ICR Attachment B - FIFRA section 3 (7 USC 136a)

Attachment B

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) - Sec. 136a.

Registration of pesticides (includes section 3(g) and Registration Review;

and section 3(c) (2)(B) for Data Call-Ins)

From the U.S. Code Online via GPO Access

[wais.access.gpo.gov]

[Laws in effect as of January 3, 2005]

[Document not affected by Public Laws enacted between

January 3, 2005 and April 21, 2006]

[CITE: 7USC136a]

TITLE 7--AGRICULTURE

CHAPTER 6--INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL

SUBCHAPTER II--ENVIRONMENTAL PESTICIDE CONTROL

Sec. 136a. Registration of pesticides

(a) Requirement of registration

Except as provided by this subchapter, no person in any State may

distribute or sell to any person any pesticide that is not registered

under this subchapter. To the extent necessary to prevent unreasonable

adverse effects on the environment, the Administrator may by regulation

limit the distribution, sale, or use in any State of any pesticide that

is not registered under this subchapter and that is not the subject of

an experimental use permit under section 136c of this title or an

emergency exemption under section 136p of this title.

(b) Exemptions

A pesticide which is not registered with the Administrator may be

transferred if--

(1) the transfer is from one registered establishment to another

registered establishment operated by the same producer solely for

packaging at the second establishment or for use as a constituent

part of another pesticide produced at the second establishment; or

(2) the transfer is pursuant to and in accordance with the

requirements of an experimental use permit.

(c) Procedure for registration

(1) Statement required

Each applicant for registration of a pesticide shall file with

the Administrator a statement which includes--

(A) the name and address of the applicant and of any other

person whose name will appear on the labeling;

(B) the name of the pesticide;

(C) a complete copy of the labeling of the pesticide, a

statement of all claims to be made for it, and any directions

for its use;

(D) the complete formula of the pesticide;

(E) a request that the pesticide be classified for general

use or for restricted use, or for both; and

(F) except as otherwise provided in paragraph (2)(D), if

requested by the Administrator, a full description of the tests

made and the results thereof upon which the claims are based, or

alternatively a citation to data that appear in the public

literature or that previously had been submitted to the

Administrator and that the Administrator may consider in

accordance with the following provisions:

(i) With respect to pesticides containing active

ingredients that are initially registered under this

subchapter after September 30, 1978, data submitted to

support the application for the original registration of the

pesticide, or an application for an amendment adding any new

use to the registration and that pertains solely to such new

use, shall not, without the written permission of the

original data submitter, be considered by the Administrator

to support an application by another person during a period

of ten years following the date the Administrator first

registers the pesticide, except that such permission shall

not be required in the case of defensive data.

(ii) The period of exclusive data use provided under

clause (i) shall be extended 1 additional year for each 3

minor uses registered after August 3, 1996, 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.

(iii) Except as otherwise provided in clause (i), with

respect to data submitted after December 31, 1969, by an

applicant or registrant to support an application for

registration, experimental use permit, or amendment adding a

new use to an existing registration, to support or maintain

in effect an existing registration, or for reregistration,

the Administrator may, without the permission of the

original data submitter, consider any such item of data in

support of an application by any other person (hereinafter

in this subparagraph referred to as the ``applicant'')

within the fifteen-year period following the date the data

were originally submitted only if the applicant has made an

offer to compensate the original data submitter and

submitted such offer to the Administrator accompanied by

evidence of delivery to the original data submitter of the

offer. The terms and amount of compensation may be fixed by

agreement between the original data submitter and the

applicant, or, failing such agreement, binding arbitration

under this subparagraph. If, at the end of ninety days after

the date of delivery to the original data submitter of the

offer to compensate, the original data submitter and the

applicant have neither agreed on the amount and terms of

compensation nor on a procedure for reaching an agreement on

the amount and terms of compensation, either person may

initiate binding arbitration proceedings by requesting the

Federal Mediation and Conciliation Service to appoint an

arbitrator from the roster of arbitrators maintained by such

Service. The procedure and rules of the Service shall be

applicable to the selection of such arbitrator and to such

arbitration proceedings, and the findings and determination

of the arbitrator shall be final and conclusive, and no

official or court of the United States shall have power or

jurisdiction to review any such findings and determination,

except for fraud, misrepresentation, or other misconduct by

one of the parties to the arbitration or the arbitrator

where there is a verified complaint with supporting

affidavits attesting to specific instances of such fraud,

misrepresentation, or other misconduct. The parties to the

arbitration shall share equally in the payment of the fee

and expenses of the arbitrator. If the Administrator

determines that an original data submitter has failed to

participate in a procedure for reaching an agreement or in

an arbitration proceeding as required by this subparagraph,

or failed to comply with the terms of an agreement or

arbitration decision concerning compensation under this

subparagraph, the original data submitter shall forfeit the

right to compensation for the use of the data in support of

the application. Notwithstanding any other provision of this

subchapter, if the Administrator determines that an

applicant has failed to participate in a procedure for

reaching an agreement or in an arbitration proceeding as

required by this subparagraph, or failed to comply with the

terms of an agreement or arbitration decision concerning

compensation under this subparagraph, the Administrator

shall deny the application or cancel the registration of the

pesticide in support of which the data were used without

further hearing. Before the Administrator takes action under

either of the preceding two sentences, the Administrator

shall furnish to the affected person, by certified mail,

notice of intent to take action and allow fifteen days from

the date of delivery of the notice for the affected person

to respond. If a registration is denied or canceled under

this subparagraph, the Administrator may make such order as

the Administrator deems appropriate concerning the continued

sale and use of existing stocks of such pesticide.

Registration action by the Administrator shall not be

delayed pending the fixing of compensation.

(iv) After expiration of any period of exclusive use and

any period for which compensation is required for the use of

an item of data under clauses (i), (ii), and (iii), the

Administrator may consider such item of data in support of

an application by any other applicant without the permission

of the original data submitter and without an offer having

been received to compensate the original data submitter for

the use of such item of data.

(v) The period of exclusive use provided under clause

(ii) shall not take effect until 1 year after August 3,

1996, 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 August 3,

1996, by an applicant or registrant to support an amendment

adding a new use to an existing registration that does not

retain any period of exclusive use, if such data relates

solely to a minor use of a pesticide, such data shall not,

without the written permission of the original data

submitter, be considered by the Administrator to support an

application for a minor use by another person during the

period of 10 years following the date of submission of such

data. The applicant or registrant at the time the new minor

use is requested shall notify the Administrator that to the

best of their knowledge the exclusive use period for the

pesticide has expired and that the data pertaining solely to

the minor use of a pesticide is eligible for the provisions

of this paragraph. If the minor use registration which is

supported by data submitted pursuant to this subsection is

voluntarily canceled or if such data are subsequently used

to support a nonminor use, the data shall no longer be

subject to the exclusive use provisions of this clause but

shall instead be considered by the Administrator in

accordance with the provisions of clause (i), as

appropriate.

