Page 213 TITLE 7—AGRICULTURE § 136a

this title, amending this section, sections 136a, 136a–1,

136d, 136q, 136s, 136w, 136w–3, 136x, and 136y of this title,

and sections 321, 331, 333, 342, and 346a of Title 21, Food

and Drugs, and enacting provisions set out as notes

under section 136i–2 of this title and sections 301 and

346a of Title 21] may be cited as the ‘Food Quality Protection Act of 1996’.’’

[Another Food Quality Protection Act of 1996 was enacted by Pub. L. 104–170, title IV, 110 Stat. 1513, see section 401(a) of Pub. L. 104–170, set out as a note under

section 301 of Title 21, Food and Drugs.]

SHORT TITLE OF 1988 AMENDMENT

Section 1(a) of Pub. L. 100–532 provided that: ‘‘This

Act [enacting section 136a–1 of this title, amending this

section and sections 136a to 136d, 136f to 136q, 136s, 136v

to 136w–2, and 136y of this title, and enacting provisions

set out as notes under this section and sections 136m

and 136y of this title] may be cited as the ‘Federal Insecticide, Fungicide, and Rodenticide Act Amendments

of 1988’.’’

SHORT TITLE OF 1978 AMENDMENT

Section 29 of Pub. L. 95–396 provided that: ‘‘This Act

[enacting sections 136w–1 to 136w–4 of this title, amending this section and sections 136a to 136f, 136h, 136j, 136l,

136o, 136q, 136r, 136u to 136w, 136x, and 136y of this title,

enacting provisions set out as notes under sections

136a, 136o, and 136w–4 of this title, and amending provisions set out as a note under this section] may be cited

as the ‘Federal Pesticide Act of 1978’.’’

SHORT TITLE

Section 1 of Pub. L. 92–516 provided: ‘‘That this Act

[amending this subchapter generally, enacting notes

set out under this section, and amending sections 1261

and 1471 of Title 15, Commerce and Trade, and sections

321 and 346a of Title 21, Foods and Drugs] may be cited

as the ‘Federal Environmental Pesticide Control Act of

1972’.’’

Section 1(a) of act June 25, 1947, as added by Pub. L.

92–516, §2, provided that: ‘‘This Act [enacting this subchapter] may be cited as the ‘Federal Insecticide, Fungicide, and Rodenticide Act’.’’

TERMINATION OF TRUST TERRITORY OF THE PACIFIC

ISLANDS

For termination of Trust Territory of the Pacific Islands, see note set out preceding section 1681 of Title

48, Territories and Insular Possessions.

FEDERAL COMPLIANCE WITH POLLUTION CONTROL

STANDARDS

For provisions relating to the responsibility of the

head of each Executive agency for compliance with applicable pollution control standards, see Ex. Ord. No.

12088, Oct. 13, 1978, 43 F.R. 47707, set out as a note under

section 4321 of Title 42, The Public Health and Welfare.

§ 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;
§ 136a TITLE 7—AGRICULTURE Page 214

(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
Page 215 TITLE 7—AGRICULTURE § 136a

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 con-
§ 136a TITLE 7—AGRICULTURE Page 216

cerning 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
Page 217 TITLE 7—AGRICULTURE § 136a

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) 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
§ 136a TITLE 7—AGRICULTURE Page 218

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 in-
Page 219 TITLE 7—AGRICULTURE § 136a

crease 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—
§ 136a TITLE 7—AGRICULTURE Page 220

(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 classi-
Page 221 TITLE 7—AGRICULTURE § 136a

fication 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

(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

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.
§ 136a TITLE 7—AGRICULTURE Page 222

(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.
Page 223 TITLE 7—AGRICULTURE § 136a

(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, §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. 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
§ 136a TITLE 7—AGRICULTURE Page 224

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).

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’’.

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
Page 225 TITLE 7—AGRICULTURE § 136a

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.

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
§ 136a–1 TITLE 7—AGRICULTURE Page 226

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.’’

§ 136a–1. Reregistration of registered pesticides

(a) General rule

The Administrator shall reregister, in accordance with this section, each registered pesticide

containing any active ingredient contained in

any pesticide first registered before November 1,

1984, except for any pesticide as to which the Administrator has determined, after November 1,

1984, and before the effective date of this section, that—

(1) there are no outstanding data requirements; and

(2) the requirements of section 136a(c)(5) of

this title have been satisfied.

(b) Reregistration phases

Reregistrations of pesticides under this section shall be carried out in the following phases:

(1) The first phase shall include the listing

under subsection (c) of this section of the active ingredients of the pesticides that will be

reregistered.

(2) The second phase shall include the submission to the Administrator under subsection

(d) of this section of notices by registrants respecting their intention to seek reregistration, identification by registrants of missing

and inadequate data for such pesticides, and

commitments by registrants to replace such

missing or inadequate data within the applicable time period.

(3) The third phase shall include submission

to the Administrator by registrants of the information required under subsection (e) of this

section.

(4) The fourth phase shall include an independent, initial review by the Administrator

under subsection (f) of this section of submissions under phases two and three, identification of outstanding data requirements, and the

issuance, as necessary, of requests for additional data.

(5) The fifth phase shall include the review

by the Administrator under subsection (g) of

this section of data submitted for reregistration and appropriate regulatory action by the

Administrator.

(c) Phase one

(1) Priority for reregistration

For purposes of the reregistration of the pesticides described in subsection (a) of this section, the Administrator shall list the active

ingredients of pesticides and shall give priority to, among others, active ingredients (other

than active ingredients for which registration

standards have been issued before the effective

date of this section) that—

(A) are in use on or in food or feed and may

result in postharvest residues;

(B) may result in residues of potential toxicological concern in potable ground water,

edible fish, or shellfish;

(C) have been determined by the Administrator before the effective date of this section to have significant outstanding data requirements; or

(D) are used on crops, including in greenhouses and nurseries, where worker exposure

is most likely to occur.

(2) Reregistration lists

For purposes of reregistration under this

section, the Administrator shall by order—

(A) not later than 70 days after the effective date of this section, list pesticide active

ingredients for which registration standards

have been issued before such effective date;

(B) not later than 4 months after such effective date, list the first 150 pesticide active

ingredients, as determined under paragraph

(1);

(C) not later than 7 months after such effective date, list the second 150 pesticide active ingredients, as determined under paragraph (1); and

(D) not later than 10 months after such effective date, list the remainder of the pesticide active ingredients, as determined

under paragraph (1).

Each list shall be published in the Federal

Register.

(3) Judicial review

The content of a list issued by the Administrator under paragraph (2) shall not be subject

to judicial review.

(4) Notice to registrants

On the publication of a list of pesticide active ingredients under paragraph (2), the Administrator shall send by certified mail to the

registrants of the pesticides containing such

active ingredients a notice of the time by

which the registrants are to notify the Administrator under subsection (d) of this section

whether the registrants intend to seek or not

to seek reregistration of such pesticides.

(d) Phase two

(1) In general

The registrant of a pesticide that contains

an active ingredient listed under subparagraph