Attachment B

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

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

and section 3(c) (2)(B) for Data Call-Ins) 
From the U.S. Code Online via GPO Access

[wais.access.gpo.gov]

[Laws in effect as of January 3, 2005]

[Document not affected by Public Laws enacted between

 January 3, 2005 and April 21, 2006]

[CITE: 7USC136a]

 TITLE 7--AGRICULTURE

 CHAPTER 6--INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL

 SUBCHAPTER II--ENVIRONMENTAL PESTICIDE CONTROL

Sec. 136a. Registration of pesticides

(a) Requirement of registration

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

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

under this subchapter. To the extent necessary to prevent unreasonable 

adverse effects on the environment, the Administrator may by regulation 

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

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

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

emergency exemption under section 136p of this title.

(b) Exemptions

 A pesticide which is not registered with the Administrator may be 

transferred if--

 (1) the transfer is from one registered establishment to 

another 

 registered establishment operated by the same producer solely for 

 packaging at the second establishment or for use as a constituent 

 part of another pesticide produced at the second establishment; or

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

 requirements of an experimental use permit.

(c) Procedure for registration

 (1) Statement required

 Each applicant for registration of a pesticide shall file with 

 the Administrator a statement which includes--

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

 person whose name will appear on the labeling;

 (B) the name of the pesticide;

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

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

 for its use;

 (D) the complete formula of the pesticide;

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

 use or for restricted use, or for both; and

 (F) except as otherwise provided in paragraph (2)(D), if 
 requested by the Administrator, a full description of the tests 

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

or 

 alternatively a citation to data that appear in the public 

 literature or that previously had been submitted to the 

 Administrator and that the Administrator may consider in 

 accordance with the following provisions:

 (i) With respect to pesticides containing active 

 ingredients that are initially registered under this 

 subchapter after September 30, 1978, data submitted to 

 support the application for the original registration of 

the 

 pesticide, or an application for an amendment adding any 

new 

 use to the registration and that pertains solely to such 

new 

 use, shall not, without the written permission of the 

 original data submitter, be considered by the Administrator 

 to support an application by another person during a period 

 of ten years following the date the Administrator first 

 registers the pesticide, except that such permission shall 

 not be required in the case of defensive data.

 (ii) The period of exclusive data use provided under 

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

 minor uses registered after August 3, 1996, and within 7 

 years of the commencement of the exclusive use period, up 

to 

 a total of 3 additional years for all minor uses registered 

 by the Administrator if the Administrator, in consultation 

 with the Secretary of Agriculture, determines that, based 

on 

 information provided by an applicant for registration or a 

 registrant, that--

 (I) there are insufficient efficacious alternative 

 registered pesticides available for the use;

 (II) the alternatives to the minor use pesticide 

 pose greater risks to the environment or human health;

 (III) the minor use pesticide plays or will play a 

 significant part in managing pest resistance; or

 (IV) the minor use pesticide plays or will play a 

 significant part in an integrated pest management 

 program.

 The registration of a pesticide for a minor use on a crop 

 grouping established by the Administrator shall be 

 considered for purposes of this clause 1 minor use for each 

 representative crop for which data are provided in the crop 

 grouping. Any additional exclusive use period under this 

 clause shall be modified as appropriate or terminated if 

the 

 registrant voluntarily cancels the product or deletes from 

 the registration the minor uses which formed the basis for 

 the extension of the additional exclusive use period or if 

 the Administrator determines that the registrant is not 

 actually marketing the product for such minor uses.

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

 respect to data submitted after December 31, 1969, by an 
 applicant or registrant to support an application for 

 registration, experimental use permit, or amendment adding 

a 

 new use to an existing registration, to support or maintain 

 in effect an existing registration, or for reregistration, 

 the Administrator may, without the permission of the 

 original data submitter, consider any such item of data in 

 support of an application by any other person (hereinafter 

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

 within the fifteen-year period following the date the data 

 were originally submitted only if the applicant has made an 

 offer to compensate the original data submitter and 

 submitted such offer to the Administrator accompanied by 

 evidence of delivery to the original data submitter of the 

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

 agreement between the original data submitter and the 

 applicant, or, failing such agreement, binding arbitration 

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

after 

 the date of delivery to the original data submitter of the 

 offer to compensate, the original data submitter and the 

 applicant have neither agreed on the amount and terms of 

 compensation nor on a procedure for reaching an agreement 

on 

 the amount and terms of compensation, either person may 

 initiate binding arbitration proceedings by requesting the 

 Federal Mediation and Conciliation Service to appoint an 

 arbitrator from the roster of arbitrators maintained by 

such 

 Service. The procedure and rules of the Service shall be 

 applicable to the selection of such arbitrator and to such 

 arbitration proceedings, and the findings and determination 

 of the arbitrator shall be final and conclusive, and no 

 official or court of the United States shall have power or 

 jurisdiction to review any such findings and determination, 

 except for fraud, misrepresentation, or other misconduct by 

 one of the parties to the arbitration or the arbitrator 

 where there is a verified complaint with supporting 

 affidavits attesting to specific instances of such fraud, 

 misrepresentation, or other misconduct. The parties to the 

 arbitration shall share equally in the payment of the fee 

 and expenses of the arbitrator. If the Administrator 

 determines that an original data submitter has failed to 

 participate in a procedure for reaching an agreement or in 

 an arbitration proceeding as required by this subparagraph, 

 or failed to comply with the terms of an agreement or 

 arbitration decision concerning compensation under this 

 subparagraph, the original data submitter shall forfeit the 

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

 the application. Notwithstanding any other provision of 

this 

 subchapter, if the Administrator determines that an 

 applicant has failed to participate in a procedure for 

 reaching an agreement or in an arbitration proceeding as 

 required by this subparagraph, or failed to comply with the 

 terms of an agreement or arbitration decision concerning 

 compensation under this subparagraph, the Administrator 
 shall deny the application or cancel the registration of 

the 

 pesticide in support of which the data were used without 

 further hearing. Before the Administrator takes action 

under 

 either of the preceding two sentences, the Administrator 

 shall furnish to the affected person, by certified mail, 

 notice of intent to take action and allow fifteen days from 

 the date of delivery of the notice for the affected person 

 to respond. If a registration is denied or canceled under 

 this subparagraph, the Administrator may make such order as 

 the Administrator deems appropriate concerning the 

continued 

 sale and use of existing stocks of such pesticide. 

