### Attachment **B**

**Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA** )

- **Sec. 136a.** Registration of pesticides (includes section 3(g) and Registration Review;

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

- Ins)From the U.S. Code Online via GPO Access

[wais.access.gpo.gov] [Laws in effect as of January 3, 2005] [Document not affected by Public Laws enacted between January 3, 2005 and April 21, 2006] [ **CITE** : **7USC136a** ]

TITLE 7

-- AGRICULTURE

CHAPTER 6

-- INSECTICIDES AN D ENVIRONMENTAL PESTICIDE CONTROL

SUBCHAPTER II

-- ENVIRONMENTAL PESTICIDE CONTROL

Sec. 136a. Registration of pesticides

(a) Requirement of registration

Except as provided by this subchapter, no person in any State may
distribute or sell to any person any pesticide that is not registered under this subchapter. To the extent necessary to prevent unreasonable adverse effects on the environment, the Administrator may by regulation limit the distribution, sale, or use in any State of a ny 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 no t 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 u se 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 wil l 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 comple te 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), ifrequested by the Administ rator, 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

A dministrator 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

subch apter 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 sol ely 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 f ollowing 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 min or 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

regist rant, 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 th e 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

s ignificant 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 cla use 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

r egistrant 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 reg istrant 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 anapplicant or registran t 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 th e ``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 o ffer 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 ori ginal 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

i nitiate 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 S ervice 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 c ourt 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 arbitr ator 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 equall y 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 arbi tration 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 forfei t 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 p articipate 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 Administratorshall deny the application or cancel the registration of

the pesticide in support of which the data were used without

further hearing. Before the Administrator t akes 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

c ontinued 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 excl usive 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) T he 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 acti ve 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 tha t 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 oramendment to the registration of a pesticide be expedited, an explanation of the basis for the request must be submitted, in

accord ance 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 suppor t 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 Administrato r 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 geograph ic 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 Ad ministrator 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 Admini strator 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 provid e

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 co st of developing, such data if they agree and advise the Administrator of their intent within ninety days after notification. Any registrant who agrees toshare in the cost of producing the data shall be entitled to

exam ine 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) i f 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 hav e 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 Mediatio n 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

ar bitration 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 determinati on, 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 su ch 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 Administ rator 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

agre ement 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 join t 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 m ay 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

shal l 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 aperson 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 co nducted 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 registrat ion 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 dec ision 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 sus pension 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 theenviro nment. 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 dat a. 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 th e 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

oth er 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 establishe d 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 signific ant 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 Admini strator 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 13 6d(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, theAdministrator may proceed in accordance with claus e (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. Notw ithstanding 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 d ate 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 ide ntify 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 pertai ning 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

ofsuch data will not prevent the Administrat or 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 par agraph (5), or notify the applicant of the Administrator's determination that it does not comply with the provisions of the subchapter in accordance with paragraph (6).

(B) Identical or substantially similar

(i) The Administrator shall, as expeditiously as possible, review and act on any application received by the Administrator

that

-- (I) proposes the initial or amended registration of an

end

- use pesticide that, if registered as proposed, would be identical or substantially similar in composition and labeling to a currently

- registered pesticide identified in the application, or that would differ in composition and labeling from such currently

- registered pesticide only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment; or (II) proposes an amendment to the registration of a registered pesticide that does not require scientific
review

of data.

(ii) In expediting the review of an application for an action described in clause (i), the Administrator shall

--

(I) within 45 days after receiving the application, notify the registrant whether or not the application is complete and, if the application is found to be incomplete, reject the application; (II) within 90 days after receiving a complete application, notify the registrant if the application has been granted or denied; and (III) if the application is denied, notify the registrant in writing of the spec ific 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 isproposed 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 prece ding 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) Adequ ate 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 Admini strator 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 Re gister, 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 acco rdance 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 efficacio us 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 registr ation

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 Administr ator'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

r eceives 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 r easons (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 ot her 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 amendthe registration of a pesticide if the Administrator determines that (i) the pesticide and proposed use are identical or substantially similar to any cu rrently 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 s hall 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 pestic ide 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 alternati ve 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 un der 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

unde r 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 registeredunder this subchapter. (C) The Adminis trator 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 la cking 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 receiv es 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 in terest.