(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.

(2) Data in support of registration

(A) In general

The Administrator shall publish guidelines specifying the

kinds of information which will be required to support the

registration of a pesticide and shall revise such guidelines

from time to time. If thereafter the Administrator requires any

additional kind of information under subparagraph (B) of this

paragraph, the Administrator shall permit sufficient time for

applicants to obtain such additional information. The

Administrator, in establishing standards for data requirements

for the registration of pesticides with respect to minor uses,

shall make such standards commensurate with the anticipated

extent of use, pattern of use, the public health and

agricultural need for such minor use, and the level and degree

of potential beneficial or adverse effects on man and the

environment. The Administrator shall not require a person to

submit, in relation to a registration or reregistration of a

pesticide for minor agricultural use under this subchapter, any

field residue data from a geographic area where the pesticide

will not be registered for such use. In the development of these

standards, the Administrator shall consider the economic factors

of potential national volume of use, extent of distribution, and

the impact of the cost of meeting the requirements on the

incentives for any potential registrant to undertake the

development of the required data. Except as provided by section

136h of this title, within 30 days after the Administrator

registers a pesticide under this subchapter the Administrator

shall make available to the public the data called for in the

registration statement together with such other scientific

information as the Administrator deems relevant to the

Administrator's decision.

(B) Additional data

(i) If the Administrator determines that additional data are

required to maintain in effect an existing registration of a

pesticide, the Administrator shall notify all existing

registrants of the pesticide to which the determination relates

and provide a list of such registrants to any interested person.

(ii) Each registrant of such pesticide shall provide

evidence within ninety days after receipt of notification that

it is taking appropriate steps to secure the additional data

that are required. Two or more registrants may agree to develop

jointly, or to share in the cost of developing, such data if

they agree and advise the Administrator of their intent within

ninety days after notification. Any registrant who agrees to

share in the cost of producing the data shall be entitled to

examine and rely upon such data in support of maintenance of

such registration. The Administrator shall issue a notice of

intent to suspend the registration of a pesticide in accordance

with the procedures prescribed by clause (iv) if a registrant

fails to comply with this clause.

(iii) If, at the end of sixty days after advising the

Administrator of their agreement to develop jointly, or share in

the cost of developing, data, the registrants have not further

agreed on the terms of the data development arrangement or on a

procedure for reaching such agreement, any of such registrants

may initiate binding arbitration proceedings by requesting the

Federal Mediation and Conciliation Service to appoint an

arbitrator from the roster of arbitrators maintained by such

Service. The procedure and rules of the Service shall be

applicable to the selection of such arbitrator and to such

arbitration proceedings, and the findings and determination of

the arbitrator shall be final and conclusive, and no official or

court of the United States shall have power or jurisdiction to

review any such findings and determination, except for fraud,

misrepresentation, or other misconduct by one of the parties to

the arbitration or the arbitrator where there is a verified

complaint with supporting affidavits attesting to specific

instances of such fraud, misrepresentation, or other misconduct.

All parties to the arbitration shall share equally in the

payment of the fee and expenses of the arbitrator. The

Administrator shall issue a notice of intent to suspend the

registration of a pesticide in accordance with the procedures

prescribed by clause (iv) if a registrant fails to comply with

this clause.

(iv) Notwithstanding any other provision of this subchapter,

if the Administrator determines that a registrant, within the

time required by the Administrator, has failed to take

appropriate steps to secure the data required under this

subparagraph, to participate in a procedure for reaching

agreement concerning a joint data development arrangement under

this subparagraph or in an arbitration proceeding as required by

this subparagraph, or to comply with the terms of an agreement

or arbitration decision concerning a joint data development

arrangement under this subparagraph, the Administrator may issue

a notice of intent to suspend such registrant's registration of

the pesticide for which additional data is required. The

Administrator may include in the notice of intent to suspend

such provisions as the Administrator deems appropriate

concerning the continued sale and use of existing stocks of such

pesticide. Any suspension proposed under this subparagraph shall

become final and effective at the end of thirty days from

receipt by the registrant of the notice of intent to suspend,

unless during that time a request for hearing is made by a

person adversely affected by the notice or the registrant has

satisfied the Administrator that the registrant has complied

fully with the requirements that served as a basis for the

notice of intent to suspend. If a hearing is requested, a

hearing shall be conducted under section 136d(d) of this title.

The only matters for resolution at that hearing shall be whether

the registrant has failed to take the action that served as the

basis for the notice of intent to suspend the registration of

the pesticide for which additional data is required, and whether

the Administrator's determination with respect to the

disposition of existing stocks is consistent with this

subchapter. If a hearing is held, a decision after completion of

such hearing shall be final. Notwithstanding any other provision

of this subchapter, a hearing shall be held and a determination

made within seventy-five days after receipt of a request for

such hearing. Any registration suspended under this subparagraph

shall be reinstated by the Administrator if the Administrator

determines that the registrant has complied fully with the

requirements that served as a basis for the suspension of the

registration.

(v) Any data submitted under this subparagraph shall be

subject to the provisions of paragraph (1)(D). Whenever such

data are submitted jointly by two or more registrants, an agent

shall be agreed on at the time of the joint submission to handle

any subsequent data compensation matters for the joint

submitters of such data.

(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 136a-1 of this

title for the other uses of the pesticide established as of

August 3, 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 136a-1 of this title;

and

(IV) the Administrator has determined that based on

existing data, such extension would not significantly

increase the risk of any unreasonable adverse effect on the

environment. If the Administrator grants an extension under

this clause, the Administrator shall monitor the development

of the data and shall ensure that the registrant is meeting

the schedule for the production of the data. If the

Administrator determines that the registrant is not meeting

or has not met the schedule for the production of such data,

the Administrator may proceed in accordance with clause (iv)

regarding the continued registration of the affected

products with the minor use and shall inform the public of

such action. Notwithstanding the provisions of this clause,

the Administrator may take action to modify or revoke the

extension under this clause if the Administrator determines

that the extension for the minor use may cause an

unreasonable adverse effect on the environment. In such

circumstance, the Administrator shall provide, in writing to

the registrant, a notice revoking the extension of time for

submission of data. Such data shall instead be due in

accordance with the date established by the Administrator

for the submission of the data.

(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 August 3, 1996, for the

submission of data under section 136a-1 of this title for the

supported uses identified pursuant to this clause unless the

Administrator determines that the absence of the data is

significant enough to cause human health or environmental

concerns. On the basis of such determination, the Administrator

may refuse the request for extension by the registrant. Upon

receipt of the request from the registrant, the Administrator

shall publish in the Federal Register a notice of the receipt of

the request and the effective date upon which the uses not being

supported will be voluntarily deleted from the registration

pursuant to section 136d(f)(1) of this title. 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 136d(f)(2)

of this title. Notwithstanding the provisions of this clause,

the Administrator may deny, modify, or revoke the temporary

extension under this subparagraph if the Administrator

determines that the continuation of the minor use may cause an

unreasonable adverse effect on the environment. In the event of

modification or revocation, the Administrator shall provide, in

writing, to the registrant a notice revoking the temporary

extension and establish a new effective date by which the minor

use shall be deleted from the registration.

