---
kind: "section"
citation: "7 U.S.C. § 136a"
title: "7"
title_heading: "Agriculture"
number: "136a"
heading: "Registration of pesticides"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/7/136a"
units:
  - "Chapter 6 — Insecticides and Environmental Pesticide Control"
  - "Subchapter II — Environmental Pesticide Control"
---

# §136a. Registration of pesticides

- (a) **Requirement of registration—** Except as provided by this subchapter, no [person](/usc/7/136.md?p=s) in any [State](/usc/7/136.md?p=aa) may distribute or sell to any [person](/usc/7/136.md?p=s) any [pesticide](/usc/7/136.md?p=u) that is not registered under this subchapter. To the extent necessary to prevent [unreasonable adverse effects on the environment](/usc/7/136.md?p=bb), the [Administrator](/usc/7/136.md?p=b) may by regulation limit the distribution, sale, or use in any [State](/usc/7/136.md?p=aa) of any [pesticide](/usc/7/136.md?p=u) that is not registered under this subchapter and that is not the subject of an experimental use permit under [section 136c of this title](/usc/7/136c.md) or an emergency exemption under [section 136p of this title](/usc/7/136p.md).
- (b) **Exemptions—** A [pesticide](/usc/7/136.md?p=u) which is not registered with the [Administrator](/usc/7/136.md?p=b) may be transferred if—
  - (1) the transfer is from one registered [establishment](/usc/7/136.md?p=dd) to another registered [establishment](/usc/7/136.md?p=dd) operated by the same [producer](/usc/7/136.md?p=w) solely for packaging at the second [establishment](/usc/7/136.md?p=dd) or for use as a constituent part of another [pesticide](/usc/7/136.md?p=u) produced at the second [establishment](/usc/7/136.md?p=dd); 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](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) shall file with the [Administrator](/usc/7/136.md?p=b) a statement which includes—
    - (A) the name and address of the applicant and of any other [person](/usc/7/136.md?p=s) whose name will appear on the [labeling](/usc/7/136.md?p=p-2);
    - (B) the name of the [pesticide](/usc/7/136.md?p=u);
    - (C) a complete copy of the [labeling](/usc/7/136.md?p=p-2) of the [pesticide](/usc/7/136.md?p=u), a statement of all claims to be made for it, and any directions for its use;
    - (D) the complete formula of the [pesticide](/usc/7/136.md?p=u);
    - (E) a request that the [pesticide](/usc/7/136.md?p=u) be classified for general use or for restricted use, or for both; and
    - (F) except as otherwise provided in [paragraph (2)(D)](#c-2-D), if requested by the [Administrator](/usc/7/136.md?p=b), 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](/usc/7/136.md?p=b) and that the [Administrator](/usc/7/136.md?p=b) may consider in accordance with the following provisions:
      - (i) With respect to [pesticides](/usc/7/136.md?p=u) containing [active ingredients](/usc/7/136.md?p=a) that are initially registered under this subchapter after September 30, 1978, data submitted to support the application for the original [registration](/usc/7/136.md?p=z) of the [pesticide](/usc/7/136.md?p=u), or an application for an amendment adding any new use to the [registration](/usc/7/136.md?p=z) and that pertains solely to such new use, shall not, without the written permission of the original data submitter, be considered by the [Administrator](/usc/7/136.md?p=b) to support an application by another [person](/usc/7/136.md?p=s) during a period of ten years following the date the [Administrator](/usc/7/136.md?p=b) first registers the [pesticide](/usc/7/136.md?p=u), 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)](#c-1-F-i) shall be extended 1 additional year for each 3 [minor uses](/usc/7/136.md?p=ll) 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](/usc/7/136.md?p=ll) registered by the [Administrator](/usc/7/136.md?p=b) if the [Administrator](/usc/7/136.md?p=b), in consultation with the [Secretary](/usc/7/499a.md?p=b-2) of Agriculture, determines that, based on information provided by an applicant for [registration](/usc/7/136.md?p=z) or a [registrant](/usc/7/136.md?p=y), that—
        - (I) there are insufficient efficacious alternative registered [pesticides](/usc/7/136.md?p=u) available for the use;
        - (II) the alternatives to the [minor use](/usc/7/136.md?p=ll) [pesticide](/usc/7/136.md?p=u) pose greater risks to the [environment](/usc/7/136.md?p=j) or human health;
        - (III) the [minor use](/usc/7/136.md?p=ll) [pesticide](/usc/7/136.md?p=u) plays or will play a significant part in managing [pest](/usc/7/136.md?p=t) resistance; or
        - (IV) the [minor use](/usc/7/136.md?p=ll) [pesticide](/usc/7/136.md?p=u) plays or will play a significant part in an integrated [pest](/usc/7/136.md?p=t) management program.

      The [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) for a [minor use](/usc/7/136.md?p=ll) on a crop grouping established by the [Administrator](/usc/7/136.md?p=b) shall be considered for purposes of this clause 1 [minor use](/usc/7/136.md?p=ll) 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](/usc/7/136.md?p=y) voluntarily cancels the product or deletes from the [registration](/usc/7/136.md?p=z) the [minor uses](/usc/7/136.md?p=ll) which formed the basis for the extension of the additional exclusive use period or if the [Administrator](/usc/7/136.md?p=b) determines that the [registrant](/usc/7/136.md?p=y) is not actually marketing the product for such [minor uses](/usc/7/136.md?p=ll).

