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(continued)
1996, 110 Stat. 1490, 1492, 1493, 1502, 1508, 1512.)

-REFTEXT-
REFERENCES IN TEXT
The Endangered Species Act of 1973, referred to in subsec. (l),
is Pub. L. 93-205, Dec. 28, 1973, 87 Stat. 884, as amended, which
is classified generally to chapter 35 (Sec. 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.
Section 321 of title 21, referred to in subsec. (u), was
subsequently amended, and subsecs. (w) and (x) of section 321 no
longer define the terms "new animal drug" and "animal feed",
respectively. However, such terms are defined elsewhere in that
section.
Section 27(b) of Federal Pesticide Act of 1978, referred to in
subsec. (ee), is section 27(b) of Pub. L. 95-396, Sept. 30, 1978,
92 Stat. 841, which was formerly set out as a note under section
136w-4 of this title.


-MISC1-
PRIOR PROVISIONS
A prior section 2 of act June 25, 1947, was classified to section
135 of this title prior to amendment of act June 25, 1947, by Pub.
L. 92-516.

AMENDMENTS
1996 - Subsec. (a)(1). Pub. L. 104-170, Sec. 105(a)(1)(A),
substituted "defoliant, desiccant, or nitrogen stabilizer" for
"defoliant, or desiccant".
Subsec. (a)(5). Pub. L. 104-170, Sec. 105(a)(1)(B)-(D), added
par. (5).
Subsec. (u). Pub. L. 104-170, Secs. 105(a)(2), 221(1), struck out
"and" before "(2)", inserted "and (3) any nitrogen stabilizer,"
after "desiccant,", and inserted at end "The term 'pesticide' does
not include liquid chemical sterilant products (including any
sterilant or subordinate disinfectant claims on such products) for
use on a critical or semi-critical device, as defined in section
321 of title 21. For purposes of the preceding sentence, the term
'critical device' includes any device which is introduced directly
into the human body, either into or in contact with the bloodstream
or normally sterile areas of the body and the term 'semi-critical
device' includes any device which contacts intact mucous membranes
but which does not ordinarily penetrate the blood barrier or
otherwise enter normally sterile areas of the body."
Subsec. (bb). Pub. L. 104-170, Sec. 304, which directed amendment
of section 2(bb) by inserting "(1)" after "means" and adding cl.
(2), without specifying the Act being amended, was executed to this
subsection, which is section 2(bb) of the Federal Insecticide,
Fungicide, and Rodenticide Act, to reflect the probable intent of
Congress.
Pub. L. 104-170, Sec. 230(a), inserted at end "The Administrator
shall consider the risks and benefits of public health pesticides
separate from the risks and benefits of other pesticides. In
weighing any regulatory action concerning a public health pesticide
under this subchapter, the Administrator shall weigh any risks of
the pesticide against the health risks such as the diseases
transmitted by the vector to be controlled by the pesticide."
Subsec. (hh). Pub. L. 104-170, Sec. 105(a)(3), added subsec.
(hh).
Subsecs. (jj), (kk). Pub. L. 104-170, Sec. 120, added subsecs.
(jj) and (kk).
Subsec. (ll). Pub. L. 104-170, Sec. 210(a), added subsec. (ll).
Subsec. (mm). Pub. L. 104-170, Sec. 221(2), added subsec. (mm).
Subsecs. (nn), (oo). Pub. L. 104-170, Sec. 230(b), added subsecs.
(nn) and (oo).
1991 - Subsec. (e)(1). Pub. L. 102-237, Sec. 1006(a)(1),