(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 August 3, 1996, the

Administrator shall develop a process to identify and assist in

alleviating future disparities between Federal and State data

requirements.

(C) Simplified procedures

Within nine months after September 30, 1978, the

Administrator shall, by regulation, prescribe simplified

procedures for the registration of pesticides, which shall

include the provisions of subparagraph (D) of this paragraph.

(D) Exemption

No applicant for registration of a pesticide who proposes to

purchase a registered pesticide from another producer in order

to formulate such purchased pesticide into the pesticide that is

the subject of the application shall be required to--

(i) submit or cite data pertaining to such purchased

product; or

(ii) offer to pay reasonable compensation otherwise

required by paragraph (1)(D) of this subsection for the use

of any such data.

(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.

(3) Application

(A) In general

The Administrator shall review the data after receipt of the

application and shall, as expeditiously as possible, either

register the pesticide in accordance with paragraph (5), or

notify the applicant of the Administrator's determination that

it does not comply with the provisions of the subchapter in

accordance with paragraph (6).

(B) Identical or substantially similar

(i) The Administrator shall, as expeditiously as possible,

review and act on any application received by the Administrator

that--

(I) proposes the initial or amended registration of an

end-use pesticide that, if registered as proposed, would be

identical or substantially similar in composition and

labeling to a currently-registered pesticide identified in

the application, or that would differ in composition and

labeling from such currently-registered pesticide only in

ways that would not significantly increase the risk of

unreasonable adverse effects on the environment; or

(II) proposes an amendment to the registration of a

registered pesticide that does not require scientific review

of data.

(ii) In expediting the review of an application for an

action described in clause (i), the Administrator shall--

(I) within 45 days after receiving the application,

notify the registrant whether or not the application is

complete and, if the application is found to be incomplete,

reject the application;

(II) within 90 days after receiving a complete

application, notify the registrant if the application has

been granted or denied; and

(III) if the application is denied, notify the

registrant in writing of the specific reasons for the denial

of the application.

(C) Minor use registration

(i) The Administrator shall, as expeditiously as possible,

review and act on any complete application--

(I) that proposes the initial registration of a new

pesticide active ingredient if the active ingredient is

proposed to be registered solely for minor uses, or proposes

a registration amendment solely for minor uses to an

existing registration; or

(II) for a registration or a registration amendment that

proposes significant minor uses.

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

(I) the term ``as expeditiously as possible'' means that

the Administrator shall, to the greatest extent practicable,

complete a review and evaluation of all data, submitted with

a complete application, within 12 months after the

submission of the complete application, and the failure of

the Administrator to complete such a review and evaluation

under clause (i) shall not be subject to judicial review;

and

(II) the term ``significant minor uses'' means 3 or more

minor uses proposed for every nonminor use, a minor use that

would, in the judgment of the Administrator, serve as a

replacement for any use which has been canceled in the 5

years preceding the receipt of the application, or a minor

use that in the opinion of the Administrator would avoid the

reissuance of an emergency exemption under section 136p of

this title 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 with the date of receipt by

the registrant of the Administrator's notice of denial.

(4) Notice of application

The Administrator shall publish in the Federal Register,

promptly after receipt of the statement and other data required

pursuant to paragraphs (1) and (2), a notice of each application for

registration of any pesticide if it contains any new active

ingredient or if it would entail a changed use pattern. The notice

shall provide for a period of 30 days in which any Federal agency or

any other interested person may comment.

(5) Approval of registration

The Administrator shall register a pesticide if the

Administrator determines that, when considered with any restrictions

imposed under subsection (d) of this section--

(A) its composition is such as to warrant the proposed

claims for it;

(B) its labeling and other material required to be submitted

comply with the requirements of this subchapter;

(C) it will perform its intended function without

unreasonable adverse effects on the environment; and

(D) when used in accordance with widespread and commonly

recognized practice it will not generally cause unreasonable

adverse effects on the environment.

The Administrator shall not make any lack of essentiality a

criterion for denying registration of any pesticide. Where two

pesticides meet the requirements of this paragraph, one should not

be registered in preference to the other. In considering an

application for the registration of a pesticide, the Administrator

may waive data requirements pertaining to efficacy, in which event

the Administrator may register the pesticide without determining

that the pesticide's composition is such as to warrant proposed

claims of efficacy. If a pesticide is found to be efficacious by any

State under section 136v(c) of this title, a presumption is

established that the Administrator shall waive data requirements

pertaining to efficacy for use of the pesticide in such State.

(6) Denial of registration

If the Administrator determines that the requirements of

paragraph (5) for registration are not satisfied, the Administrator

shall notify the applicant for registration of the Administrator's

determination and of the Administrator's reasons (including the

factual basis) therefor, and that, unless the applicant corrects the

conditions and notifies the Administrator thereof during the 30-day

period beginning with the day after the date on which the applicant

receives the notice, the Administrator may refuse to register the

pesticide. Whenever the Administrator refuses to register a

pesticide, the Administrator shall notify the applicant of the

Administrator's decision and of the Administrator's reasons

(including the factual basis) therefor. The Administrator shall

promptly publish in the Federal Register notice of such denial of

registration and the reasons therefor. Upon such notification, the

applicant for registration or other interested person with the

concurrence of the applicant shall have the same remedies as

provided for in section 136d of this title.

(7) Registration under special circumstances

Notwithstanding the provisions of paragraph (5)--

(A) The Administrator may conditionally register or amend

the registration of a pesticide if the Administrator determines

that (i) the pesticide and proposed use are identical or

substantially similar to any currently registered pesticide and

use thereof, or differ only in ways that would not significantly

increase the risk of unreasonable adverse effects on the

environment, and (ii) approving the registration or amendment in

the manner proposed by the applicant would not significantly

increase the risk of any unreasonable adverse effect on the

environment. An applicant seeking conditional registration or

amended registration under this subparagraph shall submit such

data as would be required to obtain registration of a similar

pesticide under paragraph (5). If the applicant is unable to

submit an item of data because it has not yet been generated,

the Administrator may register or amend the registration of the

pesticide under such conditions as will require the submission

of such data not later than the time such data are required to

be submitted with respect to similar pesticides already

registered under this subchapter.