      - (iii) Except as otherwise provided in [clause (i)](#c-1-F-i), with respect to data submitted after December 31, 1969, by an applicant or [registrant](/usc/7/136.md?p=y) to support an application for [registration](/usc/7/136.md?p=z), experimental use permit, or amendment adding a new use to an existing [registration](/usc/7/136.md?p=z), to support or maintain in effect an existing [registration](/usc/7/136.md?p=z), or for reregistration, the [Administrator](/usc/7/136.md?p=b) may, without the permission of the original data submitter, consider any such item of data in support of an application by any other [person](/usc/7/136.md?p=s) (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](/usc/7/136.md?p=b) 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](/usc/7/136.md?p=s) 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](/usc/7/136.md?p=b) 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](/usc/7/136.md?p=b) 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](/usc/7/136.md?p=b) shall deny the application or cancel the [registration](/usc/7/136.md?p=z) of the [pesticide](/usc/7/136.md?p=u) in support of which the data were used without further hearing. Before the [Administrator](/usc/7/136.md?p=b) takes action under either of the preceding two sentences, the [Administrator](/usc/7/136.md?p=b) shall furnish to the affected [person](/usc/7/136.md?p=s), 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](/usc/7/136.md?p=s) to respond. If a [registration](/usc/7/136.md?p=z) is denied or canceled under this subparagraph, the [Administrator](/usc/7/136.md?p=b) may make such order as the [Administrator](/usc/7/136.md?p=b) deems appropriate concerning the continued sale and use of existing stocks of such [pesticide](/usc/7/136.md?p=u). [Registration](/usc/7/136.md?p=z) action by the [Administrator](/usc/7/136.md?p=b) 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)](#c-1-F-i), [(ii)](#c-1-F-ii), and [(iii)](#c-1-F-iii), the [Administrator](/usc/7/136.md?p=b) 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)](#c-1-F-ii) shall not take effect until 1 year after August 3, 1996, except where an applicant or [registrant](/usc/7/136.md?p=y) is applying for the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) not previously registered.
      - (vi) With respect to data submitted after August 3, 1996, by an applicant or [registrant](/usc/7/136.md?p=y) to support an amendment adding a new use to an existing [registration](/usc/7/136.md?p=z) that does not retain any period of exclusive use, if such data relates solely to a [minor use](/usc/7/136.md?p=ll) of a [pesticide](/usc/7/136.md?p=u), such data shall not, without the written permission of the original data submitter, be considered by the [Administrator](/usc/7/136.md?p=b) to support an application for a [minor use](/usc/7/136.md?p=ll) by another [person](/usc/7/136.md?p=s) during the period of 10 years following the date of submission of such data. The applicant or [registrant](/usc/7/136.md?p=y) at the time the new [minor use](/usc/7/136.md?p=ll) is requested shall notify the [Administrator](/usc/7/136.md?p=b) that to the best of their knowledge the exclusive use period for the [pesticide](/usc/7/136.md?p=u) has expired and that the data pertaining solely to the [minor use](/usc/7/136.md?p=ll) of a [pesticide](/usc/7/136.md?p=u) is eligible for the provisions of this paragraph. If the [minor use](/usc/7/136.md?p=ll) [registration](/usc/7/136.md?p=z) 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](/usc/7/136.md?p=b) in accordance with the provisions of [clause (i)](#c-1-F-i), as appropriate.
    - (G) If the applicant is requesting that the [registration](/usc/7/136.md?p=z) or amendment to the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) 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](/usc/7/136.md?p=b) shall publish guidelines specifying the kinds of information which will be required to support the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) and shall revise such guidelines from time to time. If thereafter the [Administrator](/usc/7/136.md?p=b) requires any additional kind of information under subparagraph (B) of this paragraph, the [Administrator](/usc/7/136.md?p=b) shall permit sufficient time for applicants to obtain such additional information. The [Administrator](/usc/7/136.md?p=b), in establishing standards for data requirements for the [registration](/usc/7/136.md?p=z) of [pesticides](/usc/7/136.md?p=u) with respect to [minor uses](/usc/7/136.md?p=ll), shall make such standards commensurate with the anticipated extent of use, pattern of use, the public health and agricultural need for such [minor use](/usc/7/136.md?p=ll), and the level and degree of potential beneficial or adverse effects on man and the [environment](/usc/7/136.md?p=j). The [Administrator](/usc/7/136.md?p=b) shall not require a [person](/usc/7/136.md?p=s) to submit, in relation to a [registration](/usc/7/136.md?p=z) or reregistration of a [pesticide](/usc/7/136.md?p=u) for minor agricultural use under this subchapter, any field residue data from a geographic area where the [pesticide](/usc/7/136.md?p=u) will not be registered for such use. In the development of these standards, the [Administrator](/usc/7/136.md?p=b) 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](/usc/7/136.md?p=y) to undertake the development of the required data. Except as provided by [section 136h of this title](/usc/7/136h.md), within 30 days after the [Administrator](/usc/7/136.md?p=b) registers a [pesticide](/usc/7/136.md?p=u) under this subchapter the [Administrator](/usc/7/136.md?p=b) shall make available to the public the data called for in the [registration](/usc/7/136.md?p=z) statement together with such other scientific information as the [Administrator](/usc/7/136.md?p=b) deems relevant to the [Administrator](/usc/7/136.md?p=b)’s decision.
    - (B) **Additional data—**
      - (i) If the [Administrator](/usc/7/136.md?p=b) determines that additional data are required to maintain in effect an existing [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u), the [Administrator](/usc/7/136.md?p=b) shall notify all existing [registrants](/usc/7/136.md?p=y) of the [pesticide](/usc/7/136.md?p=u) to which the determination relates and provide a list of such [registrants](/usc/7/136.md?p=y) to any interested [person](/usc/7/136.md?p=s).
      - (ii) Each [registrant](/usc/7/136.md?p=y) of such [pesticide](/usc/7/136.md?p=u) 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](/usc/7/136.md?p=y) may agree to develop jointly, or to share in the cost of developing, such data if they agree and advise the [Administrator](/usc/7/136.md?p=b) of their intent within ninety days after notification. Any [registrant](/usc/7/136.md?p=y) 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](/usc/7/136.md?p=z). The [Administrator](/usc/7/136.md?p=b) shall issue a notice of intent to suspend the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) in accordance with the procedures prescribed by [clause (iv)](#c-2-B-iv) if a [registrant](/usc/7/136.md?p=y) fails to comply with this clause.
      - (iii) If, at the end of sixty days after advising the [Administrator](/usc/7/136.md?p=b) of their agreement to develop jointly, or share in the cost of developing, data, the [registrants](/usc/7/136.md?p=y) have not further agreed on the terms of the data development arrangement or on a procedure for reaching such agreement, any of such [registrants](/usc/7/136.md?p=y) 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](/usc/7/136.md?p=b) shall issue a notice of intent to suspend the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) in accordance with the procedures prescribed by [clause (iv)](#c-2-B-iv) if a [registrant](/usc/7/136.md?p=y) fails to comply with this clause.
      - (iv) Notwithstanding any other provision of this subchapter, if the [Administrator](/usc/7/136.md?p=b) determines that a [registrant](/usc/7/136.md?p=y), within the time required by the [Administrator](/usc/7/136.md?p=b), 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](/usc/7/136.md?p=b) may issue a notice of intent to suspend such [registrant](/usc/7/136.md?p=y)’s [registration](/usc/7/136.md?p=z) of the [pesticide](/usc/7/136.md?p=u) for which additional data is required. The [Administrator](/usc/7/136.md?p=b) may include in the notice of intent to suspend such provisions as the [Administrator](/usc/7/136.md?p=b) deems appropriate concerning the continued sale and use of existing stocks of such [pesticide](/usc/7/136.md?p=u). Any suspension proposed under this subparagraph shall become final and effective at the end of thirty days from receipt by the [registrant](/usc/7/136.md?p=y) of the notice of intent to suspend, unless during that time a request for hearing is made by a [person](/usc/7/136.md?p=s) adversely affected by the notice or the [registrant](/usc/7/136.md?p=y) has satisfied the [Administrator](/usc/7/136.md?p=b) that the [registrant](/usc/7/136.md?p=y) 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](/usc/7/136d.md?p=d). The only matters for resolution at that hearing shall be whether the [registrant](/usc/7/136.md?p=y) has failed to take the action that served as the basis for the notice of intent to suspend the [registration](/usc/7/136.md?p=z) of the [pesticide](/usc/7/136.md?p=u) for which additional data is required, and whether the [Administrator](/usc/7/136.md?p=b)’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](/usc/7/136.md?p=z) suspended under this subparagraph shall be reinstated by the [Administrator](/usc/7/136.md?p=b) if the [Administrator](/usc/7/136.md?p=b) determines that the [registrant](/usc/7/136.md?p=y) has complied fully with the requirements that served as a basis for the suspension of the [registration](/usc/7/136.md?p=z).
      - (v) Any data submitted under this subparagraph shall be subject to the provisions of [paragraph (1)(D)](#c-1-D). Whenever such data are submitted jointly by two or more [registrants](/usc/7/136.md?p=y), 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](/usc/7/136.md?p=y) the [Administrator](/usc/7/136.md?p=b) shall, in the case of a [minor use](/usc/7/136.md?p=ll), extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that [minor use](/usc/7/136.md?p=ll) until the final deadline for submission of data under [section 136a–1 of this title](/usc/7/136a–1.md) for the other uses of the [pesticide](/usc/7/136.md?p=u) established as of August 3, 1996, if—
        - (I) the data to support other uses of the [pesticide](/usc/7/136.md?p=u) on a food are being provided;
        - (II) the [registrant](/usc/7/136.md?p=y), 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](/usc/7/136.md?p=b) has determined that such extension will not significantly delay the [Administrator](/usc/7/136.md?p=b)’s schedule for issuing a reregistration eligibility determination required under [section 136a–1 of this title](/usc/7/136a–1.md); and
