Page 213 TITLE 7—AGRICULTURE § 136a this title, amending this section, sections 136a, 136a–1, 136d, 136q, 136s, 136w, 136w–3, 136x, and 136y of this title, and sections 321, 331, 333, 342, and 346a of Title 21, Food and Drugs, and enacting provisions set out as notes under section 136i–2 of this title and sections 301 and 346a of Title 21] may be cited as the ‘Food Quality Pro tection Act of 1996’.’’ [Another Food Quality Protection Act of 1996 was en acted by Pub. L. 104–170, title IV, 110 Stat. 1513, see sec tion 401(a) of Pub. L. 104–170, set out as a note under section 301 of Title 21, Food and Drugs.]

S HORT T ITLE OF 1988 A MENDMENT Section 1(a) of Pub. L. 100–532 provided that: ‘‘This Act [enacting section 136a–1 of this title, amending this section and sections 136a to 136d, 136f to 136q, 136s, 136v to 136w–2, and 136y of this title, and enacting provisions set out as notes under this section and sections 136m and 136y of this title] may be cited as the ‘Federal In secticide, Fungicide, and Rodenticide Act Amendments of 1988’.’’ S HORT T ITLE OF 1978 A MENDMENT Section 29 of Pub. L. 95–396 provided that: ‘‘This Act [enacting sections 136w–1 to 136w–4 of this title, amend ing this section and sections 136a to 136f, 136h, 136j, 136 l , 136 o , 136q, 136r, 136u to 136w, 136x, and 136y of this title, enacting provisions set out as notes under sections 136a, 136 o , and 136w–4 of this title, and amending provi sions set out as a note under this section] may be cited as the ‘Federal Pesticide Act of 1978’.’’ S HORT T ITLE Section 1 of Pub. L. 92–516 provided: ‘‘That this Act [amending this subchapter generally, enacting notes set out under this section, and amending sections 1261 and 1471 of Title 15, Commerce and Trade, and sections 321 and 346a of Title 21, Foods and Drugs] may be cited as the ‘Federal Environmental Pesticide Control Act of 1972’.’’ Section 1(a) of act June 25, 1947, as added by Pub. L. 92–516, §2, provided that: ‘‘This Act [enacting this sub chapter] may be cited as the ‘Federal Insecticide, Fun gicide, and Rodenticide Act’.’’ T ERMINATION OF T RUST T ERRITORY OF THE P ACIFIC I SLANDS For termination of Trust Territory of the Pacific Is lands, see note set out preceding section 1681 of Title 48, Territories and Insular Possessions. F EDERAL C OMPLIANCE W ITH P OLLUTION C ONTROL

S TANDARDS For provisions relating to the responsibility of the head of each Executive agency for compliance with ap plicable pollution control standards, see Ex. Ord. No. 12088, Oct. 13, 1978, 43 F.R. 47707, set out as a note under section 4321 of Title 42, The Public Health and Welfare. § 136a. Registration of pesticides (a) Requirement of registration Except as provided by this subchapter, no per son in any State may distribute or sell to any person any pesticide that is not registered under this subchapter. To the extent necessary to pre vent unreasonable adverse effects on the envi ronment, 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 sec tion 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 estab lishment to another registered establishment operated by the same producer solely for pack aging at the second establishment or for use as a constituent part of another pesticide pro duced at the second establishment; or (2) the transfer is pursuant to and in accord ance 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 ap pear 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 classi fied for general use or for restricted use, or for both; and (F) except as otherwise provided in para graph (2)(D), if requested by the Adminis trator, 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 follow ing provisions: (i) With respect to pesticides containing active ingredients that are initially reg istered under this subchapter after Sep tember 30, 1978, data submitted to support the application for the original registra tion 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 writ ten permission of the original data submit ter, 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 defen sive data. (ii) The period of exclusive data use pro vided under clause (i) shall be extended 1 additional year for each 3 minor uses reg istered after August 3, 1996, and within 7 years of the commencement of the exclu sive use period, up to a total of 3 addi tional years for all minor uses registered by the Administrator if the Administrator, in consultation with the Secretary of Agri culture, determines that, based on infor mation provided by an applicant for reg istration or a registrant, that— (I) there are insufficient efficacious al ternative registered pesticides available for the use; (II) the alternatives to the minor use pesticide pose greater risks to the envi ronment or human health;Page 214 TITLE 7—AGRICULTURE § 136a (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 inte grated pest management program. The registration of a pesticide for a minor use on a crop grouping established by the Administrator shall be considered for pur poses of this clause 1 minor use for each representative crop for which data are pro vided 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 deter mines 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 exist ing registration, to support or maintain in effect an existing registration, or for re registration, the Administrator may, with out 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 accom panied by evidence of delivery to the origi nal 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 origi nal data submitter of the offer to com pensate, 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, ei ther person may initiate binding arbitra tion proceedings by requesting the Federal Mediation and Conciliation Service to ap point an arbitrator from the roster of arbi trators maintained by such Service. The procedure and rules of the Service shall be applicable to the selection of such arbitra tor 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 determina tion, 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 support ing affidavits attesting to specific in stances of such fraud, misrepresentation, or other misconduct. The parties to the ar bitration shall share equally in the pay ment of the fee and expenses of the arbi trator. If the Administrator determines that an original data submitter has failed to participate in a procedure for reaching an agreement or in an arbitration proceed ing as required by this subparagraph, or failed to comply with the terms of an agreement or arbitration decision concern ing 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. Not withstanding any other provision of this subchapter, if the Administrator deter mines that an applicant has failed to par ticipate 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 com pensation 