(B) The Administrator may conditionally amend the

registration of a pesticide to permit additional uses of such

pesticide notwithstanding that data concerning the pesticide may

be insufficient to support an unconditional amendment, if the

Administrator determines that (i) the applicant has submitted

satisfactory data pertaining to the proposed additional use, and

(ii) amending the registration in the manner proposed by the

applicant would not significantly increase the risk of any

unreasonable adverse effect on the environment. Notwithstanding

the foregoing provisions of this subparagraph, no registration

of a pesticide may be amended to permit an additional use of

such pesticide if the Administrator has issued a notice stating

that such pesticide, or any ingredient thereof, meets or exceeds

risk criteria associated in whole or in part with human dietary

exposure enumerated in regulations issued under this subchapter,

and during the pendency of any risk-benefit evaluation initiated

by such notice, if (I) the additional use of such pesticide

involves a major food or feed crop, or (II) the additional use

of such pesticide involves a minor food or feed crop and the

Administrator determines, with the concurrence of the Secretary

of Agriculture, there is available an effective alternative

pesticide that does not meet or exceed such risk criteria. An

applicant seeking amended registration under this subparagraph

shall submit such data as would be required to obtain

registration of a similar pesticide under paragraph (5). If the

applicant is unable to submit an item of data (other than data

pertaining to the proposed additional use) because it has not

yet been generated, the Administrator may amend the registration

under such conditions as will require the submission of such

data not later than the time such data are required to be

submitted with respect to similar pesticides already registered

under this subchapter.

(C) The Administrator may conditionally register a pesticide

containing an active ingredient not contained in any currently

registered pesticide for a period reasonably sufficient for the

generation and submission of required data (which are lacking

because a period reasonably sufficient for generation of the

data has not elapsed since the Administrator first imposed the

data requirement) on the condition that by the end of such

period the Administrator receives such data and the data do not

meet or exceed risk criteria enumerated in regulations issued

under this subchapter, and on such other conditions as the

Administrator may prescribe. A conditional registration under

this subparagraph shall be granted only if the Administrator

determines that use of the pesticide during such period will not

cause any unreasonable adverse effect on the environment, and

that use of the pesticide is in the public interest.

(8) Interim administrative review

Notwithstanding any other provision of this subchapter, the

Administrator may not initiate a public interim administrative

review process to develop a risk-benefit evaluation of the

ingredients of a pesticide or any of its uses prior to initiating a

formal action to cancel, suspend, or deny registration of such

pesticide, required under this subchapter, unless such interim

administrative process is based on a validated test or other

significant evidence raising prudent concerns of unreasonable

adverse risk to man or to the environment. Notice of the definition

of the terms ``validated test'' and ``other significant evidence''

as used herein shall be published by the Administrator in the

Federal Register.

(9) Labeling

(A) Additional statements

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

violation of this subchapter for a registrant to modify the

labeling of an antimicrobial pesticide product to include

relevant information on product efficacy, product composition,

container composition or design, or other characteristics that

do not relate to any pesticidal claim or pesticidal activity.

(B) Requirements

Proposed labeling information under subparagraph (A) shall

not be false or misleading, shall not conflict with or detract

from any statement required by law or the Administrator as a

condition of registration, and shall be substantiated on the

request of the Administrator.

(C) Notification and disapproval

(i) Notification

A registration may be modified under subparagraph (A)

if--

(I) the registrant notifies the Administrator in

writing not later than 60 days prior to distribution or

sale of a product bearing the modified labeling; and

(II) the Administrator does not disapprove of the

modification under clause (ii).

(ii) Disapproval

Not later than 30 days after receipt of a notification

under clause (i), the Administrator may disapprove the

modification by sending the registrant notification in

writing stating that the proposed language is not acceptable

and stating the reasons why the Administrator finds the

proposed modification unacceptable.

(iii) Restriction on sale

A registrant may not sell or distribute a product

bearing a disapproved modification.

(iv) Objection

A registrant may file an objection in writing to a

disapproval under clause (ii) not later than 30 days after

receipt of notification of the disapproval.

(v) Final action

A decision by the Administrator following receipt and

consideration of an objection filed under clause (iv) shall

be considered a final agency action.

(D) Use dilution

The label or labeling required under this subchapter 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.

(10) Expedited registration of pesticides

(A) Not later than 1 year after August 3, 1996, the

Administrator shall, utilizing public comment, develop procedures

and guidelines, and expedite the review of an application for

registration of a pesticide or an amendment to a registration that

satisfies such guidelines.

(B) Any application for registration or an amendment, including

biological and conventional pesticides, will be considered for

expedited review under this paragraph. An application for

registration or an amendment shall qualify for expedited review if

use of the pesticide proposed by the application may reasonably be

expected to accomplish 1 or more of the following:

(i) Reduce the risks of pesticides to human health.

(ii) Reduce the risks of pesticides to nontarget organisms.

(iii) Reduce the potential for contamination of groundwater,

surface water, or other valued environmental resources.

(iv) Broaden the adoption of integrated pest management

strategies, or make such strategies more available or more

effective.

(C) The Administrator, not later than 30 days after receipt of

an application for expedited review, shall notify the applicant

whether the application is complete. If it is found to be

incomplete, the Administrator may either reject the request for

expedited review or ask the applicant for additional information to

satisfy the guidelines developed under subparagraph (A).

(d) Classification of pesticides

(1) Classification for general use, restricted use, or both

(A) As a part of the registration of a pesticide the

Administrator shall classify it as being for general use or for

restricted use. If the Administrator determines that some of the

uses for which the pesticide is registered should be for general use

and that other uses for which it is registered should be for

restricted use, the Administrator shall classify it for both general

use and restricted use. Pesticide uses may be classified by

regulation on the initial classification, and registered pesticides

may be classified prior to reregistration. If some of the uses of

the pesticide are classified for general use, and other uses are

classified for restricted use, the directions relating to its

general uses shall be clearly separated and distinguished from those

directions relating to its restricted uses. The Administrator may

require that its packaging and labeling for restricted uses shall be

clearly distinguishable from its packaging and labeling for general

uses.

(B) If the Administrator determines that the pesticide, when

applied in accordance with its directions for use, warnings and

cautions and for the uses for which it is registered, or for one or

more of such uses, or in accordance with a widespread and commonly

recognized practice, will not generally cause unreasonable adverse

effects on the environment, the Administrator will classify the

pesticide, or the particular use or uses of the pesticide to which

the determination applies, for general use.

(C) If the Administrator determines that the pesticide, when

applied in accordance with its directions for use, warnings and

cautions and for the uses for which it is registered, or for one or

more of such uses, or in accordance with a widespread and commonly

recognized practice, may generally cause, without additional

regulatory restrictions, unreasonable adverse effects on the

environment, including injury to the applicator, the Administrator

shall classify the pesticide, or the particular use or uses to which

the determination applies, for restricted use:

(i) If the Administrator classifies a pesticide, or one or

more uses of such pesticide, for restricted use because of a

determination that the acute dermal or inhalation toxicity of

the pesticide presents a hazard to the applicator or other

persons, the pesticide shall be applied for any use to which the

restricted classification applies only by or under the direct

supervision of a certified applicator.

