (i), the hearing shall be

conducted in accordance with section 554 of title

5, United States Code. The only matter for

resolution at the hearing shall be whether the

registrant has failed to comply with an order

under subparagraph (A) of this paragraph. A

decision by the Administrator after comple

[[Page 110 STAT. 1534||

tion of a hearing shall be considered to be a

final agency action.

``(iii) Termination of suspensions.--The

Administrator shall terminate a suspension under

this subparagraph issued with respect to a

registrant if the Administrator determines that

the registrant has complied fully with this

paragraph.

``(D) Noncompliance by other persons.--Any person

(other than a registrant) who fails to comply with an

order under subparagraph (A) shall be liable for the

same penalties and sanctions as are provided under

section 16 of the Toxic Substances Control Act (15

U.S.C. 2601 and following) in the case of a violation

referred to in that section. Such penalties and

sanctions shall be assessed and imposed in the same

manner as provided in such section 16.

``(6) Agency action.--In the case of any substance that is

found, as a result of testing and evaluation under this section,

to have an endocrine effect on humans, the Administrator shall,

as appropriate, take action under such statutory authority as is

available to the Administrator, including consideration under

other sections of this Act, as is necessary to ensure the

protection of public health.

``(7) Report to congress.--Not later than 4 years after the

date of enactment of this section, the Administrator shall

prepare and submit to Congress a report containing--

``(A) the findings of the Administrator resulting

from the screening program described in paragraph (1);

``(B) recommendations for further testing needed to

evaluate the impact on human health of the substances

tested under the screening program; and

``(C) recommendations for any further actions

(including any action described in paragraph (6)) that

the Administrator determines are appropriate based on

the findings.

``(q) Schedule for Review.--

``(1) In general.--The Administrator shall review tolerances

and exemptions for pesticide chemical residues in effect on the

day before the date of the enactment of the Food Quality

Protection Act of 1996, as expeditiously as practicable,

assuring that--

``(A) 33 percent of such tolerances and exemptions

are reviewed within 3 years of the date of enactment of

such Act;

``(B) 66 percent of such tolerances and exemptions

are reviewed within 6 years of the date of enactment of

such Act; and

``(C) 100 percent of such tolerances and exemptions

are reviewed within 10 years of the date of enactment of

such Act.

<<NOTE: Regulations.>> In conducting a re view of a tolerance or

exemption, the Administrator shall determine whether the

tolerance or exemption meets the requirements of subsections

(b)(2) or (c)(2) and shall, by the deadline for the review of

the tolerance or exemption, issue a regulation under subsection

(d)(4) or (e)(1) to modify or revoke the tolerance or exemption

if the tolerance or exemption does not meet such requirements.

[[Page 110 STAT. 1535||

``(2) Priorities.--In determining priorities for reviewing

tolerances and exemptions under paragraph (1), the Administrator

shall give priority to the review of the tolerances or

exemptions that appear to pose the greatest risk to public

health.

``(3) Publication of schedule.--Not later than 12 months

after the date of the enactment of the Food Quality Protection

Act of 1996, the Administrator shall publish a schedule for

review of tolerances and exemptions established prior to the

date of the enactment of the Food Quality Protection Act of

1996. The determination of priorities for the review of

tolerances and exemptions pursuant to this subsection is not a

rulemaking and shall not be subject to judicial review, except

that failure to take final action pursuant to the schedule

established by this paragraph shall be subject to judicial

review.

``(r) Temporary Tolerance or Exemption.--The Administrator may, upon

the request of any person who has obtained an experimental permit for a

pesticide chemical under the Federal Insecticide, Fungicide, and

Rodenticide Act or upon the Administrator's own initiative, establish a

temporary tolerance or exemption for the pesticide chemical residue for

the uses covered by the permit. Subsections (b)(2), (c)(2), (d), and (e)

shall apply to actions taken under this subsection.

``(s) Savings Clause.--Nothing in this section shall be construed to

amend or modify the provisions of the Toxic Substances Control Act or

the Federal Insecticide, Fungicide, and Rodenticide Act.''.

SEC. 406. AUTHORIZATION FOR INCREASED MONITORING.

For the fiscal years 1997 through 1999, there is authorized to be

appropriated in the aggregate an additional $12,000,000 for increased

monitoring by the Secretary of Health and Human Services of pesticide

residues in imported and domestic food.

SEC. 407. ALTERNATIVE ENFORCEMENT.

