7 U.S.C. § 136a
Registration of pesticides
Except as provided by this subchapter, no person in any State may distribute or sell to any person any pesticide that is not registered under this subchapter. To the extent necessary to prevent unreasonable adverse effects on the environment, the Administrator may by regulation limit the distribution, sale, or use in any State of any pesticide that is not registered under this subchapter and that is not the subject of an experimental use permit under section 136c of this title or an emergency exemption under section 136p of this title.
The Administrator shall publish guidelines specifying the kinds of information which will be required to support the registration of a pesticide and shall revise such guidelines from time to time. If thereafter the Administrator requires any additional kind of information under subparagraph (B) of this paragraph, the Administrator shall permit sufficient time for applicants to obtain such additional information. The Administrator, in establishing standards for data requirements for the registration of pesticides with respect to minor uses, shall make such standards commensurate with the anticipated extent of use, pattern of use, the public health and agricultural need for such minor use, and the level and degree of potential beneficial or adverse effects on man and the environment. The Administrator shall not require a person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under this subchapter, any field residue data from a geographic area where the pesticide will not be registered for such use. In the development of these standards, the Administrator shall consider the economic factors of potential national volume of use, extent of distribution, and the impact of the cost of meeting the requirements on the incentives for any potential registrant to undertake the development of the required data. Except as provided by section 136h of this title, within 30 days after the Administrator registers a pesticide under this subchapter the Administrator shall make available to the public the data called for in the registration statement together with such other scientific information as the Administrator deems relevant to the Administrator’s decision.
Within nine months after
The Administrator shall review the data after receipt of the application and shall, as expeditiously as possible, either register the pesticide in accordance with paragraph (5), or notify the applicant of the Administrator’s determination that it does not comply with the provisions of the subchapter in accordance with paragraph (6).
If a registrant makes a request for a minor use waiver, regarding data required by the Administrator, pursuant to paragraph (2)(E), and if the Administrator denies in whole or in part such data waiver request, the registrant shall have a full-time period for providing such data. For purposes of this subparagraph, the term “full-time period” means the time period originally established by the Administrator for submission of such data, beginning with the date of receipt by the registrant of the Administrator’s notice of denial.
The Administrator shall publish in the Federal Register, promptly after receipt of the statement and other data required pursuant to paragraphs (1) and (2), a notice of each application for registration of any pesticide if it contains any new active ingredient or if it would entail a changed use pattern. The notice shall provide for a period of 30 days in which any Federal agency or any other interested person may comment.
If the Administrator determines that the requirements of paragraph (5) for registration are not satisfied, the Administrator shall notify the applicant for registration of the Administrator’s determination and of the Administrator’s reasons (including the factual basis) therefor, and that, unless the applicant corrects the conditions and notifies the Administrator thereof during the 30-day period beginning with the day after the date on which the applicant receives the notice, the Administrator may refuse to register the pesticide. Whenever the Administrator refuses to register a pesticide, the Administrator shall notify the applicant of the Administrator’s decision and of the Administrator’s reasons (including the factual basis) therefor. The Administrator shall promptly publish in the Federal Register notice of such denial of registration and the reasons therefor. Upon such notification, the applicant for registration or other interested person with the concurrence of the applicant shall have the same remedies as provided for in section 136d of this title.
Notwithstanding any other provision of this subchapter, the Administrator may not initiate a public interim administrative review process to develop a risk-benefit evaluation of the ingredients of a pesticide or any of its uses prior to initiating a formal action to cancel, suspend, or deny registration of such pesticide, required under this subchapter, unless such interim administrative process is based on a validated test or other significant evidence raising prudent concerns of unreasonable adverse risk to man or to the environment. Notice of the definition of the terms “validated test” and “other significant evidence” as used herein shall be published by the Administrator in the Federal Register.
Subject to subparagraphs (B) and (C), it shall not be a violation of this subchapter for a registrant to modify the labeling of an antimicrobial pesticide product to include relevant information on product efficacy, product composition, container composition or design, or other characteristics that do not relate to any pesticidal claim or pesticidal activity.
Proposed labeling information under subparagraph (A) shall not be false or misleading, shall not conflict with or detract from any statement required by law or the Administrator as a condition of registration, and shall be substantiated on the request of the Administrator.
Not later than 30 days after receipt of a notification under clause (i), the Administrator may disapprove the modification by sending the registrant notification in writing stating that the proposed language is not acceptable and stating the reasons why the Administrator finds the proposed modification unacceptable.
A registrant may not sell or distribute a product bearing a disapproved modification.