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 Ad ministrator takes action under either of the preceding two sentences, the Adminis trator 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 de nied or canceled under this subparagraph, the Administrator may make such order as the Administrator deems appropriate con cerning the continued sale and use of ex isting stocks of such pesticide. Registra tion action by the Administrator shall not be delayed pending the fixing of compensa tion. (iv) After expiration of any period of ex clusive use and any period for which com pensation 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 reg istered. (vi) With respect to data submitted after August 3, 1996, by an applicant or reg istrant 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 dataPage 215 TITLE 7—AGRICULTURE § 136a submitter, be considered by the Adminis trator to support an application for a minor use by another person during the pe riod of 10 years following the date of sub mission of such data. The applicant or reg istrant at the time the new minor use is requested shall notify the Administrator that to the best of their knowledge the ex clusive use period for the pesticide has ex pired 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 sub section 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 registra tion of a pesticide be expedited, an expla nation 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 guide lines from time to time. If thereafter the Ad ministrator 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 require ments for the registration of pesticides with respect to minor uses, shall make such standards commensurate with the antici pated extent of use, pattern of use, the pub lic health and agricultural need for such minor use, and the level and degree of poten tial 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 sub chapter, any field residue data from a geo graphic 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 distribu tion, and the impact of the cost of meeting the requirements on the incentives for any potential registrant to undertake the devel opment of the required data. Except as pro vided by section 136h of this title, within 30 days after the Administrator registers a pes ticide under this subchapter the Adminis trator shall make available to the public the data called for in the registration statement together with such other scientific informa tion 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 de termination 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 re ceipt of notification that it is taking appro priate 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 sup port of maintenance of such registration. The Administrator shall issue a notice of in tent to suspend the registration of a pes ticide in accordance with the procedures pre scribed by clause (iv) if a registrant fails to comply with this clause. (iii) If, at the end of sixty days after advis ing the Administrator of their agreement to develop jointly, or share in the cost of devel oping, 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 Con ciliation 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 determina tion of the arbitrator shall be final and con clusive, and no official or court of the United States shall have power or jurisdic tion to review any such findings and deter mination, except for fraud, misrepresenta tion, or other misconduct by one of the par ties to the arbitration or the arbitrator where there is a verified complaint with sup porting affidavits attesting to specific in stances of such fraud, misrepresentation, or other misconduct. All parties to the arbitra tion 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 de termines that a registrant, within the time required by the Administrator, has failed to take appropriate steps to secure the data re quired under this subparagraph, to partici pate in a procedure for reaching agreement concerning a joint data development ar rangement under this subparagraph or in an arbitration proceeding as required by this subparagraph, or to comply with the terms of an agreement or arbitration decision con -Page 216 TITLE 7—AGRICULTURE § 136a cerning a joint data development arrange ment under this subparagraph, the Adminis trator may issue a notice of intent to sus pend such registrant’s registration of the pesticide for which additional data is re quired. The Administrator may include in the notice of intent to suspend such provi sions as the Administrator deems appro priate concerning the continued sale and use of existing stocks of such pesticide. Any sus pension 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 dur ing that time a request for hearing is made by a person adversely affected by the notice or the registrant has satisfied the Adminis trator that the registrant has complied fully with the requirements that served as a basis for the notice of intent to suspend. If a hear ing is requested, a hearing shall be con ducted 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 addi tional data is required, and whether the Ad ministrator’s determination with respect to the disposition of existing stocks is consist ent 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 Ad ministrator 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 subpara graph shall be subject to the provisions of paragraph (1)(D). Whenever such data are submitted jointly by two or more reg istrants, 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 sub paragraph 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 re quest for such an extension, provides a schedule, including interim dates to meas ure progress, to assure that the data pro duction will be completed before the expi ration of the extension period; (III) the Administrator has determined that such extension will not significantly delay the Administrator’s schedule for is suing a reregistration eligibility deter mination 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 Admin istrator shall monitor the development of the data and shall ensure that the reg istrant is meeting the schedule for the pro duction 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 Adminis trator may proceed in accordance with clause (iv) regarding the continued reg istration of the affected products with the minor use and shall inform the public of such action. Notwithstanding the provi sions of this clause, the Administrator may take action to modify or revoke the extension under this clause if the Adminis trator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall pro vide, in writing to the registrant, a notice revoking the extension of time for submis sion of data. Such data shall instead be due in accordance with the date estab lished by the Administrator for the sub mission 