Current as of: February 2010 (June 25, 1947, ch. 125, Sec. 3, as added Pub. L. 92-516, Sec. 2,
Oct. 21, 1972, 86 Stat. 979; amended Pub. L. 94-140, Sec. 12, Nov.
28, 1975, 89 Stat. 755; Pub. L. 95-396, Secs. 2(a), 3-8, Sept. 30,
1978, 92 Stat. 820, 824-827; Pub. L. 100-532, title I, Secs.
102(b), 103, title VI, Sec. 601(b)(1), title VIII, Sec. 801(b),
Oct. 25, 1988, 102 Stat. 2667, 2677, 2680; Pub. L. 101-624, title
XIV, Sec. 1492, Nov. 28, 1990, 104 Stat. 3628; Pub. L. 102-237,
title X, Sec. 1006(a)(3), (b)(1), (2), (c), Dec. 13, 1991, 105
Stat. 1894-1896; Pub. L. 104-170, title I, Secs. 105(b), 106(b),
title II, Secs. 210(b), (c)(1), (d), (e), (f)(2), 222-224, 231,
250, Aug. 3, 1996, 110 Stat. 1491, 1494-1497, 1499, 1503, 1504,
1508, 1510; Pub. L. 108-199, div. G, title V, Sec. 501(b), Jan. 23,
2004, 118 Stat. 419; Pub. L. 110-94, Secs. 2, 3, Oct. 9, 2007, 121
Stat. 1000.)
PRIOR PROVISIONS
A prior section 3 of act June 25, 1947, was classified to section
135a of this title prior to amendment of act June 25, 1947, by Pub.
L. 92-516.
AMENDMENTS
2007 - Subsec. (c)(3)(B)(ii)(I). Pub. L. 110-94, Sec. 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, Sec. 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, Sec. 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, Sec. 3(2), (3), added
subpar. (B) and redesignated former subpar. (B) as (C).
2004 - Subsec. (h)(2)(F). Pub. L. 108-199, Sec. 501(b)(1),
substituted "120 days" for "90 to 180 days".
Subsec. (h)(3)(D)(vi). Pub. L. 108-199, Sec. 501(b)(2)(A),
substituted "120 days" for "240 days".
Subsec. (h)(3)(F)(iv). Pub. L. 108-199, Sec. 501(b)(2)(B), added
cl. (iv).
1996 - Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104-170, Sec.
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, Sec. 250(1), added subpar.
(G).
Subsec. (c)(2)(A). Pub. L. 104-170, Secs. 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, Sec. 210(d)(2), inserted
heading.
Subsec. (c)(2)(B)(vi). Pub. L. 104-170, Sec. 210(c)(1), added cl.
(vi).
Subsec. (c)(2)(B)(vii). Pub. L. 104-170, Sec. 210(f)(2), added
cl. (vii).
Subsec. (c)(2)(B)(viii). Pub. L. 104-170, Sec. 222, added cl.
(viii).
Subsec. (c)(2)(C). Pub. L. 104-170, Sec. 210(d)(3), inserted
heading.
Subsec. (c)(2)(E). Pub. L. 104-170, Sec. 210(d)(4), added subpar.
(E).
Subsec. (c)(3)(A), (B). Pub. L. 104-170, Sec. 210(e)(1), (2),
inserted headings.
Subsec. (c)(3)(C), (D). Pub. L. 104-170, Sec. 210(e)(3), added
subpars. (C) and (D).
Subsec. (c)(9). Pub. L. 104-170, Sec. 223, added par. (9).
Subsec. (c)(10). Pub. L. 104-170, Sec. 250(2), added par. (10).
Subsec. (f)(4). Pub. L. 104-170, Sec. 105(b), added par. (4).
Subsec. (g). Pub. L. 104-170, Sec. 106(b), added subsec. (g).
Subsec. (h). Pub. L. 104-170, Sec. 224, added subsec. (h).
1991 - Subsec. (c)(1)(D). Pub. L. 102-237, Sec. 1006(a)(3)(B),
(C), added subpar. (D) and redesignated former subpar. (D) as (F).
Subsec. (c)(1)(E). Pub. L. 102-237, Sec. 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, Sec. 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, Sec. 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, Sec. 1006(c), clarified
amendment made by Pub. L. 100-532, Sec. 102(b)(2)(A). See 1988
Amendment note below.
Subsec. (c)(3)(A). Pub. L. 102-237, Sec. 1006(b)(2), substituted
"the Administrator's" for "his".
Subsec. (c)(5). Pub. L. 102-237, Sec. 1006(b)(1), substituted
"the Administrator" for "he" before "determines".
Subsec. (c)(6). Pub. L. 102-237, Sec. 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, Sec. 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, Sec. 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, Sec. 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, Sec. 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, Sec. 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, Secs. 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, Sec. 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, Sec. 102(b)(2)(A), and Pub.
L. 102-237, Sec. 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, Sec. 102(b)(2)(B), struck
out "the safety of" after "data pertaining to".