A registrant may file an objection in writing to a disapproval under clause (ii) not later than 30 days after receipt of notification of the disapproval.
A decision by the Administrator following receipt and consideration of an objection filed under clause (iv) shall be considered a final agency action.
The Administrator shall establish an interagency working group, to be comprised of representatives from each covered agency, to provide recommendations regarding, and to implement a strategy for improving, the consultation process required under section 7 of the Endangered Species Act of 1973 (16 U.S.C. 1536) for pesticide registration and registration review.
Not later than 18 months after
Chapter 10 of title 5 shall not apply to the working group established under this paragraph.
If the Administrator determines that a change in the classification of any use of a pesticide from general use to restricted use is necessary to prevent unreasonable adverse effects on the environment, the Administrator shall notify the registrant of such pesticide of such determination at least forty-five days before making the change and shall publish the proposed change in the Federal Register. The registrant, or other interested person with the concurrence of the registrant, may seek relief from such determination under section 136d(b) of this title.
The registrant of any pesticide with one or more uses classified for restricted use may petition the Administrator to change any such classification from restricted to general use. Such petition shall set out the basis for the registrant’s position that restricted use classification is unnecessary because classification of the pesticide for general use would not cause unreasonable adverse effects on the environment. The Administrator, within sixty days after receiving such petition, shall notify the registrant whether the petition has been granted or denied. Any denial shall contain an explanation therefor and any such denial shall be subject to judicial review under section 136n of this title.
Products which have the same formulation, are manufactured by the same person, the labeling of which contains the same claims, and the labels of which bear a designation identifying the product as the same pesticide may be registered as a single pesticide; and additional names and labels shall be added to the registration by supplemental statements.
If the labeling or formulation for a pesticide is changed, the registration shall be amended to reflect such change if the Administrator determines that the change will not violate any provision of this subchapter.
In no event shall registration of an article be construed as a defense for the commission of any offense under this subchapter. As long as no cancellation proceedings are in effect registration of a pesticide shall be prima facie evidence that the pesticide, its labeling and packaging comply with the registration provisions of the subchapter.
In connection with consideration of any registration or application for registration under this section, the Administrator may consult with any other Federal agency.
In the case of pesticide products classified by the Administrator as restricted use under subsection (d)(1)(A), the deadline specified in this subparagraph is the date that is 3 years following
For agricultural pesticides classified as Acute Toxicity Category I, the date that is 3 years after
For agricultural pesticides classified as Acute Toxicity Category II, the date that is 5 years after
For antimicrobial and non-agricultural pesticide products classified as Acute Toxicity Category I, the date that is 4 years after
For antimicrobial and non-agricultural pesticide products classified as Acute Toxicity Category II, the date that is 6 years after
With respect to pesticide products not described in subclause (I) or (II), the date that is 8 years after
In carrying out this paragraph, the Administrator shall allow translations of the parts of the label of a pesticide contained in the Spanish Translation Guide described in subparagraph (G) and scannable technology or other electronic methods to be added using non-notification procedures.
In this clause, the term “non-notification procedure” refers to a procedure under which a change may be made to a pesticide label without notifying the Administrator.
In carrying out this paragraph, the Administrator shall cooperate and consult with State lead agencies for pesticide regulation for the purpose of implementing bilingual labeling as provided in this paragraph as expeditiously as possible.
The labeling requirements of this paragraph shall apply to end use product labels.
Not later than 10 days after updating the Spanish Translation Guide described in subparagraph (G), the Administrator shall notify registrants of the update to such guide.
Not later than 180 days after
Not later than 3 years after
Not later than 2 years after
The Spanish Translation Guide described in this subparagraph is the Spanish Translation Guide for Pesticide Labeling issued in October 2019, as in effect on
The registrations of pesticides are to be periodically reviewed.
In accordance with this subparagraph, the Administrator shall by regulation establish a procedure for accomplishing the periodic review of registrations.
Not later than 15 years after the date on which the initial registration review is completed under clause (iii) and each 15 years thereafter, the Administrator shall complete a subsequent registration review for each pesticide or pesticide case.
No registration shall be canceled as a result of the registration review process unless the Administrator follows the procedures and substantive requirements of section 136d of this title.
The Administrator shall identify, but not include in the docket, any confidential business information the disclosure of which is prohibited by section 136h of this title.
Nothing in this subsection shall prohibit the Administrator from undertaking any other review of a pesticide pursuant to this subchapter.
The Administrator shall use the authority in subsection (c)(2)(B) to require the submission of data when such data are necessary for a registration review.
