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NB: This unofficial compilation of the U.S. Code is current as of Jan. 4, 2012 (see http://www.law.cornell.edu/uscode/uscprint.html).

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TITLE 7 - AGRICULTURE

CHAPTER 6 - INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL

SUBCHAPTER II - ENVIRONMENTAL PESTICIDE CONTROL

§ 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
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NB: This unofficial compilation of the U.S. Code is current as of Jan. 4, 2012 (see http://www.law.cornell.edu/uscode/uscprint.html).

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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
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NB: This unofficial compilation of the U.S. Code is current as of Jan. 4, 2012 (see http://www.law.cornell.edu/uscode/uscprint.html).

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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
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NB: This unofficial compilation of the U.S. Code is current as of Jan. 4, 2012 (see http://www.law.cornell.edu/uscode/uscprint.html).

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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
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NB: This unofficial compilation of the U.S. Code is current as of Jan. 4, 2012 (see http://www.law.cornell.edu/uscode/uscprint.html).

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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
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NB: This unofficial compilation of the U.S. Code is current as of Jan. 4, 2012 (see http://www.law.cornell.edu/uscode/uscprint.html).

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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—
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(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) review the application in accordance with section 136w–8 (f)(4)(B) of this title

and, if the application is found to be incomplete, reject the application;

(II) not later than the applicable decision review time established pursuant to section

136w–8 (f)(4)(B) of this title, or, if no review time is established, not later than 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
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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)—
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(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
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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.
7 USC 136a

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(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.
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(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
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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

(i) In general

The registrations of pesticides are to be periodically reviewed.

(ii) Regulations

In accordance with this subparagraph, the Administrator shall by regulation establish a

procedure for accomplishing the periodic review of registrations.

(iii) Initial registration review

The Administrator shall complete the registration review of each pesticide or pesticide

case, which may be composed of 1 or more active ingredients and the products associated

with the active ingredients, not later than the later of—

(I) October 1, 2022; or

(II) the date that is 15 years after the date on which the first pesticide containing a

new active ingredient is registered.

(iv) Subsequent registration review

Not later than 15 years after the date on which the initial registration review is completed

under clause (iii) and each 15 years thereafter, the Administrator shall complete a

subsequent registration review for each pesticide or pesticide case.

(v) Cancellation

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) Docketing

(i) In general

Subject to clause (ii), after meeting with 1 or more individuals that are not government

employees to discuss matters relating to a registration review, the Administrator shall

place in the docket minutes of the meeting, a list of attendees, and any documents

exchanged at the meeting, not later than the earlier of—

(I) the date that is 45 days after the meeting; or

(II) the date of issuance of the registration review decision.

(ii) Protected information

The Administrator shall identify, but not include in the docket, any confidential business

information the disclosure of which is prohibited by section 136h of this title.

(C) 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
7 USC 136a

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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;
7 USC 136a

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(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.
7 USC 136a

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(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, § 3, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 979; amended Pub.

L. 94–140, § 12, Nov. 28, 1975, 89 Stat. 755; Pub. L. 95–396, §§ 2(a), 3–8, Sept. 30, 1978, 92 Stat. 820,

824–827; Pub. L. 100–532, title I, §§ 102(b), 103, title VI, § 601(b)(1), title VIII, § 801(b), Oct. 25, 1988,

102 Stat. 2667, 2677, 2680; Pub. L. 101–624, title XIV, § 1492, Nov. 28, 1990, 104 Stat. 3628; Pub. L.
7 USC 136a

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102–237, title X, § 1006(a)(3), (b)(1), (2), (c), Dec. 13, 1991, 105 Stat. 1894–1896; Pub. L. 104–170,

title I, §§ 105(b), 106 (b), title II, §§ 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, § 501(b), Jan. 23,

2004, 118 Stat. 419; Pub. L. 110–94, §§ 2, 3, Oct. 9, 2007, 121 Stat. 1000.)

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

2007—Subsec. (c)(3)(B)(ii)(I). Pub. L. 110–94, § 2(1), substituted “review the application in accordance with section

136w–8 (f)(4)(B) of this title and,” for “within 45 days after receiving the application, notify the registrant whether

or not the application is complete and,”.

Subsec. (c)(3)(B)(ii)(II). Pub. L. 110–94, § 2(2), substituted “not later than the applicable decision review time

established pursuant to section 136w–8 (f)(4)(B) of this title, or, if no review time is established, not later than” for

“within”.