Section 303(g) (21 U.S.C. 333(f)) is amended--

(1) by redesignating paragraphs (2), (3), and (4) as

paragraphs (3), (4), and (5), respectively;

(2) by inserting after paragraph (1) the following:

``(2)(A) Any person who introduces into interstate commerce or

delivers for introduction into interstate commerce an article of food

that is adulterated within the meaning of section 402(a)(2)(B) shall be

subject to a civil money penalty of not more than $50,000 in the case of

an individual and $250,000 in the case of any other person for such

introduction or delivery, not to exceed $500,000 for all such violations

adjudicated in a single proceeding.

``(B) This paragraph shall not apply to any person who grew the

article of food that is adulterated. If the Secretary assesses a civil

penalty against any person under this paragraph, the Secretary may not

use the criminal authorities under this section to sanction such person

for the introduction or delivery for introduction into interstate

commerce of the article of food that is adulterated. If the Secretary

assesses a civil penalty against any person under this paragraph, the

Secretary may not use the seizure authorities of section 304 or the

injunction authorities of section 302 with respect to the article of

food that is adulterated.

``(C) In a hearing to assess a civil penalty under this paragraph,

the presiding officer shall have the same authority with regard

[[Page 110 STAT. 1536||

to compelling testimony or production of documents as a presiding

officer has under section 408(g)(2)(B). The third sentence of paragraph

(3)(A) shall not apply to any investigation under this paragraph.'';

(3) in paragraph (3), as so redesignated, by striking

``paragraph (1)'' each place it occurs and inserting ``paragraph

(1) or (2)'';

(4) in paragraph (4), as so redesignated, by striking

``(2)(A)'' and inserting ``(3)(A)''; and

(5) in paragraph (5), as so redesignated, by striking

``(3)'' each place it occurs and inserting ``(4)''.

TITLE V--FEES

SEC. 501. REREGISTRATION FEES.

(a) Section 4(i).--Section 4(i) (7 U.S.C. 136a-1(i)), as amended by

section 232(2), is amended--

(1) in paragraphs (5)(H) and (6), by striking ``1997'' and

inserting ``2001''; and

(2) in paragraph (5)(C), by inserting ``(i)'' after ``(C)''

and by adding at the end the following:

``(ii) in each of the fiscal years 1998, 1999, and

2000, the Administrator is authorized to collect up to

an additional $2,000,000 in a manner consistent with

subsection (k)(5) and the recommendations of the

Inspector General of the Environmental Protection

Agency. The total fees that may be collected under this

clause shall not exceed $6,000,000.''.

(b) Section 4(k)(1).--Section 4(k)(1) (7 U.S.C. 136a-1(k)(1)) is

amended by inserting before the period the following: ``which shall be

known as the Reregistration and Expedited Processing Fund''.

amended to read as follows:

``(2) Source and use.--

``(A) All moneys derived from fees collected by the

Administrator under subsection (i) shall be deposited in

the fund and shall be available to the Administrator,

without fiscal year limitation, specifically to offset

the costs of reregistration and expedited processing of

the applications specified in paragraph (3). Such moneys

derived from fees may not be expended in any fiscal year

to the extent such moneys derived from fees would exceed

money appropriated for use by the Administrator and

expended in such year for such costs of reregistration

and expedited processing of such applications. The

Administrator shall, prior to expending any such moneys

derived from fees--

``(i) <<NOTE: Effective date. Rules a nd

procedures.>> effective October 1, 1997, adopt

specific and cost accounting rules and procedures

as approved by the General Accounting Office and

the Inspector General of the Environmental

Protection Agency to ensure that moneys derived

from fees are allocated solely to the costs of

reregistration and expedited processing of the

applications specified in paragraph (3) in the

same portion as appropriated funds;

[[Page 110 STAT. 1537||

``(ii) prohibit the use of such moneys derived

from fees to pay for any costs other than those

necessary to achieve reregistration and expedited

processing of the applications specified in

paragraph (3); and

``(iii) ensure that personnel and facility

costs associated with the functions to be carried

out under this paragraph do not exceed agency

averages for comparable personnel and facility

costs.

``(B) The Administrator shall also--

``(i) <<NOTE: Review.>> complete the review of

unreviewed reregistration studies required to

support the reregistration eligibility decisions

scheduled for completion in accordance with

subsection (l)(2); and

``(ii) <<NOTE: Contracts.>& ;gt; contract for such

outside assistance as may be necessary for review

of required studies, using a generally accepted

competitive process for the selection of vendors

of such assistance.''.