(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 o f 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 f or 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 re quired 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) NotificationA 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 labe ling; 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 Admi nistrator
determines that

--

(i) adequate data have been submitted to support the statement proposed for the diluted solution uses; and (ii) the label or labeling provides adequate protection for exposure to the diluted solution of the pesticide.

(10) Expedited registration of pesticides

(A) Not later than 1 year after August 3, 1996, the Administrator shall, utilizing public comment, develop procedures and g uidelines, 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 con ventional 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 beexpected 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 groundwa ter,

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 expedite d 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 regi stration 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 o ther 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 pest icides 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 separa ted 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 accordanc e 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 d etermination 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

m ore 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 Administratorshall 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 res tricted 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
restricte d 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

dete rmination 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

be fore 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 th is 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 expl anation 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

sta tements.

(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 t hat 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 subc hapter. 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 n itrogen 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 subjec t 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) Registra tion review

(1) General rule

(A) Periodic reviewThe registrations of pesticides are to be periodically reviewed. The Administrator shall by regulation establish a procedure for accomplishi ng the periodic review of registrations. The goal of these regulations shall be a review of a pesticide's registration every 15 years. No registration shall be canceled as a result of the registration review

process unle ss the Administrator follows the procedures and substantive

requirements of section 136d of this title.

(B) Limitation

Nothing in this subsection shall prohibit the Administrator from undertaking any other review of a pesticide pursuant to this subchapter.

(2) Data

(A) Submission required

The Administrator shall use the authority in subsection (c)(2)(B) of this section to require the submission of data

when such data are necessary for a registration review.

(B) Data submission, compensation, and exemption

For purposes of this subsection, the provisions of subsections (c)(1), (c)(2)(B), and (c)(2)(D) of this se ction 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 practi cable 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 anti microbial 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 submissionof 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 re view 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) Implementat ion

(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 t he 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 cl ause (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 antimicrobia l 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 registrat ion 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
Administrat or 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 shal l 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 proce dures; (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, 199 6, until the finalregulations 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 amend ment 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 am endment 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 appropria te 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 pe riod 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) Exempt ion

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) L imitation

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 subpar agraph (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 Hous e 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) m easures taken to reduce the backlog of pending registration applications; (ii) progress toward achieving reforms under this subsection; and (iii) recommendations to improve the activities of the Agency pertaining to antimicrobial registrations.

(June 25, 1947, ch. 125, Sec. 3, as added Pub. L. 92

- 516, Sec. 2, Oct. 21, 1972, 86 Stat. 979; amended Pub. L. 94

- 140, Sec. 12, Nov. 28, 1975, 89 Stat. 755; Pub. L. 95

- 396, Secs. 2(a), 3

- 8, Sep t. 30, 1978, 92 Stat. 820, 824

- 827; Pub. L. 100

- 532, title I, Secs. 102(b), 103, title VI, Sec. 601(b)(1), title VIII, Sec. 801(b), Oct. 25, 1988, 102 Stat. 2667, 2677, 2680; Pub. L. 101

- 624, title XIV, Sec. 1492, Nov. 28, 1990, 104 Stat. 3628; Pub. L. 102

- 237, title X, Sec. 1006(a)(3), (b)(1), (2), (c), Dec. 13, 1991, 105 Stat. 1894

- 1896; Pub. L. 104

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

222

- 224, 231, 250, Aug. 3, 1996, 110 Stat. 1491, 1494

- 1497, 1499, 1503, 1504, 1508, 1510; Pub. L. 108

- 199, div. G, title V, Sec. 501(b), Jan. 23, 2004, 118 Stat. 419.)

Prior Provisions

A prior section 3 of act June 25, 1947, was classified to section135a of this title prior to amen dment of act June 25, 1947, by Pub. L.