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 Adminis trator determines that the absence of the data is significant enough to cause human health or environmental concerns. On the basis of such determination, the Adminis trator may refuse the request for extension by the registrant. Upon receipt of the re quest from the registrant, the Administrator shall publish in the Federal Register a no tice 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 develop ment of the data for the uses being sup ported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determinesPage 217 TITLE 7—AGRICULTURE § 136a that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in ac cordance with clause (iv) of this subpara graph 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 Ad ministrator determines that the continu ation of the minor use may cause an unrea sonable 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 tem porary extension and establish a new effec tive date by which the minor use shall be de leted from the registration. (viii)(I) If data required to support reg istration of a pesticide under subparagraph (A) is requested by a Federal or State regu latory authority, the Administrator shall, to the extent practicable, coordinate data re quirements, test protocols, timetables, and standards of review and reduce burdens and redundancy caused to the registrant by mul tiple 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 proc ess to identify and assist in alleviating fu ture 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 reg istration 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 pes ticide from another producer in order to for mulate such purchased pesticide into the pesticide that is the subject of the applica tion 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 require ments 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 envi ronment. (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 Administra tor’s determination that it does not comply with the provisions of the subchapter in ac cordance with paragraph (6). (B) Identical or substantially similar (i) The Administrator shall, as expedi tiously as possible, review and act on any application received by the Administrator that— (I) proposes the initial or amended reg istration of an end-use pesticide that, if registered as proposed, would be identical or substantially similar in composition and labeling to a currently-registered pes ticide 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 reg istration of a registered pesticide that does not require scientific review of data. (ii) In expediting the review of an applica tion for an action described in clause (i), the Administrator shall— (I) review the application in accordance with section 136w–8(f)(4)(B) of this title and, if the application is found to be in complete, reject the application; (II) not later than the applicable deci sion review time established pursuant to section 136w–8(f)(4)(B) of this title, or, if no review time is established, not later than 90 days after receiving a complete applica tion, notify the registrant if the applica tion 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 expedi tiously 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 reg istered 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 pos sible’’ means that the Administrator shall, to the greatest extent practicable, com plete 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 aPage 218 TITLE 7—AGRICULTURE § 136a 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 Adminis trator, serve as a replacement for any use which has been canceled in the 5 years pre ceding the receipt of the application, or a minor use that in the opinion of the Ad ministrator 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 reg istrant shall have a full-time period for pro viding such data. For purposes of this sub paragraph, 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 Fed eral Register, promptly after receipt of the statement and other data required pursuant to paragraphs (1) and (2), a notice of each applica tion for registration of any pesticide if it con tains 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 re quired to be submitted comply with the re quirements of this subchapter; (C) it will perform its intended function without unreasonable adverse effects on the environment; and (D) when used in accordance with wide spread and commonly recognized practice it will not generally cause unreasonable ad verse effects on the environment. The Administrator shall not make any lack of essentiality a criterion for denying registra tion 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 pes ticide is found to be efficacious by any State under section 136v(c) of this title, a presump tion 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 re quirements of paragraph (5) for registration are not satisfied, the Administrator shall no tify the applicant for registration of the Ad ministrator’s determination and of the Admin istrator’s reasons (including the factual basis) therefor, and that, unless the applicant cor rects the conditions and notifies the Adminis trator thereof during the 30-day period begin ning with the day after the date on which the applicant receives the notice, the Adminis trator may refuse to register the pesticide. Whenever the Administrator refuses to reg ister a pesticide, the Administrator shall no tify the applicant of the Administrator’s deci sion and of the Administrator’s reasons (in cluding the factual basis) therefor. The Ad ministrator shall promptly publish in the Fed eral Register notice of such denial of registra tion and the reasons therefor. Upon such noti fication, 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 pes ticide if the Administrator determines that (i) the pesticide and proposed use are iden tical or substantially similar to any cur rently registered pesticide and use thereof, or differ only in ways that would not signifi cantly increase the risk of unreasonable ad verse effects on the environment, and (ii) ap proving the registration or amendment in the manner proposed by the applicant would not significantly increase the risk of any un reasonable adverse effect on the environ ment. An applicant seeking conditional reg istration 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 per mit additional uses of such pesticide not withstanding that data concerning the pes ticide may be insufficient to support an un conditional amendment, if the Adminis trator determines that (i) the applicant has submitted satisfactory data pertaining to the proposed additional use, and (ii) amend ing the registration in the manner proposed by the applicant would not significantly in -Page 219 TITLE 7—AGRICULTURE § 136a crease the risk of any unreasonable