--- kind: "section" citation: "7 U.S.C. § 136a–1" title: "7" title_heading: "Agriculture" number: "136a–1" heading: "Reregistration of registered pesticides" release: "119-102" date: "2026-07-12" url: "https://uscodex.org/usc/7/136a-1" units: - "Chapter 6 — Insecticides and Environmental Pesticide Control" - "Subchapter II — Environmental Pesticide Control" --- # §136a–1. Reregistration of registered pesticides - (a) **General rule—** The [Administrator](/usc/7/136.md?p=b) shall reregister, in accordance with this section, each registered [pesticide](/usc/7/136.md?p=u) containing any [active ingredient](/usc/7/136.md?p=a) contained in any [pesticide](/usc/7/136.md?p=u) first registered before November 1, 1984, except for any [pesticide](/usc/7/136.md?p=u) as to which the [Administrator](/usc/7/136.md?p=b) has determined, after November 1, 1984, and before the effective date of this section, that— - (1) there are no [outstanding data requirements](/usc/7/136.md?p=ff-1); and - (2) the requirements of [section 136a(c)(5) of this title](/usc/7/136a.md?p=c-5) have been satisfied. - (b) **Reregistration phases—** Reregistrations of [pesticides](/usc/7/136.md?p=u) under this section shall be carried out in the following phases: - (1) The first phase shall include the listing under [subsection (c)](#c) of the [active ingredients](/usc/7/136.md?p=a) of the [pesticides](/usc/7/136.md?p=u) that will be reregistered. - (2) The second phase shall include the submission to the [Administrator](/usc/7/136.md?p=b) under [subsection (d)](#d) of notices by [registrants](/usc/7/136.md?p=y) respecting their intention to seek reregistration, identification by [registrants](/usc/7/136.md?p=y) of missing and inadequate data for such [pesticides](/usc/7/136.md?p=u), and commitments by [registrants](/usc/7/136.md?p=y) to replace such missing or inadequate data within the applicable time period. - (3) The third phase shall include submission to the [Administrator](/usc/7/136.md?p=b) by [registrants](/usc/7/136.md?p=y) of the information required under [subsection (e)](#e). - (4) The fourth phase shall include an independent, initial review by the [Administrator](/usc/7/136.md?p=b) under [subsection (f)](#f) of submissions under phases two and three, identification of [outstanding data requirements](/usc/7/136.md?p=ff-1), and the issuance, as necessary, of requests for additional data. - (5) The fifth phase shall include the review by the [Administrator](/usc/7/136.md?p=b) under [subsection (g)](#g) of data submitted for reregistration and appropriate regulatory action by the [Administrator](/usc/7/136.md?p=b). - (c) **Phase one—** - (1) **Priority for reregistration—** For purposes of the reregistration of the [pesticides](/usc/7/136.md?p=u) described in [subsection (a)](#a), the [Administrator](/usc/7/136.md?p=b) shall list the [active ingredients](/usc/7/136.md?p=a) of [pesticides](/usc/7/136.md?p=u) and shall give priority to, among others, [active ingredients](/usc/7/136.md?p=a) (other than [active ingredients](/usc/7/136.md?p=a) for which [registration](/usc/7/136.md?p=z) standards have been issued before the effective date of this section) that— - (A) are in use on or in food or feed and may result in postharvest residues; - (B) may result in residues of potential toxicological concern in potable ground water, edible fish, or shellfish; - (C) have been determined by the [Administrator](/usc/7/136.md?p=b) before the effective date of this section to have significant [outstanding data requirements](/usc/7/136.md?p=ff-1); or - (D) are used on crops, including in greenhouses and nurseries, where worker exposure is most likely to occur. - (2) **Reregistration lists—** For purposes of reregistration under this section, the [Administrator](/usc/7/136.md?p=b) shall by order— - (A) not later than 70 days after the effective date of this section, list [pesticide](/usc/7/136.md?p=u) [active ingredients](/usc/7/136.md?p=a) for which [registration](/usc/7/136.md?p=z) standards have been issued before such effective date; - (B) not later than 4 months after such effective date, list the first 150 [pesticide](/usc/7/136.md?p=u) [active ingredients](/usc/7/136.md?p=a), as determined under [paragraph (1)](#c-1); - (C) not later than 7 months after such effective date, list the second 150 [pesticide](/usc/7/136.md?p=u) [active ingredients](/usc/7/136.md?p=a), as determined under [paragraph (1)](#c-1); and - (D) not later than 10 months after such effective date, list the remainder of the [pesticide](/usc/7/136.md?p=u) [active ingredients](/usc/7/136.md?p=a), as determined under [paragraph (1)](#c-1). Each list shall be published in the Federal Register. - (3) **Judicial review—** The content of a list issued by the [Administrator](/usc/7/136.md?p=b) under [paragraph (2)](#c-2) shall not be subject to judicial review. - (4) **Notice to registrants—** On the publication of a list of [pesticide](/usc/7/136.md?p=u) [active ingredients](/usc/7/136.md?p=a) under [paragraph (2)](#c-2), the [Administrator](/usc/7/136.md?p=b) shall send by certified mail to the [registrants](/usc/7/136.md?p=y) of the [pesticides](/usc/7/136.md?p=u) containing such [active ingredients](/usc/7/136.md?p=a) a notice of the time by which the [registrants](/usc/7/136.md?p=y) are to notify the [Administrator](/usc/7/136.md?p=b) under [subsection (d)](#d) whether the [registrants](/usc/7/136.md?p=y) intend to seek or not to seek reregistration of such [pesticides](/usc/7/136.md?p=u). - (d) **Phase two—** - (1) **In general—** The [registrant](/usc/7/136.md?p=y) of a [pesticide](/usc/7/136.md?p=u) that contains an [active ingredient](/usc/7/136.md?p=a) listed under subparagraph [(B)](#c-2-B), [(C)](#c-2-C), or [(D)](#c-2-D) of subsection (c)(2) shall submit to the [Administrator](/usc/7/136.md?p=b), within the time period prescribed by [paragraph (4)](#d-4), the notice described in [paragraph (2)](#d-2) and any information, commitment, or offer described in [paragraph (3)](#d-3). - (2) **Notice of intent to seek or not to seek reregistration—** - (A) The [registrant](/usc/7/136.md?p=y) of a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) listed under subparagraph [(B)](#c-2-B), [(C)](#c-2-C), or [(D)](#c-2-D) of subsection (c)(2) shall notify the [Administrator](/usc/7/136.md?p=b) by certified mail whether the [registrant](/usc/7/136.md?p=y) intends to seek or does not intend to seek reregistration of the [pesticide](/usc/7/136.md?p=u). - (B) If a [registrant](/usc/7/136.md?p=y) submits a notice under [subparagraph (A)](#d-2-A) of an intention not to seek reregistration of a [pesticide](/usc/7/136.md?p=u), the [Administrator](/usc/7/136.md?p=b) shall publish a notice in the Federal Register stating that such a notice has been submitted. - (3) **Missing or inadequate data—** Each [registrant](/usc/7/136.md?p=y) of a [pesticide](/usc/7/136.md?p=u) that contains an [active ingredient](/usc/7/136.md?p=a) listed under subparagraph [(B)](#c-2-B), [(C)](#c-2-C), or [(D)](#c-2-D) of subsection (c)(2) and for which the [registrant](/usc/7/136.md?p=y) submitted a notice under [paragraph (2)](#d-2) of an intention to seek reregistration of such [pesticide](/usc/7/136.md?p=u) shall submit to the [Administrator](/usc/7/136.md?p=b)— - (A) in accordance with regulations issued by the [Administrator](/usc/7/136.md?p=b) under [section 136a of this title](/usc/7/136a.md), an identification of— - (i) all data that are required by regulation to support the [registration](/usc/7/136.md?p=z) of the [pesticide](/usc/7/136.md?p=u) with respect to such [active ingredient](/usc/7/136.md?p=a); - (ii) data that were submitted by the [registrant](/usc/7/136.md?p=y) previously in support of the [registration](/usc/7/136.md?p=z) of the [pesticide](/usc/7/136.md?p=u) that are inadequate to meet such regulations; and - (iii) data identified under [clause (i)](#d-3-A-i) that have not been submitted to the [Administrator](/usc/7/136.md?p=b); and - (B) either— - (i) a commitment to replace the data identified under [subparagraph (A)(ii)](#d-3-A-ii) and submit the data identified under [subparagraph (A)(iii)](#d-3-A-iii) within the applicable time period prescribed by [paragraph (4)(B)](#d-4-B); or - (ii) an offer to share in the cost to be incurred by a [person](/usc/7/136.md?p=s) who has made a commitment under [clause (i)](#d-3-B-i) to replace or submit the data and an offer to submit to arbitration as described by [section 136a(c)(2)(B) of this title](/usc/7/136a.md?p=c-2-B) with regard to such cost sharing. For purposes of a submission by a [registrant](/usc/7/136.md?p=y) under [subparagraph (A)(ii)](#d-3-A-ii), data are inadequate if the data are derived from a study with respect to which the [registrant](/usc/7/136.md?p=y) is unable to make the certification prescribed by [subsection (e)(1)(G)](#e-1-G) that the [registrant](/usc/7/136.md?p=y) possesses or has access to the raw data used in or generated by such study. For purposes of a submission by a [registrant](/usc/7/136.md?p=y) under such subparagraph, data shall be considered to be inadequate if the data are derived from a study submitted before January 1, 1970, unless it is demonstrated to the satisfaction of the [Administrator](/usc/7/136.md?p=b) that such data should be considered to support the [registration](/usc/7/136.md?p=z) of the [pesticide](/usc/7/136.md?p=u) that is to be reregistered. - (4) **Time periods—** - (A) A submission under paragraph [(2)](#d-2) or [(3)](#d-3) shall be made— - (i) in the case of a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) listed under [subsection (c)(2)(B)](#c-2-B), not later than 3 months after the date of publication of the listing of such [active ingredient](/usc/7/136.md?p=a); - (ii) in the case of a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) listed under [subsection (c)(2)(C)](#c-2-C), not later than 3 months after the date of publication of the listing of such [active ingredient](/usc/7/136.md?p=a); and - (iii) in the case of a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) listed under [subsection (c)(2)(D)](#c-2-D), not later than 3 months after the date of publication of the listing of such [active ingredient](/usc/7/136.md?p=a). On application, the [Administrator](/usc/7/136.md?p=b) may extend a time period prescribed by this subparagraph if the [Administrator](/usc/7/136.md?p=b) determines that factors beyond the control of the [registrant](/usc/7/136.md?p=y) prevent the [registrant](/usc/7/136.md?p=y) from complying with such period. - (B) A [registrant](/usc/7/136.md?p=y) shall submit data in accordance with a commitment entered into under [paragraph (3)(B)](#d-3-B) within a reasonable period of time, as determined by the [Administrator](/usc/7/136.md?p=b), but not more than 48 months after the date the [registrant](/usc/7/136.md?p=y) submitted the commitment. The [Administrator](/usc/7/136.md?p=b), on application of a [registrant](/usc/7/136.md?p=y), may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the [registrant](/usc/7/136.md?p=y) prevent the [registrant](/usc/7/136.md?p=y) from submitting data within such prescribed period. Upon application 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 this section 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 this section; 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 subparagraph, 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) of [section 136a(c)(2)(B) of this title](/usc/7/136a.md?p=c-2-B) or other provisions of this section, as appropriate, 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 subparagraph, the [Administrator](/usc/7/136.md?p=b) may take action to modify or revoke the extension under this subparagraph 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 written notice to the [registrant](/usc/7/136.md?p=y) revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date then established by the [Administrator](/usc/7/136.md?p=b) for submission of the data. - (5) **Cancellation and removal—** - (A) If the [registrant](/usc/7/136.md?p=y) of a [pesticide](/usc/7/136.md?p=u) does not submit a notice under paragraph [(2)](#d-2) or [(3)](#d-3) within the time prescribed by [paragraph (4)(A)](#d-4-A), the [Administrator](/usc/7/136.md?p=b) shall issue a notice of intent to cancel the [registration](/usc/7/136.md?p=z) of such [registrant](/usc/7/136.md?p=y) for such [pesticide](/usc/7/136.md?p=u) and shall publish the notice in the Federal Register and allow 60 days for the submission of comments on the notice. On expiration of such 60 days, the [Administrator](/usc/7/136.md?p=b), by order and without a hearing, may cancel the [registration](/usc/7/136.md?p=z) or take such other action, including extension of applicable time periods, as may be necessary to enable reregistration of such [pesticide](/usc/7/136.md?p=u) by another [person](/usc/7/136.md?p=s). - (B) - (i) If— - (I) no [registrant](/usc/7/136.md?p=y) of a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) listed under [subsection (c)(2)](#c-2) notifies the [Administrator](/usc/7/136.md?p=b) under [paragraph (2)](#d-2) that the [registrant](/usc/7/136.md?p=y) intends to seek reregistration of any [pesticide](/usc/7/136.md?p=u) containing that [active ingredient](/usc/7/136.md?p=a); - (II) no such [registrant](/usc/7/136.md?p=y) complies with [paragraph (3)(A)](#d-3-A); or - (III) no such [registrant](/usc/7/136.md?p=y) makes a commitment under [paragraph (3)(B)](#d-3-B) to replace or submit all data described in clauses [(ii)](#d-3-A-ii) and [(iii)](#d-3-A-iii) of paragraph (3)(A); the [Administrator](/usc/7/136.md?p=b) shall publish in the Federal Register a notice of intent to remove the [active ingredient](/usc/7/136.md?p=a) from the list established under [subsection (c)(2)](#c-2) and a notice of intent to cancel the [registrations](/usc/7/136.md?p=z) of all [pesticides](/usc/7/136.md?p=u) containing such [active ingredient](/usc/7/136.md?p=a) and shall provide 60 days for comment on such notice. - (ii) After the 60-day period has expired, the [Administrator](/usc/7/136.md?p=b), by order, may cancel any such [registration](/usc/7/136.md?p=z) without hearing, except that the [Administrator](/usc/7/136.md?p=b) shall not cancel a [registration](/usc/7/136.md?p=z) under this subparagraph if— - (I) during the comment period a [person](/usc/7/136.md?p=s) acquires the rights of the [registrant](/usc/7/136.md?p=y) in that [registration](/usc/7/136.md?p=z); - (II) during the comment period that [person](/usc/7/136.md?p=s) furnishes a notice of intent to reregister the [pesticide](/usc/7/136.md?p=u) in accordance with [paragraph (2)](#d-2); and - (III) not later than 120 days after the publication of the notice under this subparagraph, that [person](/usc/7/136.md?p=s) has complied with [paragraph (3)](#d-3) and the fee prescribed by this section has been paid. - (6) **Suspensions and penalties—** 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 [section 136a(c)(2)(B)(iv) of this title](/usc/7/136a.md?p=c-2-B-iv) if the [Administrator](/usc/7/136.md?p=b) determines that (A) progress is insufficient to ensure the submission of the data required for such [pesticide](/usc/7/136.md?p=u) under a commitment made under [paragraph (3)(B)](#d-3-B) within the time period prescribed by paragraph [(4)(B)](#d-4-B) or (B) the [registrant](/usc/7/136.md?p=y) has not submitted such data to the [Administrator](/usc/7/136.md?p=b) within such time period. 