        - (IV) the [Administrator](/usc/7/136.md?p=b) has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the [environment](/usc/7/136.md?p=j). If the [Administrator](/usc/7/136.md?p=b) grants an extension under this clause, the [Administrator](/usc/7/136.md?p=b) shall monitor the development of the data and shall ensure that the [registrant](/usc/7/136.md?p=y) is meeting the schedule for the production of the data. If the [Administrator](/usc/7/136.md?p=b) determines that the [registrant](/usc/7/136.md?p=y) is not meeting or has not met the schedule for the production of such data, the [Administrator](/usc/7/136.md?p=b) may proceed in accordance with [clause (iv)](#c-2-B-iv) regarding the continued [registration](/usc/7/136.md?p=z) of the affected products with the [minor use](/usc/7/136.md?p=ll) and shall inform the public of such action. Notwithstanding the provisions of this clause, the [Administrator](/usc/7/136.md?p=b) may take action to modify or revoke the extension under this clause if the [Administrator](/usc/7/136.md?p=b) determines that the extension for the [minor use](/usc/7/136.md?p=ll) may cause an unreasonable adverse effect on the [environment](/usc/7/136.md?p=j). In such circumstance, the [Administrator](/usc/7/136.md?p=b) shall provide, in writing to the [registrant](/usc/7/136.md?p=y), 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](/usc/7/136.md?p=b) for the submission of the data.
      - (vii) If the [registrant](/usc/7/136.md?p=y) does not commit to support a specific [minor use](/usc/7/136.md?p=ll) of the [pesticide](/usc/7/136.md?p=u), but is supporting and providing data in a timely and adequate fashion to support uses of the [pesticide](/usc/7/136.md?p=u) on a food, or if all uses of the [pesticide](/usc/7/136.md?p=u) are nonfood uses and the [registrant](/usc/7/136.md?p=y) does not commit to support a specific [minor use](/usc/7/136.md?p=ll) of the [pesticide](/usc/7/136.md?p=u) but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the [pesticide](/usc/7/136.md?p=u), the [Administrator](/usc/7/136.md?p=b), at the written request of the [registrant](/usc/7/136.md?p=y), shall not take any action pursuant to this clause in regard to such unsupported [minor use](/usc/7/136.md?p=ll) until the final deadline established as of August 3, 1996, for the submission of data under [section 136a–1 of this title](/usc/7/136a–1.md) for the supported uses identified pursuant to this clause unless the [Administrator](/usc/7/136.md?p=b) 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](/usc/7/136.md?p=b) may refuse the request for extension by the [registrant](/usc/7/136.md?p=y). Upon receipt of the request from the [registrant](/usc/7/136.md?p=y), the [Administrator](/usc/7/136.md?p=b) 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](/usc/7/136.md?p=z) pursuant to [section 136d(f)(1) of this title](/usc/7/136d.md?p=f-1). If the [Administrator](/usc/7/136.md?p=b) grants an extension under this clause, the [Administrator](/usc/7/136.md?p=b) shall monitor the development of the data for the uses being supported and shall ensure that the [registrant](/usc/7/136.md?p=y) is meeting the schedule for the production of such data. If the [Administrator](/usc/7/136.md?p=b) determines that the [registrant](/usc/7/136.md?p=y) is not meeting or has not met the schedule for the production of such data, the [Administrator](/usc/7/136.md?p=b) may proceed in accordance with clause (iv) of this subparagraph regarding the continued [registration](/usc/7/136.md?p=z) 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](/usc/7/136d.md?p=f-2). Notwithstanding the provisions of this clause, the [Administrator](/usc/7/136.md?p=b) may deny, modify, or revoke the temporary extension under this subparagraph if the [Administrator](/usc/7/136.md?p=b) determines that the continuation of the [minor use](/usc/7/136.md?p=ll) may cause an unreasonable adverse effect on the [environment](/usc/7/136.md?p=j). In the event of modification or revocation, the [Administrator](/usc/7/136.md?p=b) shall provide, in writing, to the [registrant](/usc/7/136.md?p=y) a notice revoking the temporary extension and establish a new effective date by which the [minor use](/usc/7/136.md?p=ll) shall be deleted from the [registration](/usc/7/136.md?p=z).
      - (viii)
        - (I) If data required to support [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) under [subparagraph (A)](#c-2-A) is requested by a Federal or [State](/usc/7/136.md?p=aa) regulatory authority, the [Administrator](/usc/7/136.md?p=b) shall, to the extent practicable, coordinate data requirements, test protocols, timetables, and standards of review and reduce burdens and redundancy caused to the [registrant](/usc/7/136.md?p=y) by multiple requirements on the [registrant](/usc/7/136.md?p=y).
        - (II) The [Administrator](/usc/7/136.md?p=b) may enter into a cooperative agreement with a [State](/usc/7/136.md?p=aa) to carry out [subclause (I)](#c-2-B-viii-I).
        - (III) Not later than 1 year after August 3, 1996, the [Administrator](/usc/7/136.md?p=b) shall develop a process to identify and assist in alleviating future disparities between Federal and [State](/usc/7/136.md?p=aa) data requirements.
    - (C) **Simplified procedures—** Within nine months after September 30, 1978, the [Administrator](/usc/7/136.md?p=b) shall, by regulation, prescribe simplified procedures for the [registration](/usc/7/136.md?p=z) of [pesticides](/usc/7/136.md?p=u), which shall include the provisions of subparagraph (D) of this paragraph.
    - (D) **Exemption—** No applicant for [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) who proposes to purchase a registered [pesticide](/usc/7/136.md?p=u) from another [producer](/usc/7/136.md?p=w) in order to formulate such purchased [pesticide](/usc/7/136.md?p=u) into the [pesticide](/usc/7/136.md?p=u) 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](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) for a [minor use](/usc/7/136.md?p=ll), the [Administrator](/usc/7/136.md?p=b) may waive otherwise applicable data requirements if the [Administrator](/usc/7/136.md?p=b) determines that the absence of such data will not prevent the [Administrator](/usc/7/136.md?p=b) from determining—
      - (i) the incremental risk presented by the [minor use](/usc/7/136.md?p=ll) of the [pesticide](/usc/7/136.md?p=u); and
      - (ii) that such risk, if any, would not be an unreasonable adverse effect on the [environment](/usc/7/136.md?p=j).
  - (3) **Application—**
    - (A) **In general—** The [Administrator](/usc/7/136.md?p=b) shall review the data after receipt of the application and shall, as expeditiously as possible, either register the [pesticide](/usc/7/136.md?p=u) in accordance with [paragraph (5)](#c-5), or notify the applicant of the [Administrator](/usc/7/136.md?p=b)’s determination that it does not comply with the provisions of the subchapter in accordance with [paragraph (6)](#c-6).
    - (B) **Identical or substantially similar—**
      - (i) The [Administrator](/usc/7/136.md?p=b) shall, as expeditiously as possible, review and act on any application received by the [Administrator](/usc/7/136.md?p=b) that—
        - (I) proposes the initial or amended [registration](/usc/7/136.md?p=z) of an end-use [pesticide](/usc/7/136.md?p=u) that, if registered as proposed, would be identical or substantially similar in composition and [labeling](/usc/7/136.md?p=p-2) to a currently-registered [pesticide](/usc/7/136.md?p=u) identified in the application, or that would differ in composition and [labeling](/usc/7/136.md?p=p-2) from such currently-registered [pesticide](/usc/7/136.md?p=u) only in ways that would not significantly increase the risk of [unreasonable adverse effects on the environment](/usc/7/136.md?p=bb); or
        - (II) proposes an amendment to the [registration](/usc/7/136.md?p=z) of a registered [pesticide](/usc/7/136.md?p=u) that does not require scientific review of data.
      - (ii) In expediting the review of an application for an action described in [clause (i)](#c-3-B-i), the [Administrator](/usc/7/136.md?p=b) shall—
        - (I) review the application in accordance with [section 136w–8(f)(4)(B) of this title](/usc/7/136w–8.md?p=f-4-B) and, if the application is found to be incomplete, reject the application;
        - (II) not later than the applicable decision review time established pursuant to [section 136w–8(f)(4)(B) of this title](/usc/7/136w–8.md?p=f-4-B), or, if no review time is established, not later than 90 days after receiving a complete application, notify the [registrant](/usc/7/136.md?p=y) if the application has been granted or denied; and
        - (III) if the application is denied, notify the [registrant](/usc/7/136.md?p=y) in writing of the specific reasons for the denial of the application.
    - (C) **Minor use registration—**
      - (i) The [Administrator](/usc/7/136.md?p=b) shall, as expeditiously as possible, review and act on any complete application—
        - (I) that proposes the initial [registration](/usc/7/136.md?p=z) of a new [pesticide](/usc/7/136.md?p=u) [active ingredient](/usc/7/136.md?p=a) if the [active ingredient](/usc/7/136.md?p=a) is proposed to be registered solely for [minor uses](/usc/7/136.md?p=ll), or proposes a [registration](/usc/7/136.md?p=z) amendment solely for [minor uses](/usc/7/136.md?p=ll) to an existing [registration](/usc/7/136.md?p=z); or
        - (II) for a [registration](/usc/7/136.md?p=z) or a [registration](/usc/7/136.md?p=z) amendment that proposes significant [minor uses](/usc/7/136.md?p=ll).
      - (ii) For the purposes of [clause (i)](#c-3-C-i)—
        - (I) the term “as expeditiously as possible” means that the [Administrator](/usc/7/136.md?p=b) 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](/usc/7/136.md?p=b) to complete such a review and evaluation under [clause (i)](#c-3-C-i) shall not be subject to judicial review; and
        - (II) the term “significant [minor uses](/usc/7/136.md?p=ll)” means 3 or more [minor uses](/usc/7/136.md?p=ll) proposed for every nonminor use, a [minor use](/usc/7/136.md?p=ll) that would, in the judgment of the [Administrator](/usc/7/136.md?p=b), 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](/usc/7/136.md?p=ll) that in the opinion of the [Administrator](/usc/7/136.md?p=b) would avoid the reissuance of an emergency exemption under [section 136p of this title](/usc/7/136p.md) for that [minor use](/usc/7/136.md?p=ll).
    - (D) **Adequate time for submission of minor use data—** If a [registrant](/usc/7/136.md?p=y) makes a request for a [minor use](/usc/7/136.md?p=ll) waiver, regarding data required by the [Administrator](/usc/7/136.md?p=b), pursuant to [paragraph (2)(E)](#c-2-E), and if the [Administrator](/usc/7/136.md?p=b) denies in whole or in part such data waiver request, the [registrant](/usc/7/136.md?p=y) 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](/usc/7/136.md?p=b) for submission of such data, beginning with the date of receipt by the [registrant](/usc/7/136.md?p=y) of the [Administrator](/usc/7/136.md?p=b)’s notice of denial.
  - (4) **Notice of application—** The [Administrator](/usc/7/136.md?p=b) shall publish in the Federal Register, promptly after receipt of the statement and other data required pursuant to paragraphs [(1)](#c-1) and [(2)](#c-2), a notice of each application for [registration](/usc/7/136.md?p=z) of any [pesticide](/usc/7/136.md?p=u) if it contains any new [active ingredient](/usc/7/136.md?p=a) 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](/usc/7/136.md?p=s) may comment.
  - (5) **Approval of registration—** The [Administrator](/usc/7/136.md?p=b) shall register a [pesticide](/usc/7/136.md?p=u) if the [Administrator](/usc/7/136.md?p=b) determines that, when considered with any restrictions imposed under [subsection (d)](#d)—
    - (A) its composition is such as to warrant the proposed claims for it;
    - (B) its [labeling](/usc/7/136.md?p=p-2) 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](/usc/7/136.md?p=bb); and
    - (D) when used in accordance with widespread and commonly recognized practice it will not generally cause [unreasonable adverse effects on the environment](/usc/7/136.md?p=bb).