substituted "section 136i" for "section 136b" and "uses dilutions"
for "use dilutions" and made technical amendment to reference to
subsection (ee) of this section involving corresponding provision
of original act.
Subsec. (e)(2). Pub. L. 102-237, Sec. 1006(b)(3)(A), substituted
"the applicator or the applicator's" for "him or his".
Subsec. (e)(3). Pub. L. 102-237, Sec. 1006(b)(3)(B), substituted
"the applicator" for "he".
Subsec. (q)(2)(A)(i). Pub. L. 102-237, Sec. 1006(a)(2),
substituted "size or form" for "size of form".
1988 - Subsec. (c). Pub. L. 100-532, Sec. 801(a)(1), substituted
"if - " for "if:".
Subsec. (p)(2)(B). Pub. L. 100-532, Sec. 801(a)(2), substituted
"Health and Human Services" for "Health, Education, and Welfare".
Subsec. (q)(2)(A). Pub. L. 100-532, Sec. 801(a)(3), substituted
"if - " for "if:".
Subsec. (q)(2)(C)(iii). Pub. L. 100-532, Sec. 801(a)(4),
substituted ", except that" for ": Provided, That".
Subsec. (u). Pub. L. 100-532, Sec. 801(a)(5), substituted ",
except that" for ": Provided, That", struck out "(1)(a)" after
"include any article" and "or (b)" after "section 321(w) of title
21,", and substituted "Health and Human Services" for "Health,
Education, and Welfare", "or that is" for "or (2) that is", and "a
new animal drug" for "an article covered by clause (1) of this
proviso".
Subsec. (ee). Pub. L. 100-532, Secs. 601(a)(1), 801(a)(6),
substituted ", except that" for ": Provided, That", inserted
"unless the labeling specifically prohibits deviation from the
specified dosage, concentration, or frequency" and "unless the
labeling specifically states that the product may be applied only
by the methods specified on the labeling", substituted "labeling,
(4) mixing" for "labeling, or (4) mixing", ", (5)" for ": Provided
further, That the term also shall not include", "or (6) any use"
for "or any use", and ". After" for ": And provided further, That
after".
Subsec. (ff). Pub. L. 100-532, Sec. 101, added subsec. (ff).
Subsec. (gg). Pub. L. 100-532, Sec. 601(a)(2), added subsec.
(gg).
1978 - Subsec. (e)(1). Pub. L. 95-396, Sec. 1(1), inserted
provision deeming an applicator not a seller or distributor of
pesticides when providing a service of controlling pests.
Subsec. (e)(3). Pub. L. 95-396, Sec. 1(2), substituted "an
applicator" for "a certified applicator".
Subsec. (q)(1)(H). Pub. L. 95-396, Sec. 1(3), added subpar. (H).
Subsec. (w). Pub. L. 95-396, Sec. 1(4), (5), amended definition
of "producer" and "produce" to include reference to active
ingredient used in producing a pesticide and inserted provision
that an individual did not become a producer when there was
dilution of a pesticide for personal use according to directions on
registered labels.
Subsec. (dd). Pub. L. 95-396, Sec. 1(6), inserted "or active
ingredient used in producing a pesticide".
Subsec. (ee). Pub. L. 95-396, Sec. 1(7), added subsec. (ee).
1975 - Subsec. (u). Pub. L. 94-140 inserted proviso which
excluded from term "pesticide" any article designated as "new
animal drug" and any article denominated as animal feed.
1973 - Subsec. (l). Pub. L. 93-205 substituted "or threatened by
the Secretary pursuant to the Endangered Species Act of 1973" for
"by the Secretary of the Interior under Public Law 91-135".