92

- 516.

Amendments

2004

-- Subsec. (h)(2)(F). Pub. L. 108

- 199, Sec. 501(b)(1), substituted ``120 days'' for ``90 to 180 days''. Subsec. (h)(3)(D)(vi). Pub. L. 108

- 199, Sec. 50 1(b)(2)(A), substituted ``120 days'' for ``240 days''. Subsec. (h)(3)(F)(iv). Pub. L. 108

- 199, Sec. 501(b)(2)(B), added

cl. (iv).

1996

-- Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104

- 170, Sec. 210(b), added cls. (ii), (v), and (vi), redesignated for mer cls. (ii) and (iii) as (iii) and (iv), respectively, and in cl. (iv) substituted ``(i), (ii), and (iii)'' for ``(i) and (ii)''. Subsec. (c)(1)(G). Pub. L. 104

- 170, Sec. 250(1), added subpar. (G). Subsec. (c)(2)(A). Pub. L. 104

- 170, Secs. 210( d)(1), 231, inserted heading, inserted ``the public health and agricultural need for such minor use,'' after ``pattern of use,'', and substituted ``potential

beneficial or adverse effects on man and the environment'' for ``potential exposure of man and the environment to the pesticide''. Subsec. (c)(2)(B). Pub. L. 104

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

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

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

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

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

- 170, Sec. 210(d)(4), added subpar. (E). Subsec. (c)(3) (A), (B). Pub. L. 104

- 170, Sec. 210(e)(1), (2), inserted headings. Subsec. (c)(3)(C), (D). Pub. L. 104

- 170, Sec. 210(e)(3), added subpars. (C) and (D). Subsec. (c)(9). Pub. L. 104

- 170, Sec. 223, added par. (9). Subsec. (c)(10). Pub. L. 104

- 17 0, Sec. 250(2), added par. (10). Subsec. (f)(4). Pub. L. 104

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

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

- 170, Sec. 224, added subsec. (h).

1991

-- Subsec. (c)(1)(D). Pub. L. 102

- 237, Sec. 1006(a)(3)(B), (C), added subpar. (D) and redesignated former subpar. (D) as (F). Subsec. (c)(1)(E). Pub. L. 102

- 237, Sec. 1006(a)(3)(A), (C), added subpar. (E) and struck out former subpar. (E) which read as follows:
``the co mplete formula of the pesticide; and''. Subsec. (c)(1)(F). Pub. L. 102

- 237, Sec. 1006(a)(3)(A), (B), (D), redesignated former subpar. (D) as (F), in cl. (i) substituted ``With'' for ``with'' and a period for semicolon at end, in cl. (ii) substituted ``Except'' for ``except'' and a period for semicolon at end, in cl. (iii) substituted ``After'' for ``after'' and a period for semicolon at end, and struck out former subpar. (F) which read as follows: ``a request that the pesticide be classified for g eneral use, for
restricteduse, or for both.'' Subsec. (c)(2)(A). Pub. L. 102

- 237, Sec. 1006(b)(1), (2), substituted ``the Administrator'' for ``he'' before ``requires'', ``shall permit'', ``shall make'', and ``deems'', and substituted ``the

Admini strator's'' for ``his''. Subsec. (c)(2)(D). Pub. L. 102

- 237, Sec. 1006(c), clarified amendment made by Pub. L. 100

- 532, Sec. 102(b)(2)(A). See 1988

Amendment

note below. Subsec. (c)(3)(A). Pub. L. 102

- 237, Sec. 1006(b)(2), substituted
``the Admi nistrator's'' for ``his''. Subsec. (c)(5). Pub. L. 102

- 237, Sec. 1006(b)(1), substituted ``the
Administrator'' for ``he'' before ``determines''. Subsec. (c)(6). Pub. L. 102

- 237, Sec. 1006(b)(1), (2), substituted
``the Administrator'' for ``he'' b efore ``shall notify'' in two places and ``the Administrator's'' for ``his'' in four places. Subsec. (d)(1). Pub. L. 102

- 237, Sec. 1006(b)(1), substituted ``the Administrator'' for ``he'' before ``shall classify it for both'' in subpar. (A), before ``will classify'' in subpar. (B), and before
``shall classify'' in subpar. (C). Subsec. (d)(2). Pub. L. 102

- 237, Sec. 1006(b)(1), substituted ``the Administrator'' for ``he'' before ``shall notify''.