For purposes of this subsection, the provisions of subsections (c)(1), (c)(2)(B), and (c)(2)(D) shall be utilized for and be applicable to any data required for registration review.
Not later than 270 days after
In developing the proposed regulations, the Administrator shall solicit the views from registrants and other affected parties to maximize the effectiveness of the rule development process.
The Administrator shall issue final regulations not later than 240 days after the close of the comment period for the proposed regulations.
If a goal described in paragraph (2) is not met by the final regulations, the Administrator shall identify the goal, explain why the goal was not attained, describe the element of the regulations included instead, and identify future steps to attain the goal.
This subsection does not affect the requirements or extend the deadlines or review periods contained in subsection (c)(3).
An application for the registration, or for an amendment to the registration, of a wood preservative product for which a claim of pesticidal activity listed in section 136(mm) of this title is made (regardless of any other pesticidal claim that is made with respect to the product) shall be reviewed by the Administrator within the same period as that established under this paragraph for an antimicrobial pesticide product application, consistent with the degree of risk posed by the use of the wood preservative product, if the application requires the applicant to satisfy the same data requirements as are required to support an application for a wood preservative product that is an antimicrobial pesticide.
Subject to clause (iii), the Administrator shall notify an applicant whether an application has been granted or denied not later than the final day of the appropriate review period under this paragraph, unless the applicant and the Administrator agree to a later date.
If the Administrator fails to notify an applicant within the period of time required under clause (i), the failure shall be considered an agency action unlawfully withheld or unreasonably delayed for purposes of judicial review under chapter 7 of title 5.
This subparagraph does not apply to an application for an antimicrobial pesticide that is filed under subsection (c)(3)(B) prior to 90 days after
Beginning on
The Endangered Species Act of 1973, referred to in subsec. (c)(11)(C)(i)(I), (II), (v), (vi), (G)(ii), is Pub. L. 93–205,
A prior section 3 of act
2022—Subsec. (c)(11)(F). Pub. L. 117–286 substituted “Chapter 10 of title 5” for “Federal Advisory Committee Act” in heading and “Chapter 10 of title 5” for “The Federal Advisory Committee Act (5 U.S.C. App.)” in text.
Subsec. (f)(5). Pub. L. 117–328 added par. (5).
2018—Subsec. (c)(11). Pub. L. 115–334 added par. (11).
2007—Subsec. (c)(3)(B)(ii)(I). Pub. L. 110–94, § 2(1), substituted “review the application in accordance with section 136w–8(f)(4)(B) of this title and,” for “within 45 days after receiving the application, notify the registrant whether or not the application is complete and,”.
Subsec. (c)(3)(B)(ii)(II). Pub. L. 110–94, § 2(2), substituted “not later than the applicable decision review time established pursuant to section 136w–8(f)(4)(B) of this title, or, if no review time is established, not later than” for “within”.
Subsec. (g)(1)(A). Pub. L. 110–94, § 3(1), designated first sentence as cl. (i) and inserted heading, designated second sentence as cl. (ii), inserted heading, and substituted “In accordance with this subparagraph, the Administrator” for “The Administrator”, added cls. (iii) and (iv), designated fourth sentence as cl. (v) and inserted heading, and struck out third sentence which read as follows: “The goal of these regulations shall be a review of a pesticide’s registration every 15 years.”
Subsec. (g)(1)(B), (C). Pub. L. 110–94, § 3(2), (3), added subpar. (B) and redesignated former subpar. (B) as (C).
2004—Subsec. (h)(2)(F). Pub. L. 108–199, § 501(b)(1), substituted “120 days” for “90 to 180 days”.
Subsec. (h)(3)(D)(vi). Pub. L. 108–199, § 501(b)(2)(A), substituted “120 days” for “240 days”.
Subsec. (h)(3)(F)(iv). Pub. L. 108–199, § 501(b)(2)(B), added cl. (iv).
1996—Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104–170, § 210(b), added cls. (ii), (v), and (vi), redesignated former cls. (ii) and (iii) as (iii) and (iv), respectively, and in cl. (iv) substituted “(i), (ii), and (iii)” for “(i) and (ii)”.
Subsec. (c)(1)(G). Pub. L. 104–170, § 250(1), added subpar. (G).
Subsec. (c)(2)(A). Pub. L. 104–170, §§ 210(d)(1), 231, inserted heading, inserted “the public health and agricultural need for such minor use,” after “pattern of use,”, and substituted “potential beneficial or adverse effects on man and the environment” for “potential exposure of man and the environment to the pesticide”.