 Registration action by the Administrator shall not be 

 delayed pending the fixing of compensation.

 (iv) After expiration of any period of exclusive use 

and 

 any period for which compensation is required for the use 

of 

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

 Administrator may consider such item of data in support of 

 an application by any other applicant without the 

permission 

 of the original data submitter and without an offer having 

 been received to compensate the original data submitter for 

 the use of such item of data.

 (v) The period of exclusive use provided under clause 

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

 1996, except where an applicant or registrant is applying 

 for the registration of a pesticide containing an active 

 ingredient not previously registered.

 (vi) With respect to data submitted after August 3, 

 1996, by an applicant or registrant to support an amendment 

 adding a new use to an existing registration that does not 

 retain any period of exclusive use, if such data relates 

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

 without the written permission of the original data 

 submitter, be considered by the Administrator to support an 

 application for a minor use by another person during the 

 period of 10 years following the date of submission of such 

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

 use is requested shall notify the Administrator that to the 

 best of their knowledge the exclusive use period for the 

 pesticide has expired and that the data pertaining solely 

to 

 the minor use of a pesticide is eligible for the provisions 

 of this paragraph. If the minor use registration which is 

 supported by data submitted pursuant to this subsection is 

 voluntarily canceled or if such data are subsequently used 

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

 subject to the exclusive use provisions of this clause but 

 shall instead be considered by the Administrator in 

 accordance with the provisions of clause (i), as 

 appropriate.

 (G) If the applicant is requesting that the registration or 
 amendment to the registration of a pesticide be expedited, an 

 explanation of the basis for the request must be submitted, in 

 accordance with paragraph (10) of this subsection.

 (2) Data in support of registration

 (A) In general

 The Administrator shall publish guidelines specifying the 

 kinds of information which will be required to support the 

 registration of a pesticide and shall revise such guidelines 

 from time to time. If thereafter the Administrator requires any 

 additional kind of information under subparagraph (B) of this 

 paragraph, the Administrator shall permit sufficient time for 

 applicants to obtain such additional information. The 

 Administrator, in establishing standards for data requirements 

 for the registration of pesticides with respect to minor uses, 

 shall make such standards commensurate with the anticipated 

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

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

 of potential beneficial or adverse effects on man and the 

 environment. The Administrator shall not require a person to 

 submit, in relation to a registration or reregistration of a 

 pesticide for minor agricultural use under this subchapter, any 

 field residue data from a geographic area where the pesticide 

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

these 

 standards, the Administrator shall consider the economic 

factors 

 of potential national volume of use, extent of distribution, 

and 

 the impact of the cost of meeting the requirements on the 

 incentives for any potential registrant to undertake the 

 development of the required data. Except as provided by section 

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

 registers a pesticide under this subchapter the Administrator 

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

 registration statement together with such other scientific 

 information as the Administrator deems relevant to the 

 Administrator's decision.

 (B) Additional data

 (i) If the Administrator determines that additional data 

are 

 required to maintain in effect an existing registration of a 

 pesticide, the Administrator shall notify all existing 

 registrants of the pesticide to which the determination relates 

 and provide a list of such registrants to any interested 

person.

 (ii) Each registrant of such pesticide shall provide 

 evidence within ninety days after receipt of notification that 

 it is taking appropriate steps to secure the additional data 

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

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

 they agree and advise the Administrator of their intent within 

 ninety days after notification. Any registrant who agrees to 
 share in the cost of producing the data shall be entitled to 

 examine and rely upon such data in support of maintenance of 

 such registration. The Administrator shall issue a notice of 

 intent to suspend the registration of a pesticide in accordance 

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

 fails to comply with this clause.

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

 Administrator of their agreement to develop jointly, or share 

in 

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

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

 procedure for reaching such agreement, any of such registrants 

 may initiate binding arbitration proceedings by requesting the 

 Federal Mediation and Conciliation Service to appoint an 

 arbitrator from the roster of arbitrators maintained by such 

 Service. The procedure and rules of the Service shall be 

 applicable to the selection of such arbitrator and to such 

 arbitration proceedings, and the findings and determination of 

 the arbitrator shall be final and conclusive, and no official 

or 

 court of the United States shall have power or jurisdiction to 

 review any such findings and determination, except for fraud, 

 misrepresentation, or other misconduct by one of the parties to 

 the arbitration or the arbitrator where there is a verified 

 complaint with supporting affidavits attesting to specific 

 instances of such fraud, misrepresentation, or other 

misconduct. 

 All parties to the arbitration shall share equally in the 

 payment of the fee and expenses of the arbitrator. The 

 Administrator shall issue a notice of intent to suspend the 

 registration of a pesticide in accordance with the procedures 

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

 this clause.