1990

-- Subsec. (c)(2)(A). Pub. L. 101

- 624 inser ted after third sentence ``The Administrator shall not require a person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under this subchapter, any field residue data from a geographic area where the pesticide will not be registered for such

use.''
1988

-- Subsec. (a). Pub. L. 100

- 532, Sec. 601(b)(1), substituted ``Requirement of registration'' for ``Requirement'' in heading and amended text generally. Prior to amendment, text read as follows:

`` Except as otherwise provided by this subchapter, no person in any State may distribute, sell, offer for sale, hold for sale, ship,
deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person any pesticide which i s not registered with the
Administrator.'' Subsec. (c)(1)(D). Pub. L. 100

- 532, Sec. 801(b)(1)

- (4), in introductory provisions, substituted ``paragraph (2)(D)'' for ``subsection (c)(2)(D) of this section'', in cl. (i), substituted ``(i)
with'' for ` `(i) With'' and ``, except that'' for ``: Provided, That'', in cl. (ii), substituted ``clause (i)'' for ``subparagraph (D)(i) of this paragraph'', and in cl. (iii), substituted ``clauses (i) and (ii)'' for ``subparagraphs (D)(i) and (D)(ii) of this para graph''. Subsec. (c)(2)(A). Pub. L. 100

- 532, Sec. 801(b)(5)(A), (B), substituted ``(2) Data in support of registration.

--

``(A) The'' for ``(2)(A) Data in support of registration.

-- The'', and directed that subpar. (A) be aligned with left mar gin of subsec. (d)(1)(A) of this
section. Subsec. (c)(2)(B). Pub. L. 100

- 532, Secs. 102(b)(1), 801(b)(5)(C)

- (F), substituted ``(B)(i) If'' for ``(B) Additional data to support existing registration.

-- (i) If'', directed that cls. (ii) to (v) be alig ned with left margin of subpar. (A), in cls. (ii) and (iii), inserted ``The Administrator shall issue a notice of intent to suspendthe registration of a pesticide in accordance with the procedures

prescribed by clause (iv) if a registrant fails to comp ly with this clause.'', in cl. (iv), substituted ``title. The only'' for ``title: Provided, that the only'', and in cl. (v), substituted ``paragraph (1)(D)'' for ``subsection (c)(1)(D) of this section''. Subsec. (c)(2)(C). Pub. L. 100

- 532, Sec. 801( b)(5)(G), (H), struck out ``Simplified procedures'' after ``(C)'' and directed that text be aligned with left margin of subpar. (A). Subsec. (c)(2)(D). Pub. L. 100

- 532, Sec. 102(b)(2)(A), and Pub. L.

102

- 237, Sec. 1006(c), substituted ``the pesticid e that is the subject of the application'' for ``an end

- use product''. Subsec. (c)(2)(D)(i). Pub. L. 100

- 532, Sec. 102(b)(2)(B), struck

out ``the safety of'' after ``data pertaining to''. Subsec. (c)(3). Pub. L. 100

- 532, Sec. 103, substituted ``( A) The Administrator'' for ``The Administrator'' and added subpar. (B). Subsec. (c)(7). Pub. L. 100

- 532, Sec. 801(b)(6), in introductory provisions, substituted ``paragraph (5)'' for ``subsection (c)(5) of this section'', in subpars. (A) and (B), su bstituted ``paragraph (5). If'' for ``subsection (c)(5) of this section: Provided, That, if'', and in subpar. (C), substituted ``prescribe. A'' for ``prescribe: Provided,

that a''. Subsec. (d)(1)(A). Pub. L. 100

- 532, Sec. 801(b)(7), substituted
``r estricted use. If'' for ``restricted use, provided that if'' and ``restricted uses. The Administrator'' for ``restricted uses: Provided, however, That the Administrator''. Subsec. (f)(2). Pub. L. 100