EFFECTIVE DATE OF 1988 AMENDMENT
Section 901 of Pub. L. 100-532 provided that: "Except as
otherwise provided in this Act, the amendments made by this Act
[see Short Title of 1988 Amendment note below] shall take effect on
the expiration of 60 days after the date of enactment of this Act
[Oct. 25, 1988]."

EFFECTIVE DATE OF 1973 AMENDMENT
Amendment by Pub. L. 93-205 effective Dec. 28, 1973, see section
16 of Pub. L. 93-205, set out as an Effective Date note under
section 1531 of Title 16, Conservation.

EFFECTIVE DATE
Section 4 of Pub. L. 92-516, as amended by Pub. L. 94-140, Sec.
4, Nov. 28, 1975, 89 Stat. 752; Pub. L. 95-396, Sec. 28, Sept. 30,
1978, 92 Stat. 842, provided that:
"(a) Except as otherwise provided in the Federal Insecticide,
Fungicide, and Rodenticide Act [this subchapter], as amended by
this Act and as otherwise provided by this section, the amendments
made by this Act [see Short Title note set out below] shall take
effect at the close of the date of the enactment of this Act [Oct.
21, 1972], provided if regulations are necessary for the
implementation of any provision that becomes effective on the date
of enactment, such regulations shall be promulgated and shall
become effective within 90 days from the date of enactment of this
Act.
"(b) The provisions of the Federal Insecticide, Fungicide, and
Rodenticide Act [this subchapter] and the regulations thereunder as
such existed prior to the enactment of this Act shall remain in
effect until superseded by the amendments made by this Act and
regulations thereunder.
"(c)(1) Two years after the enactment of this Act the
Administrator shall have promulgated regulations providing for the
registration and classification of pesticides under the provisions
of this Act and thereafter shall register all new applications
under such provisions.
"(2) Any requirements that a pesticide be registered for use only
by a certified applicator shall not be effective until five years
from the date of enactment of this Act.
"(3) A period of five years from date of enactment shall be
provided for certification of applicators.
"(A) One year after the enactment of this Act the Administrator
shall have prescribed the standards for the certification of
applicators.
"(B) Each State desiring to certify applicators shall submit a
State plan to the Administrator for the purpose provided by
section 4(b).
"(C) As promptly as possible but in no event more than one year
after submission of a State plan, the Administrator shall approve
the State plan or disapprove it and indicate the reasons for
disapproval. Consideration of plans resubmitted by States shall
be expedited.
"(4) One year after the enactment of this Act the Administrator
shall have promulgated and shall make effective regulations
relating to the registration of establishments, permits for
experimental use, and the keeping of books and records under the
provisions of this Act.
"(d) No person shall be subject to any criminal or civil penalty
imposed by the Federal Insecticide, Fungicide, and Rodenticide Act,
as amended by this Act, for any act (or failure to act) occurring
before the expiration of 60 days after the Administrator has
published effective regulations in the Federal Register and taken
such other action as may be necessary to permit compliance with the
provisions under which the penalty is to be imposed.
"(e) For purposes of determining any criminal or civil penalty or
liability to any third person in respect of any act or omission
occurring before the expiration of the periods referred to in this
section, the Federal Insecticide, Fungicide, and Rodenticide Act
shall be treated as continuing in effect as if this Act had not
been enacted."

SHORT TITLE OF 1996 AMENDMENT
Section 1 of Pub. L. 104-170 provided that: "This Act [enacting
sections 136i-2, 136r-1, and 136w-5 to 136w-7 of this title,
amending this section, sections 136a, 136a-1, 136d, 136q, 136s,
136w, 136w-3, 136x, and 136y of this title, and sections 321, 331,
333, 342, and 346a of Title 21, Food and Drugs, and enacting
provisions set out as notes under section 136i-2 of this title and
sections 301 and 346a of Title 21] may be cited as the 'Food
Quality Protection Act of 1996'."
[Another Food Quality Protection Act of 1996 was enacted by Pub.
L. 104-170, title IV, 110 Stat. 1513, see section 401(a) of Pub. L.
104-170, set out as a note under section 301 of Title 21, Food and
Drugs.]

SHORT TITLE OF 1988 AMENDMENT
Section 1(a) of Pub. L. 100-532 provided that: "This Act
[enacting section 136a-1 of this title, amending this section and
sections 136a to 136d, 136f to 136q, 136s, 136v to 136w-2, and 136y
of this title, and enacting provisions set out as notes under this
section and sections 136m and 136y of this title] may be cited as
the 'Federal Insecticide, Fungicide, and Rodenticide Act Amendments
of 1988'."

SHORT TITLE OF 1978 AMENDMENT
Section 29 of Pub. L. 95-396 provided that: "This Act [enacting
sections 136w-1 to 136w-4 of this title, amending this section and
sections 136a to 136f, 136h, 136j, 136l, 136o, 136q, 136r, 136u to
136w, 136x, and 136y of this title, enacting provisions set out as
notes under sections 136a, 136o, and 136w-4 of this title, and
amending provisions set out as a note under this section] may be
cited as the 'Federal Pesticide Act of 1978'."