adverse effect on the environment. Notwithstanding the foregoing provisions of this subpara graph, 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 in gredient thereof, meets or exceeds risk cri teria associated in whole or in part with human dietary exposure enumerated in regu lations issued under this subchapter, and during the pendency of any risk-benefit eval uation initiated by such notice, if (I) the ad ditional 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 deter mines, with the concurrence of the Sec retary of Agriculture, there is available an effective alternative pesticide that does not meet or exceed such risk criteria. An appli cant 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 pro posed additional use) because it has not yet been generated, the Administrator may amend the registration under such condi tions 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 in gredient not contained in any currently reg istered 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 Admin istrator first imposed the data requirement) on the condition that by the end of such pe riod the Administrator receives such data and the data do not meet or exceed risk cri teria enumerated in regulations issued under this subchapter, and on such other condi tions as the Administrator may prescribe. A conditional registration under this subpara graph shall be granted only if the Adminis trator determines that use of the pesticide during such period will not cause any unrea sonable 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 initi ate 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 pes ticide, required under this subchapter, unless such interim administrative process is based on a validated test or other significant evi dence raising prudent concerns of unreason able adverse risk to man or to the environ ment. Notice of the definition of the terms ‘‘validated test’’ and ‘‘other significant evi dence’’ 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 pes ticidal activity. (B) Requirements Proposed labeling information under sub paragraph (A) shall not be false or mislead ing, shall not conflict with or detract from any statement required by law or the Ad ministrator 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 Adminis trator 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 dis approve of the modification under clause (ii). (ii) Disapproval Not later than 30 days after receipt of a notification under clause (i), the Adminis trator may disapprove the modification by sending the registrant notification in writ ing 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 modifica tion. (iv) Objection A registrant may file an objection in writing to a disapproval under clause (ii) not later than 30 days after receipt of noti fication of the disapproval. (v) Final action A decision by the Administrator follow ing receipt and consideration of an objec tion filed under clause (iv) shall be consid ered 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 protec tive measures for use of the recommended diluted solution of the pesticide than for use of a concentrate of the pesticide if the Ad ministrator determines that—Page 220 TITLE 7—AGRICULTURE § 136a (i) adequate data have been submitted to support the statement proposed for the di luted solution uses; and (ii) the label or labeling provides ade quate protection for exposure to the di luted 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 conven tional pesticides, will be considered for expe dited review under this paragraph. An applica tion for registration or an amendment shall qualify for expedited review if use of the pes ticide proposed by the application may reason ably 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 non target organisms. (iii) Reduce the potential for contamina tion 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 expe dited review, shall notify the applicant wheth er 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 sub paragraph (A). (d) Classification of pesticides (1) Classification for general use, restricted use, or both (A) As a part of the registration of a pes ticide 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 re stricted use, the Administrator shall classify it for both general use and restricted use. Pes ticide uses may be classified by regulation on the initial classification, and registered pes ticides may be classified prior to reregistra tion. If some of the uses of the pesticide are classified for general use, and other uses are classified for restricted use, the directions re lating to its general uses shall be clearly sepa rated and distinguished from those directions relating to its restricted uses. The Adminis trator may require that its packaging and la beling for restricted uses shall be clearly dis tinguishable 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 unreason able 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 addi tional 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 ap plies, for restricted use: (i) If the Administrator classifies a pes ticide, 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 ap plicator or other persons, the pesticide shall be applied for any use to which the re stricted classification applies only by or under the direct supervision of a certified applicator. (ii) If the Administrator classifies a pes ticide, 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 de termination applies only by or under the di rect supervision of a certified applicator, or subject to such other restrictions as the Ad ministrator 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 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 pe tition the Administrator to change any such classification from restricted to general use. Such petition shall set out the basis for the registrant’s position that restricted use classi -Page 221 TITLE 7—AGRICULTURE § 136a fication is unnecessary because classification of the pesticide for general use would not cause unreasonable adverse effects on the en vironment. 