Subsec. (c)(2)(B). Pub. L. 104–170, § 210(d)(2), inserted heading.
Subsec. (c)(2)(B)(vi). Pub. L. 104–170, § 210(c)(1), added cl. (vi).
Subsec. (c)(2)(B)(vii). Pub. L. 104–170, § 210(f)(2), added cl. (vii).
Subsec. (c)(2)(B)(viii). Pub. L. 104–170, § 222, added cl. (viii).
Subsec. (c)(2)(C). Pub. L. 104–170, § 210(d)(3), inserted heading.
Subsec. (c)(2)(E). Pub. L. 104–170, § 210(d)(4), added subpar. (E).
Subsec. (c)(3)(A), (B). Pub. L. 104–170, § 210(e)(1), (2), inserted headings.
Subsec. (c)(3)(C), (D). Pub. L. 104–170, § 210(e)(3), added subpars. (C) and (D).
Subsec. (c)(9). Pub. L. 104–170, § 223, added par. (9).
Subsec. (c)(10). Pub. L. 104–170, § 250(2), added par. (10).
Subsec. (f)(4). Pub. L. 104–170, § 105(b), added par. (4).
Subsec. (g). Pub. L. 104–170, § 106(b), added subsec. (g).
Subsec. (h). Pub. L. 104–170, § 224, added subsec. (h).
1991—Subsec. (c)(1)(D). Pub. L. 102–237, § 1006(a)(3)(B), (C), added subpar. (D) and redesignated former subpar. (D) as (F).
Subsec. (c)(1)(E). Pub. L. 102–237, § 1006(a)(3)(A), (C), added subpar. (E) and struck out former subpar. (E) which read as follows: “the complete formula of the pesticide; and”.
Subsec. (c)(1)(F). Pub. L. 102–237, § 1006(a)(3)(A), (B), (D), redesignated former subpar. (D) as (F), in cl. (i) substituted “With” for “with” and a period for semicolon at end, in cl. (ii) substituted “Except” for “except” and a period for semicolon at end, in cl. (iii) substituted “After” for “after” and a period for semicolon at end, and struck out former subpar. (F) which read as follows: “a request that the pesticide be classified for general use, for restricted use, or for both.”
Subsec. (c)(2)(A). Pub. L. 102–237, § 1006(b)(1), (2), substituted “the Administrator” for “he” before “requires”, “shall permit”, “shall make”, and “deems”, and substituted “the Administrator’s” for “his”.
Subsec. (c)(2)(D). Pub. L. 102–237, § 1006(c), clarified amendment made by Pub. L. 100–532, § 102(b)(2)(A). See 1988 Amendment note below.
Subsec. (c)(3)(A). Pub. L. 102–237, § 1006(b)(2), substituted “the Administrator’s” for “his”.
Subsec. (c)(5). Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “determines”.
Subsec. (c)(6). Pub. L. 102–237, § 1006(b)(1), (2), substituted “the Administrator” for “he” before “shall notify” in two places and “the Administrator’s” for “his” in four places.
Subsec. (d)(1). Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “shall classify it for both” in subpar. (A), before “will classify” in subpar. (B), and before “shall classify” in subpar. (C).
Subsec. (d)(2). Pub. L. 102–237, § 1006(b)(1), substituted “the Administrator” for “he” before “shall notify”.
1990—Subsec. (c)(2)(A). Pub. L. 101–624 inserted after third sentence “The Administrator shall not require a person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under this subchapter, any field residue data from a geographic area where the pesticide will not be registered for such use.”
1988—Subsec. (a). Pub. L. 100–532, § 601(b)(1), substituted “Requirement of registration” for “Requirement” in heading and amended text generally. Prior to amendment, text read as follows: “Except as otherwise provided by this subchapter, no person in any State may distribute, sell, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person any pesticide which is not registered with the Administrator.”
Subsec. (c)(1)(D). Pub. L. 100–532, § 801(b)(1)–(4), in introductory provisions, substituted “paragraph (2)(D)” for “subsection (c)(2)(D) of this section”, in cl. (i), substituted “(i) with” for “(i) With” and “, except that” for “: Provided, That”, in cl. (ii), substituted “clause (i)” for “subparagraph (D)(i) of this paragraph”, and in cl. (iii), substituted “clauses (i) and (ii)” for “subparagraphs (D)(i) and (D)(ii) of this paragraph”.
Subsec. (c)(2)(A). Pub. L. 100–532, § 801(b)(5)(A), (B), substituted “(2) Data in support of registration.—
“(A) The”
for “(2)(A) Data in support of registration.—The”, and directed that subpar. (A) be aligned with left margin of subsec. (d)(1)(A) of this section.