SHORT TITLE
Section 1 of Pub. L. 92-516 provided: "That this Act [amending
this subchapter generally, enacting notes set out under this
section, and amending sections 1261 and 1471 of Title 15, Commerce
and Trade, and sections 321 and 346a of Title 21, Foods and Drugs]
may be cited as the 'Federal Environmental Pesticide Control Act of
1972'."
Section 1(a) of act June 25, 1947, as added by Pub. L. 92-516,
Sec. 2, provided that: "This Act [enacting this subchapter] may be
cited as the 'Federal Insecticide, Fungicide, and Rodenticide
Act'."


-TRANS-
TERMINATION OF TRUST TERRITORY OF THE PACIFIC ISLANDS
For termination of Trust Territory of the Pacific Islands, see
note set out preceding section 1681 of Title 48, Territories and
Insular Possessions.


-MISC2-
FEDERAL COMPLIANCE WITH POLLUTION CONTROL STANDARDS
For provisions relating to the responsibility of the head of each
Executive agency for compliance with applicable pollution control
standards, see Ex. Ord. No. 12088, Oct. 13, 1978, 43 F.R. 47707,
set out as a note under section 4321 of Title 42, The Public Health
and Welfare.

-SECREF-
SECTION REFERRED TO IN OTHER SECTIONS
This section is referred to in sections 136a, 136o, 136w, 136w-1,
138 of this title.

-FOOTNOTE-
(!1) See References in Text note below.



(!2) So in original. Period probably should not appear.

(!3) So in original. Probably should be followed by ", or".

(!4) So in original. No subsec. (ii) was enacted.


-End-



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

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

-HEAD-
Sec. 136a. Registration of pesticides

-STATUTE-
(a) Requirement of registration
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.
(b) Exemptions
A pesticide which is not registered with the Administrator may be
transferred if -
(1) the transfer is from one registered establishment to
another registered establishment operated by the same producer
solely for packaging at the second establishment or for use as a
constituent part of another pesticide produced at the second
establishment; or
(2) the transfer is pursuant to and in accordance with the
requirements of an experimental use permit.
(c) Procedure for registration
(1) Statement required
Each applicant for registration of a pesticide shall file with
the Administrator a statement which includes -
(A) the name and address of the applicant and of any other
person whose name will appear on the labeling;
(B) the name of the pesticide;
(C) a complete copy of the labeling of the pesticide, a
statement of all claims to be made for it, and any directions
for its use;
(D) the complete formula of the pesticide;
(E) a request that the pesticide be classified for general
use or for restricted use, or for both; and
(F) except as otherwise provided in paragraph (2)(D), if
requested by the Administrator, a full description of the tests
made and the results thereof upon which the claims are based,
or alternatively a citation to data that appear in the public
literature or that previously had been submitted to the
Administrator and that the Administrator may consider in
accordance with the following provisions:
(i) With respect to pesticides containing active
ingredients that are initially registered under this
subchapter after September 30, 1978, data submitted to
support the application for the original registration of the
pesticide, or an application for an amendment adding any new
use to the registration and that pertains solely to such new
use, shall not, without the written permission of the
original data submitter, be considered by the Administrator
to support an application by another person during a period
of ten years following the date the Administrator first
registers the pesticide, except that such permission shall
not be required in the case of defensive data.
(ii) The period of exclusive data use provided under clause
(i) shall be extended 1 additional year for each 3 minor uses
registered after August 3, 1996, and within 7 years of the
commencement of the exclusive use period, up to a total of 3
additional years for all minor uses registered by the
Administrator if the Administrator, in consultation with the
Secretary of Agriculture, determines that, based on
information provided by an applicant for registration or a
registrant, that -
(I) there are insufficient efficacious alternative
registered pesticides available for the use;
(II) the alternatives to the minor use pesticide pose
greater risks to the environment or human health;
(III) the minor use pesticide plays or will play a
significant part in managing pest resistance; or
(IV) the minor use pesticide plays or will play a
significant part in an integrated pest management program.