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 label ing of which contains the same claims, and the labels of which bear a designation identifying the product as the same pesticide may be reg istered as a single pesticide; and additional names and labels shall be added to the registra tion 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 de termines 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 provi sions of the subchapter. (3) Authority to consult other Federal agencies In connection with consideration of any reg istration or application for registration under this section, the Administrator may consult with any other Federal agency. (4) Mixtures of nitrogen stabilizers and fer tilizer products Any mixture or other combination of— (A) 1 or more nitrogen stabilizers reg istered 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 136 o (a)(2) of this title if the mixture or other combination is accompanied by the labeling required under this subchapter for the nitro gen stabilizer contained in the mixture or other combination, the mixture or combina tion is mixed or combined in accordance with such labeling, and the mixture or combination does not contain any active ingredient other than the nitrogen stabilizer. (g) Registration review (1) General rule (A) Periodic review (i) In general The registrations of pesticides are to be periodically reviewed. (ii) Regulations In accordance with this subparagraph, the Administrator shall by regulation es tablish a procedure for accomplishing the periodic review of registrations. (iii) Initial registration review The Administrator shall complete the registration review of each pesticide or pesticide case, which may be composed of 1 or more active ingredients and the prod ucts associated with the active ingredi ents, not later than the later of— (I) October 1, 2022; or (II) the date that is 15 years after the date on which the first pesticide contain ing a new active ingredient is registered. (iv) Subsequent registration review Not later than 15 years after the date on which the initial registration review is completed under clause (iii) and each 15 years thereafter, the Administrator shall complete a subsequent registration review for each pesticide or pesticide case. (v) Cancellation No registration shall be canceled as a re sult of the registration review process un less the Administrator follows the proce dures and substantive requirements of sec tion 136d of this title. (B) Docketing (i) In general Subject to clause (ii), after meeting with 1 or more individuals that are not govern ment employees to discuss matters relat ing to a registration review, the Adminis trator shall place in the docket minutes of the meeting, a list of attendees, and any documents exchanged at the meeting, not later than the earlier of— (I) the date that is 45 days after the meeting; or (II) the date of issuance of the registra tion review decision. (ii) Protected information The Administrator shall identify, but not include in the docket, any confidential business information the disclosure of which is prohibited by section 136h of this title. (C) Limitation Nothing in this subsection shall prohibit the Administrator from undertaking any other review of a pesticide pursuant to this subchapter. (2) Data (A) Submission required The Administrator shall use the authority in subsection (c)(2)(B) of this section to re quire the submission of data when such data are necessary for a registration review. (B) Data submission, compensation, and ex emption For purposes of this subsection, the provi sions 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.Page 222 TITLE 7—AGRICULTURE § 136a (h) Registration requirements for antimicrobial pesticides (1) Evaluation of process To the maximum extent practicable consist ent with the degrees of risk presented by an antimicrobial pesticide and the type of review appropriate to evaluate the risks, the Admin istrator shall identify and evaluate reforms to the antimicrobial registration process that would reduce review periods existing as of Au gust 3, 1996, for antimicrobial pesticide prod uct registration applications and applications for amended registration of antimicrobial pes ticide products, including— (A) new antimicrobial active ingredients; (B) new antimicrobial end-use products; (C) substantially similar or identical anti microbial 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 reduc ing 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 anti microbial product; (D) 90 days for a substantially similar or identical antimicrobial product; (E) 90 days for an amendment to an anti microbial registration that does not require scientific review of data; and (F) 120 days for an amendment to an anti microbial registration that requires sci entific review of data and that is not other wise 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 anti microbial use patterns, including house hold, industrial, and institutional dis infectants and sanitizing pesticides, pre servatives, water treatment, and pulp and paper mill additives, and other such products intended to disinfect, sanitize, reduce, or mitigate growth or develop ment of microbiological organisms, or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from con tamination, fouling, or deterioration caused by bacteria, viruses, fungi, proto zoa, algae, or slime; (II) differentiate the types of review undertaken for antimicrobial pesticides; (III) conform the degree and type of re view to the risks and benefits presented by antimicrobial pesticides and the func tion of review under this subchapter, considering the use patterns of the prod uct, toxicity, expected exposure, and product type; (IV) ensure that the registration proc ess is sufficient to maintain anti microbial pesticide efficacy and that antimicrobial pesticide products con tinue 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 regu lations not later than 240 days after the close of the comment period for the pro posed regulations. (ii) Failure to meet goal If a goal described in paragraph (2) is not met by the final regulations, the Adminis trator shall identify the goal, explain why the goal was not attained, describe the ele ment of the regulations included instead, and identify future steps to attain the goal. (iii) Requirements In issuing final regulations, the Admin istrator shall— (I) consider the establishment of a cer tification 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 labora tories as an adjunct to the review proc ess; (III) use all appropriate and cost-effec tive review mechanisms, including— (aa) expanded use of notification and non-notification procedures; (bb) revised procedures for applica tion review; and (cc) allocation of appropriate re sources to ensure streamlined manage ment of antimicrobial pesticide reg istrations; and (IV) clarify criteria for determination of the completeness of an application. (C) Expedited review This subsection does not affect the re quirements or extend the deadlines or review periods contained in subsection (c)(3) of this section.Page 223 TITLE 7—AGRICULTURE § 136a (D) Alternative review periods If the final regulations to carry out this paragraph are not effective 630 days after August 3, 1996, until the final regulations be come 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 anti microbial product; (iv) 90 days for a substantially similar or identical antimicrobial product; (v) 90 days for an amendment to an anti microbial registration that does not re quire 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 