Subsec. (c)(2)(B). Pub. L. 100–532, §§ 102(b)(1), 801(b)(5)(C)–(F), substituted “(B)(i) If” for “(B) Additional data to support existing registration.—(i) If”, directed that cls. (ii) to (v) be aligned with left margin of subpar. (A), in cls. (ii) and (iii), inserted “The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to comply with this clause.”, in cl. (iv), substituted “title. The only” for “title: Provided, that the only”, and in cl. (v), substituted “paragraph (1)(D)” for “subsection (c)(1)(D) of this section”.
Subsec. (c)(2)(C). Pub. L. 100–532, § 801(b)(5)(G), (H), struck out “Simplified procedures” after “(C)” and directed that text be aligned with left margin of subpar. (A).
Subsec. (c)(2)(D). Pub. L. 100–532, § 102(b)(2)(A), and Pub. L. 102–237, § 1006(c), substituted “the pesticide that is the subject of the application” for “an end-use product”.
Subsec. (c)(2)(D)(i). Pub. L. 100–532, § 102(b)(2)(B), struck out “the safety of” after “data pertaining to”.
Subsec. (c)(3). Pub. L. 100–532, § 103, substituted “(A) The Administrator” for “The Administrator” and added subpar. (B).
Subsec. (c)(7). Pub. L. 100–532, § 801(b)(6), in introductory provisions, substituted “paragraph (5)” for “subsection (c)(5) of this section”, in subpars. (A) and (B), substituted “paragraph (5). If” for “subsection (c)(5) of this section: Provided, That, if”, and in subpar. (C), substituted “prescribe. A” for “prescribe: Provided, that a”.
Subsec. (d)(1)(A). Pub. L. 100–532, § 801(b)(7), substituted “restricted use. If” for “restricted use, provided that if” and “restricted uses. The Administrator” for “restricted uses: Provided, however, That the Administrator”.
Subsec. (f)(2). Pub. L. 100–532, § 801(b)(8), substituted “this subchapter. As” for “this subchapter: Provided, That as”.
Subsec. (g). Pub. L. 100–532, § 801(b)(9), struck out subsec. (g) which read as follows: “The Administrator shall accomplish the reregistration of all pesticides in the most expeditious manner practicable: Provided, That, to the extent appropriate, any pesticide that results in a postharvest residue in or on food or feed crops shall be given priority in the reregistration process.”
1978—Subsec. (c)(1)(D). Pub. L. 95–396, § 2(a)(1), added subpar. (D), and struck out provisions which required the applicant for registration of a pesticide to file with the Administrator a statement containing “if requested by the Administrator, a full description of the tests made and the results thereof upon which the claims are based, except that data submitted on or after
Subsec. (c)(2). Pub. L. 95–396, §§ 2(a)(2)(A)–(D), 3, 4, designated existing provisions as subpar. (A), inserted in second sentence “under subparagraph (B) of this paragraph” after “kind of information”, struck out from introductory text of third sentence “subsection (c)(1)(D) of this section and” after “Except as provided by”, and inserted provisions relating to establishment of standards for data requirements for registration of pesticides with respect to minor uses and consideration of economic factors in development of standards and cost of development, and added subpars. (B) to (D).
Subsec. (c)(5). Pub. L. 95–396, § 5, provided for waiver of data requirements pertaining to efficacy.
Subsec. (c)(7), (8). Pub. L. 95–396, § 6, added pars. (7) and (8).
Subsec. (d)(1)(A). Pub. L. 95–396, § 7(1), authorized classification of pesticide uses by regulation on the initial classification and registered pesticides prior to reregistration.
Subsec. (d)(2). Pub. L. 95–396, § 7(2), substituted “forty-five days” for “30 days”.
Subsec. (d)(3). Pub. L. 95–396, § 7(3), added par. (3).
Subsec. (g). Pub. L. 95–396, § 8, added subsec. (g).
1975—Subsec. (c)(1)(D). Pub. L. 94–140 inserted exception relating to test data submitted on or after
Pub. L. 110–94, § 6,
Pub. L. 108–199, div. G, title V, § 501(h),
Amendment by Pub. L. 100–532 effective on expiration of 60 days after
Pub. L. 95–396, § 2(b),
For effective date of section, see section 4 of Pub. L. 92–516, set out as a note under section 136 of this title.
Pub. L. 117–328, div. HH, title VI, § 711,
Pub. L. 101–624, title XIV, § 1498,
Pub. L. 100–478, title I, § 1010,