(ii) If the Administrator classifies a pesticide, or one or

more uses of such pesticide, for restricted use because of a

determination that its use without additional regulatory

restriction may cause unreasonable adverse effects on the

environment, the pesticide shall be applied for any use to which

the determination applies only by or under the direct

supervision of a certified applicator, or subject to such other

restrictions as the Administrator may provide by regulation. Any

such regulation shall be reviewable in the appropriate court of

appeals upon petition of a person adversely affected filed

within 60 days of the publication of the regulation in final

form.

(2) Change in classification

If the Administrator determines that a change in the

classification of any use of a pesticide from general use to

restricted use is necessary to prevent unreasonable adverse effects

on the environment, the Administrator shall notify the registrant of

such pesticide of such determination at least forty-five days before

making the change and shall publish the proposed change in the

Federal Register. The registrant, or other interested person with

the concurrence of the registrant, may seek relief from such

determination under section 136d(b) of this title.

(3) Change in classification from restricted use to general

use

The registrant of any pesticide with one or more uses classified

for restricted use may petition the Administrator to change any such

classification from restricted to general use. Such petition shall

set out the basis for the registrant's position that restricted use

classification is unnecessary because classification of the

pesticide for general use would not cause unreasonable adverse

effects on the environment. The Administrator, within sixty days

after receiving such petition, shall notify the registrant whether

the petition has been granted or denied. Any denial shall contain an

explanation therefor and any such denial shall be subject to

judicial review under section 136n of this title.

(e) Products with same formulation and claims

Products which have the same formulation, are manufactured by the

same person, the labeling of which contains the same claims, and the

labels of which bear a designation identifying the product as the same

pesticide may be registered as a single pesticide; and additional names

and labels shall be added to the registration by supplemental

statements.

(f) Miscellaneous

(1) Effect of change of labeling or formulation

If the labeling or formulation for a pesticide is changed, the

registration shall be amended to reflect such change if the

Administrator determines that the change will not violate any

provision of this subchapter.

(2) Registration not a defense

In no event shall registration of an article be construed as a

defense for the commission of any offense under this subchapter. As

long as no cancellation proceedings are in effect registration of a

pesticide shall be prima facie evidence that the pesticide, its

labeling and packaging comply with the registration provisions of

the subchapter.

(3) Authority to consult other Federal agencies

In connection with consideration of any registration or

application for registration under this section, the Administrator

may consult with any other Federal agency.

(4) Mixtures of nitrogen stabilizers and fertilizer products

Any mixture or other combination of--

(A) 1 or more nitrogen stabilizers registered under this

subchapter; and

(B) 1 or more fertilizer products,

shall not be subject to the provisions of this section or sections

136a-1, 136c, 136e, 136m, and 136o(a)(2) of this title if the

mixture or other combination is accompanied by the labeling required

under this subchapter 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.

(g) Registration review

(1) General rule

(A) Periodic review

The registrations of pesticides are to be periodically

reviewed. The Administrator shall by regulation establish a

procedure for accomplishing the periodic review of

registrations. The goal of these regulations shall be a review

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

shall be canceled as a result of the registration review process

unless the Administrator follows the procedures and substantive

requirements of section 136d of this title.

(B) Limitation

Nothing in this subsection shall prohibit the Administrator

from undertaking any other review of a pesticide pursuant to

this subchapter.

(2) Data

(A) Submission required

The Administrator shall use the authority in subsection

(c)(2)(B) of this section 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) of this section

shall be utilized for and be applicable to any data required for

registration review.

(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 August 3, 1996, for

antimicrobial pesticide product registration applications and

applications for amended registration of antimicrobial pesticide

products, including--

(A) new antimicrobial active ingredients;

(B) new antimicrobial end-use products;

(C) substantially similar or identical antimicrobial

pesticides; and

(D) amendments to antimicrobial pesticide registrations.

(2) Review time period reduction goal

Each reform identified under paragraph (1) shall be designed to

achieve the goal of reducing the review period following submission

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

period of not more than--

(A) 540 days for a new antimicrobial active ingredient

pesticide registration;

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

active ingredient;

(C) 120 days for any other new antimicrobial product;

(D) 90 days for a substantially similar or identical

antimicrobial product;

(E) 90 days for an amendment to an antimicrobial

registration that does not require scientific review of data;

and

(F) 120 days for an amendment to an antimicrobial

registration that requires scientific review of data and that is

not otherwise described in this paragraph.

(3) Implementation

(A) Proposed rulemaking

(i) Issuance

Not later than 270 days after August 3, 1996, the

Administrator shall publish in the Federal Register proposed

regulations to accelerate and improve the review of

antimicrobial pesticide products designed to implement, to

the extent practicable, the goals set forth in paragraph

(2).

(ii) Requirements

Proposed regulations issued under clause (i) shall--

(I) define the various classes of antimicrobial use

patterns, including household, industrial, and

institutional disinfectants and sanitizing pesticides,

preservatives, water treatment, and pulp and paper mill

additives, and other such products intended to

disinfect, sanitize, reduce, or mitigate growth or

development of microbiological organisms, or protect

inanimate objects, industrial processes or systems,

surfaces, water, or other chemical substances from

contamination, fouling, or deterioration caused by

bacteria, viruses, fungi, protozoa, algae, or slime;

(II) differentiate the types of review undertaken

for antimicrobial pesticides;

(III) conform the degree and type of review to the

risks and benefits presented by antimicrobial pesticides

and the function of review under this subchapter,

considering the use patterns of the product, toxicity,

expected exposure, and product type;

(IV) ensure that the registration process is

sufficient to maintain antimicrobial pesticide efficacy

and that antimicrobial pesticide products continue to

meet product performance standards and effectiveness

levels for each type of label claim made; and

(V) implement effective and reliable deadlines for

process management.

(iii) Comments

In developing the proposed regulations, the

Administrator shall solicit the views from registrants and

other affected parties to maximize the effectiveness of the

rule development process.

(B) Final regulations

(i) Issuance

The Administrator shall issue final regulations not

later than 240 days after the close of the comment period

for the proposed regulations.

(ii) Failure to meet goal

If a goal described in paragraph (2) is not met by the

final regulations, the Administrator shall identify the

goal, explain why the goal was not attained, describe the

element of the regulations included instead, and identify

future steps to attain the goal.

(iii) Requirements

In issuing final regulations, the Administrator shall--

(I) consider the establishment of a certification

process for regulatory actions involving risks that can

be responsibly managed, consistent with the degree of

risk, in the most cost-efficient manner;

(II) consider the establishment of a certification

process by approved laboratories as an adjunct to the

review process;

(III) use all appropriate and cost-effective review

mechanisms, including--

(aa) expanded use of notification and non-

notification procedures;

(bb) revised procedures for application review;

and

(cc) allocation of appropriate resources to

ensure streamlined management of antimicrobial

pesticide registrations; and

(IV) clarify criteria for determination of the

completeness of an application.