Admin istrator within the same period as that es tablished under this paragraph for an anti microbial pesticide product application, con sistent 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 preserv ative product that is an antimicrobial pes ticide. (F) Notification (i) In general Subject to clause (iii), the Administrator shall notify an applicant whether an appli cation has been granted or denied not later than the final day of the appropriate re view 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 re quired under clause (i), the failure shall be considered an agency action unlawfully withheld or unreasonably delayed for pur poses 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 appli cant 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 sub paragraph (D)(vi), in the absence of a final regulation under subparagraph (B); or (II) the time period specified in para graph (2)(F), if adopted in a final regula tion 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 Representa tives and the Committee on Agriculture, Nu trition, 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 ac tivities of the Agency pertaining to anti microbial registrations. (June 25, 1947, ch. 125, §3, as added Pub. L. 92–516, §2, Oct. 21, 1972, 86 Stat. 979; amended Pub. L. 94–140, §12, Nov. 28, 1975, 89 Stat. 755; Pub. L. 95–396, §§2(a), 3–8, Sept. 30, 1978, 92 Stat. 820, 824–827; Pub. L. 100–532, title I, §§102(b), 103, title VI, §601(b)(1), title VIII, §801(b), Oct. 25, 1988, 102 Stat. 2667, 2677, 2680; Pub. L. 101–624, title XIV, §1492, Nov. 28, 1990, 104 Stat. 3628; Pub. L. 102–237, title X, §1006(a)(3), (b)(1), (2), (c), Dec. 13, 1991, 105 Stat. 1894–1896; Pub. L. 104–170, title I, §§105(b), 106(b), title II, §§210(b), (c)(1), (d), (e), (f)(2), 222–224, 231, 250, Aug. 3, 1996, 110 Stat. 1491, 1494–1497, 1499, 1503, 1504, 1508, 1510; Pub. L. 108–199, div. G, title V, §501(b), Jan. 23, 2004, 118 Stat. 419; Pub. L. 110–94, §§2, 3, Oct. 9, 2007, 121 Stat. 1000.) P RIOR P ROVISIONS 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. A MENDMENTS 2007—Subsec. (c)(3)(B)(ii)(I). Pub. L. 110–94, §2(1), sub stituted ‘‘review the application in accordance with section 136w–8(f)(4)(B) of this title and,’’ for ‘‘within 45 days after receiving the application, notify the reg istrant whether or not the application is complete and,’’. Subsec. (c)(3)(B)(ii)(II). Pub. L. 110–94, §2(2), sub stituted ‘‘not later than the applicable decision review time established pursuant to section 136w–8(f)(4)(B) of this title, or, if no review time is established, not later than’’ for ‘‘within’’. Subsec. (g)(1)(A). Pub. L. 110–94, §3(1), designated first sentence as cl. (i) and inserted heading, designated sec ond sentence as cl. (ii), inserted heading, and sub stituted ‘‘In accordance with this subparagraph, the Administrator’’ for ‘‘The Administrator’’, added cls. (iii) and (iv), designated fourth sentence as cl. (v) andPage 224 TITLE 7—AGRICULTURE § 136a inserted heading, and struck out third sentence which read as follows: ‘‘The goal of these regulations shall be a review of a pesticide’s registration every 15 years.’’ Subsec. (g)(1)(B), (C). Pub. L. 110–94, §3(2), (3), added subpar. (B) and redesignated former subpar. (B) as (C). 2004—Subsec. (h)(2)(F). Pub. L. 108–199, §501(b)(1), sub stituted ‘‘120 days’’ for ‘‘90 to 180 days’’. Subsec. (h)(3)(D)(vi). Pub. L. 108–199, §501(b)(2)(A), substituted ‘‘120 days’’ for ‘‘240 days’’. Subsec. (h)(3)(F)(iv). Pub. L. 108–199, §501(b)(2)(B), added cl. (iv). 1996—Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104–170, §210(b), added cls. (ii), (v), and (vi), redesignated former cls. (ii) and (iii) as (iii) and (iv), respectively, and in cl. (iv) substituted ‘‘(i), (ii), and (iii)’’ for ‘‘(i) and (ii)’’. Subsec. (c)(1)(G). Pub. L. 104–170, §250(1), added sub par. (G). Subsec. (c)(2)(A). Pub. L. 104–170, §§210(d)(1), 231, in serted heading, inserted ‘‘the public health and agricul tural need for such minor use,’’ after ‘‘pattern of use,’’, and substituted ‘‘potential beneficial or adverse effects on man and the environment’’ for ‘‘potential exposure of man and the environment to the pesticide’’. Subsec. (c)(2)(B). Pub. L. 104–170, §210(d)(2), inserted heading. Subsec. (c)(2)(B)(vi). Pub. L. 104–170, §210(c)(1), added cl. (vi). Subsec. (c)(2)(B)(vii). Pub. L. 104–170, §210(f)(2), added cl. (vii). Subsec. (c)(2)(B)(viii). Pub. L. 104–170, §222, added cl. (viii). Subsec. (c)(2)(C). Pub. L. 104–170, §210(d)(3), inserted heading. Subsec. (c)(2)(E). Pub. L. 104–170, §210(d)(4), added sub par. (E). Subsec. (c)(3)(A), (B). Pub. L. 104–170, §210(e)(1), (2), inserted headings. Subsec. (c)(3)(C), (D). Pub. L. 104–170, §210(e)(3), added subpars. (C) and (D). Subsec. (c)(9). Pub. L. 104–170, §223, added par. (9). Subsec. (c)(10). Pub. L. 104–170, §250(2), added par. (10). Subsec. (f)(4). Pub. L. 104–170, §105(b), added par. (4). Subsec. (g). Pub. L. 104–170, §106(b), added subsec. (g). Subsec. (h). Pub. L. 104–170, §224, added subsec. (h). 1991—Subsec. (c)(1)(D). Pub. L. 102–237, §1006(a)(3)(B), (C), added subpar. (D) and redesignated former subpar. (D) as (F). Subsec. (c)(1)(E). Pub. L. 102–237, §1006(a)(3)(A), (C), added subpar. (E) and struck out former subpar. (E) which read as follows: ‘‘the complete formula of the pesticide; and’’. Subsec. (c)(1)(F). Pub. L. 102–237, §1006(a)(3)(A), (B), (D), redesignated former subpar. (D) as (F), in cl. (i) substituted ‘‘With’’ for ‘‘with’’ and a period for semi colon at end, in cl. (ii) substituted ‘‘Except’’ for ‘‘ex cept’’ and a period for semicolon at end, in cl. (iii) sub stituted ‘‘After’’ for ‘‘after’’ and a period for semicolon at end, and struck out former subpar. (F) which read as follows: ‘‘a request that the pesticide be classified for general use, for restricted use, or for both.’’ Subsec. (c)(2)(A). Pub. L. 102–237, §1006(b)(1), (2), sub stituted ‘‘the Administrator’’ for ‘‘he’’ before ‘‘re quires’’, ‘‘shall permit’’, ‘‘shall make’’, and ‘‘deems’’, and substituted ‘‘the Administrator’s’’ for ‘‘his’’. Subsec. (c)(2)(D). Pub. L. 102–237, §1006(c), clarified amendment made by Pub. L. 100–532, §102(b)(2)(A). See 1988 Amendment note below. Subsec. (c)(3)(A). Pub. L. 102–237, §1006(b)(2), sub stituted ‘‘the Administrator’s’’ for ‘‘his’’. Subsec. (c)(5). Pub. L. 102–237, §1006(b)(1), substituted ‘‘the Administrator’’ for ‘‘he’’ before ‘‘determines’’. Subsec. (c)(6). Pub. L. 102–237, §1006(b)(1), (2), sub stituted ‘‘the Administrator’’ for ‘‘he’’ before ‘‘shall no tify’’ in two places and ‘‘the Administrator’s’’ for ‘‘his’’ in four places. Subsec. (d)(1). Pub. L. 102–237, §1006(b)(1), substituted ‘‘the Administrator’’ for ‘‘he’’ before ‘‘shall classify it for both’’ in subpar. (A), before ‘‘will classify’’ in sub par. (B), and before ‘‘shall classify’’ in subpar. (C). Subsec. (d)(2). Pub. L. 102–237, §1006(b)(1), substituted ‘‘the Administrator’’ for ‘‘he’’ before ‘‘shall notify’’. 