    The [Administrator](/usc/7/136.md?p=b) shall not make any lack of essentiality a criterion for denying [registration](/usc/7/136.md?p=z) of any [pesticide](/usc/7/136.md?p=u). Where two [pesticides](/usc/7/136.md?p=u) meet the requirements of this paragraph, one should not be registered in preference to the other. In considering an application for the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u), the [Administrator](/usc/7/136.md?p=b) may waive data requirements pertaining to efficacy, in which event the [Administrator](/usc/7/136.md?p=b) may register the [pesticide](/usc/7/136.md?p=u) without determining that the [pesticide](/usc/7/136.md?p=u)’s composition is such as to warrant proposed claims of efficacy. If a [pesticide](/usc/7/136.md?p=u) is found to be efficacious by any [State](/usc/7/136.md?p=aa) under [section 136v(c) of this title](/usc/7/136v.md?p=c), a presumption is established that the [Administrator](/usc/7/136.md?p=b) shall waive data requirements pertaining to efficacy for use of the [pesticide](/usc/7/136.md?p=u) in such [State](/usc/7/136.md?p=aa).

  - (6) **Denial of registration—** If the [Administrator](/usc/7/136.md?p=b) determines that the requirements of [paragraph (5)](#c-5) for [registration](/usc/7/136.md?p=z) are not satisfied, the [Administrator](/usc/7/136.md?p=b) shall notify the applicant for [registration](/usc/7/136.md?p=z) of the [Administrator](/usc/7/136.md?p=b)’s determination and of the [Administrator](/usc/7/136.md?p=b)’s reasons (including the factual basis) therefor, and that, unless the applicant corrects the conditions and notifies the [Administrator](/usc/7/136.md?p=b) thereof during the 30-day period beginning with the day after the date on which the applicant receives the notice, the [Administrator](/usc/7/136.md?p=b) may refuse to register the [pesticide](/usc/7/136.md?p=u). Whenever the [Administrator](/usc/7/136.md?p=b) refuses to register a [pesticide](/usc/7/136.md?p=u), the [Administrator](/usc/7/136.md?p=b) shall notify the applicant of the [Administrator](/usc/7/136.md?p=b)’s decision and of the [Administrator](/usc/7/136.md?p=b)’s reasons (including the factual basis) therefor. The [Administrator](/usc/7/136.md?p=b) shall promptly publish in the Federal Register notice of such denial of [registration](/usc/7/136.md?p=z) and the reasons therefor. Upon such notification, the applicant for [registration](/usc/7/136.md?p=z) or other interested [person](/usc/7/136.md?p=s) with the concurrence of the applicant shall have the same remedies as provided for in [section 136d of this title](/usc/7/136d.md).
  - (7) **Registration under special circumstances—** Notwithstanding the provisions of [paragraph (5)](#c-5)—
    - (A) The [Administrator](/usc/7/136.md?p=b) may conditionally register or amend the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) if the [Administrator](/usc/7/136.md?p=b) determines that (i) the [pesticide](/usc/7/136.md?p=u) and proposed use are identical or substantially similar to any currently registered [pesticide](/usc/7/136.md?p=u) and use thereof, or differ only in ways that would not significantly increase the risk of [unreasonable adverse effects on the environment](/usc/7/136.md?p=bb), and (ii) approving the [registration](/usc/7/136.md?p=z) or amendment in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the [environment](/usc/7/136.md?p=j). An applicant seeking conditional [registration](/usc/7/136.md?p=z) or amended [registration](/usc/7/136.md?p=z) under this subparagraph shall submit such data as would be required to obtain [registration](/usc/7/136.md?p=z) of a similar [pesticide](/usc/7/136.md?p=u) under [paragraph (5)](#c-5). If the applicant is unable to submit an item of data because it has not yet been generated, the [Administrator](/usc/7/136.md?p=b) may register or amend the [registration](/usc/7/136.md?p=z) of the [pesticide](/usc/7/136.md?p=u) 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](/usc/7/136.md?p=u) already registered under this subchapter.
    - (B) The [Administrator](/usc/7/136.md?p=b) may conditionally amend the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) to permit additional uses of such [pesticide](/usc/7/136.md?p=u) notwithstanding that data concerning the [pesticide](/usc/7/136.md?p=u) may be insufficient to support an unconditional amendment, if the [Administrator](/usc/7/136.md?p=b) determines that (i) the applicant has submitted satisfactory data pertaining to the proposed additional use, and (ii) amending the [registration](/usc/7/136.md?p=z) in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the [environment](/usc/7/136.md?p=j). Notwithstanding the foregoing provisions of this subparagraph, no [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) may be amended to permit an additional use of such [pesticide](/usc/7/136.md?p=u) if the [Administrator](/usc/7/136.md?p=b) has issued a notice stating that such [pesticide](/usc/7/136.md?p=u), 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](/usc/7/136.md?p=u) involves a major food or feed crop, or (II) the additional use of such [pesticide](/usc/7/136.md?p=u) involves a minor food or feed crop and the [Administrator](/usc/7/136.md?p=b) determines, with the concurrence of the [Secretary](/usc/7/499a.md?p=b-2) of Agriculture, there is available an effective alternative [pesticide](/usc/7/136.md?p=u) that does not meet or exceed such risk criteria. An applicant seeking amended [registration](/usc/7/136.md?p=z) under this subparagraph shall submit such data as would be required to obtain [registration](/usc/7/136.md?p=z) of a similar [pesticide](/usc/7/136.md?p=u) under [paragraph (5)](#c-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](/usc/7/136.md?p=b) may amend the [registration](/usc/7/136.md?p=z) 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](/usc/7/136.md?p=u) already registered under this subchapter.
    - (C) The [Administrator](/usc/7/136.md?p=b) may conditionally register a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) not contained in any currently registered [pesticide](/usc/7/136.md?p=u) 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](/usc/7/136.md?p=b) first imposed the data requirement) on the condition that by the end of such period the [Administrator](/usc/7/136.md?p=b) 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](/usc/7/136.md?p=b) may prescribe. A conditional [registration](/usc/7/136.md?p=z) under this subparagraph shall be granted only if the [Administrator](/usc/7/136.md?p=b) determines that use of the [pesticide](/usc/7/136.md?p=u) during such period will not cause any unreasonable adverse effect on the [environment](/usc/7/136.md?p=j), and that use of the [pesticide](/usc/7/136.md?p=u) is in the public interest.
  - (8) **Interim administrative review—** Notwithstanding any other provision of this subchapter, the [Administrator](/usc/7/136.md?p=b) may not initiate a public interim administrative review process to develop a risk-benefit evaluation of the ingredients of a [pesticide](/usc/7/136.md?p=u) or any of its uses prior to initiating a formal action to cancel, suspend, or deny [registration](/usc/7/136.md?p=z) of such [pesticide](/usc/7/136.md?p=u), 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](/usc/7/136.md?p=j). Notice of the definition of the terms “validated test” and “other significant evidence” as used herein shall be published by the [Administrator](/usc/7/136.md?p=b) in the Federal Register.
  - (9) **Labeling—**
    - (A) **Additional statements—** Subject to subparagraphs [(B)](#c-9-B) and [(C)](#c-9-C), it shall not be a violation of this subchapter for a [registrant](/usc/7/136.md?p=y) to modify the [labeling](/usc/7/136.md?p=p-2) of an [antimicrobial pesticide](/usc/7/136.md?p=mm-1) 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](/usc/7/136.md?p=p-2) information under [subparagraph (A)](#c-9-A) shall not be false or misleading, shall not conflict with or detract from any statement required by law or the [Administrator](/usc/7/136.md?p=b) as a condition of [registration](/usc/7/136.md?p=z), and shall be substantiated on the request of the [Administrator](/usc/7/136.md?p=b).
    - (C) **Notification and disapproval—**
      - (i) **Notification—** A [registration](/usc/7/136.md?p=z) may be modified under [subparagraph (A)](#c-9-A) if—
        - (I) the [registrant](/usc/7/136.md?p=y) notifies the [Administrator](/usc/7/136.md?p=b) in writing not later than 60 days prior to distribution or sale of a product bearing the modified [labeling](/usc/7/136.md?p=p-2); and
        - (II) the [Administrator](/usc/7/136.md?p=b) does not disapprove of the modification under [clause (ii)](#c-9-C-ii).
      - (ii) **Disapproval—** Not later than 30 days after receipt of a notification under [clause (i)](#c-9-C-i), the [Administrator](/usc/7/136.md?p=b) may disapprove the modification by sending the [registrant](/usc/7/136.md?p=y) notification in writing stating that the proposed language is not acceptable and stating the reasons why the [Administrator](/usc/7/136.md?p=b) finds the proposed modification unacceptable.
      - (iii) **Restriction on sale—** A [registrant](/usc/7/136.md?p=y) may not sell or distribute a product bearing a disapproved modification.
      - (iv) **Objection—** A [registrant](/usc/7/136.md?p=y) may file an objection in writing to a disapproval under [clause (ii)](#c-9-C-ii) not later than 30 days after receipt of notification of the disapproval.
      - (v) **Final action—** A decision by the [Administrator](/usc/7/136.md?p=b) following receipt and consideration of an objection filed under [clause (iv)](#c-9-C-iv) shall be considered a final agency action.
    - (D) **Use dilution—** The [label](/usc/7/136.md?p=p-1) or [labeling](/usc/7/136.md?p=p-2) required under this subchapter for an [antimicrobial pesticide](/usc/7/136.md?p=mm-1) 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](/usc/7/136.md?p=u) than for use of a concentrate of the [pesticide](/usc/7/136.md?p=u) if the [Administrator](/usc/7/136.md?p=b) determines that—
      - (i) adequate data have been submitted to support the statement proposed for the diluted solution uses; and
      - (ii) the [label](/usc/7/136.md?p=p-1) or [labeling](/usc/7/136.md?p=p-2) provides adequate protection for exposure to the diluted solution of the [pesticide](/usc/7/136.md?p=u).
  - (10) **Expedited registration of pesticides—**
    - (A) Not later than 1 year after August 3, 1996, the [Administrator](/usc/7/136.md?p=b) shall, utilizing public comment, develop procedures and guidelines, and expedite the review of an application for [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) or an amendment to a [registration](/usc/7/136.md?p=z) that satisfies such guidelines.
    - (B) Any application for [registration](/usc/7/136.md?p=z) or an amendment, including biological and conventional [pesticides](/usc/7/136.md?p=u), will be considered for expedited review under this paragraph. An application for [registration](/usc/7/136.md?p=z) or an amendment shall qualify for expedited review if use of the [pesticide](/usc/7/136.md?p=u) proposed by the application may reasonably be expected to accomplish 1 or more of the following:
      - (i) Reduce the risks of [pesticides](/usc/7/136.md?p=u) to human health.
      - (ii) Reduce the risks of [pesticides](/usc/7/136.md?p=u) 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](/usc/7/136.md?p=t) management strategies, or make such strategies more available or more effective.
    - (C) The [Administrator](/usc/7/136.md?p=b), 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](/usc/7/136.md?p=b) may either reject the request for expedited review or ask the applicant for additional information to satisfy the guidelines developed under [subparagraph (A)](#c-10-A).
  - (11) **Interagency working group—**
    - (A) **Definition of covered agency—** In this paragraph, the term “covered agency” means any of the following:
      - (i) The Department of Agriculture.
      - (ii) The Department of Commerce.
      - (iii) The Department of the Interior.
      - (iv) The Council on Environmental Quality.
      - (v) The Environmental Protection Agency.
    - (B) **Establishment—** The [Administrator](/usc/7/136.md?p=b) shall establish an interagency working group, to be comprised of representatives from each covered agency, to provide recommendations regarding, and to implement a strategy for improving, the consultation process required under section 7 of the Endangered Species Act of 1973 ([16 U.S.C. 1536](/usc/16/1536.md)) for [pesticide](/usc/7/136.md?p=u) [registration](/usc/7/136.md?p=z) and [registration](/usc/7/136.md?p=z) review.
    - (C) **Duties—** The interagency working group established under [subparagraph (B)](#c-11-B) shall—
      - (i) analyze relevant Federal law (including regulations) and case law for purposes of providing an outline of the legal and regulatory framework for the consultation process referred to in that subparagraph, including—
        - (I) requirements under this subchapter and the Endangered Species Act of 1973 ([16 U.S.C. 1531](/usc/16/1531.md) et seq.);