 (iv) Notwithstanding any other provision of this 

subchapter, 

 if the Administrator determines that a registrant, within the 

 time required by the Administrator, has failed to take 

 appropriate steps to secure the data required under this 

 subparagraph, to participate in a procedure for reaching 

 agreement concerning a joint data development arrangement under 

 this subparagraph or in an arbitration proceeding as required 

by 

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

 or arbitration decision concerning a joint data development 

 arrangement under this subparagraph, the Administrator may 

issue 

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

 the pesticide for which additional data is required. The 

 Administrator may include in the notice of intent to suspend 

 such provisions as the Administrator deems appropriate 

 concerning the continued sale and use of existing stocks of 

such 

 pesticide. Any suspension proposed under this subparagraph 

shall 

 become final and effective at the end of thirty days from 

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

 unless during that time a request for hearing is made by a 
 person adversely affected by the notice or the registrant has 

 satisfied the Administrator that the registrant has complied 

 fully with the requirements that served as a basis for the 

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

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

 The only matters for resolution at that hearing shall be 

whether 

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

 basis for the notice of intent to suspend the registration of 

 the pesticide for which additional data is required, and 

whether 

 the Administrator's determination with respect to the 

 disposition of existing stocks is consistent with this 

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

of 

 such hearing shall be final. Notwithstanding any other 

provision 

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

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

 such hearing. Any registration suspended under this 

subparagraph 

 shall be reinstated by the Administrator if the Administrator 

 determines that the registrant has complied fully with the 

 requirements that served as a basis for the suspension of the 

 registration.

 (v) Any data submitted under this subparagraph shall be 

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

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

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

handle 

 any subsequent data compensation matters for the joint 

 submitters of such data.

 (vi) Upon the request of a registrant the Administrator 

 shall, in the case of a minor use, extend the deadline for the 

 production of residue chemistry data under this subparagraph 

for 

 data required solely to support that minor use until the final 

 deadline for submission of data under section 136a-1 of this 

 title for the other uses of the pesticide established as of 

 August 3, 1996, if--

 (I) the data to support other uses of the pesticide on 

a 

 food are being provided;

 (II) the registrant, in submitting a request for such 

an 

 extension, provides a schedule, including interim dates to 

 measure progress, to assure that the data production will 

be 

 completed before the expiration of the extension period;

 (III) the Administrator has determined that such 

 extension will not significantly delay the Administrator's 

 schedule for issuing a reregistration eligibility 

 determination required under section 136a-1 of this title; 

 and

 (IV) the Administrator has determined that based on 

 existing data, such extension would not significantly 

 increase the risk of any unreasonable adverse effect on the 
 environment. If the Administrator grants an extension under 

 this clause, the Administrator shall monitor the 

development 

 of the data and shall ensure that the registrant is meeting 

 the schedule for the production of the data. If the 

 Administrator determines that the registrant is not meeting 

 or has not met the schedule for the production of such 

data, 

 the Administrator may proceed in accordance with clause 

(iv) 

 regarding the continued registration of the affected 

 products with the minor use and shall inform the public of 

 such action. Notwithstanding the provisions of this clause, 

 the Administrator may take action to modify or revoke the

 extension under this clause if the Administrator determines 

 that the extension for the minor use may cause an 

 unreasonable adverse effect on the environment. In such 

 circumstance, the Administrator shall provide, in writing 

to 

 the registrant, a notice revoking the extension of time for 

 submission of data. Such data shall instead be due in 

 accordance with the date established by the Administrator 

 for the submission of the data.

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

 specific minor use of the pesticide, but is supporting and 

 providing data in a timely and adequate fashion to support uses 

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

 nonfood uses and the registrant does not commit to support a 

 specific minor use of the pesticide but is supporting and 

 providing data in a timely and adequate fashion to support 

other 

 nonfood uses of the pesticide, the Administrator, at the 

written 

 request of the registrant, shall not take any action pursuant 

to 

 this clause in regard to such unsupported minor use until the 

 final deadline established as of August 3, 1996, for the 

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

 supported uses identified pursuant to this clause unless the 

 Administrator determines that the absence of the data is 

 significant enough to cause human health or environmental 

 concerns. On the basis of such determination, the Administrator 

 may refuse the request for extension by the registrant. Upon 

 receipt of the request from the registrant, the Administrator 

 shall publish in the Federal Register a notice of the receipt 

of 

 the request and the effective date upon which the uses not 

being 

 supported will be voluntarily deleted from the registration 

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

 Administrator grants an extension under this clause, the 

 Administrator shall monitor the development of the data for the 

 uses being supported and shall ensure that the registrant is 

 meeting the schedule for the production of such data. If the 

 Administrator determines that the registrant is not meeting or 

 has not met the schedule for the production of such data, the 
 Administrator may proceed in accordance with clause (iv) of 

this 

 subparagraph regarding the continued registration of the 

 affected products with the minor and other uses and shall 

inform 

 the public of such action in accordance with section 136d(f)(2) 

 of this title. Notwithstanding the provisions of this clause, 

 the Administrator may deny, modify, or revoke the temporary 

 extension under this subparagraph if the Administrator 

 determines that the continuation of the minor use may cause an 

 unreasonable adverse effect on the environment. In the event of 

 modification or revocation, the Administrator shall provide, in 

 writing, to the registrant a notice revoking the temporary 

 extension and establish a new effective date by which the minor 

 use shall be deleted from the registration.

 (viii)(I) If data required to support registration of a 

 pesticide under subparagraph (A) is requested by a Federal or 

 State regulatory authority, the Administrator shall, to the 

 extent practicable, coordinate data requirements, test 

 protocols, timetables, and standards of review and reduce 

 burdens and redundancy caused to the registrant by multiple 

 requirements on the registrant.

 (II) The Administrator may enter into a cooperative 

 agreement with a State to carry out subclause (I).

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

 Administrator shall develop a process to identify and assist in 

 alleviating future disparities between Federal and State data 

 requirements.