(d) Section 4(k)(3).--Section 4(k)(3) (7 U.S.C. 136a-1(k)(3)) is

amended--

(1) in subparagraph (A), by striking out ``for each of the

fiscal years 1992, 1993, and 1994, \1/7\th of the maintenance

fees collected, up to 2 million each year'' and inserting in

lieu thereof ``for each of the fiscal years 1997 through 2001,

not more than \1/7\ of the maintenance fees collected in such

fiscal year''; and

(2) by adding a new subparagraph (C) to read as follows:

``(C) So long as the Administrator has not met the

time frames specified in clause (ii) of section

3(c)(3)(B) with respect to any application subject to

section 3(c)(3)(B) that was received prior to the date

of enactment of the Food Quality Protection Act of 1996,

the Administrator shall use the full amount of the fees

specified in subparagraph (A) for the purposes specified

therein. Once all applications subject to section

3(c)(3)(B) that were received prior to such date of

enactment have been acted upon, no limitation shall be

imposed by the preceding sentence of this subparagraph

so long as the Administrator meets the time frames

specified in clause (ii) of section 3(c)(3)(B) on 90

percent of affected applications in a fiscal year.

Should the <<NOTE: Applicability.>&g t; Administrator not

meet such time frames in a fiscal year, the limitations

imposed by the first sentence of this subparagraph shall

apply until all overdue applications subject to section

3(c)(3)(B) have been acted upon.''.

(e) Section 4(k)(5).--Section 4(k)(5) (7 U.S.C. 136a-1(k)(5)) is

amended to read as follows:

``(5) Accounting and performance.--The Administrator shall

take all steps necessary to ensure that expenditures from fees

authorized by subsection (i)(5)(C)(ii) are used only to carry

out the goals established under subsection (l). The

Reregistration and Expedited Processing Fund shall be designated

as an Environmental Protection Agency component for purposes of

section 3515(c) of title 31, United States Code. The annual

audit required under section 3521 of such title of the financial

statements of activities under this Act under section 3515(b) of

such title shall include an audit of the fees collected under

subsection (i)(5)(C) and disbursed, of the amount appropriated

to match such fees, and of the Administrator's attainment

[[Page 110 STAT. 1538||

of performance measures and goals established under subsection

(l). Such an audit shall also include a review of the

reasonableness of the overhead allocation and adequacy of

disclosures of direct and indirect costs associated with

carrying out the reregistration and expedited processing of the

applications specified in paragraph (3), and the basis for and

accuracy of all costs paid with moneys derived from such

fees. <<NOTE: Reports.>> The Inspector Ge neral shall conduct the

annual audit and report the findings and recommendations of such

audit to the Administrator and to the Committees on Agriculture

of the House of Representatives and the Senate. The cost of such

audit shall be paid for out of the fees collected under

subsection (i)(5)(C).''.

(f) Goals.--Subsections (l) and (m) of section 4 (7 U.S.C. 136a-1),

as amended by section 237, are redesignated as subsections (m) and (n)

respectively and the following is inserted after subsection (k):

``(l) <<NOTE: Federal Register, publication.>&gt ; Performance Measures

and Goal.--The Administrator shall establish and publish annually in the

Federal Register performance measures and goals. Such measures and goals

shall include--

``(1) the number of products reregistered, canceled, or

amended, the status of reregistration, the number and type of

data requests under section 3(c)(2)(B) issued to support product

reregistration by active ingredient, the progress in reducing

the number of unreviewed, required reregistration studies, the

aggregate status of tolerances reassessed, and the number of

applications for registration submitted under subsection (k)(3)

that were approved or disapproved;

``(2) the future schedule for reregistrations, including the

projection for such schedules that will be issued under

subsection (g)(2)(A) and (B) in the current fiscal year and the

succeeding fiscal year; and

``(3) the projected year of completion of the

reregistrations under this section.''.

Approved August 3, 1996.

LEGISLATIVE HISTORY--H.R. 1627:

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HOUSE REPORTS: ?No. 104-669, Pt. 1 (Comm. on Agriculture) and Pt. 2

(Comm. on Commerce).

CONGRESSIONAL RECORD, Vol. 142 (1996):

July 23, considered and passed House.

July 24, considered and passed Senate.

WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 32 (1996):

Aug. 3, Presidential remarks and statement.

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