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 paragraph 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 this section for the supported uses identified pursuant to this paragraph 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 such a 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 paragraph, 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 [section 136a(c)(2)(B)(iv) of this title](/usc/7/136a.md?p=c-2-B-iv) 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 this subparagraph, the [Administrator](/usc/7/136.md?p=b) may deny, modify, or revoke the temporary extension under this paragraph 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). - (e) **Phase three—** - (1) **Information about studies—** Each [registrant](/usc/7/136.md?p=y) of a [pesticide](/usc/7/136.md?p=u) that contains an [active ingredient](/usc/7/136.md?p=a) listed under subparagraph [(B)](#c-2-B), [(C)](#c-2-C), or [(D)](#c-2-D) of subsection (c)(2) who has submitted a notice under [subsection (d)(2)](#d-2) of an intent to seek the reregistration of such [pesticide](/usc/7/136.md?p=u) shall submit, in accordance with the guidelines issued under [paragraph (4)](#e-4), to the [Administrator](/usc/7/136.md?p=b)— - (A) a summary of each study concerning the [active ingredient](/usc/7/136.md?p=a) previously submitted by the [registrant](/usc/7/136.md?p=y) in support of the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) containing such [active ingredient](/usc/7/136.md?p=a) and considered by the [registrant](/usc/7/136.md?p=y) to be adequate to meet the requirements of [section 136a of this title](/usc/7/136a.md) and the regulations issued under such section; - (B) a summary of each study concerning the [active ingredient](/usc/7/136.md?p=a) previously submitted by the [registrant](/usc/7/136.md?p=y) in support of the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) containing such [active ingredient](/usc/7/136.md?p=a) that may not comply with the requirements of [section 136a of this title](/usc/7/136a.md) and the regulations issued under such section but which the [registrant](/usc/7/136.md?p=y) asserts should be deemed to comply with such requirements and regulations; - (C) a reformat of the data from each study summarized under subparagraph [(A)](#e-1-A) or [(B)](#e-1-B) by the [registrant](/usc/7/136.md?p=y) concerning chronic dosing, oncogenicity, reproductive effects, mutagenicity, neurotoxicity, teratogenicity, or residue chemistry of the [active ingredient](/usc/7/136.md?p=a) that were submitted to the [Administrator](/usc/7/136.md?p=b) before January 1, 1982; - (D) where data described in [subparagraph (C)](#e-1-C) are not required for the [active ingredient](/usc/7/136.md?p=a) by regulations issued under [section 136a of this title](/usc/7/136a.md), a reformat of acute and subchronic dosing data submitted by the [registrant](/usc/7/136.md?p=y) to the [Administrator](/usc/7/136.md?p=b) before January 1, 1982, that the [registrant](/usc/7/136.md?p=y) considers to be adequate to meet the requirements of [section 136a of this title](/usc/7/136a.md) and the regulations issued under such section; - (E) an identification of data that are required to be submitted to the [Administrator](/usc/7/136.md?p=b) under [section 136d(a)(2) of this title](/usc/7/136d.md?p=a-2), indicating an adverse effect of the [pesticide](/usc/7/136.md?p=u); - (F) an identification of any other information available that in the view of the [registrant](/usc/7/136.md?p=y) supports the [registration](/usc/7/136.md?p=z); - (G) a certification that the [registrant](/usc/7/136.md?p=y) or the [Administrator](/usc/7/136.md?p=b) possesses or has access to the raw data used in or generated by the studies that the [registrant](/usc/7/136.md?p=y) summarized under subparagraph [(A)](#e-1-A) or [(B)](#e-1-B); - (H) either— - (i) a commitment to submit data to fill each [outstanding data requirement](/usc/7/136.md?p=ff-1) identified by the [registrant](/usc/7/136.md?p=y); or - (ii) an offer to share in the cost of developing such data to be incurred by a [person](/usc/7/136.md?p=s) who has made a commitment under [clause (i)](#e-1-H-i) to submit such data, and an offer to submit to arbitration as described by [section 136a(c)(2)(B) of this title](/usc/7/136a.md?p=c-2-B) with regard to such cost sharing; and - (I) evidence of compliance with [section 136a(c)(1)(D)(ii)](/usc/7/136a.md)[^1] of this title and regulations issued thereunder with regard to previously submitted data as if the [registrant](/usc/7/136.md?p=y) were now seeking the original [registration](/usc/7/136.md?p=z) of the [pesticide](/usc/7/136.md?p=u). A [registrant](/usc/7/136.md?p=y) who submits a certification under [subparagraph (G)](#e-1-G) that is false shall be considered to have violated this subchapter and shall be subject to the penalties prescribed by [section 136l](/usc/7/136l.md) of this title. - (2) **Time periods—** - (A) The information required by [paragraph (1)](#e-1) shall be submitted to the [Administrator](/usc/7/136.md?p=b)— - (i) in the case of a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) listed under [subsection (c)(2)(B)](#c-2-B), not later than 12 months after the date of publication of the listing of such [active ingredient](/usc/7/136.md?p=a); - (ii) in the case of a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) listed under [subsection (c)(2)(C)](#c-2-C), not later than 12 months after the date of publication of the listing of such [active ingredient](/usc/7/136.md?p=a); and - (iii) in the case of a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) listed under [subsection (c)(2)(D)](#c-2-D), not later than 12 months after the date of publication of the listing of such [active ingredient](/usc/7/136.md?p=a). - (B) A [registrant](/usc/7/136.md?p=y) shall submit data in accordance with a commitment entered into under [paragraph (1)(H)](#e-1-H) within a reasonable period of time, as determined by the [Administrator](/usc/7/136.md?p=b), but not more than 48 months after the date the [registrant](/usc/7/136.md?p=y) submitted the commitment under such paragraph. The [Administrator](/usc/7/136.md?p=b), on application of a [registrant](/usc/7/136.md?p=y), may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the [registrant](/usc/7/136.md?p=y) prevent the [registrant](/usc/7/136.md?p=y) from submitting data within such prescribed period. Upon application 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 this section 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 this section; 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 subparagraph, 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) of [section 136a(c)(2)(B) of this title](/usc/7/136a.md?p=c-2-B) or other provisions of this section, as appropriate, 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 subparagraph, the [Administrator](/usc/7/136.md?p=b) may take action to modify or revoke the extension under this subparagraph 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 written notice to the [registrant](/usc/7/136.md?p=y) revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date then established by the [Administrator](/usc/7/136.md?p=b) for submission of the data. - (3) **Cancellation—** - (A) If the [registrant](/usc/7/136.md?p=y) of a [pesticide](/usc/7/136.md?p=u) fails to submit the information required by [paragraph (1)](#e-1) within the time prescribed by [paragraph (2)](#e-2), the [Administrator](/usc/7/136.md?p=b), by order and without hearing, shall cancel the [registration](/usc/7/136.md?p=z) of such [pesticide](/usc/7/136.md?p=u). 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 subparagraph 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 this section for the supported uses identified pursuant to this subparagraph 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 subparagraph, 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 [section 136a(c)(2)(B)(iv) of this title](/usc/7/136a.md?p=c-2-B-iv) 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 this subparagraph, 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). - (B) - (i) If the [registrant](/usc/7/136.md?p=y) of a [pesticide](/usc/7/136.md?p=u) submits the information required by [paragraph (1)](#e-1) within the time prescribed by [paragraph (2)](#e-2) and such information does not conform to the guidelines for submissions established by the [Administrator](/usc/7/136.md?p=b), the [Administrator](/usc/7/136.md?p=b) shall determine whether the [registrant](/usc/7/136.md?p=y) made a good faith attempt to conform its submission to such guidelines. - (ii) If the [Administrator](/usc/7/136.md?p=b) determines that the [registrant](/usc/7/136.md?p=y) made a good faith attempt to conform its submission to such guidelines, the [Administrator](/usc/7/136.md?p=b) shall provide the [registrant](/usc/7/136.md?p=y) a reasonable period of time to make any necessary changes or corrections. - (iii) - (I) If the [Administrator](/usc/7/136.md?p=b) determines that the [registrant](/usc/7/136.md?p=y) did not make a good faith attempt to conform its submission to such guidelines, the [Administrator](/usc/7/136.md?p=b) may issue a notice of intent to cancel the [registration](/usc/7/136.md?p=z). Such a notice shall be sent to the [registrant](/usc/7/136.md?p=y) by certified mail. - (II) The [registration](/usc/7/136.md?p=z) shall be canceled without a hearing or further notice at the end of 30 days after receipt by the [registrant](/usc/7/136.md?p=y) of the notice unless during that time a request for a hearing is made by the [registrant](/usc/7/136.md?p=y). - (III) If a hearing is requested, a hearing shall be conducted under [section 136d(d) of this title](/usc/7/136d.md?p=d), except that the only matter for resolution at the hearing shall be whether the [registrant](/usc/7/136.md?p=y) made a good faith attempt to conform its submission to such guidelines. The hearing shall be held and a determination made within 75 days after receipt of a request for hearing. - (4) **Guidelines—** - (A) Not later than 1 year after the effective date of this section, the [Administrator](/usc/7/136.md?p=b), by order, shall issue guidelines to be followed by [registrants](/usc/7/136.md?p=y) in— - (i) summarizing studies; - (ii) reformatting studies; - (iii) identifying adverse information; and - (iv) identifying studies that have been submitted previously that may not meet the requirements of [section 136a of this title](/usc/7/136a.md) or regulations issued under such section, under [paragraph (1)](#e-1). - (B) Guidelines issued under [subparagraph (A)](#e-4-A) shall not be subject to judicial review. - (5) **Monitoring—** The [Administrator](/usc/7/136.md?p=b) shall monitor the progress of [registrants](/usc/7/136.md?p=y) in acquiring and submitting the data required under [paragraph (1)](#e-1). - (f) **Phase four—** - (1) **Independent review and identification of outstanding data requirements—** - (A) The [Administrator](/usc/7/136.md?p=b) shall review the submissions of all [registrants](/usc/7/136.md?p=y) of [pesticides](/usc/7/136.md?p=u) containing a particular [active ingredient](/usc/7/136.md?p=a) under subsections [(d)(3)](#d-3) and [(e)(1)](#e-1) to determine if such submissions identified all the data that are missing or inadequate for such [active ingredient](/usc/7/136.md?p=a). To assist the review of the [Administrator](/usc/7/136.md?p=b) under this subparagraph, the [Administrator](/usc/7/136.md?p=b) may require a [registrant](/usc/7/136.md?p=y) seeking reregistration to submit complete copies of studies summarized under [subsection (e)(1)](#e-1). - (B) The [Administrator](/usc/7/136.md?p=b) shall independently identify and publish in the Federal