 (C) Simplified procedures

 Within nine months after September 30, 1978, the 

 Administrator shall, by regulation, prescribe simplified 

 procedures for the registration of pesticides, which shall 

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

 (D) Exemption

 No applicant for registration of a pesticide who proposes 

to

 purchase a registered pesticide from another producer in order 

 to formulate such purchased pesticide into the pesticide that 

is 

 the subject of the application shall be required to--

 (i) submit or cite data pertaining to such purchased 

 product; or

 (ii) offer to pay reasonable compensation otherwise 

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

 of any such data.

 (E) Minor use waiver

 In handling the registration of a pesticide for a minor 

use, 

 the Administrator may waive otherwise applicable data 

 requirements if the Administrator determines that the absence 

of 
 such data will not prevent the Administrator from determining--

 (i) the incremental risk presented by the minor use of 

 the pesticide; and

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

 unreasonable adverse effect on the environment.

 (3) Application

 (A) In general

 The Administrator shall review the data after receipt of 

the 

 application and shall, as expeditiously as possible, either 

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

 notify the applicant of the Administrator's determination that 

 it does not comply with the provisions of the subchapter in 

 accordance with paragraph (6).

 (B) Identical or substantially similar

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

 review and act on any application received by the Administrator 

 that--

 (I) proposes the initial or amended registration of an 

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

 identical or substantially similar in composition and 

 labeling to a currently-registered pesticide identified in 

 the application, or that would differ in composition and 

 labeling from such currently-registered pesticide only in 

 ways that would not significantly increase the risk of 

 unreasonable adverse effects on the environment; or

 (II) proposes an amendment to the registration of a 

 registered pesticide that does not require scientific 

review 

 of data.

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

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

 (I) within 45 days after receiving the application, 

 notify the registrant whether or not the application is 

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

 reject the application;

 (II) within 90 days after receiving a complete 

 application, notify the registrant if the application has 

 been granted or denied; and

 (III) if the application is denied, notify the 

 registrant in writing of the specific reasons for the 

denial 

 of the application.

 (C) Minor use registration

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

 review and act on any complete application--

 (I) that proposes the initial registration of a new 

 pesticide active ingredient if the active ingredient is 
 proposed to be registered solely for minor uses, or 

proposes 

 a registration amendment solely for minor uses to an 

 existing registration; or

 (II) for a registration or a registration amendment 

that 

 proposes significant minor uses.

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

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

that 

 the Administrator shall, to the greatest extent 

practicable, 

 complete a review and evaluation of all data, submitted 

with 

 a complete application, within 12 months after the 

 submission of the complete application, and the failure of 

 the Administrator to complete such a review and evaluation 

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

 and

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

more 

 minor uses proposed for every nonminor use, a minor use 

that 

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

 replacement for any use which has been canceled in the 5 

 years preceding the receipt of the application, or a minor 

 use that in the opinion of the Administrator would avoid 

the 

 reissuance of an emergency exemption under section 136p of 

 this title for that minor use.

 (D) Adequate time for submission of minor use data

 If a registrant makes a request for a minor use waiver, 

 regarding data required by the Administrator, pursuant to 

 paragraph (2)(E), and if the Administrator denies in whole or 

in 

 part such data waiver request, the registrant shall have a 

full-

 time period for providing such data. For purposes of this 

 subparagraph, the term ``full-time period'' means the time 

 period originally established by the Administrator for 

 submission of such data, beginning with the date of receipt by 

 the registrant of the Administrator's notice of denial.

 (4) Notice of application

 The Administrator shall publish in the Federal Register, 

 promptly after receipt of the statement and other data required 

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

for 

 registration of any pesticide if it contains any new active 

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

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

or 

 any other interested person may comment.
 (5) Approval of registration

 The Administrator shall register a pesticide if the 

 Administrator determines that, when considered with any 

restrictions 

 imposed under subsection (d) of this section--

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

 claims for it;

 (B) its labeling and other material required to be 

submitted 

 comply with the requirements of this subchapter;

 (C) it will perform its intended function without 

 unreasonable adverse effects on the environment; and

 (D) when used in accordance with widespread and commonly 

 recognized practice it will not generally cause unreasonable 

 adverse effects on the environment.

 The Administrator shall not make any lack of essentiality a 

 criterion for denying registration of any pesticide. Where two 

 pesticides meet the requirements of this paragraph, one should not 

 be registered in preference to the other. In considering an 

 application for the registration of a pesticide, the Administrator 

 may waive data requirements pertaining to efficacy, in which event 

 the Administrator may register the pesticide without determining 

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

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

any 

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

 established that the Administrator shall waive data requirements 

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

 (6) Denial of registration

 If the Administrator determines that the requirements of 

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

 shall notify the applicant for registration of the Administrator's 

 determination and of the Administrator's reasons (including the 

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

the 

 conditions and notifies the Administrator thereof during the 30-day 

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

 receives the notice, the Administrator may refuse to register the 

 pesticide. Whenever the Administrator refuses to register a 

 pesticide, the Administrator shall notify the applicant of the 

 Administrator's decision and of the Administrator's reasons 

 (including the factual basis) therefor. The Administrator shall 

 promptly publish in the Federal Register notice of such denial of 

 registration and the reasons therefor. Upon such notification, the 

 applicant for registration or other interested person with the 

 concurrence of the applicant shall have the same remedies as 

 provided for in section 136d of this title.

 (7) Registration under special circumstances

 Notwithstanding the provisions of paragraph (5)--

 (A) The Administrator may conditionally register or amend 
 the registration of a pesticide if the Administrator determines 

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

 substantially similar to any currently registered pesticide and 

 use thereof, or differ only in ways that would not 

significantly 

 increase the risk of unreasonable adverse effects on the 

 environment, and (ii) approving the registration or amendment 

in 

 the manner proposed by the applicant would not significantly 

 increase the risk of any unreasonable adverse effect on the 

 environment. An applicant seeking conditional registration or 

 amended registration under this subparagraph shall submit such 

 data as would be required to obtain registration of a similar 

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

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

 the Administrator may register or amend the registration of the 

 pesticide under such conditions as will require the submission 

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

 be submitted with respect to similar pesticides already 

 registered under this subchapter.