        - (II) Federal case law regarding the intersection of this subchapter and the Endangered Species Act of 1973 ([16 U.S.C. 1531](/usc/16/1531.md) et seq.); and
        - (III) Federal regulations relating to the [pesticide](/usc/7/136.md?p=u) consultation process;
      - (ii) provide advice regarding methods of—
        - (I) defining the scope of actions of the covered agencies that are subject to the consultation requirement referred to in [subparagraph (B)](#c-11-B); and
        - (II) properly identifying and classifying effects of actions of the covered agencies with respect to that consultation requirement;
      - (iii) identify the obligations and limitations under Federal law of each covered agency for purposes of providing a legal and regulatory framework for developing the recommendations referred to in [subparagraph (B)](#c-11-B);
      - (iv) review practices for the consultation referred to in [subparagraph (B)](#c-11-B) to identify problem areas, areas for improvement, and best practices for conducting that consultation among the covered agencies;
      - (v) develop scientific and policy approaches to increase the accuracy and timeliness of the process for that consultation, in accordance with requirements of this subchapter and the Endangered Species Act of 1973 ([16 U.S.C. 1531](/usc/16/1531.md) et seq.), including—
        - (I) processes to efficiently share data and coordinate analyses among the Department of Agriculture, the Department of Commerce, the Department of the Interior, and the Environmental Protection Agency;
        - (II) a streamlined process for identifying which actions require no consultation, informal consultation, or formal consultation;
        - (III) an approach that will provide clarity with respect to what constitutes the best scientific and commercial data available in the fields of [pesticide](/usc/7/136.md?p=u) use and ecological risk assessment, pursuant to section 7(a)(2) of the Endangered Species Act of 1973 ([16 U.S.C. 1536(a)(2)](/usc/16/1536.md?p=a-2)); and
        - (IV) approaches that enable the Environmental Protection Agency to better assist the Department of the Interior and the Department of Commerce in carrying out obligations under that section in a timely and efficient manner; and
      - (vi) propose and implement a strategy to implement approaches to consultations under the Endangered Species Act of 1973 ([16 U.S.C. 1531](/usc/16/1531.md) et seq.) and document that strategy in a memorandum of understanding, revised regulations, or another appropriate format to promote durable cooperation among the covered agencies.
    - (D) **Reports—**
      - (i) **Progress reports—**
        - (I) **In general—** Not later than 18 months after December 20, 2018, the [Administrator](/usc/7/136.md?p=b), in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing the progress of the working group in developing the recommendations under [subparagraph (B)](#c-11-B).
        - (II) **Requirements—** The report under this clause shall—
          - (aa) reflect the perspectives of each covered agency; and
          - (bb) identify areas of new consensus and continuing topics of disagreement and debate.
      - (ii) **Results—**
        - (I) **In general—** Not later than 1 year after December 20, 2018, the [Administrator](/usc/7/136.md?p=b), in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing—
          - (aa) the recommendations developed under [subparagraph (B)](#c-11-B); and
          - (bb) plans for implementation of those recommendations.
        - (II) **Requirements—** The report under this clause shall—
          - (aa) reflect the perspectives of each covered agency; and
          - (bb) identify areas of consensus and continuing topics of disagreement and debate, if any.
      - (iii) **Implementation—** Not later than 1 year after the date of submission of the report under [clause (i)](#c-11-D-i), the [Administrator](/usc/7/136.md?p=b), in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing—
        - (I) the implementation of the recommendations referred to in that clause;
        - (II) the extent to which that implementation improved the consultation process referred to in [subparagraph (B)](#c-11-B); and
        - (III) any additional recommendations for improvements to the process described in [subparagraph (B)](#c-11-B).
      - (iv) **Other reports—** Not later than the date that is 180 days after the date of submission of the report under [clause (iii)](#c-11-D-iii), and not less frequently than once every 180 days thereafter during the 5-year period beginning on that date, the [Administrator](/usc/7/136.md?p=b), in coordination with the head of each other covered agency, shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report describing—
        - (I) the implementation of the recommendations referred to in that clause;
        - (II) the extent to which that implementation improved the consultation process referred to in [subparagraph (B)](#c-11-B); and
        - (III) any additional recommendations for improvements to the process described in [subparagraph (B)](#c-11-B).
    - (E) **Consultation with private sector—** In carrying out the duties under this paragraph, the working group shall, as appropriate—
      - (i) consult with, representatives of interested industry stakeholders and nongovernmental organizations; and
      - (ii) take into consideration factors, such as actual and potential differences in interest between, and the views of, those stakeholders and organizations.
    - (F) **Chapter 10 of title 5—** [Chapter 10](/usc/5/chptI/ch10.md) of title 5 shall not apply to the working group established under this paragraph.
    - (G) **Savings clause—** Nothing in this paragraph supersedes any provision of—
      - (i) this subchapter; or
      - (ii) the Endangered Species Act of 1973 ([16 U.S.C. 1531](/usc/16/1531.md) et seq.), including the requirements under [section 7](/usc/7/7.md) of that Act ([16 U.S.C. 1536](/usc/16/1536.md)).
- (d) **Classification of pesticides—**
  - (1) **Classification for general use, restricted use, or both—**
    - (A) As a part of the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) the [Administrator](/usc/7/136.md?p=b) shall classify it as being for general use or for restricted use. If the [Administrator](/usc/7/136.md?p=b) determines that some of the uses for which the [pesticide](/usc/7/136.md?p=u) is registered should be for general use and that other uses for which it is registered should be for restricted use, the [Administrator](/usc/7/136.md?p=b) shall classify it for both general use and restricted use. [Pesticide](/usc/7/136.md?p=u) uses may be classified by regulation on the initial classification, and registered [pesticides](/usc/7/136.md?p=u) may be classified prior to reregistration. If some of the uses of the [pesticide](/usc/7/136.md?p=u) 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](/usc/7/136.md?p=b) may require that its packaging and [labeling](/usc/7/136.md?p=p-2) for restricted uses shall be clearly distinguishable from its packaging and [labeling](/usc/7/136.md?p=p-2) for general uses.
    - (B) If the [Administrator](/usc/7/136.md?p=b) determines that the [pesticide](/usc/7/136.md?p=u), 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](/usc/7/136.md?p=bb), the [Administrator](/usc/7/136.md?p=b) will classify the [pesticide](/usc/7/136.md?p=u), or the particular use or uses of the [pesticide](/usc/7/136.md?p=u) to which the determination applies, for general use.
    - (C) If the [Administrator](/usc/7/136.md?p=b) determines that the [pesticide](/usc/7/136.md?p=u), 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](/usc/7/136.md?p=bb), including injury to the applicator, the [Administrator](/usc/7/136.md?p=b) shall classify the [pesticide](/usc/7/136.md?p=u), or the particular use or uses to which the determination applies, for restricted use:
      - (i) If the [Administrator](/usc/7/136.md?p=b) classifies a [pesticide](/usc/7/136.md?p=u), or one or more uses of such [pesticide](/usc/7/136.md?p=u), for restricted use because of a determination that the acute dermal or inhalation toxicity of the [pesticide](/usc/7/136.md?p=u) presents a hazard to the applicator or other [persons](/usc/7/136.md?p=s), the [pesticide](/usc/7/136.md?p=u) shall be applied for any use to which the restricted classification applies only by or under the direct supervision of a [certified applicator](/usc/7/136.md?p=e-1).
      - (ii) If the [Administrator](/usc/7/136.md?p=b) classifies a [pesticide](/usc/7/136.md?p=u), or one or more uses of such [pesticide](/usc/7/136.md?p=u), for restricted use because of a determination that its use without additional regulatory restriction may cause [unreasonable adverse effects on the environment](/usc/7/136.md?p=bb), the [pesticide](/usc/7/136.md?p=u) shall be applied for any use to which the determination applies only by or under the direct supervision of a [certified applicator](/usc/7/136.md?p=e-1), or subject to such other restrictions as the [Administrator](/usc/7/136.md?p=b) may provide by regulation. Any such regulation shall be reviewable in the appropriate court of appeals upon petition of a [person](/usc/7/136.md?p=s) adversely affected filed within 60 days of the publication of the regulation in final form.
  - (2) **Change in classification—** If the [Administrator](/usc/7/136.md?p=b) determines that a change in the classification of any use of a [pesticide](/usc/7/136.md?p=u) from general use to restricted use is necessary to prevent [unreasonable adverse effects on the environment](/usc/7/136.md?p=bb), the [Administrator](/usc/7/136.md?p=b) shall notify the [registrant](/usc/7/136.md?p=y) of such [pesticide](/usc/7/136.md?p=u) of such determination at least forty-five days before making the change and shall publish the proposed change in the Federal Register. The [registrant](/usc/7/136.md?p=y), or other interested [person](/usc/7/136.md?p=s) with the concurrence of the [registrant](/usc/7/136.md?p=y), may seek relief from such determination under [section 136d(b) of this title](/usc/7/136d.md?p=b).
  - (3) **Change in classification from restricted use to general use—** The [registrant](/usc/7/136.md?p=y) of any [pesticide](/usc/7/136.md?p=u) with one or more uses classified for restricted use may petition the [Administrator](/usc/7/136.md?p=b) to change any such classification from restricted to general use. Such petition shall set out the basis for the [registrant](/usc/7/136.md?p=y)’s position that restricted use classification is unnecessary because classification of the [pesticide](/usc/7/136.md?p=u) for general use would not cause [unreasonable adverse effects on the environment](/usc/7/136.md?p=bb). The [Administrator](/usc/7/136.md?p=b), within sixty days after receiving such petition, shall notify the [registrant](/usc/7/136.md?p=y) 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](/usc/7/136n.md).
- (e) **Products with same formulation and claims—** Products which have the same formulation, are manufactured by the same [person](/usc/7/136.md?p=s), the [labeling](/usc/7/136.md?p=p-2) of which contains the same claims, and the [labels](/usc/7/136.md?p=p-1) of which bear a designation identifying the product as the same [pesticide](/usc/7/136.md?p=u) may be registered as a single [pesticide](/usc/7/136.md?p=u); and additional names and [labels](/usc/7/136.md?p=p-1) shall be added to the [registration](/usc/7/136.md?p=z) by supplemental statements.
- (f) **Miscellaneous—**
  - (1) **Effect of change of labeling or formulation—** If the [labeling](/usc/7/136.md?p=p-2) or formulation for a [pesticide](/usc/7/136.md?p=u) is changed, the [registration](/usc/7/136.md?p=z) shall be amended to reflect such change if the [Administrator](/usc/7/136.md?p=b) determines that the change will not violate any provision of this subchapter.
  - (2) **Registration not a defense—** In no event shall [registration](/usc/7/136.md?p=z) 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](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) shall be prima facie evidence that the [pesticide](/usc/7/136.md?p=u), its [labeling](/usc/7/136.md?p=p-2) and packaging comply with the [registration](/usc/7/136.md?p=z) provisions of the subchapter.
  - (3) **Authority to consult other Federal agencies—** In connection with consideration of any [registration](/usc/7/136.md?p=z) or application for [registration](/usc/7/136.md?p=z) under this section, the [Administrator](/usc/7/136.md?p=b) 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](/usc/7/136.md?p=hh) 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](/usc/7/136a–1.md), [136c](/usc/7/136c.md), [136e](/usc/7/136e.md), [136m](/usc/7/136m.md), and [136o(a)(2)](/usc/7/136o.md?p=a-2) of this title if the mixture or other combination is accompanied by the [labeling](/usc/7/136.md?p=p-2) required under this subchapter for the [nitrogen stabilizer](/usc/7/136.md?p=hh) contained in the mixture or other combination, the mixture or combination is mixed or combined in accordance with such [labeling](/usc/7/136.md?p=p-2), and the mixture or combination does not contain any [active ingredient](/usc/7/136.md?p=a) other than the [nitrogen stabilizer](/usc/7/136.md?p=hh).