- 532, Sec. 801(b)(8), substituted ``this subchapte r. As'' for ``this subchapter: Provided, That as''. Subsec. (g). Pub. L. 100

- 532, Sec. 801(b)(9), struck out subsec. (g) which read as follows: ``The Administrator shall accomplish the reregistration of all pesticides in the most expeditious manner practicable: Provided, That, to the extent appropriate, any pesticide that results in a postharvest residue in or on food or feed crops shall be given priority in the reregistration process.''

1978

-- Subsec. (c)(1)(D). Pub. L. 95

- 396, Sec. 2(a)(1), ad ded 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 ther eof 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 registr ation 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 compen sation 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 Administra tor shall make such determination and may fix such other terms and conditions as may be reasonable under the circumstances. TheAdministrator'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 de layed pending the determination of reasonable compensation between the applicants, by the Administrator or by the court.''. Subsec. (c)(2). Pub. L. 95

- 396, Secs. 2(a)(2)(A)

- (D), 3, 4, designated existing provisions as subpar. (A), inserted in second sentence ``under subparagraph (B) of this paragraph'' after ``kind of information'', struck out from introductory text of third sentence ``subsection (c)(1)(D) of this section and'' after ``Except as provided by'', and inserted provisions relating to establishment of standards

for data requirements for registration of pesticides with respect to minor uses and consideration of economic factors in development of standards and cost of development, and added subpars. (B) to (D). Subsec. (c)(5). Pub. L. 95

- 396, Sec. 5, provided for waiver of data requirements pertaining to efficacy. Subsec. (c)(7), (8). Pub. L. 95

- 396, Sec. 6, added pars. (7) and (8). Subsec. (d)(1)(A). Pub. L. 95

- 396, Sec. 7(1), authorized classification of pesticide uses by regulation on the initial classification and registered pesticides prior to reregistration. Subsec. (d)(2). Pub. L. 95

- 396, Sec. 7(2), substituted ``forty

- five days'' for ``30 days''. Subsec. (d)(3). Pub. L. 95

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

- 396, Sec. 8, added subsec. (g).
1975

-- Subsec. (c)(1)(D). Pub. L. 94

- 140 inserted exception relating to test data submitted on or after January 1, 1970, in support of application, inserted provision that compensation for pr oducing 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 l ess than amount determined by Administrator, and substituted ``If either party'' for ``If the owner

of

the test data''.

Effective Date of 2004 Amendment

Pub. L. 108

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

Stat. 4 34, 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 AmendmentAmendment 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 Dat e 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 ap ply 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 no te 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 ye ar 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 agencie s and offices that shall be based on the study conducted under such subsection and the recommendation of the National Academy of Sciences, and other public comment.''

Education, Study, and Report

Pub. L. 100

- 478, title I, Sec . 1010, Oct. 7, 1988, 102 Stat. 2313, provided that: ``(a) Education.

-- The Administrator of the Environmental Protection Agency in cooperation with the Secretary of Agriculture and the Secretary of the Interior, promptly upon enactment of this Act [ Oct. 7, 1988], shall conduct a program to inform and educate fully persons engaged in agricultural food and fiber commodity production of any proposed pesticide labeling program or requirements that may be imposed by the Administrator in compliance wit h the Endangered Species Act (16 U.S.C. 1531 et seq.). The Administrator also shall provide the public with notice of, and opportunity for comment on, the elements of any

suchprogram and requirements based on compliance with the Endangered

Species

Act , including (but not limited to) an identification of any pesticides affected by the program; an explanation of the restriction or prohibition on the user or applicator of any such pesticide; an identification of those geographic areas affected by any p esticide 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 g eographic 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 agricultur al 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 pesticid es 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 m ay 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.''