Subsec. (g)(1)(A). Pub. L. 110–94, § 3(1), designated first sentence as cl. (i) and inserted heading, designated second

sentence as cl. (ii), inserted heading, and substituted “In accordance with this subparagraph, the Administrator” for

“The Administrator”, added cls. (iii) and (iv), designated fourth sentence as cl. (v) and inserted heading, and struck

out third sentence which read as follows: “The goal of these regulations shall be a review of a pesticide’s registration

every 15 years.”

Subsec. (g)(1)(B), (C). Pub. L. 110–94, § 3(2), (3), added subpar. (B) and redesignated former subpar. (B) as (C).

2004—Subsec. (h)(2)(F). Pub. L. 108–199, § 501(b)(1), substituted “120 days” for “90 to 180 days”.

Subsec. (h)(3)(D)(vi). Pub. L. 108–199, § 501(b)(2)(A), substituted “120 days” for “240 days”.

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

1996—Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104–170, § 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, § 250(1), added subpar. (G).

Subsec. (c)(2)(A). Pub. L. 104–170, §§ 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, § 210(d)(2), inserted heading.

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

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

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

Subsec. (c)(2)(C). Pub. L. 104–170, § 210(d)(3), inserted heading.

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

Subsec. (c)(3)(A), (B). Pub. L. 104–170, § 210(e)(1), (2), inserted headings.

Subsec. (c)(3)(C), (D). Pub. L. 104–170, § 210(e)(3), added subpars. (C) and (D).

Subsec. (c)(9). Pub. L. 104–170, § 223, added par. (9).

Subsec. (c)(10). Pub. L. 104–170, § 250(2), added par. (10).

Subsec. (f)(4). Pub. L. 104–170, § 105(b), added par. (4).

Subsec. (g). Pub. L. 104–170, § 106(b), added subsec. (g).

Subsec. (h). Pub. L. 104–170, § 224, added subsec. (h).

1991—Subsec. (c)(1)(D). Pub. L. 102–237, § 1006(a)(3)(B), (C), added subpar. (D) and redesignated former subpar.

(D) as (F).
7 USC 136a

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Subsec. (c)(1)(E). Pub. L. 102–237, § 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, § 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, § 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, § 1006(c), clarified amendment made by Pub. L. 100–532, § 102(b)(2)(A). See

1988 Amendment note below.

Subsec. (c)(3)(A). Pub. L. 102–237, § 1006(b)(2), substituted “the Administrator’s” for “his”.

Subsec. (c)(5). Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “determines”.

Subsec. (c)(6). Pub. L. 102–237, § 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, § 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, § 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, § 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, § 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, § 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, §§ 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, § 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, § 102(b)(2)(A), and Pub. L. 102–237, § 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, § 102(b)(2)(B), struck out “the safety of” after “data pertaining to”.

Subsec. (c)(3). Pub. L. 100–532, § 103, substituted “(A) The Administrator” for “The Administrator” and added subpar.

(B).

Subsec. (c)(7). Pub. L. 100–532, § 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, § 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”.
7 USC 136a

NB: This unofficial compilation of the U.S. Code is current as of Jan. 4, 2012 (see http://www.law.cornell.edu/uscode/uscprint.html).

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Subsec. (f)(2). Pub. L. 100–532, § 801(b)(8), substituted “this subchapter. As” for “this subchapter: Provided, That as”.

Subsec. (g). Pub. L. 100–532, § 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, § 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, §§ 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, § 5, provided for waiver of data requirements pertaining to efficacy.

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

Subsec. (d)(1)(A). Pub. L. 95–396, § 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, § 7(2), substituted “forty-five days” for “30 days”.

Subsec. (d)(3). Pub. L. 95–396, § 7(3), added par. (3).

Subsec. (g). Pub. L. 95–396, § 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 2007 Amendment

Pub. L. 110–94, § 6, Oct. 9, 2007, 121 Stat. 1007, provided that: “This Act [see Short Title of 2007 Amendment note

set out under section 136 of this title] and the amendments made by this Act take effect on October 1, 2007.”

Effective Date of 2004 Amendment

Pub. L. 108–199, div. G, title V, § 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.
7 USC 136a

NB: This unofficial compilation of the U.S. Code is current as of Jan. 4, 2012 (see http://www.law.cornell.edu/uscode/uscprint.html).

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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, § 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 [of 1973] (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 [of 1973], 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.”