The registration of a pesticide for a minor use on a crop
grouping established by the Administrator shall be considered
for purposes of this clause 1 minor use for each
representative crop for which data are provided in the crop
grouping. Any additional exclusive use period under this
clause shall be modified as appropriate or terminated if the
registrant voluntarily cancels the product or deletes from
the registration the minor uses which formed the basis for
the extension of the additional exclusive use period or if
the Administrator determines that the registrant is not
actually marketing the product for such minor uses.
(iii) Except as otherwise provided in clause (i), with
respect to data submitted after December 31, 1969, by an
applicant or registrant to support an application for
registration, experimental use permit, or amendment adding a
new use to an existing registration, to support or maintain
in effect an existing registration, or for reregistration,
the Administrator may, without the permission of the original
data submitter, consider any such item of data in support of
an application by any other person (hereinafter in this
subparagraph referred to as the "applicant") within the
fifteen-year period following the date the data were
originally submitted only if the applicant has made an offer
to compensate the original data submitter and submitted such
offer to the Administrator accompanied by evidence of
delivery to the original data submitter of the offer. The
terms and amount of compensation may be fixed by agreement
between the original data submitter and the applicant, or,
failing such agreement, binding arbitration under this
subparagraph. If, at the end of ninety days after the date of
delivery to the original data submitter of the offer to
compensate, the original data submitter and the applicant
have neither agreed on the amount and terms of compensation
nor on a procedure for reaching an agreement on the amount
and terms of compensation, either person may initiate binding
arbitration proceedings by requesting the Federal Mediation
and Conciliation Service to appoint an arbitrator from the
roster of arbitrators maintained by such Service. The
procedure and rules of the Service shall be applicable to the
selection of such arbitrator and to such arbitration
proceedings, and the findings and determination of the
arbitrator shall be final and conclusive, and no official or
court of the United States shall have power or jurisdiction
to review any such findings and determination, except for
fraud, misrepresentation, or other misconduct by one of the
parties to the arbitration or the arbitrator where there is a
verified complaint with supporting affidavits attesting to
specific instances of such fraud, misrepresentation, or other
misconduct. The parties to the arbitration shall share
equally in the payment of the fee and expenses of the
arbitrator. If the Administrator determines that an original
data submitter has failed to participate in a procedure for
reaching an agreement or in an arbitration proceeding as
required by this subparagraph, or failed to comply with the
terms of an agreement or arbitration decision concerning
compensation under this subparagraph, the original data
submitter shall forfeit the right to compensation for the use
of the data in support of the application. Notwithstanding
any other provision of this subchapter, if the Administrator
determines that an applicant has failed to participate in a
procedure for reaching an agreement or in an arbitration
proceeding as required by this subparagraph, or failed to
comply with the terms of an agreement or arbitration decision
concerning compensation under this subparagraph, the
Administrator shall deny the application or cancel the
registration of the pesticide in support of which the data
were used without further hearing. Before the Administrator
takes action under either of the preceding two sentences, the
Administrator shall furnish to the affected person, by
certified mail, notice of intent to take action and allow
fifteen days from the date of delivery of the notice for the
affected person to respond. If a registration is denied or
canceled under this subparagraph, the Administrator may make
such order as the Administrator deems appropriate concerning
the continued sale and use of existing stocks of such
pesticide. Registration action by the Administrator shall not
be delayed pending the fixing of compensation.
(iv) After expiration of any period of exclusive use and
any period for which compensation is required for the use of
an item of data under clauses (i), (ii), and (iii), the
Administrator may consider such item of data in support of an
application by any other applicant without the permission of
the original data submitter and without an offer having been
received to compensate the original data submitter for the
use of such item of data.
(v) The period of exclusive use provided under clause (ii)
shall not take effect until 1 year after August 3, 1996,
except where an applicant or registrant is applying for the
registration of a pesticide containing an active ingredient
not previously registered.
(vi) With respect to data submitted after August 3, 1996,
by an applicant or registrant to support an amendment adding
a new use to an existing registration that does not retain
any period of exclusive use, if such data relates solely to a
minor use of a pesticide, such data shall not, without the
written permission of the original data submitter, be
considered by the Administrator to support an application for
a minor use by another person during the period of 10 years
following the date of submission of such data. The applicant
or registrant at the time the new minor use is requested
shall notify the Administrator that to the best of their
knowledge the exclusive use period for the pesticide has
expired and that the data pertaining solely to the minor use
of a pesticide is eligible for the provisions of this
paragraph. If the minor use registration which is supported
by data submitted pursuant to this subsection is voluntarily
canceled or if such data are subsequently used to support a
nonminor use, the data shall no longer be subject to the
exclusive use provisions of this clause but shall instead be
considered by the Administrator in accordance with the
provisions of clause (i), as appropriate.