 (B) The Administrator may conditionally amend the 

 registration of a pesticide to permit additional uses of such 

 pesticide notwithstanding that data concerning the pesticide 

may 

 be insufficient to support an unconditional amendment, if the 

 Administrator determines that (i) the applicant has submitted 

 satisfactory data pertaining to the proposed additional use, 

and 

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

 applicant would not significantly increase the risk of any 

 unreasonable adverse effect on the environment. Notwithstanding 

 the foregoing provisions of this subparagraph, no registration 

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

 such pesticide if the Administrator has issued a notice stating 

 that such pesticide, or any ingredient thereof, meets or 

exceeds 

 risk criteria associated in whole or in part with human dietary 

 exposure enumerated in regulations issued under this 

subchapter, 

 and during the pendency of any risk-benefit evaluation 

initiated 

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

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

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

 Administrator determines, with the concurrence of the Secretary 

 of Agriculture, there is available an effective alternative 

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

 applicant seeking amended registration under this subparagraph 

 shall submit such data as would be required to obtain 

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

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

 pertaining to the proposed additional use) because it has not 

 yet been generated, the Administrator may amend the 

registration 

 under such conditions as will require the submission of such 

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

 submitted with respect to similar pesticides already registered 
 under this subchapter.

 (C) The Administrator may conditionally register a 

pesticide 

 containing an active ingredient not contained in any currently 

 registered pesticide for a period reasonably sufficient for the 

 generation and submission of required data (which are lacking 

 because a period reasonably sufficient for generation of the 

 data has not elapsed since the Administrator first imposed the 

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

 period the Administrator receives such data and the data do not 

 meet or exceed risk criteria enumerated in regulations issued 

 under this subchapter, and on such other conditions as the 

 Administrator may prescribe. A conditional registration under 

 this subparagraph shall be granted only if the Administrator 

 determines that use of the pesticide during such period will 

not 

 cause any unreasonable adverse effect on the environment, and 

 that use of the pesticide is in the public interest.

 (8) Interim administrative review

 Notwithstanding any other provision of this subchapter, the 

 Administrator may not initiate a public interim administrative 

 review process to develop a risk-benefit evaluation of the 

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

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

 pesticide, required under this subchapter, unless such interim 

 administrative process is based on a validated test or other 

 significant evidence raising prudent concerns of unreasonable 

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

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

 as used herein shall be published by the Administrator in the 

 Federal Register.

 (9) Labeling

 (A) Additional statements

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

 violation of this subchapter for a registrant to modify the 

 labeling of an antimicrobial pesticide product to include 

 relevant information on product efficacy, product composition, 

 container composition or design, or other characteristics that 

 do not relate to any pesticidal claim or pesticidal activity.

 (B) Requirements

 Proposed labeling information under subparagraph (A) shall 

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

 from any statement required by law or the Administrator as a 

 condition of registration, and shall be substantiated on the 

 request of the Administrator.

 (C) Notification and disapproval

 (i) Notification
 A registration may be modified under subparagraph (A) 

 if--

 (I) the registrant notifies the Administrator in 

 writing not later than 60 days prior to distribution or 

 sale of a product bearing the modified labeling; and

 (II) the Administrator does not disapprove of the 

 modification under clause (ii).

 (ii) Disapproval

 Not later than 30 days after receipt of a notification 

 under clause (i), the Administrator may disapprove the 

 modification by sending the registrant notification in 

 writing stating that the proposed language is not 

acceptable 

 and stating the reasons why the Administrator finds the 

 proposed modification unacceptable.

 (iii) Restriction on sale

 A registrant may not sell or distribute a product 

 bearing a disapproved modification.

 (iv) Objection

 A registrant may file an objection in writing to a 

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

 receipt of notification of the disapproval.

 (v) Final action

 A decision by the Administrator following receipt and 

 consideration of an objection filed under clause (iv) shall 

 be considered a final agency action.

 (D) Use dilution

 The label or labeling required under this subchapter for an 

 antimicrobial pesticide that is or may be diluted for use may 

 have a different statement of caution or protective measures 

for 

 use of the recommended diluted solution of the pesticide than 

 for use of a concentrate of the pesticide if the Administrator 

 determines that--

 (i) adequate data have been submitted to support the 

 statement proposed for the diluted solution uses; and

 (ii) the label or labeling provides adequate protection 

 for exposure to the diluted solution of the pesticide.

 (10) Expedited registration of pesticides

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

 Administrator shall, utilizing public comment, develop procedures 

 and guidelines, and expedite the review of an application for 

 registration of a pesticide or an amendment to a registration that 

 satisfies such guidelines.

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

 biological and conventional pesticides, will be considered for 

 expedited review under this paragraph. An application for 

 registration or an amendment shall qualify for expedited review if 

 use of the pesticide proposed by the application may reasonably be 
 expected to accomplish 1 or more of the following:

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

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

 (iii) Reduce the potential for contamination of 

groundwater, 

 surface water, or other valued environmental resources.

 (iv) Broaden the adoption of integrated pest management 

 strategies, or make such strategies more available or more 

 effective.

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

 an application for expedited review, shall notify the applicant 

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

 incomplete, the Administrator may either reject the request for 

 expedited review or ask the applicant for additional information to 

 satisfy the guidelines developed under subparagraph (A).

