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(continued)
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.
(7) Registration under special circumstances
Notwithstanding the provisions of paragraph (5) -
(A) The Administrator may conditionally register or amend the
registration of a pesticide if the Administrator determines
that (i) the pesticide and proposed use are identical or
substantially similar to any currently registered pesticide and
use thereof, or differ only in ways that would not
significantly increase the risk of unreasonable adverse effects
on the environment, and (ii) approving the registration or
amendment in the manner proposed by the applicant would not
significantly increase the risk of any unreasonable adverse
effect on the environment. An applicant seeking conditional
registration or amended registration under this subparagraph
shall submit such data as would be required to obtain
registration of a similar pesticide under paragraph (5). If the
applicant is unable to submit an item of data because it has
not yet been generated, the Administrator may register or amend
the registration of the pesticide under such conditions as will
require the submission of such data not later than the time
such data are required to be submitted with respect to similar
pesticides already registered under this subchapter.
(B) The Administrator may conditionally amend the
registration of a pesticide to permit additional uses of such
pesticide notwithstanding that data concerning the pesticide
may be insufficient to support an unconditional amendment, if
the Administrator determines that (i) the applicant has
submitted satisfactory data pertaining to the proposed
additional use, and (ii) amending the registration in the
manner proposed by the applicant would not significantly
increase the risk of any unreasonable adverse effect on the
environment. Notwithstanding the foregoing provisions of this
subparagraph, no registration of a pesticide may be amended to
permit an additional use of such pesticide if the Administrator
has issued a notice stating that such pesticide, or any
ingredient thereof, meets or exceeds risk criteria associated
in whole or in part with human dietary exposure enumerated in
regulations issued under this subchapter, and during the
pendency of any risk-benefit evaluation initiated by such
notice, if (I) the additional use of such pesticide involves a
major food or feed crop, or (II) the additional use of such
pesticide involves a minor food or feed crop and the
Administrator determines, with the concurrence of the Secretary
of Agriculture, there is available an effective alternative
pesticide that does not meet or exceed such risk criteria. An
applicant seeking amended registration under this subparagraph
shall submit such data as would be required to obtain
registration of a similar pesticide under paragraph (5). If the
applicant is unable to submit an item of data (other than data
pertaining to the proposed additional use) because it has not
yet been generated, the Administrator may amend the
registration under such conditions as will require the
submission of such data not later than the time such data are
required to be submitted with respect to similar pesticides
already registered under this subchapter.
(C) The Administrator may conditionally register a pesticide
containing an active ingredient not contained in any currently
registered pesticide for a period reasonably sufficient for the
generation and submission of required data (which are lacking
because a period reasonably sufficient for generation of the
data has not elapsed since the Administrator first imposed the
data requirement) on the condition that by the end of such
period the Administrator receives such data and the data do not
meet or exceed risk criteria enumerated in regulations issued
under this subchapter, and on such other conditions as the
Administrator may prescribe. A conditional registration under
this subparagraph shall be granted only if the Administrator
determines that use of the pesticide during such period will
not cause any unreasonable adverse effect on the environment,
and that use of the pesticide is in the public interest.
(8) Interim administrative review
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.
(9) Labeling
(A) Additional statements
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.
(B) Requirements
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.
(C) Notification and disapproval
(i) Notification
A registration may be modified under subparagraph (A) if -
(I) the registrant notifies the Administrator in writing
not later than 60 days prior to distribution or sale of a
product bearing the modified labeling; and
(II) the Administrator does not disapprove of the
modification under clause (ii).
(ii) Disapproval
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.
(iii) Restriction on sale
A registrant may not sell or distribute a product bearing a
disapproved modification.
(iv) Objection
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.
(v) Final action
A decision by the Administrator following receipt and
consideration of an objection filed under clause (iv) shall
be considered a final agency action.
(D) Use dilution
The label or labeling required under this subchapter for an
antimicrobial pesticide that is or may be diluted for use may
have a different statement of caution or protective measures
for use of the recommended diluted solution of the pesticide
than for use of a concentrate of the pesticide if the
Administrator determines that -
(i) adequate data have been submitted to support the
statement proposed for the diluted solution uses; and
(ii) the label or labeling provides adequate protection for
exposure to the diluted solution of the pesticide.
(10) Expedited registration of pesticides
(A) Not later than 1 year after August 3, 1996, the
Administrator shall, utilizing public comment, develop procedures
and guidelines, and expedite the review of an application for
registration of a pesticide or an amendment to a registration
that satisfies such guidelines.
(B) Any application for registration or an amendment, including
biological and conventional pesticides, will be considered for
expedited review under this paragraph. An application for
registration or an amendment shall qualify for expedited review
if use of the pesticide proposed by the application may
reasonably be expected to accomplish 1 or more of the following:
(i) Reduce the risks of pesticides to human health.
(ii) Reduce the risks of pesticides to nontarget organisms.
(iii) Reduce the potential for contamination of groundwater,
surface water, or other valued environmental resources.
(iv) Broaden the adoption of integrated pest management
strategies, or make such strategies more available or more
effective.