(G) If the applicant is requesting that the registration or
amendment to the registration of a pesticide be expedited, an
explanation of the basis for the request must be submitted, in
accordance with paragraph (10) of this subsection.
(2) Data in support of registration
(A) In general
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.
(B) Additional data
(i) If the Administrator determines that additional data are
required to maintain in effect an existing registration of a
pesticide, the Administrator shall notify all existing
registrants of the pesticide to which the determination relates
and provide a list of such registrants to any interested
person.
(ii) Each registrant of such pesticide shall provide evidence
within ninety days after receipt of notification that it is
taking appropriate steps to secure the additional data that are
required. Two or more registrants may agree to develop jointly,
or to share in the cost of developing, such data if they agree
and advise the Administrator of their intent within ninety days
after notification. Any registrant who agrees to share in the
cost of producing the data shall be entitled to examine and
rely upon such data in support of maintenance of such
registration. 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.
(iii) If, at the end of sixty days after advising the
Administrator of their agreement to develop jointly, or share
in the cost of developing, data, the registrants have not
further agreed on the terms of the data development arrangement
or on a procedure for reaching such agreement, any of such
registrants may initiate binding arbitration proceedings by
requesting the Federal Mediation and Conciliation Service to
appoint an arbitrator from the roster of arbitrators maintained
by such Service. The procedure and rules of the Service shall
be applicable to the selection of such arbitrator and to such
arbitration proceedings, and the findings and determination of
the arbitrator shall be final and conclusive, and no official
or court of the United States shall have power or jurisdiction
to review any such findings and determination, except for
fraud, misrepresentation, or other misconduct by one of the
parties to the arbitration or the arbitrator where there is a
verified complaint with supporting affidavits attesting to
specific instances of such fraud, misrepresentation, or other
misconduct. All parties to the arbitration shall share equally
in the payment of the fee and expenses of the arbitrator. 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.
(iv) Notwithstanding any other provision of this subchapter,
if the Administrator determines that a registrant, within the
time required by the Administrator, has failed to take
appropriate steps to secure the data required under this
subparagraph, to participate in a procedure for reaching
agreement concerning a joint data development arrangement under
this subparagraph or in an arbitration proceeding as required
by this subparagraph, or to comply with the terms of an
agreement or arbitration decision concerning a joint data
development arrangement under this subparagraph, the
Administrator may issue a notice of intent to suspend such
registrant's registration of the pesticide for which additional
data is required. The Administrator may include in the notice
of intent to suspend such provisions as the Administrator deems
appropriate concerning the continued sale and use of existing
stocks of such pesticide. Any suspension proposed under this
subparagraph shall become final and effective at the end of
thirty days from receipt by the registrant of the notice of
intent to suspend, unless during that time a request for
hearing is made by a person adversely affected by the notice or
the registrant has satisfied the Administrator that the
registrant has complied fully with the requirements that served
as a basis for the notice of intent to suspend. If a hearing is
requested, a hearing shall be conducted under section 136d(d)
of this title. The only matters for resolution at that hearing
shall be whether the registrant has failed to take the action
that served as the basis for the notice of intent to suspend
the registration of the pesticide for which additional data is
required, and whether the Administrator's determination with
respect to the disposition of existing stocks is consistent
with this subchapter. If a hearing is held, a decision after
completion of such hearing shall be final. Notwithstanding any
other provision of this subchapter, a hearing shall be held and
a determination made within seventy-five days after receipt of
a request for such hearing. Any registration suspended under
this subparagraph shall be reinstated by the Administrator if
the Administrator determines that the registrant has complied
fully with the requirements that served as a basis for the
suspension of the registration.
(v) Any data submitted under this subparagraph shall be
subject to the provisions of paragraph (1)(D). Whenever such
data are submitted jointly by two or more registrants, an agent
shall be agreed on at the time of the joint submission to
handle any subsequent data compensation matters for the joint
submitters of such data.
(vi) Upon the request of a registrant the Administrator
shall, in the case of a minor use, extend the deadline for the
production of residue chemistry data under this subparagraph
for data required solely to support that minor use until the
final deadline for submission of data under section 136a-1 of
this title for the other uses of the pesticide established as
of August 3, 1996, if -
(I) the data to support other uses of the pesticide on a
food are being provided;
(II) the registrant, in submitting a request for such an
extension, provides a schedule, including interim dates to
measure progress, to assure that the data production will be
completed before the expiration of the extension period;
(III) the Administrator has determined that such extension
will not significantly delay the Administrator's schedule for
issuing a reregistration eligibility determination required
under section 136a-1 of this title; and
(IV) the Administrator has determined that based on
existing data, such extension would not significantly
increase the risk of any unreasonable adverse effect on the
environment. If the Administrator grants an extension under
this clause, the Administrator shall monitor the development
of the data and shall ensure that the registrant is meeting
the schedule for the production of the data. If the
Administrator determines that the registrant is not meeting
or has not met the schedule for the production of such data,
the Administrator may proceed in accordance with clause (iv)
regarding the continued registration of the affected products
with the minor use and shall inform the public of such
action. Notwithstanding the provisions of this clause, the
Administrator may take action to modify or revoke the
extension under this clause if the Administrator determines
that the extension for the minor use may cause an
unreasonable adverse effect on the environment. In such
circumstance, the Administrator shall provide, in writing to
the registrant, a notice revoking the extension of time for
submission of data. Such data shall instead be due in
accordance with the date established by the Administrator for
the submission of the data.