1990—Subsec. (c)(2)(A). Pub. L. 101–624 inserted after third sentence ‘‘The Administrator shall not require a person to submit, in relation to a registration or rereg istration of a pesticide for minor agricultural use under this subchapter, any field residue data from a geo graphic area where the pesticide will not be registered for such use.’’ 1988—Subsec. (a). Pub. L. 100–532, §601(b)(1), sub stituted ‘‘Requirement of registration’’ for ‘‘Require ment’’ 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 re ceived) deliver or offer to deliver, to any person any pesticide which is not registered with the Adminis trator.’’ Subsec. (c)(1)(D). Pub. L. 100–532, §801(b)(1)–(4), in in troductory provisions, substituted ‘‘paragraph (2)(D)’’ for ‘‘subsection (c)(2)(D) of this section’’, in cl. (i), sub stituted ‘‘(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 ‘‘subpara graphs (D)(i) and (D)(ii) of this paragraph’’. Subsec. (c)(2)(A). Pub. L. 100–532, §801(b)(5)(A), (B), substituted ‘‘(2) Data in support of registration.— ‘‘(A) The’’ for ‘‘(2)(A) Data in support of registration.—The’’, and directed that subpar. (A) be aligned with left margin of subsec. (d)(1)(A) of this section. Subsec. (c)(2)(B). Pub. L. 100–532, §§102(b)(1), 801(b)(5)(C)–(F), substituted ‘‘(B)(i) If’’ for ‘‘(B) Addi tional data to support existing registration.—(i) If’’, di rected that cls. (ii) to (v) be aligned with left margin of subpar. (A), in cls. (ii) and (iii), inserted ‘‘The Adminis trator shall issue a notice of intent to suspend the reg istration of a pesticide in accordance with the proce dures prescribed by clause (iv) if a registrant fails to comply with this clause.’’, in cl. (iv), substituted ‘‘title. The only’’ for ‘‘title: Provided , that the only’’, and in cl. (v), substituted ‘‘paragraph (1)(D)’’ for ‘‘subsection (c)(1)(D) of this section’’. Subsec. (c)(2)(C). Pub. L. 100–532, §801(b)(5)(G), (H), struck out ‘‘Simplified procedures’’ after ‘‘(C)’’ and di rected that text be aligned with left margin of subpar. (A). Subsec. (c)(2)(D). Pub. L. 100–532, §102(b)(2)(A), and Pub. L. 102–237, §1006(c), substituted ‘‘the pesticide that is the subject of the application’’ for ‘‘an end-use prod uct’’. Subsec. (c)(2)(D)(i). Pub. L. 100–532, §102(b)(2)(B), struck out ‘‘the safety of’’ after ‘‘data pertaining to’’. Subsec. (c)(3). Pub. L. 100–532, §103, substituted ‘‘(A) The Administrator’’ for ‘‘The Administrator’’ and added subpar. (B). Subsec. (c)(7). Pub. L. 100–532, §801(b)(6), in introduc tory provisions, substituted ‘‘paragraph (5)’’ for ‘‘sub section (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), sub stituted ‘‘prescribe. A’’ for ‘‘prescribe: Provided , that a’’. Subsec. (d)(1)(A). Pub. L. 100–532, §801(b)(7), sub stituted ‘‘restricted use. If’’ for ‘‘restricted use, pro vided that if’’ and ‘‘restricted uses. The Administrator’’ for ‘‘restricted uses: Provided, however , That the Admin istrator’’. Subsec. (f)(2). Pub. L. 100–532, §801(b)(8), substituted ‘‘this subchapter. As’’ for ‘‘this subchapter: Provided , That as’’. Subsec. (g). Pub. L. 100–532, §801(b)(9), struck out sub sec. (g) which read as follows: ‘‘The Administrator shall accomplish the reregistration of all pesticides in the most expeditious manner practicable: Provided , That, to the extent appropriate, any pesticide that results in a postharvest residue in or on food or feed crops shall be given priority in the reregistration process.’’ 1978—Subsec. (c)(1)(D). Pub. L. 95–396, §2(a)(1), added subpar. (D), and struck out provisions which requiredPage 225 TITLE 7—AGRICULTURE § 136a the applicant for registration of a pesticide to file with the Administrator a statement containing ‘‘if re quested 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 applica tion 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 re registration submitted on or after October 21, 1972. If the parties cannot agree on the amount and method of payment, the Administrator shall make such deter mination and may fix such other terms and conditions as may be reasonable under the circumstances. The Ad ministrator’s determination shall be made on the record after notice and opportunity for hearing. If ei ther 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 com pensation between the applicants, by the Adminis trator or by the court.’’. Subsec. (c)(2). Pub. L. 95–396, §§2(a)(2)(A)–(D), 3, 4, des ignated existing provisions as subpar. (A), inserted in second sentence ‘‘under subparagraph (B) of this para graph’’ after ‘‘kind of information’’, struck out from in troductory text of third sentence ‘‘subsection (c)(1)(D) of this section and’’ after ‘‘Except as provided by’’, and inserted provisions relating to establishment of stand ards for data requirements for registration of pesticides with respect to minor uses and consideration of eco nomic factors in development of standards and cost of development, and added subpars. (B) to (D). Subsec. (c)(5). Pub. L. 95–396, §5, provided for waiver of data requirements pertaining to efficacy. Subsec. (c)(7), (8). Pub. L. 95–396, §6, added pars. (7) and (8). Subsec. (d)(1)(A). Pub. L. 95–396, §7(1), authorized classification of pesticide uses by regulation on the ini tial classification and registered pesticides prior to re registration. Subsec. (d)(2). Pub. L. 95–396, §7(2), substituted ‘‘forty-five days’’ for ‘‘30 days’’. Subsec. (d)(3). Pub. L. 95–396, §7(3), added par. (3). Subsec. (g). Pub. L. 95–396, §8, added subsec. (g). 1975—Subsec. (c)(1)(D). Pub. L. 94–140 inserted excep tion relating to test data submitted on or after Janu ary 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 Adminis trator, and substituted ‘‘If either party’’ for ‘‘If the owner of the test data’’.

E FFECTIVE D ATE OF 2007 A MENDMENT Pub. L. 110–94, §6, Oct. 9, 2007, 121 Stat. 1007, provided that: ‘‘This Act [see Short Title of 2007 Amendment note set out under section 136 of this title] and the amendments made by this Act take effect on October 1, 2007.’’ E FFECTIVE D ATE OF 2004 A MENDMENT Pub. L. 108–199, div. G, title V, §501(h), Jan. 23, 2004, 118 Stat. 434, provided that: ‘‘Except as otherwise pro vided 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].’’

E FFECTIVE D ATE OF 1988 A MENDMENT 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.

E FFECTIVE D ATE OF 1978 A MENDMENT Section 2(b) of Pub. L. 95–396 provided that: ‘‘The amendment to section 3(c)(1)(D) of the Federal Insecti cide, 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 registra tion approved after the date of enactment of this Act [Sept. 30, 1978].’’ E FFECTIVE D ATE For effective date of section, see section 4 of Pub. L. 92–516, set out as a note under section 136 of this title.