(C) The Administrator, not later than 30 days after receipt of
an application for expedited review, shall notify the applicant
whether the application is complete. If it is found to be
incomplete, the Administrator may either reject the request for
expedited review or ask the applicant for additional information
to satisfy the guidelines developed under subparagraph (A).
(d) Classification of pesticides
(1) Classification for general use, restricted use, or both
(A) As a part of the registration of a pesticide the
Administrator shall classify it as being for general use or for
restricted use. If the Administrator determines that some of the
uses for which the pesticide is registered should be for general
use and that other uses for which it is registered should be for
restricted use, the Administrator shall classify it for both
general use and restricted use. Pesticide uses may be classified
by regulation on the initial classification, and registered
pesticides may be classified prior to reregistration. If some of
the uses of the pesticide are classified for general use, and
other uses are classified for restricted use, the directions
relating to its general uses shall be clearly separated and
distinguished from those directions relating to its restricted
uses. The Administrator may require that its packaging and
labeling for restricted uses shall be clearly distinguishable
from its packaging and labeling for general uses.
(B) If the Administrator determines that the pesticide, when
applied in accordance with its directions for use, warnings and
cautions and for the uses for which it is registered, or for one
or more of such uses, or in accordance with a widespread and
commonly recognized practice, will not generally cause
unreasonable adverse effects on the environment, the
Administrator will classify the pesticide, or the particular use
or uses of the pesticide to which the determination applies, for
general use.
(C) If the Administrator determines that the pesticide, when
applied in accordance with its directions for use, warnings and
cautions and for the uses for which it is registered, or for one
or more of such uses, or in accordance with a widespread and
commonly recognized practice, may generally cause, without
additional regulatory restrictions, unreasonable adverse effects
on the environment, including injury to the applicator, the
Administrator shall classify the pesticide, or the particular use
or uses to which the determination applies, for restricted use:
(i) If the Administrator classifies a pesticide, or one or
more uses of such pesticide, for restricted use because of a
determination that the acute dermal or inhalation toxicity of
the pesticide presents a hazard to the applicator or other
persons, the pesticide shall be applied for any use to which
the restricted classification applies only by or under the
direct supervision of a certified applicator.
(ii) If the Administrator classifies a pesticide, or one or
more uses of such pesticide, for restricted use because of a
determination that its use without additional regulatory
restriction may cause unreasonable adverse effects on the
environment, the pesticide shall be applied for any use to
which the determination applies only by or under the direct
supervision of a certified applicator, or subject to such other
restrictions as the Administrator may provide by regulation.
Any such regulation shall be reviewable in the appropriate
court of appeals upon petition of a person adversely affected
filed within 60 days of the publication of the regulation in
final form.
(2) Change in classification
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.
(3) Change in classification from restricted use to general use
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.
(e) Products with same formulation and claims
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.
(f) Miscellaneous
(1) Effect of change of labeling or formulation
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.
(2) Registration not a defense
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.
(3) Authority to consult other Federal agencies
In connection with consideration of any registration or
application for registration under this section, the
Administrator may consult with any other Federal agency.
(4) Mixtures of nitrogen stabilizers and fertilizer products
Any mixture or other combination of -
(A) 1 or more nitrogen stabilizers registered under this
subchapter; and
(B) 1 or more fertilizer products,