  - (5) **Bilingual labeling—**
    - (A) **Requirement—**
      - (i) **In general—** Subject to [clause (ii)](#f-5-A-ii), not later than the applicable deadline described in [subparagraph (B)](#f-5-B), each registered [pesticide](/usc/7/136.md?p=u) product released for shipment shall include—
        - (I) the translation of the parts of the [labeling](/usc/7/136.md?p=p-2) contained in the Spanish Translation Guide described in [subparagraph (G)](#f-5-G) on the product container; or
        - (II) a link to such translation via scannable technology or other electronic methods readily accessible on the product [label](/usc/7/136.md?p=p-1).
      - (ii) **Exceptions—** Notwithstanding [clause (i)](#f-5-A-i)—
        - (I) an [antimicrobial pesticide](/usc/7/136.md?p=mm-1) product may, in lieu of including a translation or a link under [clause (i)](#f-5-A-i), provide a link to the safety data sheets in Spanish via scannable technology or other electronic methods readily accessible on the product [label](/usc/7/136.md?p=p-1); or
        - (II) a non-agricultural [pesticide](/usc/7/136.md?p=u) product that is not classified by the [Administrator](/usc/7/136.md?p=b) as restricted use under [subsection (d)(1)(A)](#d-1-A) may, in lieu of including a translation or a link under [clause (i)](#f-5-A-i), provide a link to the safety data sheets in Spanish via scannable technology or other electronic methods readily accessible on the product [label](/usc/7/136.md?p=p-1).
    - (B) **Deadlines for bilingual labeling—**
      - (i) **Pesticide products classified as restricted use—** In the case of [pesticide](/usc/7/136.md?p=u) products classified by the [Administrator](/usc/7/136.md?p=b) as restricted use under [subsection (d)(1)(A)](#d-1-A), the deadline specified in this subparagraph is the date that is 3 years following December 29, 2022.
      - (ii) **Pesticide products not classified as restricted use—** In the case of [pesticide](/usc/7/136.md?p=u) products not classified by the [Administrator](/usc/7/136.md?p=b) as restricted use under [subsection (d)(1)(A)](#d-1-A), the deadline specified in this subparagraph shall be as follows:
        - (I) **Agricultural—**
          - (aa) **Acute Toxicity Category I—** For agricultural [pesticides](/usc/7/136.md?p=u) classified as Acute Toxicity Category I, the date that is 3 years after December 29, 2022.
          - (bb) **Acute Toxicity Category II—** For agricultural [pesticides](/usc/7/136.md?p=u) classified as Acute Toxicity Category II, the date that is 5 years after December 29, 2022.
        - (II) **Antimicrobial and non-agricultural—**
          - (aa) **Acute Toxicity Category I—** For antimicrobial and non-agricultural [pesticide](/usc/7/136.md?p=u) products classified as Acute Toxicity Category I, the date that is 4 years after December 29, 2022.
          - (bb) **Acute Toxicity Category II—** For antimicrobial and non-agricultural [pesticide](/usc/7/136.md?p=u) products classified as Acute Toxicity Category II, the date that is 6 years after December 29, 2022.
        - (III) **Other pesticide products—** With respect to [pesticide](/usc/7/136.md?p=u) products not described in subclause [(I)](#f-5-B-ii-I) or [(II)](#f-5-B-ii-II), the date that is 8 years after December 29, 2022.
    - (C) **Implementation—**
      - (i) **Non-notification—**
        - (I) **In general—** In carrying out this paragraph, the [Administrator](/usc/7/136.md?p=b) shall allow translations of the parts of the [label](/usc/7/136.md?p=p-1) of a [pesticide](/usc/7/136.md?p=u) contained in the Spanish Translation Guide described in [subparagraph (G)](#f-5-G) and scannable technology or other electronic methods to be added using non-notification procedures.
        - (II) **Non-notification procedure defined—** In this clause, the term “non-notification procedure” refers to a procedure under which a change may be made to a [pesticide](/usc/7/136.md?p=u) [label](/usc/7/136.md?p=p-1) without notifying the [Administrator](/usc/7/136.md?p=b).
      - (ii) **Cooperation and consultation—** In carrying out this paragraph, the [Administrator](/usc/7/136.md?p=b) shall cooperate and consult with [State](/usc/7/136.md?p=aa) lead agencies for [pesticide](/usc/7/136.md?p=u) regulation for the purpose of implementing bilingual [labeling](/usc/7/136.md?p=p-2) as provided in this paragraph as expeditiously as possible.
      - (iii) **End use labeling—** The [labeling](/usc/7/136.md?p=p-2) requirements of this paragraph shall apply to end use product [labels](/usc/7/136.md?p=p-1).
      - (iv) **Incorporation timeframe—** After initial translation deadlines provided in [subparagraph (B)](#f-5-B), updates to the Spanish Translation Guide described in [subparagraph (G)](#f-5-G) shall be incorporated into [labeling](/usc/7/136.md?p=p-2) on the earlier of—
        - (I) in the case of agricultural use [pesticide](/usc/7/136.md?p=u) [labels](/usc/7/136.md?p=p-1), as determined by the [Administrator](/usc/7/136.md?p=b)—
          - (aa) 1 year after the date of publication of the updated Spanish [Label](/usc/7/136.md?p=p-1) Translation Guide described in [subparagraph (G)](#f-5-G); or
          - (bb) the released for shipment date specified on the EPA Stamped Approved [Label](/usc/7/136.md?p=p-1) after the [pesticide](/usc/7/136.md?p=u) [label](/usc/7/136.md?p=p-1) is next changed or amended following the date of publication of the updated Spanish [Label](/usc/7/136.md?p=p-1) Translation Guide described in [subparagraph (G)](#f-5-G); and
        - (II) in the case of antimicrobial and non-agricultural use [pesticide](/usc/7/136.md?p=u) [labels](/usc/7/136.md?p=p-1), as determined by the [Administrator](/usc/7/136.md?p=b)—
          - (aa) 2 years after the date of publication of the updated Spanish [Label](/usc/7/136.md?p=p-1) Translation Guide described in [subparagraph (G)](#f-5-G); or
          - (bb) the released for shipment date specified on the EPA Stamped Approved [Label](/usc/7/136.md?p=p-1) after the [pesticide](/usc/7/136.md?p=u) [label](/usc/7/136.md?p=p-1) is next changed or amended following the date of publication of the updated Spanish [Label](/usc/7/136.md?p=p-1) Translation Guide described in [subparagraph (G)](#f-5-G).
      - (v) **Notification of updates to the Spanish Translation Guide for Pesticide Labeling—** Not later than 10 days after updating the Spanish Translation Guide described in [subparagraph (G)](#f-5-G), the [Administrator](/usc/7/136.md?p=b) shall notify [registrants](/usc/7/136.md?p=y) of the update to such guide.
    - (D) **Accessibility of bilingual labeling for farm workers—** Not later than 180 days after December 29, 2022, to the maximum extent practicable, the [Administrator](/usc/7/136.md?p=b) shall seek stakeholder input on ways to make bilingual [labeling](/usc/7/136.md?p=p-2) required under this paragraph accessible to farm workers.
    - (E) **Plan—** Not later than 3 years after December 29, 2022, the [Administrator](/usc/7/136.md?p=b) shall implement a plan to ensure that farm workers have access to the bilingual [labeling](/usc/7/136.md?p=p-2) required under this paragraph.
    - (F) **Reporting—** Not later than 2 years after December 29, 2022, the [Administrator](/usc/7/136.md?p=b) shall develop and implement, and make publicly available, a plan for tracking the adoption of the bilingual [labeling](/usc/7/136.md?p=p-2) required under this paragraph.
    - (G) **Spanish Translation Guide described—** The Spanish Translation Guide described in this subparagraph is the Spanish Translation Guide for [Pesticide](/usc/7/136.md?p=u) [Labeling](/usc/7/136.md?p=p-2) issued in October 2019, as in effect on December 29, 2022, and any successor guides or amendments to such guide.
- (g) **Registration review—**
  - (1) **General rule—**
    - (A) **Periodic review—**
      - (i) **In general—** The [registrations](/usc/7/136.md?p=z) of [pesticides](/usc/7/136.md?p=u) are to be periodically reviewed.
      - (ii) **Regulations—** In accordance with this subparagraph, the [Administrator](/usc/7/136.md?p=b) shall by regulation establish a procedure for accomplishing the periodic review of [registrations](/usc/7/136.md?p=z).
      - (iii) **Initial registration review—** The [Administrator](/usc/7/136.md?p=b) shall complete the [registration](/usc/7/136.md?p=z) review of each [pesticide](/usc/7/136.md?p=u) or [pesticide](/usc/7/136.md?p=u) case, which may be composed of 1 or more [active ingredients](/usc/7/136.md?p=a) and the products associated with the [active ingredients](/usc/7/136.md?p=a), 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](/usc/7/136.md?p=u) containing a new [active ingredient](/usc/7/136.md?p=a) is registered.
      - (iv) **Subsequent registration review—** Not later than 15 years after the date on which the initial [registration](/usc/7/136.md?p=z) review is completed under [clause (iii)](#g-1-A-iii) and each 15 years thereafter, the [Administrator](/usc/7/136.md?p=b) shall complete a subsequent [registration](/usc/7/136.md?p=z) review for each [pesticide](/usc/7/136.md?p=u) or [pesticide](/usc/7/136.md?p=u) case.
      - (v) **Cancellation—** No [registration](/usc/7/136.md?p=z) shall be canceled as a result of the [registration](/usc/7/136.md?p=z) review process unless the [Administrator](/usc/7/136.md?p=b) follows the procedures and substantive requirements of [section 136d of this title](/usc/7/136d.md).
    - (B) **Docketing—**
      - (i) **In general—** Subject to [clause (ii)](#g-1-B-ii), after meeting with 1 or more individuals that are not government employees to discuss matters relating to a [registration](/usc/7/136.md?p=z) review, the [Administrator](/usc/7/136.md?p=b) shall place in the docket minutes of the meeting, a list of attendees, and any documents exchanged at the meeting, not later than the earlier of—
        - (I) the date that is 45 days after the meeting; or
        - (II) the date of issuance of the [registration](/usc/7/136.md?p=z) review decision.
      - (ii) **Protected information—** The [Administrator](/usc/7/136.md?p=b) shall identify, but not include in the docket, any confidential business information the disclosure of which is prohibited by [section 136h of this title](/usc/7/136h.md).
    - (C) **Limitation—** Nothing in this subsection shall prohibit the [Administrator](/usc/7/136.md?p=b) from undertaking any other review of a [pesticide](/usc/7/136.md?p=u) pursuant to this subchapter.
  - (2) **Data—**
    - (A) **Submission required—** The [Administrator](/usc/7/136.md?p=b) shall use the authority in [subsection (c)(2)(B)](#c-2-B) to require the submission of data when such data are necessary for a [registration](/usc/7/136.md?p=z) review.
    - (B) **Data submission, compensation, and exemption—** For purposes of this subsection, the provisions of subsections [(c)(1)](#c-1), [(c)(2)(B)](#c-2-B), and [(c)(2)(D)](#c-2-D) shall be utilized for and be applicable to any data required for [registration](/usc/7/136.md?p=z) 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](/usc/7/136.md?p=mm-1) and the type of review appropriate to evaluate the risks, the [Administrator](/usc/7/136.md?p=b) shall identify and evaluate reforms to the antimicrobial [registration](/usc/7/136.md?p=z) process that would reduce review periods existing as of August 3, 1996, for [antimicrobial pesticide](/usc/7/136.md?p=mm-1) product [registration](/usc/7/136.md?p=z) applications and applications for amended [registration](/usc/7/136.md?p=z) of [antimicrobial pesticide](/usc/7/136.md?p=mm-1) products, including—
    - (A) new antimicrobial [active ingredients](/usc/7/136.md?p=a);
    - (B) new antimicrobial end-use products;
    - (C) substantially similar or identical [antimicrobial pesticides](/usc/7/136.md?p=mm-1); and
    - (D) amendments to [antimicrobial pesticide](/usc/7/136.md?p=mm-1) [registrations](/usc/7/136.md?p=z).
  - (2) **Review time period reduction goal—** Each reform identified under [paragraph (1)](#h-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](/usc/7/136.md?p=a) [pesticide](/usc/7/136.md?p=u) [registration](/usc/7/136.md?p=z);
    - (B) 270 days for a new antimicrobial use of a registered [active ingredient](/usc/7/136.md?p=a);
    - (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](/usc/7/136.md?p=z) that does not require scientific review of data; and
    - (F) 120 days for an amendment to an antimicrobial [registration](/usc/7/136.md?p=z) 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](/usc/7/136.md?p=b) shall publish in the Federal Register proposed regulations to accelerate and improve the review of [antimicrobial pesticide](/usc/7/136.md?p=mm-1) products designed to implement, to the extent practicable, the goals set forth in [paragraph (2)](#h-2).
      - (ii) **Requirements—** Proposed regulations issued under [clause (i)](#h-3-A-i) shall—
        - (I) define the various classes of antimicrobial use patterns, including household, industrial, and institutional disinfectants and sanitizing [pesticides](/usc/7/136.md?p=u), 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](/usc/7/136.md?p=mm-1);
        - (III) conform the degree and type of review to the risks and benefits presented by [antimicrobial pesticides](/usc/7/136.md?p=mm-1) 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](/usc/7/136.md?p=z) process is sufficient to maintain [antimicrobial pesticide](/usc/7/136.md?p=mm-1) efficacy and that [antimicrobial pesticide](/usc/7/136.md?p=mm-1) products continue to meet product performance standards and effectiveness levels for each type of [label](/usc/7/136.md?p=p-1) claim made; and
        - (V) implement effective and reliable deadlines for process management.
      - (iii) **Comments—** In developing the proposed regulations, the [Administrator](/usc/7/136.md?p=b) shall solicit the views from [registrants](/usc/7/136.md?p=y) and other affected parties to maximize the effectiveness of the rule development process.
    - (B) **Final regulations—**
      - (i) **Issuance—** The [Administrator](/usc/7/136.md?p=b) 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)](#h-2) is not met by the final regulations, the [Administrator](/usc/7/136.md?p=b) 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](/usc/7/136.md?p=b) shall—
        - (I) consider the [establishment](/usc/7/136.md?p=dd) 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](/usc/7/136.md?p=dd) 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](/usc/7/136.md?p=mm-1) [registrations](/usc/7/136.md?p=z); 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)](#c-3).
    - (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](/usc/7/136.md?p=a) [pesticide](/usc/7/136.md?p=u) [registration](/usc/7/136.md?p=z);
      - (ii) 1 year for a new antimicrobial use of a registered [active ingredient](/usc/7/136.md?p=a);
      - (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](/usc/7/136.md?p=z) that does not require scientific review of data; and
      - (vi) 120 days for an amendment to an antimicrobial [registration](/usc/7/136.md?p=z) that requires scientific review of data and that is not otherwise described in this subparagraph.
    - (E) **Wood preservatives—** An application for the [registration](/usc/7/136.md?p=z), or for an amendment to the [registration](/usc/7/136.md?p=z), of a wood preservative product for which a claim of pesticidal activity listed in [section 136(mm) of this title](/usc/7/136.md?p=mm) is made (regardless of any other pesticidal claim that is made with respect to the product) shall be reviewed by the [Administrator](/usc/7/136.md?p=b) within the same period as that established under this paragraph for an [antimicrobial pesticide](/usc/7/136.md?p=mm-1) 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](/usc/7/136.md?p=mm-1).
    - (F) **Notification—**
      - (i) **In general—** Subject to [clause (iii)](#h-3-F-iii), the [Administrator](/usc/7/136.md?p=b) 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](/usc/7/136.md?p=b) agree to a later date.
      - (ii) **Final decision—** If the [Administrator](/usc/7/136.md?p=b) fails to notify an applicant within the period of time required under [clause (i)](#h-3-F-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](/usc/7/136.md?p=mm-1) that is filed under [subsection (c)(3)(B)](#c-3-B) prior to 90 days after August 3, 1996.
      - (iv) **Limitation—** Notwithstanding [clause (ii)](#h-3-F-ii), the failure of the [Administrator](/usc/7/136.md?p=b) to notify an applicant for an amendment to a [registration](/usc/7/136.md?p=z) for an [antimicrobial pesticide](/usc/7/136.md?p=mm-1) shall not be judicially reviewable in a Federal or [State](/usc/7/136.md?p=aa) court if the amendment requires scientific review of data within—
        - (I) the time period specified in [subparagraph (D)(vi)](#h-3-D-vi), in the absence of a final regulation under [subparagraph (B)](#h-3-B); or
        - (II) the time period specified in [paragraph (2)(F)](#h-2-F), if adopted in a final regulation under [subparagraph (B)](#h-3-B).
  - (4) **Annual report—**
    - (A) **Submission—** Beginning on August 3, 1996, and ending on the date that the goals under [paragraph (2)](#h-2) are achieved, the [Administrator](/usc/7/136.md?p=b) 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)](#h-4-A) shall include a description of—
      - (i) measures taken to reduce the backlog of pending [registration](/usc/7/136.md?p=z) applications;
      - (ii) progress toward achieving reforms under this subsection; and
      - (iii) recommendations to improve the activities of the Agency pertaining to antimicrobial [registrations](/usc/7/136.md?p=z).