Register the [outstanding data requirements](/usc/7/136.md?p=ff-1) for each [active ingredient](/usc/7/136.md?p=a) that is listed under subparagraph [(B)](#c-2-B), [(C)](#c-2-C), or [(D)](#c-2-D) of subsection (c)(2) and that is contained in a [pesticide](/usc/7/136.md?p=u) to be reregistered under this section. The [Administrator](/usc/7/136.md?p=b), at the same time, shall issue a notice under [section 136a(c)(2)(B) of this title](/usc/7/136a.md?p=c-2-B) for the submission of the additional data that are required to meet such requirements. - (2) **Time periods—** - (A) The [Administrator](/usc/7/136.md?p=b) shall take the action required by [paragraph (1)](#f-1)— - (i) in the case of a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) listed under [subsection (c)(2)(B)](#c-2-B), not later than 18 months after the date of the listing of such [active ingredient](/usc/7/136.md?p=a); - (ii) in the case of a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) listed under [subsection (c)(2)(C)](#c-2-C), not later than 24 months after the date of the listing of such [active ingredient](/usc/7/136.md?p=a); and - (iii) in the case of a [pesticide](/usc/7/136.md?p=u) containing an [active ingredient](/usc/7/136.md?p=a) listed under [subsection (c)(2)(D)](#c-2-D), not later than 33 months after the date of the listing of such [active ingredient](/usc/7/136.md?p=a). - (B) If the [Administrator](/usc/7/136.md?p=b) issues a notice to a [registrant](/usc/7/136.md?p=y) under [paragraph (1)(B)](#f-1-B) for the submission of additional data, the [registrant](/usc/7/136.md?p=y) shall submit such data within a reasonable period of time, as determined by the [Administrator](/usc/7/136.md?p=b), but not to exceed 48 months after the issuance of such notice. The [Administrator](/usc/7/136.md?p=b), on application of a [registrant](/usc/7/136.md?p=y), may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the [registrant](/usc/7/136.md?p=y) prevent the [registrant](/usc/7/136.md?p=y) from submitting data within such prescribed period. Upon application 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 this section 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 this section; 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 subparagraph, 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) of [section 136a(c)(2)(B) of this title](/usc/7/136a.md?p=c-2-B) or other provisions of this section, as appropriate, 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 subparagraph, the [Administrator](/usc/7/136.md?p=b) may take action to modify or revoke the extension under this subparagraph 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 written notice to the [registrant](/usc/7/136.md?p=y) revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date then established by the [Administrator](/usc/7/136.md?p=b) for submission of the data. - (3) **Suspensions and penalties—** 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 [section 136a(c)(2)(B)(iv) of this title](/usc/7/136a.md?p=c-2-B-iv) if the [Administrator](/usc/7/136.md?p=b) determines that (A) tests necessary to fill an [outstanding data requirement](/usc/7/136.md?p=ff-1) for such [pesticide](/usc/7/136.md?p=u) have not been initiated within 1 year after the issuance of a notice under paragraph [(1)(B)](#f-1-B), or (B) progress is insufficient to ensure submission of the data referred to in clause (A) within the time period prescribed by [paragraph (2)(B)](#f-2-B) or the required data have not been submitted to the [Administrator](/usc/7/136.md?p=b) within such time period. 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 paragraph 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 this section for the supported uses identified pursuant to this paragraph 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 such a 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 paragraph, 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 [section 136a(c)(2)(B)(iv) of this title](/usc/7/136a.md?p=c-2-B-iv) 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 this subparagraph, the [Administrator](/usc/7/136.md?p=b) may deny, modify, or revoke the temporary extension under this paragraph 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). - (g) **Phase five—** - (1) **Data review—** The [Administrator](/usc/7/136.md?p=b) shall conduct a thorough examination of all data submitted under this section concerning an [active ingredient](/usc/7/136.md?p=a) listed under [subsection (c)(2)](#c-2) and of all other available data found by the [Administrator](/usc/7/136.md?p=b) to be relevant. - (2) **Reregistration and other actions—** - (A) **In general.—** The [Administrator](/usc/7/136.md?p=b) shall make a determination as to eligibility for reregistration— - (i) for all [active ingredients](/usc/7/136.md?p=a) subject to reregistration under this section for which tolerances or exemptions from tolerances are required under the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 301](/usc/21/301.md) et seq.), not later than the last date for tolerance reassessment established under section 408(q)(1)(C) of that Act ([21 U.S.C. 346a(q)(1)(C)](/usc/21/346a.md?p=q-1-C)); and - (ii) for all other [active ingredients](/usc/7/136.md?p=a) subject to reregistration under this section, not later than October 3, 2008. - (B) **Product-specific data.—** - (i) **In general.—** Before reregistering a [pesticide](/usc/7/136.md?p=u), the [Administrator](/usc/7/136.md?p=b) shall obtain any needed product-specific data regarding the [pesticide](/usc/7/136.md?p=u) by use of [section 136a(c)(2)(B) of this title](/usc/7/136a.md?p=c-2-B) and shall review such data within 90 days after its submission. - (ii) **Timing.—** - (I) **In general.—** Subject to [subclause (II)](#g-2-B-ii-II), the [Administrator](/usc/7/136.md?p=b) shall require that data under this subparagraph be submitted to the [Administrator](/usc/7/136.md?p=b) not later than 8 months after a determination of eligibility under [subparagraph (A)](#g-2-A) has been made for each [active ingredient](/usc/7/136.md?p=a) of the [pesticide](/usc/7/136.md?p=u), unless the [Administrator](/usc/7/136.md?p=b) determines that a longer period is required for the generation of the data. - (II) **Extraordinary circumstances.—** In the case of extraordinary circumstances, the [Administrator](/usc/7/136.md?p=b) may provide such a longer period, of not more than 2 additional years, for submission of data to the [Administrator](/usc/7/136.md?p=b) under this subparagraph. - (C) After conducting the review required by [paragraph (1)](#g-1) for each [active ingredient](/usc/7/136.md?p=a) of a [pesticide](/usc/7/136.md?p=u) and the review required by subparagraph (B) of this paragraph, the [Administrator](/usc/7/136.md?p=b) shall determine whether to reregister a [pesticide](/usc/7/136.md?p=u) by determining whether such [pesticide](/usc/7/136.md?p=u) meets the requirements of [section 136a(c)(5) of this title](/usc/7/136a.md?p=c-5). If the [Administrator](/usc/7/136.md?p=b) determines that a [pesticide](/usc/7/136.md?p=u) is eligible to be reregistered, the [Administrator](/usc/7/136.md?p=b) shall reregister such [pesticide](/usc/7/136.md?p=u) within 6 months after the submission of the data concerning such [pesticide](/usc/7/136.md?p=u) under [subparagraph (B)](#g-2-B). - (D) **Determination to not reregister.—** - (i) **In general.—** If after conducting a review under [paragraph (1)](#g-1) or subparagraph (B) of this paragraph the [Administrator](/usc/7/136.md?p=b) determines that a [pesticide](/usc/7/136.md?p=u) should not be reregistered, the [Administrator](/usc/7/136.md?p=b) shall take appropriate regulatory action. - (ii) **Timing for regulatory action.—** Regulatory action under [clause (i)](#g-2-D-i) shall be completed as expeditiously as possible. - (E) As soon as the [Administrator](/usc/7/136.md?p=b) has sufficient information with respect to the dietary risk of a particular [active ingredient](/usc/7/136.md?p=a), but in any event no later than the time the [Administrator](/usc/7/136.md?p=b) makes a determination under subparagraph [(C)](#g-2-C) or [(D)](#g-2-D) with respect to [pesticides](/usc/7/136.md?p=u) containing a particular [active ingredient](/usc/7/136.md?p=a), the [Administrator](/usc/7/136.md?p=b) shall— - (i) reassess each associated tolerance and exemption from the requirement for a tolerance issued under section 408 of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 346a](/usc/21/346a.md)); - (ii) determine whether such tolerance or exemption meets the requirements of that Act [[21 U.S.C. 301](/usc/21/301.md) et seq.]; - (iii) determine whether additional tolerances or exemptions should be issued; - (iv) publish in the Federal Register a notice setting forth the determinations made under this subparagraph; and - (v) commence promptly such proceedings under this subchapter and section 408 of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 346a](/usc/21/346a.md)] as are warranted by such determinations. - (h) **Compensation of data submitter—** If data that are submitted by a [registrant](/usc/7/136.md?p=y) under subsection [(d)](#d), [(e)](#e), [(f)](#f), or [(g)](#g) are used to support the application of another [person](/usc/7/136.md?p=s) under [section 136a of this title](/usc/7/136a.md), the [registrant](/usc/7/136.md?p=y) who submitted such data shall be entitled to compensation for the use of such data as prescribed by [section 136a(c)(1)(D)](/usc/7/136a.md?p=c-1-D)[^1] of this title. In determining the amount of such compensation, the fees paid by the [registrant](/usc/7/136.md?p=y) under this section shall be taken into account. - (i) **Fees—** - (1) **Maintenance fee—** - (A) **In general.—** Subject to other provisions of this paragraph, each [registrant](/usc/7/136.md?p=y) of a [pesticide](/usc/7/136.md?p=u) shall pay an annual fee by January 15 of each year for each [registration](/usc/7/136.md?p=z), except that no fee shall be charged for more than 200 [registrations](/usc/7/136.md?p=z) held by any [registrant](/usc/7/136.md?p=y). - (B) In the case of a [pesticide](/usc/7/136.md?p=u) that is registered for a minor agricultural use, the [Administrator](/usc/7/136.md?p=b) may reduce or waive the payment of the fee imposed under this paragraph if the [Administrator](/usc/7/136.md?p=b) determines that the fee would significantly reduce the availability of the [pesticide](/usc/7/136.md?p=u) for the use. - (C) **Total amount of fees.—** The amount of each fee prescribed under [subparagraph (A)](#i-1-A) shall be adjusted by the [Administrator](/usc/7/136.md?p=b) to a level that will result in the collection under this paragraph of, to the extent practicable, an average amount of $31,000,000 for each of fiscal years 2019 through 2022, and $42,000,000 for each of fiscal years 2023 through 2027. - (D) **Maximum amount of fees for registrants.—** The maximum annual fee payable under this paragraph by— - (i) a [registrant](/usc/7/136.md?p=y) holding not more than 50 [pesticide](/usc/7/136.md?p=u) [registrations](/usc/7/136.md?p=z) shall be $129,400 for each of fiscal years 2019 through 2022, and $172,000 for each of fiscal years 2023 through 2027; and - (ii) a [registrant](/usc/7/136.md?p=y) holding over 50 [registrations](/usc/7/136.md?p=z) shall be $207,000 for each of fiscal years 2019 through 2022, and $277,200 for each of fiscal years 2023 through 2027. - (E) **Maximum amount of fees for small businesses.—** - (i) **In general.—** For a small business, the maximum annual fee payable under this paragraph by— - (I) a [registrant](/usc/7/136.md?p=y) holding not more than 50 [pesticide](/usc/7/136.md?p=u) [registrations](/usc/7/136.md?p=z) shall be $79,100 for each of fiscal years 2019 through 2022, and $105,000 for each of fiscal years 2023 through 2027; and - (II) a [registrant](/usc/7/136.md?p=y) holding over 50 [pesticide](/usc/7/136.md?p=u) [registrations](/usc/7/136.md?p=z) shall be $136,800 for each of fiscal years 2019 through 2022, and $184,800 for each of fiscal years 2023 through 2027. - (ii) **Definition of small business.—** - (I) **In general.—** In [clause (i)](#i-1-E-i), the term “small business” means a corporation, partnership, or unincorporated business that— - (aa) has 500 or fewer employees; and - (bb) during the 3-year period prior to the most recent maintenance fee billing cycle, had an average annual global gross revenue from [pesticides](/usc/7/136.md?p=u) that did not exceed $60,000,000. - (II) **Affiliates.—** - (aa) **In general.—** In the case of a business entity with 1 or more affiliates, the gross revenue limit under [subclause (I)(bb)](#i-1-E-ii-I-bb) shall apply to the gross revenue for the entity and all of the affiliates of the entity, including parents and subsidiaries, if applicable. - (bb) **Affiliated persons.—** For the purpose of [item (aa)](#i-1-E-ii-II-aa), [persons](/usc/7/136.md?p=s) are affiliates of each other if, directly or indirectly, either [person](/usc/7/136.md?p=s) controls or has the power to control the other [person](/usc/7/136.md?p=s), or a third [person](/usc/7/136.md?p=s) controls or has the power to control both [persons](/usc/7/136.md?p=s). - (cc) **Indicia of control.—** For the purpose of [item (aa)](#i-1-E-ii-II-aa), indicia of control include interlocking management or ownership, identity of interests among family members, shared facilities and equipment, and common use of employees. - (F) **Fee reduction for certain small businesses.—** - (i) **Definition.