(d) Classification of pesticides

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

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

 Administrator shall classify it as being for general use or for 

 restricted use. If the Administrator determines that some of the 

 uses for which the pesticide is registered should be for general 

use 

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

 restricted use, the Administrator shall classify it for both 

general 

 use and restricted use. Pesticide uses may be classified by 

 regulation on the initial classification, and registered pesticides 

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

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

 classified for restricted use, the directions relating to its 

 general uses shall be clearly separated and distinguished from 

those 

 directions relating to its restricted uses. The Administrator may 

 require that its packaging and labeling for restricted uses shall 

be 

 clearly distinguishable from its packaging and labeling for general 

 uses.

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

 applied in accordance with its directions for use, warnings and 

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

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

 recognized practice, will not generally cause unreasonable adverse 

 effects on the environment, the Administrator will classify the 

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

 the determination applies, for general use.

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

 applied in accordance with its directions for use, warnings and 

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

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

 recognized practice, may generally cause, without additional 

 regulatory restrictions, unreasonable adverse effects on the 

 environment, including injury to the applicator, the Administrator 
 shall classify the pesticide, or the particular use or uses to 

which 

 the determination applies, for restricted use:

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

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

 determination that the acute dermal or inhalation toxicity of 

 the pesticide presents a hazard to the applicator or other 

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

the 

 restricted classification applies only by or under the direct 

 supervision of a certified applicator.

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

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

 determination that its use without additional regulatory 

 restriction may cause unreasonable adverse effects on the 

 environment, the pesticide shall be applied for any use to 

which 

 the determination applies only by or under the direct

 supervision of a certified applicator, or subject to such other 

 restrictions as the Administrator may provide by regulation. 

Any 

 such regulation shall be reviewable in the appropriate court of 

 appeals upon petition of a person adversely affected filed 

 within 60 days of the publication of the regulation in final 

 form.

 (2) Change in classification

 If the Administrator determines that a change in the 

 classification of any use of a pesticide from general use to 

 restricted use is necessary to prevent unreasonable adverse effects 

 on the environment, the Administrator shall notify the registrant 

of 

 such pesticide of such determination at least forty-five days 

before 

 making the change and shall publish the proposed change in the 

 Federal Register. The registrant, or other interested person with 

 the concurrence of the registrant, may seek relief from such 

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

 (3) Change in classification from restricted use to general 

 use

 The registrant of any pesticide with one or more uses 

classified 

 for restricted use may petition the Administrator to change any 

such 

 classification from restricted to general use. Such petition shall 

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

 classification is unnecessary because classification of the 

 pesticide for general use would not cause unreasonable adverse 

 effects on the environment. The Administrator, within sixty days 

 after receiving such petition, shall notify the registrant whether 

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

an 

 explanation therefor and any such denial shall be subject to 

 judicial review under section 136n of this title.
(e) Products with same formulation and claims

 Products which have the same formulation, are manufactured by the 

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

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

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

and labels shall be added to the registration by supplemental 

statements.

(f) Miscellaneous

 (1) Effect of change of labeling or formulation

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

 registration shall be amended to reflect such change if the 

 Administrator determines that the change will not violate any 

 provision of this subchapter.

 (2) Registration not a defense

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

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

 long as no cancellation proceedings are in effect registration of a 

 pesticide shall be prima facie evidence that the pesticide, its 

 labeling and packaging comply with the registration provisions of 

 the subchapter.

 (3) Authority to consult other Federal agencies

 In connection with consideration of any registration or 

 application for registration under this section, the Administrator 

 may consult with any other Federal agency.

 (4) Mixtures of nitrogen stabilizers and fertilizer products

 Any mixture or other combination of--

 (A) 1 or more nitrogen stabilizers registered under this 

 subchapter; and

 (B) 1 or more fertilizer products,

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

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

 mixture or other combination is accompanied by the labeling 

required 

 under this subchapter for the nitrogen stabilizer contained in the 

 mixture or other combination, the mixture or combination is mixed 

or 

 combined in accordance with such labeling, and the mixture or 

 combination does not contain any active ingredient other than the 

 nitrogen stabilizer.

(g) Registration review

 (1) General rule

 (A) Periodic review
 The registrations of pesticides are to be periodically 

 reviewed. The Administrator shall by regulation establish a 

 procedure for accomplishing the periodic review of 

 registrations. The goal of these regulations shall be a review 

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

 shall be canceled as a result of the registration review 

process 

 unless the Administrator follows the procedures and substantive 

 requirements of section 136d of this title.

 (B) Limitation

 Nothing in this subsection shall prohibit the Administrator 

 from undertaking any other review of a pesticide pursuant to 

 this subchapter.

 (2) Data

 (A) Submission required

 The Administrator shall use the authority in subsection 

 (c)(2)(B) of this section to require the submission of data 

when 

 such data are necessary for a registration review.

 (B) Data submission, compensation, and exemption

 For purposes of this subsection, the provisions of 

 subsections (c)(1), (c)(2)(B), and (c)(2)(D) of this section 

 shall be utilized for and be applicable to any data required 

for 

 registration review.

(h) Registration requirements for antimicrobial pesticides

 (1) Evaluation of process

 To the maximum extent practicable consistent with the degrees 

of 

 risk presented by an antimicrobial pesticide and the type of review 

 appropriate to evaluate the risks, the Administrator shall identify 

 and evaluate reforms to the antimicrobial registration process that 

 would reduce review periods existing as of August 3, 1996, for 

 antimicrobial pesticide product registration applications and 

 applications for amended registration of antimicrobial pesticide 

 products, including--

 (A) new antimicrobial active ingredients;

 (B) new antimicrobial end-use products;

 (C) substantially similar or identical antimicrobial 

 pesticides; and

 (D) amendments to antimicrobial pesticide registrations.