## Source credit

(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; Pub. L. 115–334, title X, § 10115, Dec. 20, 2018, 132 Stat. 4914; Pub. L. 117–286, § 4(a)(21), Dec. 27, 2022, 136 Stat. 4307; Pub. L. 117–328, div. HH, title VI, § 702, Dec. 29, 2022, 136 Stat. 5996.)

## Notes

### Editorial Notes

### References in Text

The Endangered Species Act of 1973, referred to in subsec. (c)(11)(C)(i)(I), (II), (v), (vi), (G)(ii), is Pub. L. 93–205, Dec. 28, 1973, 87 Stat. 884, which is classified generally to chapter 35 (§ 1531 et seq.) of Title 16, Conservation. For complete classification of this Act to the Code, see Short Title note set out under section 1531 of Title 16 and Tables.

### 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

2022—Subsec. (c)(11)(F). Pub. L. 117–286 substituted “Chapter 10 of title 5” for “Federal Advisory Committee Act” in heading and “Chapter 10 of title 5” for “The Federal Advisory Committee Act (5 U.S.C. App.)” in text.

Subsec. (f)(5). Pub. L. 117–328 added par. (5).

2018—Subsec. (c)(11). Pub. L. 115–334 added par. (11).

2007—Subsec. (c)(3)(B)(ii)(I). Pub. L. 110–94, § 2(1), substituted “review the application in accordance with section 136w–8(f)(4)(B) of this title and,” for “within 45 days after receiving the application, notify the registrant whether or not the application is complete and,”.

Subsec. (c)(3)(B)(ii)(II). Pub. L. 110–94, § 2(2), substituted “not later than the applicable decision review time established pursuant to section 136w–8(f)(4)(B) of this title, or, if no review time is established, not later than” for “within”.

Subsec. (g)(1)(A). Pub. L. 110–94, § 3(1), designated first sentence as cl. (i) and inserted heading, designated second sentence as cl. (ii), inserted heading, and substituted “In accordance with this subparagraph, the Administrator” for “The Administrator”, added cls. (iii) and (iv), designated fourth sentence as cl. (v) and inserted heading, and struck out third sentence which read as follows: “The goal of these regulations shall be a review of a pesticide’s registration every 15 years.”

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

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

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

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

1996—Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104–170, § 210(b), added cls. (ii), (v), and (vi), redesignated former cls. (ii) and (iii) as (iii) and (iv), respectively, and in cl. (iv) substituted “(i), (ii), and (iii)” for “(i) and (ii)”.

Subsec. (c)(1)(G). Pub. L. 104–170, § 250(1), added subpar. (G).

Subsec. (c)(2)(A). Pub. L. 104–170, §§ 210(d)(1), 231, inserted heading, inserted “the public health and agricultural need for such minor use,” after “pattern of use,”, and substituted “potential beneficial or adverse effects on man and the environment” for “potential exposure of man and the environment to the pesticide”.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Subsec. (c)(1)(E). Pub. L. 102–237, § 1006(a)(3)(A), (C), added subpar. (E) and struck out former subpar. (E) which read as follows: “the complete formula of the pesticide; and”.

Subsec. (c)(1)(F). Pub. L. 102–237, § 1006(a)(3)(A), (B), (D), redesignated former subpar. (D) as (F), in cl. (i) substituted “With” for “with” and a period for semicolon at end, in cl. (ii) substituted “Except” for “except” and a period for semicolon at end, in cl. (iii) substituted “After” for “after” and a period for semicolon at end, and struck out former subpar. (F) which read as follows: “a request that the pesticide be classified for general use, for restricted use, or for both.”

Subsec. (c)(2)(A). Pub. L. 102–237, § 1006(b)(1), (2), substituted “the Administrator” for “he” before “requires”, “shall permit”, “shall make”, and “deems”, and substituted “the Administrator’s” for “his”.