B IOLOGICAL P ESTICIDE H ANDLING S TUDY Section 1498 of Pub. L. 101–624 provided that: ‘‘(a) S TUDY .—Not later than September 30, 1992, the National Academy of Sciences shall conduct a study of the biological control programs and registration proce dures utilized by the Food and Drug Administration, the Animal and Plant Health Inspection Service, and the Environmental Protection Agency. ‘‘(b) D EVELOPMENT OF P ROCEDURES .—Not later than 1 year after the completion of the study under subsection (a), the agencies and offices described in such sub section shall develop and implement a common process for reviewing and approving biological control applica tions 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.’’

E DUCATION , S TUDY , AND R EPORT Pub. L. 100–478, title I, §1010, Oct. 7, 1988, 102 Stat. 2313, provided that: ‘‘(a) E DUCATION .—The Administrator of the Environ mental Protection Agency in cooperation with the Sec retary 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 commod ity production of any proposed pesticide labeling pro gram or requirements that may be imposed by the Ad ministrator in compliance with the Endangered Species Act [of 1973] (16 U.S.C. 1531 et seq.). The Administrator also shall provide the public with notice of, and oppor tunity for comment on, the elements of any such pro gram and requirements based on compliance with the Endangered Species Act [of 1973], including (but not limited to) an identification of any pesticides affected by the program; an explanation of the restriction or prohibition on the user or applicator of any such pes ticide; an identification of those geographic areas affected by any pesticide restriction or prohibition; an identification of the effects of any restricted or prohib ited pesticide on endangered or threatened species; and an identification of the endangered or threatened spe cies along with a general description of the geographic areas in which such species are located wherein the ap plication of a pesticide will be restricted, prohibited, or its use otherwise limited, unless the Secretary of the Interior determines that the disclosure of such infor mation may create a substantial risk of harm to such species or its habitat. ‘‘(b) S TUDY .—The Administrator of the Environ mental 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 whichPage 226 TITLE 7—AGRICULTURE § 136a–1 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 Adminis trator 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 alter natives 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 re stricted by the labeling program; examination of meth ods to improve coordination among the Environmental Protection Agency, Department of Agriculture, and De partment of the Interior in administration of the label ing program; and analysis of the means of implement ing 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 ag ricultural food and fiber commodity production and other affected pesticide users and applicators. ‘‘(c) R EPORT .—The Administrator of the Environ mental Protection Agency in cooperation with the Sec retary of Agriculture and the Secretary of the Interior shall submit a report within one year of the date of en actment 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 Com mittee on Environment and Public Works and the Com mittee on Agriculture, Nutrition, and Forestry of the United States Senate.’’ § 136a–1. Reregistration of registered pesticides (a) General rule The Administrator shall reregister, in accord ance with this section, each registered pesticide containing any active ingredient contained in any pesticide first registered before November 1, 1984, except for any pesticide as to which the Ad ministrator has determined, after November 1, 1984, and before the effective date of this sec tion, that— (1) there are no outstanding data require ments; and (2) the requirements of section 136a(c)(5) of this title have been satisfied. (b) Reregistration phases Reregistrations of pesticides under this sec tion shall be carried out in the following phases: (1) The first phase shall include the listing under subsection (c) of this section of the ac tive ingredients of the pesticides that will be reregistered. (2) The second phase shall include the sub mission to the Administrator under subsection (d) of this section of notices by registrants re specting their intention to seek reregistra tion, identification by registrants of missing and inadequate data for such pesticides, and commitments by registrants to replace such missing or inadequate data within the applica ble time period. (3) The third phase shall include submission to the Administrator by registrants of the in formation required under subsection (e) of this section. (4) The fourth phase shall include an inde pendent, initial review by the Administrator under subsection (f) of this section of submis sions under phases two and three, identifica tion of outstanding data requirements, and the issuance, as necessary, of requests for addi tional data. (5) The fifth phase shall include the review by the Administrator under subsection (g) of this section of data submitted for reregistra tion and appropriate regulatory action by the Administrator. (c) Phase one (1) Priority for reregistration For purposes of the reregistration of the pes ticides described in subsection (a) of this sec tion, the Administrator shall list the active ingredients of pesticides and shall give prior ity to, among others, active ingredients (other than active ingredients for which registration standards have been issued before the effective date of this section) that— (A) are in use on or in food or feed and may result in postharvest residues; (B) may result in residues of potential tox icological concern in potable ground water, edible fish, or shellfish; (C) have been determined by the Adminis trator before the effective date of this sec tion to have significant outstanding data re quirements; or (D) are used on crops, including in green houses and nurseries, where worker exposure is most likely to occur. (2) Reregistration lists For purposes of reregistration under this section, the Administrator shall by order— (A) not later than 70 days after the effec tive date of this section, list pesticide active ingredients for which registration standards have been issued before such effective date; (B) not later than 4 months after such effective date, list the first 150 pesticide active ingredients, as determined under paragraph (1); (C) not later than 7 months after such effective date, list the second 150 pesticide ac tive ingredients, as determined under para graph (1); and (D) not later than 10 months after such effective date, list the remainder of the pes ticide active ingredients, as determined under paragraph (1). Each list shall be published in the Federal Register. (3) Judicial review The content of a list issued by the Adminis trator under paragraph (2) shall not be subject to judicial review. (4) Notice to registrants On the publication of a list of pesticide ac tive ingredients under paragraph (2), the Ad ministrator shall send by certified mail to the registrants of the pesticides containing such active ingredients a notice of the time by which the registrants are to notify the Admin istrator under subsection (d) of this section whether the registrants intend to seek or not to seek reregistration of such pesticides. (d) Phase two (1) In general The registrant of a pesticide that contains an active ingredient listed under subparagraph