—** In this subparagraph, the term “qualified small business entity” means a corporation, partnership, or unincorporated business that— - (I) has 500 or fewer employees; - (II) during the 3-year period prior to the most recent maintenance fee billing cycle, had an average annual global gross revenue from all sources that did not exceed $10,000,000; and - (III) holds not more than 5 [pesticide](/usc/7/136.md?p=u) [registrations](/usc/7/136.md?p=z) under this paragraph. - (ii) **Waiver.—** Except as provided in [clause (iii)](#i-1-F-iii), the [Administrator](/usc/7/136.md?p=b) shall waive 25 percent of the fee under this paragraph applicable to the first [registration](/usc/7/136.md?p=z) of any qualified small business entity under this paragraph. - (iii) **Limitation.—** The [Administrator](/usc/7/136.md?p=b) shall not grant a waiver under [clause (ii)](#i-1-F-ii) to a qualified small business entity if the [Administrator](/usc/7/136.md?p=b) determines that the entity has been formed or manipulated primarily for the purpose of qualifying for the waiver. - (G) **Farm worker training and education grants.—** - (i) **Set-aside.—** In addition to amounts otherwise available, for fiscal years 2023 through 2027, the [Administrator](/usc/7/136.md?p=b) shall use not more than $7,500,000 of the amounts collected under this paragraph to provide grants to organizations described in [clause (ii)](#i-1-G-ii) for purposes of facilitating— - (I) training of farm workers; - (II) education of farm workers with respect to— - (aa) rights of farm workers relating to [pesticide](/usc/7/136.md?p=u) safety; and - (bb) the worker protection standard under part 170 of title 40, Code of Federal Regulations (or successor regulations); - (III) the development of new informational materials; - (IV) the development of training modules; and - (V) the development of innovative methods of delivery of such informational materials and training modules. - (ii) **Eligibility.—** To be eligible to receive a grant under this subparagraph, an organization shall have demonstrated experience in— - (I) providing training and education services for farm workers or handlers of [pesticides](/usc/7/136.md?p=u); or - (II) developing informational materials for farm workers or handlers of [pesticides](/usc/7/136.md?p=u). - (iii) **Community-based organizations.—** - (I) **Community-based non-profit farm worker organization grants.—** The [Administrator](/usc/7/136.md?p=b) shall use funds available under [clause (i)](#i-1-G-i) to provide grants to community-based non-profit farm worker organizations. - (II) **Application of funds.—** The [Administrator](/usc/7/136.md?p=b) shall apply the unspent balance of funds available (up to $1,800,000) under [clause (i)](#i-1-G-i) in fiscal years 2025 through 2027 to carry out [subclause (I)](#i-1-G-iii-I). - (iv) **Interim funding.—** In addition to amounts otherwise available, the [Administrator](/usc/7/136.md?p=b) may use not more than $1,200,000 in fiscal years 2023 and 2024 to fund existing cooperative agreements that were authorized under [section 136w–8(c)(3)(B) of this title](/usc/7/136w–8.md?p=c-3-B), as such section was in effect as of March 8, 2019. - (v) **Partnerships.—** Organizations described in [clause (ii)](#i-1-G-ii) may apply for a grant under this subparagraph as a partnership with another organization, provided such organizations, at the time of application, have entered into an agreement designating— - (I) a member of the partnership that will enter into the assistance agreement with the Environmental Protection Agency for the purposes of accountability for the proper expenditure of Federal funds; - (II) performance of the assistance agreement; - (III) liability for claims for recovery of unallowable costs incurred under the agreement; and - (IV) specifying roles in performing the proposed scope of work for the assistance agreement. - (H) **Health care provider training.—** - (i) **Set-aside.—** In addition to other amounts available, for the period of fiscal years 2023 through 2027, the [Administrator](/usc/7/136.md?p=b) shall use not more than $2,500,000 of the amounts collected under this paragraph to provide grants to nonprofit organizations described in [clause (ii)](#i-1-H-ii) for purposes of facilitating— - (I) technical assistance and training of health care providers relating to the recognition, treatment, and management of [pesticide](/usc/7/136.md?p=u)-related injuries and illnesses; - (II) the development of informational materials for technical assistance and training described in [subclause (I)](#i-1-H-i-I); and - (III) the development of outreach and delivery methods relating to the recognition, treatment, and management of [pesticide](/usc/7/136.md?p=u)-related illnesses. - (ii) **Eligibility.—** To be eligible to receive a grant under this subparagraph, a nonprofit organization shall have demonstrated experience in providing technical assistance and training to health care providers who serve farm worker populations. - (iii) **Partnerships.—** Organizations described in [clause (ii)](#i-1-H-ii) may apply for a grant under this subparagraph as a partnership with another organization, provided such organizations, at the time of application, have entered into an agreement designating— - (I) a member of the partnership that will enter into the assistance agreement with the Environmental Protection Agency for the purposes of accountability for the proper expenditure of Federal funds; - (II) performance of the assistance agreement; - (III) liability for claims for recovery of unallowable costs incurred under the agreement; and - (IV) roles in performing the proposed scope of work for the assistance agreement. - (I) **Partnership grants.—** In addition to funds otherwise available, for each of fiscal years 2023 through 2027, the [Administrator](/usc/7/136.md?p=b) shall use not more than $500,000 of the amounts collected under this paragraph for partnership grants. - (J) **Pesticide safety education program.—** In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the [Administrator](/usc/7/136.md?p=b) shall use not more than $500,000 of the amounts collected under this paragraph to carry out the [pesticide](/usc/7/136.md?p=u) safety education program. - (K) **Technical assistance to grantees.—** - (i) **Set-aside.—** In addition to other amounts available, for fiscal years 2023 through 2027, the [Administrator](/usc/7/136.md?p=b) shall use not more than $1,750,000 of the amounts collected under this paragraph to provide grants to nonprofit organizations, subject to such conditions as the [Administrator](/usc/7/136.md?p=b) establishes to prevent conflicts of interest, to provide easily accessible technical assistance to grantees receiving, and potential grantees applying for, grants under subparagraphs [(G)](#i-1-G) and [(H)](#i-1-H). - (ii) **Considerations.—** In evaluating requests for grants under this subparagraph, the [Administrator](/usc/7/136.md?p=b) shall consider, at a minimum, the extent to which— - (I) the organization applying for the grant has experience providing technical assistance to farm worker or clinician-training organizations; and - (II) the proposed project would make specific technical assistance available to organizations seeking information and assistance concerning— - (aa) the grant application process; - (bb) the drafting of grant applications; and - (cc) compliance with grant management and reporting requirements. - (iii) **No suitable organization.—** If no suitable organization requests a grant under this subparagraph, the [Administrator](/usc/7/136.md?p=b) shall provide technical assistance described in [clause (i)](#i-1-K-i) using the amounts made available by that clause. - (iv) **Stakeholder input.—** In formulating requests for proposals for grants under subparagraphs [(G)](#i-1-G) and [(H)](#i-1-H) for a fiscal year, the [Administrator](/usc/7/136.md?p=b) shall solicit and consider, in an open and transparent manner that does not provide a competitive advantage to any [person](/usc/7/136.md?p=s) or [persons](/usc/7/136.md?p=s), input from [persons](/usc/7/136.md?p=s) who conduct farm worker education and training, or technical assistance and training of clinicians, regarding the request for proposals. - (L) The [Administrator](/usc/7/136.md?p=b) shall exempt any [public health pesticide](/usc/7/136.md?p=nn) from the payment of the fee prescribed under this paragraph if, in consultation with the [Secretary](/usc/7/499a.md?p=b-2) of Health and Human Services, the [Administrator](/usc/7/136.md?p=b) determines, based on information supplied by the [registrant](/usc/7/136.md?p=y), that the economic return to the [registrant](/usc/7/136.md?p=y) from sales of the [pesticide](/usc/7/136.md?p=u) does not support the [registration](/usc/7/136.md?p=z) or reregistration of the [pesticide](/usc/7/136.md?p=u). - (M) If any fee prescribed by this paragraph with respect to the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) is not paid by a [registrant](/usc/7/136.md?p=y) by the time prescribed, the [Administrator](/usc/7/136.md?p=b), by order and without hearing, may cancel the [registration](/usc/7/136.md?p=z). - (N) The authority provided under this paragraph shall terminate on September 30, 2027. - (2) **Other fees—** Except as provided in [section 136w–8 of this title](/usc/7/136w–8.md), during the period beginning on December 29, 2022, and ending on September 30, 2029, the [Administrator](/usc/7/136.md?p=b) may not levy any other fees for the [registration](/usc/7/136.md?p=z) of a [pesticide](/usc/7/136.md?p=u) under this subchapter or any other action covered under a table specified in [section 136w–8(b)(3)(B) of this title](/usc/7/136w–8.md?p=b-3-B), except as provided in [paragraph (1)](#i-1). - (j) **Exemption of certain registrants—** The requirements of subsections [(d)](#d), [(e)](#e), [(f)](#f), and [(i)](#i) (other than [subsection (i)(1)](#i-1)) regarding data concerning an [active ingredient](/usc/7/136.md?p=a) and fees for review of such data shall not apply to any [person](/usc/7/136.md?p=s) who is the [registrant](/usc/7/136.md?p=y) of a [pesticide](/usc/7/136.md?p=u) to the extent that, under [section 136a(c)(2)(D) of this title](/usc/7/136a.md?p=c-2-D), the [person](/usc/7/136.md?p=s) would not be required to submit or cite such data to obtain an initial [registration](/usc/7/136.md?p=z) of such [pesticide](/usc/7/136.md?p=u). - (k) **Reregistration and expedited processing fund—** - (1) **Establishment—** There shall be established in the Treasury of the United States a reregistration and expedited processing fund which shall be known as the Reregistration and Expedited Processing Fund. - (2) **Source and use—** - (A) All moneys derived from fees collected by the [Administrator](/usc/7/136.md?p=b) under [subsection (i)](#i) shall be deposited in the Reregistration and Expedited Processing Fund and shall be available to the [Administrator](/usc/7/136.md?p=b), without fiscal year limitation, including, to the maximum extent practicable, during periods in which Environmental Protection Agency employees are on shutdown or emergency furlough as a result of a lapse in appropriations, specifically to offset the costs of reregistration and expedited processing of the applications specified in [paragraph (3)](#k-3), to offset the costs of [registration](/usc/7/136.md?p=z) review under [section 136a(g) of this title](/usc/7/136a.md?p=g), including the costs associated with any review under the Endangered Species Act of 1973 ([16 U.S.C. 1531](/usc/16/1531.md) et seq.) required as part of the [registration](/usc/7/136.md?p=z) review, to offset the costs associated with tracking and implementing [registration](/usc/7/136.md?p=z) review decisions, including [registration](/usc/7/136.md?p=z) review decisions designed to reduce risk, for the purposes specified in paragraphs [(4)](#k-4) and [(5)](#k-5), and to enhance the information systems capabilities to improve the tracking of [pesticide](/usc/7/136.md?p=u) [registration](/usc/7/136.md?p=z) decisions. The [Administrator](/usc/7/136.md?p=b) shall, prior to expending any such moneys derived from fees— - (i) effective October 1, 1997, adopt specific and cost accounting rules and procedures as approved by the Government Accountability Office and the Inspector General of the Environmental Protection Agency to ensure that moneys derived from fees are allocated solely for the purposes specified in the first sentence of this subparagraph; - (ii) prohibit the use of such moneys derived from fees to pay for any costs other than those necessary to achieve the purposes specified in the first sentence of this subparagraph; and - (iii) ensure that personnel and facility costs associated with the functions to be carried out under this paragraph do not exceed agency averages for comparable personnel and facility costs. - (B) The [Administrator](/usc/7/136.md?p=b) shall also— - (i) complete the review of unreviewed reregistration studies required to support the reregistration eligibility decisions scheduled for completion in accordance with [subsection (l)(2)](#l-2); and - (ii) contract for such outside assistance as may be necessary for review of required studies, using a generally accepted competitive process for the selection of vendors of such assistance. - (3) **Review of registrant submissions not covered by section 136w–8(b)(3)(B) of this title—** - (A) **Definition of submission not covered by section 136w–8(b)(3)(B) of this title—** In this paragraph, the term “submission not covered by [section 136w–8(b)(3)(B) of this title](/usc/7/136w–8.md?p=b-3-B)” means any