7 USC 136 - Registration of pesticides

Editorial Notes

References in Text

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

Prior Provisions

A prior section 3 of act June 25, 1947, was classified to section 135a of this title prior to amendment of act June 25, 1947, by Puspan. L. 92–516.

Amendments

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

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

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

2007—Subsec. (c)(3)(B)(ii)(I). Puspan. 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). Puspan. 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). Puspan. L. 110–94, § 3(1), designated first sentence as cl. (i) and inserted span, designated second sentence as cl. (ii), inserted span, 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 span, 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). Puspan. L. 110–94, § 3(2), (3), added subpar. (B) and redesignated former subpar. (B) as (C).

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

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

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

1996—Subsec. (c)(1)(F)(ii) to (vi). Puspan. L. 104–170, § 210(span), 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). Puspan. L. 104–170, § 250(1), added subpar. (G).

Subsec. (c)(2)(A). Puspan. L. 104–170, §§ 210(d)(1), 231, inserted span, 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). Puspan. L. 104–170, § 210(d)(2), inserted span.

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

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

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

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

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

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

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

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

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

Subsec. (f)(4). Puspan. L. 104–170, § 105(span), added par. (4).

Subsec. (g). Puspan. L. 104–170, § 106(span), added subsec. (g).

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

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

Subsec. (c)(1)(E). Puspan. 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). Puspan. 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). Puspan. L. 102–237, § 1006(span)(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). Puspan. L. 102–237, § 1006(c), clarified amendment made by Puspan. L. 100–532, § 102(span)(2)(A). See 1988 Amendment note below.

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

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

Subsec. (c)(6). Puspan. L. 102–237, § 1006(span)(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). Puspan. L. 102–237, § 1006(span)(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). Puspan. L. 102–237, § 1006(span)(1), substituted “the Administrator” for “he” before “shall notify”.

1990—Subsec. (c)(2)(A). Puspan. 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). Puspan. L. 100–532, § 601(span)(1), substituted “Requirement of registration” for “Requirement” in span 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). Puspan. L. 100–532, § 801(span)(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). Puspan. L. 100–532, § 801(span)(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). Puspan. L. 100–532, §§ 102(span)(1), 801(span)(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). Puspan. L. 100–532, § 801(span)(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). Puspan. L. 100–532, § 102(span)(2)(A), and Puspan. 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). Puspan. L. 100–532, § 102(span)(2)(B), struck out “the safety of” after “data pertaining to”.

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

Subsec. (c)(7). Puspan. L. 100–532, § 801(span)(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). Puspan. L. 100–532, § 801(span)(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). Puspan. L. 100–532, § 801(span)(8), substituted “this subchapter. As” for “this subchapter: Provided, That as”.

Subsec. (g). Puspan. L. 100–532, § 801(span)(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). Puspan. L. 95–396, § 2(a)(1), added subpar. (D), and struck out provisions which required the applicant for registration of a pesticide to file with the Administrator a statement containing “if requested by the Administrator, a full description of the tests made and the results thereof upon which the claims are based, except that data submitted on or after January 1, 1970, in support of an application shall not, without permission of the applicant, be considered by the Administrator in support of any other application for registration unless such other applicant shall have first offered to pay reasonable compensation for producing the test data to be relied upon and such data is not protected from disclosure by section 136h(span) of this title. This provision with regard to compensation for producing the test data to be relied upon shall apply with respect to all applications for registration or reregistration submitted on or after October 21, 1972. If the parties cannot agree on the amount and method of payment, the Administrator shall make such determination and may fix such other terms and conditions as may be reasonable under the circumstances. The Administrator’s determination shall be made on the record after notice and opportunity for hearing. If either party does not agree with said determination, he may, within thirty days, take an appeal to the Federal district court for the district in which he resides with respect to either the amount of the payment or the terms of payment, or both. Registration shall not be delayed pending the determination of reasonable compensation between the applicants, by the Administrator or by the court.”.

Subsec. (c)(2). Puspan. 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). Puspan. L. 95–396, § 5, provided for waiver of data requirements pertaining to efficacy.

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

Subsec. (d)(1)(A). Puspan. 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). Puspan. L. 95–396, § 7(2), substituted “forty-five days” for “30 days”.