 (2) Review time period reduction goal

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

 achieve the goal of reducing the review period following submission 
 of a complete application, consistent with the degree of risk, to a 

 period of not more than--

 (A) 540 days for a new antimicrobial active ingredient 

 pesticide registration;

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

 active ingredient;

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

 (D) 90 days for a substantially similar or identical 

 antimicrobial product;

 (E) 90 days for an amendment to an antimicrobial 

 registration that does not require scientific review of data; 

 and

 (F) 120 days for an amendment to an antimicrobial 

 registration that requires scientific review of data and that 

is 

 not otherwise described in this paragraph.

 (3) Implementation

 (A) Proposed rulemaking

 (i) Issuance

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

 Administrator shall publish in the Federal Register 

proposed 

 regulations to accelerate and improve the review of 

 antimicrobial pesticide products designed to implement, to 

 the extent practicable, the goals set forth in paragraph 

 (2).

 (ii) Requirements

 Proposed regulations issued under clause (i) shall--

 (I) define the various classes of antimicrobial use 

 patterns, including household, industrial, and 

 institutional disinfectants and sanitizing pesticides, 

 preservatives, water treatment, and pulp and paper mill 

 additives, and other such products intended to 

 disinfect, sanitize, reduce, or mitigate growth or 

 development of microbiological organisms, or protect 

 inanimate objects, industrial processes or systems, 

 surfaces, water, or other chemical substances from 

 contamination, fouling, or deterioration caused by 

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

 (II) differentiate the types of review undertaken 

 for antimicrobial pesticides;

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

 risks and benefits presented by antimicrobial 

pesticides 

 and the function of review under this subchapter, 

 considering the use patterns of the product, toxicity, 

 expected exposure, and product type;

 (IV) ensure that the registration process is 

 sufficient to maintain antimicrobial pesticide efficacy 

 and that antimicrobial pesticide products continue to 

 meet product performance standards and effectiveness 

 levels for each type of label claim made; and
 (V) implement effective and reliable deadlines for 

 process management.

 (iii) Comments

 In developing the proposed regulations, the 

 Administrator shall solicit the views from registrants and 

 other affected parties to maximize the effectiveness of the 

 rule development process.

 (B) Final regulations

 (i) Issuance

 The Administrator shall issue final regulations not 

 later than 240 days after the close of the comment period 

 for the proposed regulations.

 (ii) Failure to meet goal

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

 final regulations, the Administrator shall identify the 

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

 element of the regulations included instead, and identify 

 future steps to attain the goal.

 (iii) Requirements

 In issuing final regulations, the Administrator shall--

 (I) consider the establishment of a certification 

 process for regulatory actions involving risks that can 

 be responsibly managed, consistent with the degree of 

 risk, in the most cost-efficient manner;

 (II) consider the establishment of a certification 

 process by approved laboratories as an adjunct to the 

 review process;

 (III) use all appropriate and cost-effective review 

 mechanisms, including--

 (aa) expanded use of notification and non-

 notification procedures;

 (bb) revised procedures for application review; 

 and

 (cc) allocation of appropriate resources to 

 ensure streamlined management of antimicrobial 

 pesticide registrations; and

 (IV) clarify criteria for determination of the 

 completeness of an application.

 (C) Expedited review

 This subsection does not affect the requirements or extend 

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

 of this section.

 (D) Alternative review periods

 If the final regulations to carry out this paragraph are 

not 

 effective 630 days after August 3, 1996, until the final 
 regulations become effective, the review period, beginning on 

 the date of receipt by the Agency of a complete application, 

 shall be--

 (i) 2 years for a new antimicrobial active ingredient 

 pesticide registration;

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

 active ingredient;

 (iii) 180 days for any other new antimicrobial product;

 (iv) 90 days for a substantially similar or identical 

 antimicrobial product;

 (v) 90 days for an amendment to an antimicrobial 

 registration that does not require scientific review of 

 data; and

 (vi) 120 days for an amendment to an antimicrobial 

 registration that requires scientific review of data and 

 that is not otherwise described in this subparagraph.

 (E) Wood preservatives

 An application for the registration, or for an amendment to 

 the registration, of a wood preservative product for which a 

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

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

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

 Administrator within the same period as that established under 

 this paragraph for an antimicrobial pesticide product 

 application, consistent with the degree of risk posed by the 

use 

 of the wood preservative product, if the application requires 

 the applicant to satisfy the same data requirements as are 

 required to support an application for a wood preservative 

 product that is an antimicrobial pesticide.

 (F) Notification

 (i) In general

 Subject to clause (iii), the Administrator shall notify 

 an applicant whether an application has been granted or 

 denied not later than the final day of the appropriate 

 review period under this paragraph, unless the applicant 

and 

 the Administrator agree to a later date.

 (ii) Final decision

 If the Administrator fails to notify an applicant 

within 

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

 shall be considered an agency action unlawfully withheld or 

 unreasonably delayed for purposes of judicial review under 

 chapter 7 of title 5.

 (iii) Exemption

 This subparagraph does not apply to an application for 

 an antimicrobial pesticide that is filed under subsection 

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

 1996.
 (iv) Limitation

 Notwithstanding clause (ii), the failure of the 

 Administrator to notify an applicant for an amendment to a 

 registration for an antimicrobial pesticide shall not be 

 judicially reviewable in a Federal or State court if the 

 amendment requires scientific review of data within--

 (I) the time period specified in subparagraph 

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

 subparagraph (B); or

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

 if adopted in a final regulation under subparagraph 

(B).

 (4) Annual report

 (A) Submission

 Beginning on August 3, 1996, and ending on the date that 

the 

 goals under paragraph (2) are achieved, the Administrator 

shall, 

 not later than March 1 of each year, prepare and submit an 

 annual report to the Committee on Agriculture of the House of 

 Representatives and the Committee on Agriculture, Nutrition, 

and 

 Forestry of the Senate.