Subsec. (c)(3). Pub. L. 100-532, Sec. 103, substituted "(A) The
Administrator" for "The Administrator" and added subpar. (B).
Subsec. (c)(7). Pub. L. 100-532, Sec. 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, Sec. 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, Sec. 801(b)(8), substituted
"this subchapter. As" for "this subchapter: Provided, That as".
Subsec. (g). Pub. L. 100-532, Sec. 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, Sec. 2(a)(1), added
subpar. (D), and struck out provisions which required the applicant
for registration of a pesticide to file with the Administrator a
statement containing "if requested by the Administrator, a full
description of the tests made and the results thereof upon which
the claims are based, except that data submitted on or after
January 1, 1970, in support of an application shall not, without
permission of the applicant, be considered by the Administrator in
support of any other application for registration unless such other
applicant shall have first offered to pay reasonable compensation
for producing the test data to be relied upon and such data is not
protected from disclosure by section 136h(b) of this title. This
provision with regard to compensation for producing the test data
to be relied upon shall apply with respect to all applications for
registration or reregistration submitted on or after October 21,
1972. If the parties cannot agree on the amount and method of
payment, the Administrator shall make such determination and may
fix such other terms and conditions as may be reasonable under the
circumstances. The Administrator's determination shall be made on
the record after notice and opportunity for hearing. If either
party does not agree with said determination, he may, within thirty
days, take an appeal to the Federal district court for the district
in which he resides with respect to either the amount of the
payment or the terms of payment, or both. Registration shall not be
delayed pending the determination of reasonable compensation
between the applicants, by the Administrator or by the court.".
Subsec. (c)(2). Pub. L. 95-396, Secs. 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, Sec. 5, provided for waiver of
data requirements pertaining to efficacy.
Subsec. (c)(7), (8). Pub. L. 95-396, Sec. 6, added pars. (7) and
(8).
Subsec. (d)(1)(A). Pub. L. 95-396, Sec. 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, Sec. 7(2), substituted "forty-
five days" for "30 days".
Subsec. (d)(3). Pub. L. 95-396, Sec. 7(3), added par. (3).
Subsec. (g). Pub. L. 95-396, Sec. 8, added subsec. (g).
1975 - Subsec. (c)(1)(D). Pub. L. 94-140 inserted exception
relating to test data submitted on or after January 1, 1970, in
support of application, inserted provision that compensation for
producing test data shall apply to all applications submitted on or
after October 21, 1972, and provision relating to delay of
registration pending determination of reasonable compensation,
struck out requirement that payment determined by court not be less
than amount determined by Administrator, and substituted "If either
party" for "If the owner of the test data".
EFFECTIVE DATE OF 2007 AMENDMENT
Pub. L. 110-94, Sec. 6, Oct. 9, 2007, 121 Stat. 1007, provided
that: "This Act [see Short Title of 2007 Amendment note set out
under section 136 of this title] and the amendments made by this
Act take effect on October 1, 2007."
EFFECTIVE DATE OF 2004 AMENDMENT
Pub. L. 108-199, div. G, title V, Sec. 501(h), Jan. 23, 2004, 118
Stat. 434, provided that: "Except as otherwise provided in this
section [enacting section 136w-8 of this title, amending this
section and sections 136a-1, 136x, and 136y of this title, and
enacting provisions set out as notes under sections 136 of this
title and section 346a of Title 21, Food and Drugs] and the
amendments made by this section, this section and the amendments
made by this section take effect on the date that is 60 days after
the date of enactment of this Act [Jan. 23, 2004]."
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as
a note under section 136 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Section 2(b) of Pub. L. 95-396 provided that: "The amendment to
section 3(c)(1)(D) of the Federal Insecticide, Fungicide, and
Rodenticide Act [subsec. (c)(1)(D) of this section] made by
[subsec. (a)(1) of] this section shall apply with respect to all
applications for registration approved after the date of enactment
of this Act [Sept. 30, 1978]."
EFFECTIVE DATE
For effective date of section, see section 4 of Pub. L. 92-516,
set out as a note under section 136 of this title.
BIOLOGICAL PESTICIDE HANDLING STUDY
Section 1498 of Pub. L. 101-624 provided that:
"(a) Study. - Not later than September 30, 1992, the National
Academy of Sciences shall 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.
"(b) Development of Procedures. - Not later than 1 year after the
completion of the study under subsection (a), the agencies and
offices described in such subsection shall develop and implement a
common process for reviewing and approving biological control
applications that are submitted to such agencies and offices that
shall be based on the study conducted under such subsection and the
recommendation of the National Academy of Sciences, and other
public comment."
EDUCATION, STUDY, AND REPORT
Pub. L. 100-478, title I, Sec. 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 (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,
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.
"(b) 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 (b) of this
section to the Committee on Merchant Marine and Fisheries and the
Committee on Agriculture of the United States House of
Representatives, and the Committee on Environment and Public Works
and the Committee on Agriculture, Nutrition, and Forestry of the
United States Senate."Statute Text Prev ________________________________________________________________________
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