Subsec. (c)(2)(D). Pub. L. 102–237, § 1006(c), clarified amendment made by Pub. L. 100–532, § 102(b)(2)(A). See 1988 Amendment note below.

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

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

Subsec. (c)(6). Pub. L. 102–237, § 1006(b)(1), (2), substituted “the Administrator” for “he” before “shall notify” in two places and “the Administrator’s” for “his” in four places.

Subsec. (d)(1). Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “shall classify it for both” in subpar. (A), before “will classify” in subpar. (B), and before “shall classify” in subpar. (C).

Subsec. (d)(2). Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “shall notify”.

1990—Subsec. (c)(2)(A). Pub. L. 101–624 inserted after third sentence “The Administrator shall not require a person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under this subchapter, any field residue data from a geographic area where the pesticide will not be registered for such use.”

1988—Subsec. (a). Pub. L. 100–532, § 601(b)(1), substituted “Requirement of registration” for “Requirement” in heading and amended text generally. Prior to amendment, text read as follows: “Except as otherwise provided by this subchapter, no person in any State may distribute, sell, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person any pesticide which is not registered with the Administrator.”

Subsec. (c)(1)(D). Pub. L. 100–532, § 801(b)(1)–(4), in introductory provisions, substituted “paragraph (2)(D)” for “subsection (c)(2)(D) of this section”, in cl. (i), substituted “(i) with” for “(i) With” and “, except that” for “: Provided, That”, in cl. (ii), substituted “clause (i)” for “subparagraph (D)(i) of this paragraph”, and in cl. (iii), substituted “clauses (i) and (ii)” for “subparagraphs (D)(i) and (D)(ii) of this paragraph”.

Subsec. (c)(2)(A). Pub. L. 100–532, § 801(b)(5)(A), (B), substituted “(2) Data in support of registration.—

“(A) The”

for “(2)(A) Data in support of registration.—The”, and directed that subpar. (A) be aligned with left margin of subsec. (d)(1)(A) of this section.

Subsec. (c)(2)(B). Pub. L. 100–532, §§ 102(b)(1), 801(b)(5)(C)–(F), substituted “(B)(i) If” for “(B) Additional data to support existing registration.—(i) If”, directed that cls. (ii) to (v) be aligned with left margin of subpar. (A), in cls. (ii) and (iii), inserted “The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to comply with this clause.”, in cl. (iv), substituted “title. The only” for “title: Provided, that the only”, and in cl. (v), substituted “paragraph (1)(D)” for “subsection (c)(1)(D) of this section”.

Subsec. (c)(2)(C). Pub. L. 100–532, § 801(b)(5)(G), (H), struck out “Simplified procedures” after “(C)” and directed that text be aligned with left margin of subpar. (A).

Subsec. (c)(2)(D). Pub. L. 100–532, § 102(b)(2)(A), and Pub. L. 102–237, § 1006(c), substituted “the pesticide that is the subject of the application” for “an end-use product”.

Subsec. (c)(2)(D)(i). Pub. L. 100–532, § 102(b)(2)(B), struck out “the safety of” after “data pertaining to”.

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

Subsec. (c)(7). Pub. L. 100–532, § 801(b)(6), in introductory provisions, substituted “paragraph (5)” for “subsection (c)(5) of this section”, in subpars. (A) and (B), substituted “paragraph (5). If” for “subsection (c)(5) of this section: Provided, That, if”, and in subpar. (C), substituted “prescribe. A” for “prescribe: Provided, that a”.

Subsec. (d)(1)(A). Pub. L. 100–532, § 801(b)(7), substituted “restricted use. If” for “restricted use, provided that if” and “restricted uses. The Administrator” for “restricted uses: Provided, however, That the Administrator”.

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

Subsec. (g). Pub. L. 100–532, § 801(b)(9), struck out subsec. (g) which read as follows: “The Administrator shall accomplish the reregistration of all pesticides in the most expeditious manner practicable: Provided, That, to the extent appropriate, any pesticide that results in a postharvest residue in or on food or feed crops shall be given priority in the reregistration process.”

1978—Subsec. (c)(1)(D). Pub. L. 95–396, § 2(a)(1), added subpar. (D), and struck out provisions which required the applicant for registration of a pesticide to file with the Administrator a statement containing “if requested by the Administrator, a full description of the tests made and the results thereof upon which the claims are based, except that data submitted on or after January 1, 1970, in support of an application shall not, without permission of the applicant, be considered by the Administrator in support of any other application for registration unless such other applicant shall have first offered to pay reasonable compensation for producing the test data to be relied upon and such data is not protected from disclosure by section 136h(b) of this title. This provision with regard to compensation for producing the test data to be relied upon shall apply with respect to all applications for registration or reregistration submitted on or after October 21, 1972. If the parties cannot agree on the amount and method of payment, the Administrator shall make such determination and may fix such other terms and conditions as may be reasonable under the circumstances. The Administrator’s determination shall be made on the record after notice and opportunity for hearing. If either party does not agree with said determination, he may, within thirty days, take an appeal to the Federal district court for the district in which he resides with respect to either the amount of the payment or the terms of payment, or both. Registration shall not be delayed pending the determination of reasonable compensation between the applicants, by the Administrator or by the court.”.

Subsec. (c)(2). Pub. L. 95–396, §§ 2(a)(2)(A)–(D), 3, 4, designated existing provisions as subpar. (A), inserted in second sentence “under subparagraph (B) of this paragraph” after “kind of information”, struck out from introductory text of third sentence “subsection (c)(1)(D) of this section and” after “Except as provided by”, and inserted provisions relating to establishment of standards for data requirements for registration of pesticides with respect to minor uses and consideration of economic factors in development of standards and cost of development, and added subpars. (B) to (D).

Subsec. (c)(5). Pub. L. 95–396, § 5, provided for waiver of data requirements pertaining to efficacy.

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

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

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

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

Subsec. (g). Pub. L. 95–396, § 8, added subsec. (g).

1975—Subsec. (c)(1)(D). Pub. L. 94–140 inserted exception relating to test data submitted on or after January 1, 1970, in support of application, inserted provision that compensation for producing test data shall apply to all applications submitted on or after October 21, 1972, and provision relating to delay of registration pending determination of reasonable compensation, struck out requirement that payment determined by court not be less than amount determined by Administrator, and substituted “If either party” for “If the owner of the test data”.

### Statutory Notes and Related Subsidiaries

### Effective Date of 2007 Amendment

Pub. L. 110–94, § 6, Oct. 9, 2007, 121 Stat. 1007, provided that: “This Act [see Short Title of 2007 Amendment note set out under section 136 of this title] and the amendments made by this Act take effect on October 1, 2007.”

### Effective Date of 2004 Amendment

Pub. L. 108–199, div. G, title V, § 501(h), Jan. 23, 2004, 118 Stat. 434, provided that: “Except as otherwise provided in this section [enacting section 136w–8 of this title, amending this section and sections 136a–1, 136x, and 136y of this title, and enacting provisions set out as notes under sections 136 of this title and section 346a of Title 21, Food and Drugs] and the amendments made by this section, this section and the amendments made by this section take effect on the date that is 60 days after the date of enactment of this Act [Jan. 23, 2004].”

### Effective Date of 1988 Amendment

Amendment by Pub. L. 100–532 effective on expiration of 60 days after Oct. 25, 1988, see section 901 of Pub. L. 100–532, set out as a note under section 136 of this title.

### Effective Date of 1978 Amendment

Pub. L. 95–396, § 2(b), Sept. 30, 1978, 92 Stat. 824, 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.

### Registration Review Deadline Extension

Pub. L. 117–328, div. HH, title VI, § 711, Dec. 29, 2022, 136 Stat. 6083, provided that: In General.—Notwithstanding section 3(g)(1)(A)(iii)(I) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(g)(1)(A)(iii)(I)), the Administrator of the Environmental Protection Agency (referred to in this section as the ‘Administrator’) shall complete the initial registration review of each pesticide or pesticide case covered by that section not later than October 1, 2026.Interim Registration Review Decision Requirements.— Definition of covered interim registration review decision.—In this subsection, the term ‘covered interim registration review decision’ means an interim registration review decision— that is associated with an initial registration review described in subsection (a); that is noticed in the Federal Register during the period beginning on the date of enactment of this Act [Dec. 29, 2022] and ending on October 1, 2026; and for which the Administrator has not, as of the date on which the decision is noticed in the Federal Register, made effects determinations or completed any necessary consultation under section 7(a)(2) of the Endangered Species Act of 1973 (16 U.S.C. 1536(a)(2)). Requirements.—Any covered interim registration review decision shall include, where applicable, measures to reduce the effects of the applicable pesticide on— species listed under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.); or any designated critical habitat. Consultation.—In developing measures described in paragraph (2), the Administrator shall take into account the input received from the Secretary of Agriculture and other members of the interagency working group established under section 3(c)(11) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)(11)).”

### Biological Pesticide Handling Study

Pub. L. 101–624, title XIV, § 1498, Nov. 28, 1990, 104 Stat. 3631, provided that the National Academy of Sciences would 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, and within 1 year after completion of the study, develop and implement a common process for reviewing and approving biological control applications submitted to such agencies and offices based on the study conducted, the recommendation of the National Academy of Sciences, and other public comment.

### Education, Study, and Report

Pub. L. 100–478, title I, § 1010, Oct. 7, 1988, 102 Stat. 2313, provided that: Education.—The Administrator of the Environmental Protection Agency in cooperation with the Secretary of Agriculture and the Secretary of the Interior, promptly upon enactment of this Act [Oct. 7, 1988], shall conduct a program to inform and educate fully persons engaged in agricultural food and fiber commodity production of any proposed pesticide labeling program or requirements that may be imposed by the Administrator in compliance with the Endangered Species Act [of 1973] (16 U.S.C. 1531 et seq.). The Administrator also shall provide the public with notice of, and opportunity for comment on, the elements of any such program and requirements based on compliance with the Endangered Species Act [of 1973], including (but not limited to) an identification of any pesticides affected by the program; an explanation of the restriction or prohibition on the user or applicator of any such pesticide; an identification of those geographic areas affected by any pesticide restriction or prohibition; an identification of the effects of any restricted or prohibited pesticide on endangered or threatened species; and an identification of the endangered or threatened species along with a general description of the geographic areas in which such species are located wherein the application of a pesticide will be restricted, prohibited, or its use otherwise limited, unless the Secretary of the Interior determines that the disclosure of such information may create a substantial risk of harm to such species or its habitat. 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. 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.”