(C) Expedited review

This subsection does not affect the requirements or extend

the deadlines or review periods contained in subsection (c)(3)

of this section.

(D) Alternative review periods

If the final regulations to carry out this paragraph are not

effective 630 days after August 3, 1996, 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) 120 days for an amendment to an antimicrobial

registration that requires scientific review of data and

that is not otherwise described in this subparagraph.

(E) Wood preservatives

An application for the registration, or for an amendment to

the registration, of a wood preservative product for which a

claim of pesticidal activity listed in section 136(mm) of this

title is made (regardless of any other pesticidal claim that is

made with respect to the product) shall be reviewed by the

Administrator within the same period as that established under

this paragraph for an antimicrobial pesticide product

application, consistent with the degree of risk posed by the use

of the wood preservative product, if the application requires

the applicant to satisfy the same data requirements as are

required to support an application for a wood preservative

product that is an antimicrobial pesticide.

(F) Notification

(i) In general

Subject to clause (iii), the Administrator shall notify

an applicant whether an application has been granted or

denied not later than the final day of the appropriate

review period under this paragraph, unless the applicant and

the Administrator agree to a later date.

(ii) Final decision

If the Administrator fails to notify an applicant within

the period of time required under clause (i), the failure

shall be considered an agency action unlawfully withheld or

unreasonably delayed for purposes of judicial review under

chapter 7 of title 5.

(iii) Exemption

This subparagraph does not apply to an application for

an antimicrobial pesticide that is filed under subsection

(c)(3)(B) of this section prior to 90 days after August 3,

1996.

(iv) Limitation

Notwithstanding clause (ii), the failure of the

Administrator to notify an applicant for an amendment to a

registration for an antimicrobial pesticide shall not be

judicially reviewable in a Federal or State court if the

amendment requires scientific review of data within--

(I) the time period specified in subparagraph

(D)(vi), in the absence of a final regulation under

subparagraph (B); or

(II) the time period specified in paragraph (2)(F),

if adopted in a final regulation under subparagraph (B).

(4) Annual report

(A) Submission

Beginning on August 3, 1996, 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.

(June 25, 1947, ch. 125, Sec. 3, as added Pub. L. 92-516, Sec. 2, Oct.

21, 1972, 86 Stat. 979; amended Pub. L. 94-140, Sec. 12, Nov. 28, 1975,

89 Stat. 755; Pub. L. 95-396, Secs. 2(a), 3-8, Sept. 30, 1978, 92 Stat.

820, 824-827; Pub. L. 100-532, title I, Secs. 102(b), 103, title VI,

Sec. 601(b)(1), title VIII, Sec. 801(b), Oct. 25, 1988, 102 Stat. 2667,

2677, 2680; Pub. L. 101-624, title XIV, Sec. 1492, Nov. 28, 1990, 104

Stat. 3628; Pub. L. 102-237, title X, Sec. 1006(a)(3), (b)(1), (2), (c),

Dec. 13, 1991, 105 Stat. 1894-1896; Pub. L. 104-170, title I,

Secs. 105(b), 106(b), title II, Secs. 210(b), (c)(1), (d), (e), (f)(2),

222-224, 231, 250, Aug. 3, 1996, 110 Stat. 1491, 1494-1497, 1499, 1503,

1504, 1508, 1510; Pub. L. 108-199, div. G, title V, Sec. 501(b), Jan.

23, 2004, 118 Stat. 419.)

Prior Provisions

A prior section 3 of act June 25, 1947, was classified to section

135a of this title prior to amendment of act June 25, 1947, by Pub. L.

92-516.

Amendments

2004--Subsec. (h)(2)(F). Pub. L. 108-199, Sec. 501(b)(1),

substituted ``120 days'' for ``90 to 180 days''.

Subsec. (h)(3)(D)(vi). Pub. L. 108-199, Sec. 501(b)(2)(A),

substituted ``120 days'' for ``240 days''.

Subsec. (h)(3)(F)(iv). Pub. L. 108-199, Sec. 501(b)(2)(B), added cl.

(iv).

1996--Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104-170, Sec. 210(b),

added cls. (ii), (v), and (vi), redesignated former cls. (ii) and (iii)

as (iii) and (iv), respectively, and in cl. (iv) substituted ``(i),

(ii), and (iii)'' for ``(i) and (ii)''.

Subsec. (c)(1)(G). Pub. L. 104-170, Sec. 250(1), added subpar. (G).

Subsec. (c)(2)(A). Pub. L. 104-170, Secs. 210(d)(1), 231, inserted

heading, inserted ``the public health and agricultural need for such

minor use,'' after ``pattern of use,'', and substituted ``potential

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

``potential exposure of man and the environment to the pesticide''.

Subsec. (c)(2)(B). Pub. L. 104-170, Sec. 210(d)(2), inserted

heading.

Subsec. (c)(2)(B)(vi). Pub. L. 104-170, Sec. 210(c)(1), added cl.

(vi).

Subsec. (c)(2)(B)(vii). Pub. L. 104-170, Sec. 210(f)(2), added cl.

(vii).

Subsec. (c)(2)(B)(viii). Pub. L. 104-170, Sec. 222, added cl.

(viii).

Subsec. (c)(2)(C). Pub. L. 104-170, Sec. 210(d)(3), inserted

heading.

Subsec. (c)(2)(E). Pub. L. 104-170, Sec. 210(d)(4), added subpar.

(E).

Subsec. (c)(3)(A), (B). Pub. L. 104-170, Sec. 210(e)(1), (2),

inserted headings.

Subsec. (c)(3)(C), (D). Pub. L. 104-170, Sec. 210(e)(3), added

subpars. (C) and (D).

Subsec. (c)(9). Pub. L. 104-170, Sec. 223, added par. (9).

Subsec. (c)(10). Pub. L. 104-170, Sec. 250(2), added par. (10).

Subsec. (f)(4). Pub. L. 104-170, Sec. 105(b), added par. (4).

Subsec. (g). Pub. L. 104-170, Sec. 106(b), added subsec. (g).

Subsec. (h). Pub. L. 104-170, Sec. 224, added subsec. (h).

1991--Subsec. (c)(1)(D). Pub. L. 102-237, Sec. 1006(a)(3)(B), (C),

added subpar. (D) and redesignated former subpar. (D) as (F).

Subsec. (c)(1)(E). Pub. L. 102-237, Sec. 1006(a)(3)(A), (C), added

subpar. (E) and struck out former subpar. (E) which read as follows:

``the complete formula of the pesticide; and''.

Subsec. (c)(1)(F). Pub. L. 102-237, Sec. 1006(a)(3)(A), (B), (D),

redesignated former subpar. (D) as (F), in cl. (i) substituted ``With''

for ``with'' and a period for semicolon at end, in cl. (ii) substituted

``Except'' for ``except'' and a period for semicolon at end, in cl.