submission filed by a [registrant](/usc/7/136.md?p=y) with the [Administrator](/usc/7/136.md?p=b) relating to a [registration](/usc/7/136.md?p=z) that is not covered by a fee table under [section 136w–8(b)(3)(B) of this title](/usc/7/136w–8.md?p=b-3-B). - (B) **Set-aside—** - (i) **In general—** In addition to amounts otherwise available for each of fiscal years 2023 through 2027, the [Administrator](/usc/7/136.md?p=b) shall use approximately ⅛ of the amounts made available to the [Administrator](/usc/7/136.md?p=b) in the Reregistration and Expedited Processing Fund for the activities described in [clause (ii)](#k-3-B-ii). - (ii) **Activities—** In addition to amounts otherwise available, the [Administrator](/usc/7/136.md?p=b) shall use amounts made available under [clause (i)](#k-3-B-i) to obtain sufficient personnel and resources to process submissions not covered by [section 136w–8(b)(3)(B) of this title](/usc/7/136w–8.md?p=b-3-B) to meet the applicable deadlines described in— - (I) the notice of the [Administrator](/usc/7/136.md?p=b) entitled “[Pesticide](/usc/7/136.md?p=u) [Registration](/usc/7/136.md?p=z) Notice (PR) 98–10: Notifications, Non-Notifications and Minor Formulation Amendments” and dated October 22, 1998 (and any successor amendments to such notice); and - (II) subsections (c)(3)(B) and (h) of [section 136a of this title](/usc/7/136a.md). - (4) **Development of public health performance standards for antimicrobial pesticide devices—** - (A) **Set-aside—** In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the [Administrator](/usc/7/136.md?p=b) shall use not more than $500,000 of the amounts made available to the [Administrator](/usc/7/136.md?p=b) in the Reregistration and Expedited Processing Fund for the activities described in [subparagraph (B)](#k-4-B). - (B) **Antimicrobial pesticide devices—** The [Administrator](/usc/7/136.md?p=b) shall use amounts made available under [subparagraph (A)](#k-4-A) to develop efficacy test methods for [antimicrobial pesticide](/usc/7/136.md?p=mm-1) [devices](/usc/7/136.md?p=h) making public health claims. - (5) **Good laboratory practices inspections—** - (A) **Set-aside—** For each of fiscal years 2023 through 2027, the [Administrator](/usc/7/136.md?p=b) shall use not more than $500,000 of the amounts made available to the [Administrator](/usc/7/136.md?p=b) in the Reregistration and Expedited Processing Fund for the activities described in [subparagraph (B)](#k-5-B). - (B) **Activities—** The [Administrator](/usc/7/136.md?p=b) shall use amounts made available under [subparagraph (A)](#k-5-A) for enhancements to the good laboratory practices standards compliance monitoring program established under part 160 of title 40 of the Code of Federal Regulations (or successor regulations), with respect to laboratory inspections and data audits conducted in support of [pesticide](/usc/7/136.md?p=u) product [registrations](/usc/7/136.md?p=z) under this subchapter. As part of such monitoring program, the [Administrator](/usc/7/136.md?p=b) shall make available to each laboratory inspected under such program in support of such [registrations](/usc/7/136.md?p=z) a preliminary summary of inspection observations not later than 60 days after the date on which such an inspection is completed. - (6) **Agency training and staff—** - (A) **Set-aside—** In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the [Administrator](/usc/7/136.md?p=b) shall use not more than $500,000 of the amounts made available to the [Administrator](/usc/7/136.md?p=b) in the Reregistration and Expedited Processing Fund for the activities described in [subparagraph (B)](#k-6-B). - (B) **Activities—** The [Administrator](/usc/7/136.md?p=b) shall use amounts made available under [subparagraph (A)](#k-6-A) to carry out the following activities: - (i) **Training for agency employees—** The [Administrator](/usc/7/136.md?p=b) shall administer training and education programs for employees of the Environmental Protection Agency, relating to the regulatory responsibilities and policies established by this subchapter, including programs— - (I) for improving the scientific, technical, and administrative skills of officers and employees authorized to administer programs under this subchapter; - (II) to align competencies identified by the [Administrator](/usc/7/136.md?p=b) for mission accomplishment; - (III) for addressing best practices for operational performance and improvement; - (IV) for improving administrative processes and procedures and addressing efficiency issues; - (V) to promote consistent regulatory decision-making; and - (VI) for educating [registrants](/usc/7/136.md?p=y) and regulated stakeholders on regulatory procedures. - (ii) **Agreements with institutions of higher education—** Not later than 1 year, to the maximum extent practicable, after December 29, 2022, the [Administrator](/usc/7/136.md?p=b) shall establish a competitive grant program to develop training curricula and programs in accordance with [clause (i)](#k-6-B-i) through financial assistance agreements with 1 or more of the following institutions of higher education: - (I) Non-land-grant colleges of agriculture (as defined in [section 3103 of this title](/usc/7/3103.md)). - (II) Land-grant colleges and universities (as defined in [section 3103 of this title](/usc/7/3103.md)). - (III) [1994 Institutions](/usc/7/7614.md?p=7) (as defined in section 532 of the Equity in Educational Land-Grant Status Act of 1994 ([7 U.S.C. 301](/usc/7/301.md) note; Public Law 103–382)). - (7) **Vector expedited review vouchers—** - (A) **Set-aside—** In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the [Administrator](/usc/7/136.md?p=b) shall use not more than $500,000 of the amounts made available to the [Administrator](/usc/7/136.md?p=b) in the Reregistration and Expedited Processing Fund to establish and carry out the [Vector](/usc/7/136.md?p=oo) Expedited Review Voucher program in accordance with [subparagraph (B)](#k-7-B). - (B) **Vector Expedited Review Voucher program—** - (i) **Definitions—** In this subparagraph: - (I) **Program—** The term “program” means the [Vector](/usc/7/136.md?p=oo) Expedited Review Voucher program established under [clause (ii)](#k-7-B-ii). - (II) **Voucher—** The term “voucher” means a voucher— - (aa) issued under the program by the [Administrator](/usc/7/136.md?p=b) to a [pesticide](/usc/7/136.md?p=u) [registration](/usc/7/136.md?p=z) applicant that entitles the holder to an expedited review described under [clause (vi)](#k-7-B-vi) of a single different [pesticide](/usc/7/136.md?p=u) [registration](/usc/7/136.md?p=z) action; and - (bb) the entitlement to which may be transferred (including by sale) by the holder of the voucher, without limitation on the number of times the voucher may be transferred, before the voucher is redeemed. - (ii) **Establishment—** Not later than one year after December 29, 2022, the [Administrator](/usc/7/136.md?p=b), acting though the Office of [Pesticide](/usc/7/136.md?p=u) Programs, shall establish a program to be known as the [Vector](/usc/7/136.md?p=oo) Expedited Review Voucher program. - (iii) **Purpose—** The purpose of the program is to incentivize the development of new insecticides to control and prevent the spread of [vector](/usc/7/136.md?p=oo) borne disease by expediting reviews by decreasing decision review times provided in [section 136w–8(b)(3)(B) of this title](/usc/7/136w–8.md?p=b-3-B). - (iv) **Issuance of vouchers—** - (I) **In general—** For each of fiscal years 2023 through 2027, the [Administrator](/usc/7/136.md?p=b) shall issue a voucher to a [pesticide](/usc/7/136.md?p=u) [registration](/usc/7/136.md?p=z) applicant for a new [active ingredient](/usc/7/136.md?p=a) if the applicant submits and has successfully registered a mosquito-control product that— - (aa) demonstrates a proven efficacy against pyrethroid or other insecticide-resistant mosquitoes; - (bb) prevents, mitigates, destroys, or repels pyrethroid or other insecticide-resistant mosquitoes, with a novel or unique mechanism or mode of action, different from other insecticides already registered by the [Administrator](/usc/7/136.md?p=b) for mosquito control; - (cc) targets mosquitoes capable of spreading such diseases as Malaria, Dengue, Zika, Chikungunya, St. Louis encephalitis, Eastern encephalitis, Western encephalitis, West Nile encephalitis, Cache Valley encephalitis, LaCrosse encephalitis, and Yellow Fever; - (dd) the [registrant](/usc/7/136.md?p=y) has submitted a global access plan that will be made publicly available for the [active ingredient](/usc/7/136.md?p=a) and that includes— - (AA) manufacturing locations, including any licensed third-party manufacturers; - (BB) distribution and procurement processes for malaria [vector](/usc/7/136.md?p=oo) control programs in selected countries; and - (CC) the prices for common quantities of the product; - (ee) meets the appropriate guidelines as being effective in the primary [vector](/usc/7/136.md?p=oo) control intervention areas, including insecticide-treated nets and indoor residual spray; - (ff) is made accessible for use in— - (AA) the United States, including territories or possessions of the United States; and - (BB) countries where mosquito-borne diseases, such as malaria, are prevalent; - (gg) meets [registration](/usc/7/136.md?p=z) requirements for human health and environmental effects, [labeling](/usc/7/136.md?p=p-2), and presents no unreasonable adverse effects to the [environment](/usc/7/136.md?p=j); - (hh) broadens the adoption of integrated [pest](/usc/7/136.md?p=t) management strategies, such as insecticide resistance management, or makes those strategies more effective; - (ii) is not contained in any [pesticide](/usc/7/136.md?p=u) product registered by the [Administrator](/usc/7/136.md?p=b) as of December 29, 2022; or - (jj) does not contain as attested to by the [registrant](/usc/7/136.md?p=y), an [active ingredient](/usc/7/136.md?p=a) approved in the 2-year period preceding the date of [registration](/usc/7/136.md?p=z) by any global stringent regulatory authority for the same uses, [vectors](/usc/7/136.md?p=oo), and applications. - (II) **Mosquito vector priority—** For each of fiscal years 2023 through 2027, the focus of the program shall be to incentivize the development of insecticides to control and prevent the spread of mosquitoes bearing diseases described in [subclause (I)(cc)](#k-7-B-iv-I-cc). - (III) **Exception—** If the [Administrator](/usc/7/136.md?p=b) determines that there is a significant public health benefit, an [active ingredient](/usc/7/136.md?p=a) that is registered for agricultural use that is repurposed and submitted for control of mosquitoes and that otherwise meets the requirements of [subclause (I)](#k-7-B-iv-I) (excluding items [(bb)](#k-7-B-iv-I-bb) and [(jj)](#k-7-B-iv-I-jj)) as determined necessary by the [Administrator](/usc/7/136.md?p=b), shall be considered a mosquito control product meeting the criteria specified in such subclause. - (IV) **Eligibility criteria modifications—** - (aa) **In general—** Beginning in fiscal year 2028, the [Administrator](/usc/7/136.md?p=b) shall review the program and recommend— - (AA) modifications to the requirements described in [subclause (I)](#k-7-B-iv-I); and - (BB) additional [vectors](/usc/7/136.md?p=oo) to be included in the program, prioritizing [vectors](/usc/7/136.md?p=oo) that pose the most significant population health risks. - (bb) **Public involvement—** In carrying out [item (aa)](#k-7-B-iv-IV-aa), the [Administrator](/usc/7/136.md?p=b) shall solicit the involvement of [registrants](/usc/7/136.md?p=y), nongovernmental organizations, and governmental agencies engaged in [vector](/usc/7/136.md?p=oo)-borne disease mitigation and treatment. - (v) **Redemption of vouchers—** To redeem a voucher, the holder shall— - (I) notify the [Administrator](/usc/7/136.md?p=b) of the intent of the holder to submit a [pesticide](/usc/7/136.md?p=u) application with a voucher for expedited review not less than 90 days before the submission of the application; and - (II) pay the applicable [registration](/usc/7/136.md?p=z) service fee under [section 136w–8(b) of this title](/usc/7/136w–8.md?p=b). - (vi) **Expedited review—** On redemption of a voucher, in furtherance of the purpose described in [clause (iii)](#k-7-B-iii), the [Administrator](/usc/7/136.md?p=b) shall expedite decision review times as follows: - (I) 6 months less than the decision review time for Category R010, New [Active Ingredient](/usc/7/136.md?p=a), Food use. - (II) 6 months less than the decision review time for Category R020, New [Active Ingredient](/usc/7/136.md?p=a), Food use; reduced risk. - (III) 6 months less than the decision review time for Category R060, New [Active Ingredient](/usc/7/136.md?p=a), Non-food use; outdoor. - (IV) 6 months less than the decision review time for Category R110, New [Active Ingredient](/usc/7/136.md?p=a), Non-food use; indoor. - (V) 4 months less than the decision review time for Category R070, New [Active Ingredient](/usc/7/136.md?p=a), Non-food use; outdoor; reduced risk. - (VI) 2 months less than the decision review time for Category R120, New [Active Ingredient](/usc/7/136.md?p=a), Non-food use; indoor; reduced risk. - (vii) **Reports—** Not later than September 30, 2025, and not later than September 30 of each year thereafter, the [Administrator](/usc/7/136.md?p=b) shall issue a report on the program, including— - (I) the number of submissions seeking a voucher; - (II) the total time in review for each such submission; - (III) the number of such vouchers