shall not be subject to the provisions of this section or
sections 136a-1, 136c, 136e, 136m, and 136o(a)(2) of this title
if the mixture or other combination is accompanied by the
labeling required under this subchapter for the nitrogen
stabilizer contained in the mixture or other combination, the
mixture or combination is mixed or combined in accordance with
such labeling, and the mixture or combination does not contain
any active ingredient other than the nitrogen stabilizer.
(g) Registration review
(1) General rule
(A) Periodic review
The registrations of pesticides are to be periodically
reviewed. The Administrator shall by regulation establish a
procedure for accomplishing the periodic review of
registrations. The goal of these regulations shall be a review
of a pesticide's registration every 15 years. 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.
(B) Limitation
Nothing in this subsection shall prohibit the Administrator
from undertaking any other review of a pesticide pursuant to
this subchapter.
(2) Data
(A) Submission required
The Administrator shall use the authority in subsection
(c)(2)(B) of this section to require the submission of data
when such data are necessary for a registration review.
(B) Data submission, compensation, and exemption
For purposes of this subsection, the provisions of
subsections (c)(1), (c)(2)(B), and (c)(2)(D) of this section
shall be utilized for and be applicable to any data required
for registration review.
(h) Registration requirements for antimicrobial pesticides
(1) Evaluation of process
To the maximum extent practicable consistent with the degrees
of risk presented by an antimicrobial pesticide and the type of
review appropriate to evaluate the risks, the Administrator shall
identify and evaluate reforms to the antimicrobial registration
process that would reduce review periods existing as of August 3,
1996, for antimicrobial pesticide product registration
applications and applications for amended registration of
antimicrobial pesticide products, including -
(A) new antimicrobial active ingredients;
(B) new antimicrobial end-use products;
(C) substantially similar or identical antimicrobial
pesticides; and
(D) amendments to antimicrobial pesticide registrations.
(2) Review time period reduction goal
Each reform identified under paragraph (1) shall be designed to
achieve the goal of reducing the review period following
submission of a complete application, consistent with the degree
of risk, to a period of not more than -
(A) 540 days for a new antimicrobial active ingredient
pesticide registration;
(B) 270 days for a new antimicrobial use of a registered
active ingredient;
(C) 120 days for any other new antimicrobial product;
(D) 90 days for a substantially similar or identical
antimicrobial product;
(E) 90 days for an amendment to an antimicrobial registration
that does not require scientific review of data; and
(F) 90 to 180 days for an amendment to an antimicrobial
registration that requires scientific review of data and that
is not otherwise described in this paragraph.
(3) Implementation
(A) Proposed rulemaking
(i) Issuance
Not later than 270 days after August 3, 1996, the
Administrator shall publish in the Federal Register proposed
regulations to accelerate and improve the review of
antimicrobial pesticide products designed to implement, to
the extent practicable, the goals set forth in paragraph (2).
(ii) Requirements
Proposed regulations issued under clause (i) shall -
(I) define the various classes of antimicrobial use
patterns, including household, industrial, and
institutional disinfectants and sanitizing pesticides,
preservatives, water treatment, and pulp and paper mill
additives, and other such products intended to disinfect,
sanitize, reduce, or mitigate growth or development of
microbiological organisms, or protect inanimate objects,
industrial processes or systems, surfaces, water, or other
chemical substances from contamination, fouling, or
deterioration caused by bacteria, viruses, fungi, protozoa,
algae, or slime;
(II) differentiate the types of review undertaken for
antimicrobial pesticides;
(III) conform the degree and type of review to the risks
and benefits presented by antimicrobial pesticides and the
function of review under this subchapter, considering the
use patterns of the product, toxicity, expected exposure,
and product type;
(IV) ensure that the registration process is sufficient
to maintain antimicrobial pesticide efficacy and that
antimicrobial pesticide products continue to meet product
performance standards and effectiveness levels for each
type of label claim made; and
(V) implement effective and reliable deadlines for
process management.
(iii) Comments
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.
(B) Final regulations
(i) Issuance
The Administrator shall issue final regulations not later
than 240 days after the close of the comment period for the
proposed regulations.
(ii) Failure to meet goal
If a goal described in paragraph (2) 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.
(iii) Requirements
In issuing final regulations, the Administrator shall -
(I) consider the establishment of a certification process
for regulatory actions involving risks that can be
responsibly managed, consistent with the degree of risk, in
the most cost-efficient manner;
(II) consider the establishment of a certification
process by approved laboratories as an adjunct to the
review process;
(III) use all appropriate and cost-effective review
mechanisms, including -
(aa) expanded use of notification and non-notification
procedures;
(bb) revised procedures for application review; and
(cc) allocation of appropriate resources to ensure
streamlined management of antimicrobial pesticide
registrations; and