(iii) substituted ``After'' for ``after'' and a period for semicolon at

end, and struck out former subpar. (F) which read as follows: ``a

request that the pesticide be classified for general use, for restricted

use, or for both.''

Subsec. (c)(2)(A). Pub. L. 102-237, Sec. 1006(b)(1), (2),

substituted ``the Administrator'' for ``he'' before ``requires'',

``shall permit'', ``shall make'', and ``deems'', and substituted ``the

Administrator's'' for ``his''.

Subsec. (c)(2)(D). Pub. L. 102-237, Sec. 1006(c), clarified

amendment made by Pub. L. 100-532, Sec. 102(b)(2)(A). See 1988 Amendment

note below.

Subsec. (c)(3)(A). Pub. L. 102-237, Sec. 1006(b)(2), substituted

``the Administrator's'' for ``his''.

Subsec. (c)(5). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the

Administrator'' for ``he'' before ``determines''.

Subsec. (c)(6). Pub. L. 102-237, Sec. 1006(b)(1), (2), substituted

``the Administrator'' for ``he'' before ``shall notify'' in two places

and ``the Administrator's'' for ``his'' in four places.

Subsec. (d)(1). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the

Administrator'' for ``he'' before ``shall classify it for both'' in

subpar. (A), before ``will classify'' in subpar. (B), and before ``shall

classify'' in subpar. (C).

Subsec. (d)(2). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the

Administrator'' for ``he'' before ``shall notify''.

1990--Subsec. (c)(2)(A). Pub. L. 101-624 inserted after third

sentence ``The Administrator shall not require a person to submit, in

relation to a registration or reregistration of a pesticide for minor

agricultural use under this subchapter, any field residue data from a

geographic area where the pesticide will not be registered for such

use.''

1988--Subsec. (a). Pub. L. 100-532, Sec. 601(b)(1), substituted

``Requirement of registration'' for ``Requirement'' in heading and

amended text generally. Prior to amendment, text read as follows:

``Except as otherwise provided by this subchapter, no person in any

State may distribute, sell, offer for sale, hold for sale, ship, deliver

for shipment, or receive and (having so received) deliver or offer to

deliver, to any person any pesticide which is not registered with the

Administrator.''

Subsec. (c)(1)(D). Pub. L. 100-532, Sec. 801(b)(1)-(4), in

introductory provisions, substituted ``paragraph (2)(D)'' for

``subsection (c)(2)(D) of this section'', in cl. (i), substituted ``(i)

with'' for ``(i) With'' and ``, except that'' for ``: Provided, That'',

in cl. (ii), substituted ``clause (i)'' for ``subparagraph (D)(i) of

this paragraph'', and in cl. (iii), substituted ``clauses (i) and (ii)''

for ``subparagraphs (D)(i) and (D)(ii) of this paragraph''.

Subsec. (c)(2)(A). Pub. L. 100-532, Sec. 801(b)(5)(A), (B),

substituted ``(2) Data in support of registration.--

``(A) The''

for ``(2)(A) Data in support of registration.--The'', and directed that

subpar. (A) be aligned with left margin of subsec. (d)(1)(A) of this

section.

Subsec. (c)(2)(B). Pub. L. 100-532, Secs. 102(b)(1), 801(b)(5)(C)-

(F), substituted ``(B)(i) If'' for ``(B) Additional data to support

existing registration.--(i) If'', directed that cls. (ii) to (v) be

aligned with left margin of subpar. (A), in cls. (ii) and (iii),

inserted ``The Administrator shall issue a notice of intent to suspend

the registration of a pesticide in accordance with the procedures

prescribed by clause (iv) if a registrant fails to comply with this

clause.'', in cl. (iv), substituted ``title. The only'' for ``title:

Provided, that the only'', and in cl. (v), substituted ``paragraph

(1)(D)'' for ``subsection (c)(1)(D) of this section''.

Subsec. (c)(2)(C). Pub. L. 100-532, Sec. 801(b)(5)(G), (H), struck

out ``Simplified procedures'' after ``(C)'' and directed that text be

aligned with left margin of subpar. (A).

Subsec. (c)(2)(D). Pub. L. 100-532, Sec. 102(b)(2)(A), and Pub. L.

102-237, Sec. 1006(c), substituted ``the pesticide that is the subject

of the application'' for ``an end-use product''.

Subsec. (c)(2)(D)(i). Pub. L. 100-532, Sec. 102(b)(2)(B), struck out

``the safety of'' after ``data pertaining to''.

Subsec. (c)(3). Pub. L. 100-532, Sec. 103, substituted ``(A) The

Administrator'' for ``The Administrator'' and added subpar. (B).

Subsec. (c)(7). Pub. L. 100-532, Sec. 801(b)(6), in introductory

provisions, substituted ``paragraph (5)'' for ``subsection (c)(5) of

this section'', in subpars. (A) and (B), substituted ``paragraph (5).

If'' for ``subsection (c)(5) of this section: Provided, That, if'', and

in subpar. (C), substituted ``prescribe. A'' for ``prescribe: Provided,

that a''.

Subsec. (d)(1)(A). Pub. L. 100-532, Sec. 801(b)(7), substituted

``restricted use. If'' for ``restricted use, provided that if'' and

``restricted uses. The Administrator'' for ``restricted uses: Provided,

however, That the Administrator''.

Subsec. (f)(2). Pub. L. 100-532, Sec. 801(b)(8), substituted ``this

subchapter. As'' for ``this subchapter: Provided, That as''.

Subsec. (g). Pub. L. 100-532, Sec. 801(b)(9), struck out subsec. (g)

which read as follows: ``The Administrator shall accomplish the

reregistration of all pesticides in the most expeditious manner

practicable: Provided, That, to the extent appropriate, any pesticide

that results in a postharvest residue in or on food or feed crops shall

be given priority in the reregistration process.''

1978--Subsec. (c)(1)(D). Pub. L. 95-396, Sec. 2(a)(1), added subpar.

(D), and struck out provisions which required the applicant for

registration of a pesticide to file with the Administrator a statement

containing ``if requested by the Administrator, a full description of

the tests made and the results thereof upon which the claims are based,

except that data submitted on or after January 1, 1970, in support of an

application shall not, without permission of the applicant, be

considered by the Administrator in support of any other application for

registration unless such other applicant shall have first offered to pay

reasonable compensation for producing the test data to be relied upon

and such data is not protected from disclosure by section 136h(b) of

this title. This provision with regard to compensation for producing the

test data to be relied upon shall apply with respect to all applications

for registration or reregistration submitted on or after October 21,

1972. If the parties cannot agree on the amount and method of payment,

the Administrator shall make such determination and may fix such other

terms and conditions as may be reasonable under the circumstances. The

Administrator's determination shall be made on the record after notice

and opportunity for hearing. If either party does not agree with said

determination, he may, within thirty days, take an appeal to the Federal

district court for the district in which he resides with respect to

either the amount of the payment or the terms of payment, or both.