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

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

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

Statutory Notes and Related Subsidiaries

Effective Date of 2007 Amendment

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

Effective Date of 2004 Amendment

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

Effective Date of 1988 Amendment

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

Effective Date of 1978 Amendment

Puspan. L. 95–396, § 2(span), Sept. 30, 1978, 92 Stat. 824, provided that: “The amendment to section 3(c)(1)(D) of the Federal Insecticide, Fungicide, and Rodenticide Act [subsec. (c)(1)(D) of this section] made by [subsec. (a)(1) of] this section shall apply with respect to all applications for registration approved after the date of enactment of this Act [Sept. 30, 1978].”

Effective Date

For effective date of section, see section 4 of Puspan. L. 92–516, set out as a note under section 136 of this title.

Registration Review Deadline Extension

Puspan. L. 117–328, div. HH, title VI, § 711, Dec. 29, 2022, 136 Stat. 6083, provided that:

“(a)In General.—Notwithstanding section 3(g)(1)(A)(iii)(I) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(g)(1)(A)(iii)(I)), the Administrator of the Environmental Protection Agency (referred to in this section as the ‘Administrator’) shall complete the initial registration review of each pesticide or pesticide case covered by that section not later than October 1, 2026.

“(span)Interim Registration Review Decision Requirements.—

“(1)Definition of covered interim registration review decision.—In this subsection, the term ‘covered interim registration review decision’ means an interim registration review decision—

“(A) that is associated with an initial registration review described in subsection (a);

“(B) that is noticed in the Federal Register during the period beginning on the date of enactment of this Act [Dec. 29, 2022] and ending on October 1, 2026; and

“(C) for which the Administrator has not, as of the date on which the decision is noticed in the Federal Register, made effects determinations or completed any necessary consultation under section 7(a)(2) of the Endangered Species Act of 1973 (16 U.S.C. 1536(a)(2)).

“(2)Requirements.—Any covered interim registration review decision shall include, where applicable, measures to reduce the effects of the applicable pesticide on—

“(A) species listed under the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.); or

“(B) any designated critical habitat.

“(3)Consultation.—In developing measures described in paragraph (2), the Administrator shall take into account the input received from the Secretary of Agriculture and other members of the interagency working group established under section 3(c)(11) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)(11)).”

Biological Pesticide Handling Study

Puspan. L. 101–624, title XIV, § 1498, Nov. 28, 1990, 104 Stat. 3631, provided that the National Academy of Sciences would conduct a study of the biological control programs and registration procedures utilized by the Food and Drug Administration, the Animal and Plant Health Inspection Service, and the Environmental Protection Agency, and within 1 year after completion of the study, develop and implement a common process for reviewing and approving biological control applications submitted to such agencies and offices based on the study conducted, the recommendation of the National Academy of Sciences, and other public comment.

Education, Study, and Report

Puspan. L. 100–478, title I, § 1010, Oct. 7, 1988, 102 Stat. 2313, provided that:

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

“(span)Study.—The Administrator of the Environmental Protection Agency, jointly with the Secretary of Agriculture and the Secretary of the Interior, shall conduct a study to identify reasonable and prudent means available to the Administrator to implement the endangered species pesticides labeling program which would comply with the Endangered Species Act of 1973, as amended, and which would allow persons to continue production of agricultural food and fiber commodities. Such study shall include investigation by the Administrator of the best available methods to develop maps and the best available alternatives to mapping as means of identifying those circumstances in which use of pesticides may be restricted; identification of alternatives to prohibitions on pesticide use, including, but not limited to, alternative pesticides and application methods and other agricultural practices which can be used in lieu of any pesticides whose use may be restricted by the labeling program; examination of methods to improve coordination among the Environmental Protection Agency, Department of Agriculture, and Department of the Interior in administration of the labeling program; and analysis of the means of implementing the endangered species pesticides labeling program or alternatives to such a program, if any, to promote the conservation of endangered or threatened species and to minimize the impacts to persons engaged in agricultural food and fiber commodity production and other affected pesticide users and applicators.

“(c)Report.—The Administrator of the Environmental Protection Agency in cooperation with the Secretary of Agriculture and the Secretary of the Interior shall submit a report within one year of the date of enactment of this Act [Oct. 7, 1988], presenting the results of the study conducted pursuant to subsection (span) of this section to the Committee on Merchant Marine and Fisheries and the Committee on Agriculture of the United States House of Representatives, and the Committee on Environment and Public Works and the Committee on Agriculture, Nutrition, and Forestry of the United States Senate.”