 (B) Requirements

 A report submitted under subparagraph (A) shall include a 

 description of--

 (i) measures taken to reduce the backlog of pending 

 registration applications;

 (ii) progress toward achieving reforms under this 

 subsection; and

 (iii) recommendations to improve the activities of the 

 Agency pertaining to antimicrobial registrations.

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

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

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

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

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

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

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

(c), 

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

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

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

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

23, 2004, 118 Stat. 419.)

 Prior Provisions

 A prior section 3 of act June 25, 1947, was classified to section 
135a of this title prior to amendment of act June 25, 1947, by Pub. L. 

92-516.

 Amendments

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

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

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

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

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

cl. 

(iv).

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

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

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

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

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

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

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

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

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

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

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

heading.

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

(vi).

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

(vii).

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

(viii).

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

heading.

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

(E).

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

inserted headings.

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

subpars. (C) and (D).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

request that the pesticide be classified for general use, for 

restricted 
use, or for both.''

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

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

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

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

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

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

Amendment 

note below.

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

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

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

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

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

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

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

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

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

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

``shall 

classify'' in subpar. (C).

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

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

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

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

relation to a registration or reregistration of a pesticide for minor 

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

geographic area where the pesticide will not be registered for such 

use.''

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

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

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

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

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

deliver 

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

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

Administrator.''

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

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

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

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

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

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

(ii)'' 

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

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

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

 ``(A) The''

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

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

section.

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

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

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

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

inserted ``The Administrator shall issue a notice of intent to suspend 
the registration of a pesticide in accordance with the procedures 

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

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

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

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

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

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

aligned with left margin of subpar. (A).

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

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

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

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

out 

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

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

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

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

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

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

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

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

that a''.

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

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

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

however, That the Administrator''.

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

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

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

(g) 

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

reregistration of all pesticides in the most expeditious manner 

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

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

be given priority in the reregistration process.''

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

subpar. 

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

registration of a pesticide to file with the Administrator a statement 

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

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

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

an 

application shall not, without permission of the applicant, be 

considered by the Administrator in support of any other application for 

registration unless such other applicant shall have first offered to 

pay 

reasonable compensation for producing the test data to be relied upon 

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

this title. This provision with regard to compensation for producing 

the 

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

applications 

for registration or reregistration submitted on or after October 21, 

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

the Administrator shall make such determination and may fix such other 

terms and conditions as may be reasonable under the circumstances. The 
Administrator's determination shall be made on the record after notice 

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

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

Federal 

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

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

Registration shall not be delayed pending the determination of 

reasonable compensation between the applicants, by the Administrator or 

by the court.''.

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

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

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

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

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

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

for 

data requirements for registration of pesticides with respect to minor 

uses and consideration of economic factors in development of standards 

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

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

requirements pertaining to efficacy.

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

(8).

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

classification of pesticide uses by regulation on the initial 

classification and registered pesticides prior to reregistration.

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

days'' for ``30 days''.

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

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

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

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

application, inserted provision that compensation for producing test 

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

1972, and provision relating to delay of registration pending 

determination of reasonable compensation, struck out requirement that 

payment determined by court not be less than amount determined by 

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

of 

the test data''.

 Effective Date of 2004 Amendment

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

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

section 

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

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

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

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

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

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

2004].''

 Effective Date of 1988 Amendment
 Amendment by Pub. L. 100-532 effective on expiration of 60 days 

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

note under section 136 of this title.

 Effective Date of 1978 Amendment

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

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

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

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

for 

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

30, 

1978].''

 Effective Date

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

out as a note under section 136 of this title.

 Biological Pesticide Handling Study

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

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

Academy of Sciences shall conduct a study of the biological control 

programs and registration procedures utilized by the Food and Drug 

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

Environmental Protection Agency.

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

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

described in such subsection shall develop and implement a common 

process for reviewing and approving biological control applications 

that 

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

study conducted under such subsection and the recommendation of the 

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

 Education, Study, and Report

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

provided that:

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

Agency in cooperation with the Secretary of Agriculture and the 

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

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

engaged in agricultural food and fiber commodity production of any 

proposed pesticide labeling program or requirements that may be imposed 

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

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

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

such 
program and requirements based on compliance with the Endangered 

Species 

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

affected by the program; an explanation of the restriction or 

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

identification of those geographic areas affected by any pesticide 

restriction or prohibition; an identification of the effects of any 

restricted or prohibited pesticide on endangered or threatened species; 

and an identification of the endangered or threatened species along 

with 

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

located wherein the application of a pesticide will be restricted, 

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

Interior determines that the disclosure of such information may create 

a 

substantial risk of harm to such species or its habitat.

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

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

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

means available to the Administrator to implement the endangered 

species 

pesticides labeling program which would comply with the Endangered 

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

continue production of agricultural food and fiber commodities. Such 

study shall include investigation by the Administrator of the best 

available methods to develop maps and the best available alternatives 

to 

mapping as means of identifying those circumstances in which use of 

pesticides may be restricted; identification of alternatives to 

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

alternative pesticides and application methods and other agricultural 

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

restricted by the labeling program; examination of methods to improve 

coordination among the Environmental Protection Agency, Department of 

Agriculture, and Department of the Interior in administration of the 

labeling program; and analysis of the means of implementing the 

endangered species pesticides labeling program or alternatives to such 

a 

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

threatened 

species and to minimize the impacts to persons engaged in agricultural 

food and fiber commodity production and other affected pesticide users 

and applicators.

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

Agency in cooperation with the Secretary of Agriculture and the 

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

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

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

Committee on Merchant Marine and Fisheries and the Committee on 

Agriculture of the United States House of Representatives, and the 

Committee on Environment and Public Works and the Committee on 

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