awarded; - (IV) the number of such vouchers redeemed; and - (V) with respect to each such redeemed voucher— - (aa) the decision review time for the [pesticide](/usc/7/136.md?p=u) application for which the voucher was redeemed; and - (bb) the average standard decision review time for the applicable [pesticide](/usc/7/136.md?p=u) category. - (C) **Unused amounts—** Any unused amounts made available under this paragraph at the end of each fiscal year shall be made available to the [Administrator](/usc/7/136.md?p=b) to carry out other activities for which amounts in the Reregistration and Expedited Processing Fund are authorized to be used. - (8) **Pesticide surveillance program—** In addition to amounts otherwise available, for each of fiscal years 2023 through 2027, the [Administrator](/usc/7/136.md?p=b) shall use not more than $500,000 of the amounts made available to the [Administrator](/usc/7/136.md?p=b) in the Reregistration and Expedited Processing Fund to support the interagency agreement with the National Institute for Occupational Safety and Health to support the Sentinel Event Notification System for Occupational Risk [pesticides](/usc/7/136.md?p=u) program— - (A) with a goal of increasing the number of participating [States](/usc/7/136.md?p=aa), prioritizing expansion in [States](/usc/7/136.md?p=aa) with the highest numbers of agricultural workers; and - (B) to improve reporting by participating [States](/usc/7/136.md?p=aa). - (9) **Unused funds—** Money in the fund not currently needed to carry out this section shall be— - (A) maintained on hand or on deposit; - (B) invested in obligations of the United States or guaranteed thereby; or - (C) invested in obligations, participations, or other instruments that are lawful investments for fiduciary, trust, or public funds. - (10) **Accounting and performance—** The [Administrator](/usc/7/136.md?p=b) shall take all steps necessary to ensure that expenditures from fees authorized by subsection (i)(1)(C)(ii)[^1] are used only for the purposes described in paragraphs [(2)](#k-2) through [(8)](#k-8) and to carry out the goals established under [subsection (l)](#l). The Reregistration and Expedited Processing Fund shall be designated as an Environmental Protection Agency component for purposes of [section 3515(c) of title 31](/usc/31/3515.md?p=c). The annual audit required under [section 3521](/usc/31/3521.md) of such title of the financial statements of activities under this subchapter under [section 3515(b)](/usc/31/3515.md?p=b) of such title shall include an audit of the fees collected under [subsection (i)(1)(C)](#i-1-C) and disbursed, of the amount appropriated to match such fees, and of the [Administrator](/usc/7/136.md?p=b)’s attainment of performance measures and goals established under [subsection (l)](#l). Such an audit shall also include a review of the reasonableness of the overhead allocation and adequacy of disclosures of direct and indirect costs associated with carrying out the reregistration and expedited processing of the applications specified in [paragraph (3)](#k-3), and the basis for and accuracy of all costs paid with moneys derived from such fees. The Inspector General shall conduct the annual audit and report the findings and recommendations of such audit to the [Administrator](/usc/7/136.md?p=b) and to the Committees on Agriculture of the House of Representatives and the Senate. The cost of such audit shall be paid for out of the fees collected under [subsection (i)(1)(C)](#i-1-C). - (l) **Performance measures and goals—** The [Administrator](/usc/7/136.md?p=b) shall establish and publish annually in the Federal Register performance measures and goals. Such measures and goals shall include— - (1) the number of products reregistered, canceled, or amended, the status of reregistration, the number and type of data requests under [section 136a(c)(2)(B) of this title](/usc/7/136a.md?p=c-2-B) issued to support product reregistration by [active ingredient](/usc/7/136.md?p=a), the progress in reducing the number of unreviewed, required reregistration studies, the aggregate status of tolerances reassessed, and the number of applications for [registration](/usc/7/136.md?p=z) submitted under [subsection (k)(3)](#k-3) that were approved or disapproved; - (2) the future schedule for reregistrations, including the projection for such schedules that will be issued under subsection [(g)(2)(A)](#g-2-A) and (B) in the current fiscal year and the succeeding fiscal year; and - (3) the projected year of completion of the reregistrations under this section. - (m) **Judicial review—** Any failure of the [Administrator](/usc/7/136.md?p=b) to take any action required by this section shall be subject to judicial review under the procedures prescribed by [section 136n(b) of this title](/usc/7/136n.md?p=b). - (n) **Authorization of funds to develop public health data—** - (1) **“Secretary” defined—** For the purposes of this section, “[Secretary](/usc/7/499a.md?p=b-2)” means the [Secretary](/usc/7/499a.md?p=b-2) of Health and Human Services, acting through the Public Health Service. - (2) **Consultation—** In the case of a [pesticide](/usc/7/136.md?p=u) registered for use in public health programs for [vector](/usc/7/136.md?p=oo) control or for other uses the [Administrator](/usc/7/136.md?p=b) determines to be human health protection uses, the [Administrator](/usc/7/136.md?p=b) shall, upon timely request by the [registrant](/usc/7/136.md?p=y) or any other interested [person](/usc/7/136.md?p=s), or on the [Administrator](/usc/7/136.md?p=b)’s own initiative may, consult with the [Secretary](/usc/7/499a.md?p=b-2) prior to taking final action to suspend [registration](/usc/7/136.md?p=z) under [section 136a(c)(2)(B)(iv) of this title](/usc/7/136a.md?p=c-2-B-iv), or cancel a [registration](/usc/7/136.md?p=z) under section 136a–1, [136d(e)](/usc/7/136d.md?p=e), or [136d(f)](/usc/7/136d.md?p=f) of this title. In consultation with the [Secretary](/usc/7/499a.md?p=b-2), the [Administrator](/usc/7/136.md?p=b) shall prescribe the form and content of requests under this section. - (3) **Benefits to support family—** The [Administrator](/usc/7/136.md?p=b), after consulting with the [Secretary](/usc/7/499a.md?p=b-2), shall make a determination whether the potential benefits of continued use of the [pesticide](/usc/7/136.md?p=u) for public health or health protection purposes are of such significance as to warrant a commitment by the [Secretary](/usc/7/499a.md?p=b-2) to conduct or to arrange for the conduct of the studies required by the [Administrator](/usc/7/136.md?p=b) to support continued [registration](/usc/7/136.md?p=z) under [section 136a of this title](/usc/7/136a.md) or reregistration under this section. - (4) **Additional time—** If the [Administrator](/usc/7/136.md?p=b) determines that such a commitment is warranted and in the public interest, the [Administrator](/usc/7/136.md?p=b) shall notify the [Secretary](/usc/7/499a.md?p=b-2) and shall, to the extent necessary, amend a notice issued under [section 136a(c)(2)(B) of this title](/usc/7/136a.md?p=c-2-B) to specify additional reasonable time periods for submission of the data. - (5) **Arrangements—** The [Secretary](/usc/7/499a.md?p=b-2) shall make such arrangements for the conduct of required studies as the [Secretary](/usc/7/499a.md?p=b-2) finds necessary and appropriate to permit submission of data in accordance with the time periods prescribed by the [Administrator](/usc/7/136.md?p=b). Such arrangements may include Public Health Service intramural research activities, grants, contracts, or cooperative agreements with academic, public health, or other organizations qualified by experience and training to conduct such studies. - (6) **Support—** The [Secretary](/usc/7/499a.md?p=b-2) may provide for support of the required studies using funds authorized to be appropriated under this section, the Public Health Service Act [[42 U.S.C. 201](/usc/42/201.md) et seq.], or other appropriate authorities. After a determination is made under [subsection (d)](#d), the [Secretary](/usc/7/499a.md?p=b-2) shall notify the Committees on Appropriations of the House of Representatives and the Senate of the sums required to conduct the necessary studies. - (7) **Authorization of appropriations—** There is authorized to be appropriated to carry out the purposes of this section $12,000,000 for fiscal year 1997, and such sums as may be necessary for succeeding fiscal years. ## Footnotes [^1]: See References in Text note below. ## Source credit (June 25, 1947, ch. 125, § 4, formerly § 3A, as added and renumbered § 4, Pub. L. 100–532, title I, § 102(a), title VIII, § 801(q)(2)(A), Oct. 25, 1988, 102 Stat. 2655, 2683; amended Pub. L. 101–624, title XIV, § 1493, Nov. 28, 1990, 104 Stat. 3628; Pub. L. 102–237, title X, § 1006(a)(4), (e), (f), Dec. 13, 1991, 105 Stat. 1895–1897; Pub. L. 104–170, title I, § 103, title II, §§ 210(c)(2), (f)(1), 232, 237, title V, § 501, Aug. 3, 1996, 110 Stat. 1490, 1496, 1498, 1508, 1509, 1536; Pub. L. 107–73, title III, [(1)–(4)], Nov. 26, 2001, 115 Stat. 686; Pub. L. 108–7, div. K, title III, [(1)–(4)], Feb. 20, 2003, 117 Stat. 513; Pub. L. 108–199, div. G, title V, § 501(c), (d)(1), (e), Jan. 23, 2004, 118 Stat. 419, 422; Pub. L. 108–271, § 8(b), July 7, 2004, 118 Stat. 814; Pub. L. 110–94, § 4(a)–(d)(1), (e), Oct. 9, 2007, 121 Stat. 1001, 1002; Pub. L. 112–177, § 2(a)(1), (2)(A), (4), Sept. 28, 2012, 126 Stat. 1327, 1329; Pub. L. 116–8, §§ 2(a), (b), 3, Mar. 8, 2019, 133 Stat. 484, 485; Pub. L. 117–328, div. HH, title VI, §§ 703(a), 704, Dec. 29, 2022, 136 Stat. 5999, 6002.) ## Notes ### Editorial Notes ### References in Text The effective date of this section, referred to in subsecs. (a), (c)(1), (2), and (e)(4)(A), is 60 days after Oct. 25, 1988. See Effective Date note below. Section 136a(c)(1)(D) of this title, referred to in subsecs. (e)(1)(I) and (h), was redesignated section 136a(c)(1)(F) of this title by Pub. L. 102–237, title X, § 1006(a)(3)(B), Dec. 13, 1991, 105 Stat. 1894. The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (g)(2)(A)(1), (E)(ii), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables. Section 136w–8(c)(3)(B) of this title, as such section was in effect as of March 8, 2019, referred to in subsec. (i)(1)(G)(iv), means section 136w–8(c)(3)(B) of this title as amended by Pub. L. 116–8, § 5(b), and prior to its repeal and reenactment by Pub. L. 117–328, § 705(b)(1). See 2022 Amendment note under section 136w–8 of this title. The Endangered Species Act of 1973, referred to in subsec. (k)(2)(A), is Pub. L. 93–205, Dec. 28, 1973, 87 Stat. 884, which is classified principally 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. Subsection (i)(1)(C)(ii) of this section, referred to in subsec. (k)(10), was previously a reference to subsec. (i)(5)(C)(ii), which was repealed and a new subsec. (i)(5)(C)(ii) was added by Pub. L. 108–199, § 501(c)(2). Subsec. (i)(5)(C) was amended by Pub. L. 110–94, § 4(a), and, as so amended, related to fees but no longer contained a cl. (ii). Subsec. (i)(5) was redesignated (i)(1) by Pub. L. 112–177, § 2(a)(1)(C). The Public Health Service Act, referred to in subsec. (n)(6), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables. ### Prior Provisions A prior section 4 of act June 25, 1947, which was classified to section 136b of this title was transferred to section 11(a)–(c) of act June 25, 1947, which is classified to section 136i(a)–(c) of this title. Another prior section 4 of act June 25, 1947, was classified to section 135b of this title prior to amendment of act June 25, 1947, by Pub. L. 92–516. ### Amendments 2022—Subsec. (i)(1)(C). Pub. L. 117–328, § 703(a)(1)(A), substituted “2022, and $42,000,000 for each of fiscal years 2023 through 2027” for “2023”. Subsec. (i)(1)(D)(i). Pub. L. 117–328, § 703(a)(1)(B)(i), substituted “2022, and $172,000 for each of fiscal years 2023 through 2027” for “2023”. Subsec. (i)(1)(D)(ii). Pub. L. 117–328, § 703(a)(1)(B)(ii), substituted “2022, and $277,200 for each of fiscal years 2023 through 2027” for “2023”. Subsec. (i)(1)(E)(i)(I). Pub. L. 117–328, § 703(a)(1)(C)(i), substituted “2022, and $105,000 for each of fiscal years 2023 through 2027” for “2023”. Subsec. (i)(1)(E)(i)(II). Pub. L. 117–328, § 703(a)(1)(C)(ii), substituted “2022, and $184,800 for each of fiscal years 2023 through 2027” for “2023”. Subsec. (i)(1)(G) to (M). Pub. L. 117–328, § 703(a)(1)(D), (E), added subpars. (G) to (K) and redesignated former subpars. (G) and (H) as (L) and (M), respectively. Former subpar. (I) redesignated (N). Subsec. (i)(1)(N). Pub. L. 117–328, § 703(a)(1)(D), (F), redesignated subpar. (I) as (N) and substituted “2027” for “2023”. Subsec. (i)(2). Pub. L. 117–328, § 703(a)(2), substituted “December 29, 2022, and ending on September 30, 2029” for “March 8, 2019, and ending on September 30, 2025” and “section 136w–8(b)(3)(B)” for “section 136w–8(b)(3)”. Subsec. (k)(2)(A). Pub. L. 117–328, § 704(1), inserted “including, to the maximum extent practicable, during periods in which Environmental Protection Agency employees are on shutdown or emergency furlough as a result of a lapse in appropriations,” after “limitation,”. Subsec. (k)(3), (4). Pub. L. 117–328, § 704(2), added pars. (3) and (4) and struck out former pars. (3) and (4) which related, respectively, to use of maintenance fees for review of inert ingredients and expedited processing of similar applications and to expedited rulemaking and guidance development for certain product performance data requirements. Subsec. (k)(5)(A). Pub. L. 117–328, § 704(3), substituted “2023 through 2027” for “2018 through 2023”. Subsec. (k)(6) to (9). Pub. L. 117–328, § 704(4), (5), added pars. (6) to (8) and redesignated former par. (6) as (9). Former par. (7) redesignated (10). Subsec. (k)(10). Pub. L. 117–328, § 704(4), (6), redesignated par. (7) as (10) and substituted “paragraphs (2) through (8)” for “paragraphs (2), (3), (4), and (5)”. 