Registration shall not be delayed pending the determination of

reasonable compensation between the applicants, by the Administrator or

by the court.''.

Subsec. (c)(2). Pub. L. 95-396, Secs. 2(a)(2)(A)-(D), 3, 4,

designated existing provisions as subpar. (A), inserted in second

sentence ``under subparagraph (B) of this paragraph'' after ``kind of

information'', struck out from introductory text of third sentence

``subsection (c)(1)(D) of this section and'' after ``Except as provided

by'', and inserted provisions relating to establishment of standards for

data requirements for registration of pesticides with respect to minor

uses and consideration of economic factors in development of standards

and cost of development, and added subpars. (B) to (D).

Subsec. (c)(5). Pub. L. 95-396, Sec. 5, provided for waiver of data

requirements pertaining to efficacy.

Subsec. (c)(7), (8). Pub. L. 95-396, Sec. 6, added pars. (7) and

(8).

Subsec. (d)(1)(A). Pub. L. 95-396, Sec. 7(1), authorized

classification of pesticide uses by regulation on the initial

classification and registered pesticides prior to reregistration.

Subsec. (d)(2). Pub. L. 95-396, Sec. 7(2), substituted ``forty-five

days'' for ``30 days''.

Subsec. (d)(3). Pub. L. 95-396, Sec. 7(3), added par. (3).

Subsec. (g). Pub. L. 95-396, Sec. 8, added subsec. (g).

1975--Subsec. (c)(1)(D). Pub. L. 94-140 inserted exception relating

to test data submitted on or after January 1, 1970, in support of

application, inserted provision that compensation for producing test

data shall apply to all applications submitted on or after October 21,

1972, and provision relating to delay of registration pending

determination of reasonable compensation, struck out requirement that

payment determined by court not be less than amount determined by

Administrator, and substituted ``If either party'' for ``If the owner of

the test data''.

Effective Date of 2004 Amendment

Pub. L. 108-199, div. G, title V, Sec. 501(h), Jan. 23, 2004, 118

Stat. 434, provided that: ``Except as otherwise provided in this section

[enacting section 136w-8 of this title, amending this section and

sections 136a-1, 136x, and 136y of this title, and enacting provisions

set out as notes under sections 136 of this title and section 346a of

Title 21, Food and Drugs] and the amendments made by this section, this

section and the amendments made by this section take effect on the date

that is 60 days after the date of enactment of this Act [Jan. 23,

2004].''

Effective Date of 1988 Amendment

Amendment by Pub. L. 100-532 effective on expiration of 60 days

after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a

note under section 136 of this title.

Effective Date of 1978 Amendment

Section 2(b) of Pub. L. 95-396 provided that: ``The amendment to

section 3(c)(1)(D) of the Federal Insecticide, Fungicide, and

Rodenticide Act [subsec. (c)(1)(D) of this section] made by [subsec.

(a)(1) of] this section shall apply with respect to all applications for

registration approved after the date of enactment of this Act [Sept. 30,

1978].''

Effective Date

For effective date of section, see section 4 of Pub. L. 92-516, set

out as a note under section 136 of this title.

Biological Pesticide Handling Study

Section 1498 of Pub. L. 101-624 provided that:

``(a) Study.--Not later than September 30, 1992, the National

Academy of Sciences shall conduct a study of the biological control

programs and registration procedures utilized by the Food and Drug

Administration, the Animal and Plant Health Inspection Service, and the

Environmental Protection Agency.

``(b) Development of Procedures.--Not later than 1 year after the

completion of the study under subsection (a), the agencies and offices

described in such subsection shall develop and implement a common

process for reviewing and approving biological control applications that

are submitted to such agencies and offices that shall be based on the

study conducted under such subsection and the recommendation of the

National Academy of Sciences, and other public comment.''

Education, Study, and Report

Pub. L. 100-478, title I, Sec. 1010, Oct. 7, 1988, 102 Stat. 2313,

provided that:

``(a) Education.--The Administrator of the Environmental Protection

Agency in cooperation with the Secretary of Agriculture and the

Secretary of the Interior, promptly upon enactment of this Act [Oct. 7,

1988], shall conduct a program to inform and educate fully persons

engaged in agricultural food and fiber commodity production of any

proposed pesticide labeling program or requirements that may be imposed

by the Administrator in compliance with the Endangered Species Act (16

U.S.C. 1531 et seq.). The Administrator also shall provide the public

with notice of, and opportunity for comment on, the elements of any such

program and requirements based on compliance with the Endangered Species

Act, including (but not limited to) an identification of any pesticides

affected by the program; an explanation of the restriction or

prohibition on the user or applicator of any such pesticide; an

identification of those geographic areas affected by any pesticide

restriction or prohibition; an identification of the effects of any

restricted or prohibited pesticide on endangered or threatened species;

and an identification of the endangered or threatened species along with

a general description of the geographic areas in which such species are

located wherein the application of a pesticide will be restricted,

prohibited, or its use otherwise limited, unless the Secretary of the

Interior determines that the disclosure of such information may create a

substantial risk of harm to such species or its habitat.

``(b) Study.--The Administrator of the Environmental Protection

Agency, jointly with the Secretary of Agriculture and the Secretary of

the Interior, shall conduct a study to identify reasonable and prudent

means available to the Administrator to implement the endangered species

pesticides labeling program which would comply with the Endangered

Species Act of 1973, as amended, and which would allow persons to

continue production of agricultural food and fiber commodities. Such

study shall include investigation by the Administrator of the best

available methods to develop maps and the best available alternatives to

mapping as means of identifying those circumstances in which use of

pesticides may be restricted; identification of alternatives to

prohibitions on pesticide use, including, but not limited to,

alternative pesticides and application methods and other agricultural

practices which can be used in lieu of any pesticides whose use may be

restricted by the labeling program; examination of methods to improve

coordination among the Environmental Protection Agency, Department of

Agriculture, and Department of the Interior in administration of the

labeling program; and analysis of the means of implementing the

endangered species pesticides labeling program or alternatives to such a

program, if any, to promote the conservation of endangered or threatened

species and to minimize the impacts to persons engaged in agricultural

food and fiber commodity production and other affected pesticide users

and applicators.

``(c) Report.--The Administrator of the Environmental Protection

Agency in cooperation with the Secretary of Agriculture and the

Secretary of the Interior shall submit a report within one year of the

date of enactment of this Act [Oct. 7, 1988], presenting the results of

the study conducted pursuant to subsection (b) of this section to the

Committee on Merchant Marine and Fisheries and the Committee on

Agriculture of the United States House of Representatives, and the

Committee on Environment and Public Works and the Committee on

Agriculture, Nutrition, and Forestry of the United States Senate.''