(IV) clarify criteria for determination of the
completeness of an application.
(C) Expedited review
This subsection does not affect the requirements or extend
the deadlines or review periods contained in subsection (c)(3)
of this section.
(D) Alternative review periods
If the final regulations to carry out this paragraph are not
effective 630 days after August 3, 1996, until the final
regulations become effective, the review period, beginning on
the date of receipt by the Agency of a complete application,
shall be -
(i) 2 years for a new antimicrobial active ingredient
pesticide registration;
(ii) 1 year for a new antimicrobial use of a registered
active ingredient;
(iii) 180 days for any other new antimicrobial product;
(iv) 90 days for a substantially similar or identical
antimicrobial product;
(v) 90 days for an amendment to an antimicrobial
registration that does not require scientific review of data;
and
(vi) 240 days for an amendment to an antimicrobial
registration that requires scientific review of data and that
is not otherwise described in this subparagraph.
(E) Wood preservatives
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.
(F) Notification
(i) In general
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.
(ii) Final decision
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.
(iii) Exemption
This subparagraph does not apply to an application for an
antimicrobial pesticide that is filed under subsection
(c)(3)(B) of this section prior to 90 days after August 3,
1996.
(4) Annual report
(A) Submission
Beginning on August 3, 1996, and ending on the date that the
goals under paragraph (2) are achieved, the Administrator
shall, not later than March 1 of each year, prepare and submit
an annual report to the Committee on Agriculture of the House
of Representatives and the Committee on Agriculture, Nutrition,
and Forestry of the Senate.
(B) Requirements
A report submitted under subparagraph (A) shall include a
description of -
(i) measures taken to reduce the backlog of pending
registration applications;
(ii) progress toward achieving reforms under this
subsection; and
(iii) recommendations to improve the activities of the
Agency pertaining to antimicrobial registrations.

-SOURCE-
(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.)


-MISC1-
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
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 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."

-SECREF-
SECTION REFERRED TO IN OTHER SECTIONS
This section is referred to in sections 136, 136a-1, 136c, 136d,
136h, 136i-1, 136j, 136k, 136l, 136m, 136o, 136q, 136v, 136w-7 of
this title; title 21 section 346a; title 42 section 300j-13.

-End-



-CITE-
7 USC Sec. 136a-1 01/19/04

-EXPCITE-
TITLE 7 - AGRICULTURE
CHAPTER 6 - INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL
SUBCHAPTER II - ENVIRONMENTAL PESTICIDE CONTROL

-HEAD-
Sec. 136a-1. Reregistration of registered pesticides

-STATUTE-
(a) General rule
The Administrator shall reregister, in accordance with this
section, each registered pesticide containing any active ingredient
contained in any pesticide first registered before November 1,
1984, except for any pesticide as to which the Administrator has
determined, after November 1, 1984, and before the effective date
of this section, that -
(1) there are no outstanding data requirements; and
(2) the requirements of section 136a(c)(5) of this title have
been satisfied.
(b) Reregistration phases
Reregistrations of pesticides under this section shall be carried
out in the following phases:
(1) The first phase shall include the listing under subsection
(c) of this section of the active ingredients of the pesticides
that will be reregistered.
(2) The second phase shall include the submission to the
Administrator under subsection (d) of this section of notices by
registrants respecting their intention to seek reregistration,
identification by registrants of missing and inadequate data for
such pesticides, and commitments by registrants to replace such
missing or inadequate data within the applicable time period.
(3) The third phase shall include submission to the
Administrator by registrants of the information required under
subsection (e) of this section.
(4) The fourth phase shall include an independent, initial
review by the Administrator under subsection (f) of this section
of submissions under phases two and three, identification of
outstanding data requirements, and the issuance, as necessary, of
requests for additional data.
(5) The fifth phase shall include the review by the
Administrator under subsection (g) of this section of data
submitted for reregistration and appropriate regulatory action by
the Administrator.
(c) Phase one
(1) Priority for reregistration
For purposes of the reregistration of the pesticides describedin subsection (a) of this section, the Administrator shall list (continued)