2019—Subsec. (i)(1)(C). Pub. L. 116–8, § 2(a)(1), substituted “an average amount of $31,000,000 for each of fiscal years 2019 through 2023” for “an aggregate amount of $27,800,000 for each of fiscal years 2013 through 2017”. Subsec. (i)(1)(D)(i). Pub. L. 116–8, § 2(a)(2)(A), substituted “$129,400 for each of fiscal years 2019 through 2023” for “$115,500 for each of fiscal years 2013 through 2017”. Subsec. (i)(1)(D)(ii). Pub. L. 116–8, § 2(a)(2)(B), substituted “$207,000 for each of fiscal years 2019 through 2023” for “$184,800 for each of fiscal years 2013 through 2017”. Subsec. (i)(1)(E)(i)(I). Pub. L. 116–8, § 2(a)(3)(A), substituted “$79,100 for each of fiscal years 2019 through 2023” for “$70,600 for each of fiscal years 2013 through 2017”. Subsec. (i)(1)(E)(i)(II). Pub. L. 116–8, § 2(a)(3)(B), substituted “$136,800 for each of fiscal years 2019 through 2023” for “$122,100 for each of fiscal years 2013 through 2017”. Subsec. (i)(1)(I). Pub. L. 116–8, § 2(a)(4), substituted “2023.” for “2017..” Subsec. (i)(2). Pub. L. 116–8, § 2(b), substituted “March 8, 2019, and ending on September 30, 2025” for “October 25, 1988, and ending on September 30, 2019” and inserted “or any other action covered under a table specified in section 136w–8(b)(3) of this title,” after “registration of a pesticide under this subchapter”. Subsec. (k)(2)(A). Pub. L. 116–8, § 3(a)(1), (2), in introductory provisions, substituted “the Reregistration and Expedited Processing Fund” for “the fund” and “paragraph (3), to offset the costs of registration review under section 136a(g) of this title, including the costs associated with any review under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.) required as part of the registration review, to offset the costs associated with tracking and implementing registration review decisions, including registration review decisions designed to reduce risk, for the purposes specified in paragraphs (4) and (5), and to enhance the information systems capabilities to improve the tracking of pesticide registration decisions.” for “paragraph (3), to enhance the information systems capabilities to improve the tracking of pesticide registration decisions, and to offset the costs of registration review under section 136a(g) of this title. Such moneys derived from fees may not be expended in any fiscal year to the extent such moneys derived from fees would exceed money appropriated for use by the Administrator and expended in such year for such costs of reregistration and expedited processing of such applications.” Subsec. (k)(2)(A)(i). Pub. L. 116–8, § 3(a)(3), substituted “are allocated solely for the purposes specified in the first sentence of this subparagraph;” for “are allocated solely to offset the costs of reregistration and expedited processing of the applications specified in paragraph (3), to enhance the information systems capabilities to improve the tracking of pesticide registration decisions, and to offset the costs of registration review under section 136a(g) of this title;”. Subsec. (k)(2)(A)(ii). Pub. L. 116–8, § 3(a)(4), substituted “necessary to achieve the purposes specified in the first sentence of this subparagraph;” for “necessary to achieve reregistration and expedited processing of the applications specified in paragraph (3), to enhance the information systems capabilities to improve the tracking of pesticide registration decisions, and to offset the costs of registration review under section 136a(g) of this title;”. Subsec. (k)(3)(A). Pub. L. 116–8, § 3(b), in introductory provisions, substituted “For each of fiscal years 2018 through 2023, the Administrator shall use between ⅑ and ⅛ of the maintenance fees collected in such fiscal year to obtain sufficient personnel and resources—” for “The Administrator shall use for each of the fiscal years 2004 through 2006, approximately $3,300,000, and for each of fiscal years 2013 through 2017, between ⅑ and ⅛, of the maintenance fees collected in such fiscal year to obtain sufficient personnel and resources—”. Subsec. (k)(4). Pub. L. 116–8, § 3(c), amended par. (4) generally. Prior to amendment, par. (4) related to enhancements of information technology systems for improvement in review of pesticide applications. Subsec. (k)(5) to (7). Pub. L. 116–8, § 3(d), added par. (5), redesignated former pars. (5) and (6) as (6) and (7), respectively, and substituted “paragraphs (2), (3), (4), and (5)” for “paragraphs (2), (3), and (4)” in par. (7). 2012—Subsec. (d)(5)(B)(ii)(III). Pub. L. 112–177, § 2(a)(2)(A)(i), substituted “this section” for “subsection (i)(1)”. Subsec. (i)(1) to (4). Pub. L. 112–177, § 2(a)(1)(C), (D), redesignated pars. (5) and (6) as (1) and (2), respectively, and struck out former pars. (1) to (4) which related to initial fee for food or feed use pesticide active ingredients, final fee for food or feed use pesticide active ingredients, fees for other pesticide active ingredients, and reduction or waiver of fees for minor use and other pesticides, respectively. Subsec. (i)(5). Pub. L. 112–177, § 2(a)(1)(D), redesignated par. (5) as (1). Subsec. (i)(5)(C). Pub. L. 112–177, § 2(a)(1)(A)(i), substituted “aggregate amount of $27,800,000 for each of fiscal years 2013 through 2017.” for “aggregate amount of $22,000,000 for each of fiscal years 2008 through 2012”. Subsec. (i)(5)(D)(i). Pub. L. 112–177, § 2(a)(1)(A)(ii)(I), substituted “shall be $115,500 for each of fiscal years 2013 through 2017;” for “shall be $71,000 for each of fiscal years 2008 through 2012;”. Subsec. (i)(5)(D)(ii). Pub. L. 112–177, § 2(a)(1)(A)(ii)(II), substituted “shall be $184,800 for each of fiscal years 2013 through 2017.” for “shall be $123,000 for each of fiscal years 2008 through 2012.” Subsec. (i)(5)(E)(i)(I). Pub. L. 112–177, § 2(a)(1)(A)(iii)(I), substituted “shall be $70,600 for each of fiscal years 2013 through 2017;” for “shall be $50,000 for each of fiscal years 2008 through 2012;”. Subsec. (i)(5)(E)(i)(II). Pub. L. 112–177, § 2(a)(1)(A)(iii)(II), substituted “shall be $122,100 for each of fiscal years 2013 through 2017.” for “shall be $86,000 for each of fiscal years 2008 through 2012.” Subsec. (i)(5)(F). Pub. L. 112–177, § 2(a)(1)(A)(vi), added subpar. (F). Former subpar. (F) redesignated (G). Pub. L. 112–177, § 2(a)(1)(A)(iv), substituted “this paragraph” for “paragraph (3)” and “Human” for “Humans”. Subsec. (i)(5)(G), (H). Pub. L. 112–177, § 2(a)(1)(A)(v), redesignated subpars. (F) and (G) as (G) and (H), respectively. Subsec. (i)(5)(I). Pub. L. 112–177, § 2(a)(1)(A)(v), (vii), redesignated subpar. (H) as (I) and substituted “2017” for “2012”. Subsec. (i)(6). Pub. L. 112–177, § 2(a)(1)(D), redesignated par. (6) as (2). Pub. L. 112–177, § 2(a)(1)(B), substituted “2019” for “2014” and “paragraph (1)” for “paragraphs (1) through (5)”. Subsec. (i)(7). Pub. L. 112–177, § 2(a)(1)(C), struck out par. (7) which related to apportionment of certain fees among registrants of pesticides. Subsec. (j). Pub. L. 112–177, § 2(a)(2)(A)(ii), substituted “subsection (i)(1)” for “subsection (i)(5)”. Subsec. (k)(2)(A). Pub. L. 112–177, § 2(a)(4)(A)(i), inserted “, to enhance the information systems capabilities to improve the tracking of pesticide registration decisions,” after “paragraph (3)” wherever appearing. Subsec. (k)(2)(A)(i). Pub. L. 112–177, § 2(a)(4)(A)(ii), inserted “offset” before “the costs of reregistration” and struck out “in the same portion as appropriated funds” before semicolon at end. Subsec. (k)(3)(A). Pub. L. 112–177, § 2(a)(4)(B), in introductory provisions, substituted “2013 through 2017, between ⅑ and ⅛” for “2008 through 2012, between ⅛ and ⅐”; in cl. (i), struck out “new” before “inert”; and, in cl. (ii), substituted “any application that—” for “any application that—”. Subsec. (k)(4). Pub. L. 112–177, § 2(a)(4)(C)(ii), added par. (4). Former par. (4) redesignated (5). Subsec. (k)(5). Pub. L. 112–177, § 2(a)(4)(C)(i), redesignated par. (4) as (5). Former par. (5) redesignated (6). Pub. L. 112–177, § 2(a)(2)(A)(iii), substituted “subsection (i)(1)(C)(ii)” for “subsection (i)(5)(C)(ii)” and “subsection (i)(1)(C)” for “subsection (i)(5)(C)” in two places. Subsec. (k)(6). Pub. L. 112–177, § 2(a)(4)(C)(i), (iii), redesignated par. (5) as (6) and substituted “for the purposes described in paragraphs (2), (3), and (4) and to carry out the goals established under subsection (l)” for “to carry out the goals established under subsection (l)”. 2007—Subsec. (i)(5)(C). Pub. L. 110–94, § 4(a), which directed substitution of “amount of $22,000,000 for each of fiscal years 2008 through 2012” for “amount of” and all that follows through the end of clause (v), was executed by making the substitution for “amount of— “(i) for fiscal year 2004, $26,000,000; “(ii) for fiscal year 2005, $27,000,000; “(iii) for fiscal year 2006, $27,000,000; “(iv) for fiscal year 2007, $21,000,000; and “(v) for fiscal year 2008, $15,000,000.” to reflect the probable intent of Congress. The words “amount of” appeared in the heading and twice in the text. Subsec. (i)(5)(D)(i). Pub. L. 110–94, § 4(b)(1)(A), substituted “shall be $71,000 for each of fiscal years 2008 through 2012; and” for “shall be— “(I) for fiscal year 2004, $84,000; “(II) for each of fiscal years 2005 and 2006, $87,000; “(III) for fiscal year 2007, $68,000; and “(IV) for fiscal year 2008, $55,000; and”. Subsec. (i)(5)(D)(ii). Pub. L. 110–94, § 4(b)(1)(B), substituted “shall be $123,000 for each of fiscal years 2008 through 2012.” for “shall be— “(I) for fiscal year 2004, $145,000; “(II) for each of fiscal years 2005 and 2006, $151,000; “(III) for fiscal year 2007, $117,000; and “(IV) for fiscal year 2008, $95,000.” Subsec. (i)(5)(E)(i)(I). Pub. L. 110–94, § 4(b)(2)(A), substituted “shall be $50,000 for each of fiscal years 2008 through 2012; and” for “shall be— “(aa) for fiscal year 2004, $59,000; “(bb) for each of fiscal years 2005 and 2006, $61,000; “(cc) for fiscal year 2007, $48,000; and “(dd) for fiscal year 2008, $38,500; and”. Subsec. (i)(5)(E)(i)(II). Pub. L. 110–94, § 4(b)(2)(B), substituted “shall be $86,000 for each of fiscal years 2008 through 2012.” for “shall be— “(aa) for fiscal year 2004, $102,000; “(bb) for each of fiscal years 2005 and 2006, $106,000; “(cc) for fiscal year 2007, $82,000; and “(dd) for fiscal year 2008, $66,500.” Subsec. (i)(5)(H). Pub. L. 110–94, § 4(c), substituted “2012.” for “2008”. Subsec. (i)(6). Pub. L. 110–94, § 4(d)(1), substituted “2014” for “2010”. Subsec. (k)(2)(A). Pub. L. 110–94, § 4(e)(1), inserted “and to offset the costs of registration review under section 136a(g) of this title” after “paragraph (3)” wherever appearing. Subsec. (k)(3)(A). Pub. L. 110–94, § 4(e)(2), substituted “2008 through 2012” for “2007 and 2008”. 2004—Subsec. (g)(2)(A). Pub. L. 108–199, § 501(c)(5)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: “Within 1 year after the submission of all data concerning an active ingredient of a pesticide under subsection (f) of this section, the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration. For extraordinary circumstances, the Administrator may extend such period for not more than 1 additional year.” Subsec. (g)(2)(B). Pub. L. 108–199, § 501(c)(5)(B), inserted subpar. (B) and cl. (i) headings, designated first sentence of existing provisions as cl. (i), inserted cl. (ii) and subcl. (I) headings, designated second sentence of existing provisions as cl. (ii)(I), substituted “Subject to subclause (II), the Administrator” for “The Administrator” in subcl. (I), and added subcl. (II). Subsec. (g)(2)(D). Pub. L. 108–199, § 501(c)(5)(C), inserted subpar. (D) and cl. (i) headings, designated existing provisions as cl. (i), and added cl. (ii). Subsec. (i)(5)(A). Pub. L. 108–199, § 501(c)(1)(A), inserted subpar. (A) heading and substituted “for each registration” for “of— “(i) $650 for the first registration; and “(ii) $1,300 for each additional registration”. Subsec. (i)(5)(C). Pub. L. 108–199, § 501(c)(2), struck out cl. (i) designation before “The amount of each”, inserted subpar. (C) heading, substituted “aggregate amount of—” for “aggregate amount of $21,500,000 for fiscal year 2003.”, added cls. (i) to (v), and struck out former cl. (ii), which related to collection of additional fees in fiscal years 1998, 1999, and 2000. Subsec. (i)(5)(D). Pub. L. 108–199, § 501(c)(1)(B), inserted subpar. (D) heading, substituted “shall be—” for “shall be $55,000; and” and added subcls. (I) to (IV) in cl. (i), and substituted “shall be—” for “shall be $95,000.” and added subcls. (I) to (IV) in cl. (ii). Subsec. (i)(5)(E)(i). Pub. L. 108–199, § 501(c)(1)(C), inserted subpar. (E) and cl. (i) headings, realigned margins of subcls. (I) and (II), substituted “shall be—” for “shall be $38,500; and” and inserted items (aa) to (dd) in subcl. (I), and substituted “shall be—” for “shall be $66,500.” and inserted items (aa) to (dd) in subcl. (II). Subsec. (i)(5)(E)(ii). Pub. L. 108–199, § 501(c)(3), inserted cl. (ii) heading, redesignated existing provisions as subcl. (I), inserted subcl. (I) heading, substituted “In” for “For purposes of” in subcl. (I), redesignated former subcls. (I) and (II) as items (aa) and (bb) respectively, and realigned margins, substituted “500” for “150” in item (aa), substituted “global gross revenue from pesticides that did not exceed $60,000,000.” for “gross revenue from chemicals that did not exceed $40,000,000.” in item (bb), and added subcl. (II). Subsec. (i)(5)(H). Pub. L. 108–199, § 501(c)(4), substituted “2008” for “2003”. Subsec. (i)(6). Pub. L. 108–199, § 501(d)(1), substituted “Except as provided in section 136w–8 of this title, during” for “During”, and substituted “2010” for “2003”. Subsec. (k)(2)(A)(i). Pub. L. 108–271 substituted “Government Accountability Office” for “General Accounting Office”. Subsec. (k)(3). Pub. L. 108–199, § 501(e)(1), substituted “Review of inert ingredients; expedited” for “Expedited” in par. heading. Subsec. (k)(3)(A). Pub. L. 108–199, § 501(e)(2), substituted “2004 through 2006, approximately $3,300,000, and for each of fiscal years 2007 and 2008, between ⅛ and ⅐, of the maintenance fees” for “1997 through 2003, not more than ⅒ of the maintenance fees”, substituted “resources” for “resources to assure the expedited processing and review of any application that”, added cl. (i), inserted cl. (ii) designation and introductory provisions, and redesignated former cls. (i) to (iii) as subcls. (I) to (III), respectively, of cl. (ii). 2003—Pub. L. 108–7, which directed the amendment of “Section 136a–1 of title 7, U.S.C.”, was executed by making the amendments to this section, which is section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act, to reflect the probable intent of Congress. See below. Subsec. (i)(5)(C)(i). Pub. L. 108–7, [(1)], substituted “$21,500,000 for fiscal year 2003” for “$17,000,000 fiscal year 2002”. Subsec. (i)(5)(H). Pub. L. 108–7, [(2)], substituted “2003” for “2002”. Subsec. (i)(6). Pub. L. 108–7, [(3)], substituted “2003” for “2002”. Subsec. (k)(3)(A). Pub. L. 108–7, [(4)], substituted “2003” for “2002”. 2001—Pub. L. 107–73, which directed the amendment of “Section 136a–1 of title 7, U.S.C.”, was executed by making the amendments to this section, which is section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act, to reflect the probable intent of Congress. See below. Subsec. (i)(5)(C)(i). Pub. L. 107–73, [(1)], substituted “$17,000,000” for “$14,000,000” and “fiscal year 2002” for “each fiscal year”. Subsec. (i)(5)(H). Pub. L. 107–73, [(2)], substituted “2002” for “2001”. Subsec. (i)(6). Pub. L. 107–73, [(3)], substituted “2002” for “2001”. Subsec. (k)(3)(A). Pub. L. 107–73, [(4)], substituted “2002” for “2001” and “⅒” for “⅐” in introductory provisions. 1996—Pub. L. 104–170, § 501, which directed amendment of section 4 without specifying the name of the Act being amended, was executed to this section, which is section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act, to reflect the probable intent of Congress. Subsec. (d)(4)(B). Pub. L. 104–170, § 210(c)(2), inserted at end provisions authorizing extension of deadline for production of residue chemistry data in case of minor use and setting forth conditions to be met for such extension in cls. (i) to (iv). Subsec. (d)(6). Pub. L. 104–170, § 210(f)(1)(A), inserted at end provisions delaying upon written request action with regard to unsupported minor uses, authorizing refusal of request where there are health or environmental concerns, authorizing publication of notice in Federal Register and monitoring of development of data, setting forth procedures where registrant is not meeting or has not met schedule for production of data, and authorizing denial, modification, or revocation of temporary extension where use may cause adverse effect on environment and requiring notice of such revocation to registrant. Subsec. (e)(2)(B). Pub. L. 104–170, § 210(c)(2), inserted at end provisions authorizing extension of deadline for production of residue chemistry data in case of minor use and setting forth conditions to be met for such extension in cls. (i) to (iv). Subsec. (e)(3)(A). Pub. L. 104–170, § 210(f)(1)(B), inserted at end provisions delaying upon written request action with regard to unsupported minor uses, authorizing refusal of request where there are health or environmental concerns, authorizing publication of notice in Federal Register and monitoring of development of data, setting forth procedures where registrant is not meeting or has not met schedule for production of data, and authorizing denial, modification, or revocation of temporary extension where use may cause adverse effect on environment and requiring notice of such revocation to registrant. Subsec. (f)(2)(B). Pub. L. 104–170, § 210(c)(2), inserted at end provisions authorizing extension of deadline for production of residue chemistry data in case of minor use and setting forth conditions to be met for such extension in cls. (i) to (iv). Subsec. (f)(3). Pub. L. 104–170, § 210(f)(1)(A), inserted at end provisions delaying upon written request action with regard to unsupported minor uses, authorizing refusal of request where there are health or environmental concerns, authorizing publication of notice in Federal Register and monitoring of development of data, setting forth procedures where registrant is not meeting or has not met schedule for production of data, and authorizing denial, modification, or revocation of temporary extension where use may cause adverse effect on environment and requiring notice of such revocation to registrant. Subsec. (g)(2)(E). Pub. L. 104–170, § 103, added subpar. (E). Subsec. (i)(4)(B) to (D). Pub. L. 104–170, § 232(1), added subpar. (B) and redesignated former subpars. (B) and (C) as (C) and (D), respectively. Subsec. (i)(5)(C). Pub. L. 104–170, § 501(a)(2), designated existing provisions as cl. (i) and added cl. (ii). Subsec. (i)(5)(F), (G). Pub. L. 104–170, § 232(2), added subpar. (F) and redesignated former subpar. (F) as (G). Subsec. (i)(5)(H). Pub. L. 104–170, § 501(a)(1), substituted “2001” for “1997”. Pub. L. 104–170, § 232(2), redesignated subpar. (G) as (H). Subsec. (i)(6). Pub. L. 104–170, § 501(a)(1), substituted “2001” for “1997”. Subsec. (i)(7)(B). Pub. L. 104–170, § 232(3), substituted “, to determine the registrant’s eligibility” for “or to determine the registrant’s eligibility” and inserted before period at end “, or to determine the volume usage for public health pesticides”. Subsec. (k)(1). Pub. L. 104–170, § 501(b), inserted “which shall be known as the Reregistration and Expedited Processing Fund” before period at end. Subsec. (k)(2). Pub. L. 104–170, § 501(c), amended heading and text of par. (2) generally. Prior to amendment, text read as follows: “All fees collected by the Administrator under subsection (i) of this section shall be deposited into the fund and shall be available to the Administrator, without fiscal year limitation, to carry out reregistration and expedited processing of similar applications.” Subsec. (k)(3)(A). Pub. L. 104–170, § 501(d)(1), which directed the amendment of introductory provisions by substituting “for each of the fiscal years 1997 through 2001, not more than ⅐ of the maintenance fees collected in such fiscal year” for “for each of the fiscal years 1992, 1993, and 1994, ⅐th of the maintenance fees collected, up to 2 million each year”, was executed by making the substitution for text which contained the phrase “$2 million”, to reflect the probable intent of Congress. Subsec. (k)(3)(A)(iii). Pub. L. 104–170, § 232(4), added cl. (iii). Subsec. (k)(3)(C). Pub. L. 104–170, § 501(d)(2), added subpar. (C). Subsec. (k)(5). Pub. L. 104–170, § 501(e), amended heading and text of par. (5) generally. Prior to amendment, text read as follows: “The Administrator shall— “(A) provide an annual accounting of the fees collected and disbursed from the fund; and “(B) take all steps necessary to ensure that expenditures from such fund are used only to carry out this section.” Subsec. (l). Pub. L. 104–170, § 501(f), added subsec. (l). Former subsec. (l) redesignated (m). Subsec. (m). Pub. L. 104–170, § 501(f), redesignated subsec. (l) as (m). Former subsec. (m) redesignated (n). Pub. L. 104–170, § 237, added subsec. (m). Subsec. (n). Pub. L. 104–170, § 501(f), redesignated subsec. (m) as (n). 1991—Subsec. (f)(3). Pub. L. 102–237, § 1006(a)(4), realigned margin. Subsec. (i)(5). Pub. L. 102–237, § 1006(e), amended par. (5) generally, substituting, in subpar. (A), provisions relating to January 15 for provisions relating to March 1, in subpar. (A)(i), provisions relating to fee of $650 for first registration for provisions relating to fee of $425 for each registration for registrants holding not more than 50 registrations, and in subpar. (A)(ii), provisions relating to fee of $1,300 for each additional registration up to 200 registrations, with no fee thereafter, for provisions relating to fee of $425 for each registration up to 50, $100 for each registration over 50, with no fee after 200 registrations, redesignating provisions formerly set out in subpar. (A), following cl. (ii), as subpar. (B), and substituting provisions relating to fee under this par. for provisions relating to fee under this subpar., redesignating former subpar. (B) as (C), striking former subpar. (C), which set maximum annual fee for registrants under subpar. (A)(i) at $20,000, and for registrants under subpar. (A)(ii) at $35,000, adding subpars. (D) and (E), and redesignating former subpars. (D) and (E) as (F) and (G), respectively. Subsec. (k)(3)(A). Pub. L. 102–237, § 1006(f), substituted “for each of the fiscal years 1992, 1993, and 1994, ⅐th of the maintenance fees collected, up to $2 million each year” for “each fiscal year not more than $2,000,000 of the amounts in the fund”. 1990—Subsec. (i)(5)(A). Pub. L. 101–624 inserted sentence at end relating to reduction or waiver of fee where pesticide is registered for minor agricultural use. ### Statutory Notes and Related Subsidiaries ### Effective Date of 2012 Amendment Pub. L. 112–177, § 2(c), Sept. 28, 2012, 126 Stat. 1407, provided that: “This section [amending this section, section 136w–8 of this title, and section 346a of Title 21, Food and Drugs, and enacting provisions set out as a note under this section] and the amendments made by this section take effect on October 1, 2012.” ### Effective Date of 2007 Amendment Amendment by Pub. L. 110–94 effective Oct. 1, 2007, see section 6 of Pub. L. 110–94, set out as a note under section 136a of this title. ### Effective Date of 2004 Amendment Amendment by Pub. L. 108–199 effective on the date that is 60 days after Jan. 23, 2004, except as otherwise provided, see section 501(h) of Pub. L. 108–199, set out as a note under section 136a of this title. ### Effective Date Section effective on expiration of 60 days after Oct. 25, 1988, see section 901 of Pub. L. 100–532, set out as an Effective Date of 1988 Amendment note under section 136 of this title. ### Implementation Dates With Respect to Fees Pub. L. 117–328, div. HH, title VI, § 708, Dec. 29, 2022, 136 Stat. 6082, provided that:Fee Increases.— Registration service fees.—With respect to amendments made by this title [see Short Title of 2022 Amendment note set out under section 136 of this title] to increase registration service fees specified in section 33 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8), such increases shall not be effective until the date that is 60 days after the date of the enactment of this title [Dec. 29, 2022], regardless of whether such section 33 specifies (as so amended) that such increases are effective for fiscal year 2023. Maintenance fees.—With respect to amendments made by this title to increase the amount of maintenance fees to be collected under section 4(i) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(i)), such increases shall be effective beginning on October 1, 2022. Set-asides.—With respect to any set-asides specified in subsection (i) or (k) of section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1), such set-asides shall be effective beginning on October 1, 2022.” ### Extension of Limitations on Fee Amounts and Usage of Fees Pub. L. 115–141, div. M, title IV, § 401(a), Mar. 23, 2018, 132 Stat. 1049, provided that subsecs. (i)(1)(C)–(E) and (k)(3), (4) of this section and section 136w–8(c)(3)(B) of this title would continue in effect through Sept. 30, 2018. Pub. L. 115–141, div. M, title IV, § 401(b)(1), Mar. 23, 2018, 132 Stat. 1050, extended the authority under subsec. (i)(1) of this section through Sept. 30, 2018. ### Relationship of Pub. L. 112–177 to Other Law Pub. L. 112–177, § 2(d), Sept. 28, 2012, 126 Stat. 1407, provided that: “In the case of any conflict between this section [amending this section, section 136w–8 of this title, and section 346a of Title 21, Food and Drugs, and enacting provisions set out as a note under this section] (including the amendments made by this section) and a joint resolution making continuing appropriations for fiscal year 2013 (including any amendments made by such a joint resolution), this section and the amendments made by this section shall control.” ### Adjustment of Maximum Annual Fee Payable by Pesticide Registrants Pub. L. 108–11, title II, Apr. 16, 2003, 117 Stat. 603, provided that: “Within 30 days of enactment of this Act [Apr. 16, 2003], the Administrator of the Environmental Protection Agency shall adjust each ‘maximum annual fee payable’ pursuant to 7 U.S.C. 136a–1(i)(5)(D) and (E) in a manner such that maintenance fee collections made to reach the level authorized in division K of Public Law 108–7 [see Tables for classification] shall be established in the same proportion as those maintenance fee collections authorized in Public Law 107–73 [see Tables for classification].”