(vii) If the registrant does not commit to support a specific
minor use of the pesticide, but is supporting and providing
data in a timely and adequate fashion to support uses of the
pesticide on a food, or if all uses of the pesticide are
nonfood uses and the registrant does not commit to support a
specific minor use of the pesticide but is supporting and
providing data in a timely and adequate fashion to support
other nonfood uses of the pesticide, the Administrator, at the
written request of the registrant, shall not take any action
pursuant to this clause in regard to such unsupported minor use
until the final deadline established as of August 3, 1996, for
the submission of data under section 136a-1 of this title for
the supported uses identified pursuant to this clause unless
the Administrator determines that the absence of the data is
significant enough to cause human health or environmental
concerns. On the basis of such determination, the Administrator
may refuse the request for extension by the registrant. Upon
receipt of the request from the registrant, the Administrator
shall publish in the Federal Register a notice of the receipt
of the request and the effective date upon which the uses not
being supported will be voluntarily deleted from the
registration pursuant to section 136d(f)(1) of this title. If
the Administrator grants an extension under this clause, the
Administrator shall monitor the development of the data for the
uses being supported and shall ensure that the registrant is
meeting the schedule for the production of such data. If the
Administrator determines that the registrant is not meeting or
has not met the schedule for the production of such data, the
Administrator may proceed in accordance with clause (iv) of
this subparagraph regarding the continued registration of the
affected products with the minor and other uses and shall
inform the public of such action in accordance with section
136d(f)(2) of this title. Notwithstanding the provisions of
this clause, the Administrator may deny, modify, or revoke the
temporary extension under this subparagraph if the
Administrator determines that the continuation of the minor use
may cause an unreasonable adverse effect on the environment. In
the event of modification or revocation, the Administrator
shall provide, in writing, to the registrant a notice revoking
the temporary extension and establish a new effective date by
which the minor use shall be deleted from the registration.
(viii)(I) If data required to support registration of a
pesticide under subparagraph (A) is requested by a Federal or
State regulatory authority, the Administrator shall, to the
extent practicable, coordinate data requirements, test
protocols, timetables, and standards of review and reduce
burdens and redundancy caused to the registrant by multiple
requirements on the registrant.
(II) The Administrator may enter into a cooperative agreement
with a State to carry out subclause (I).
(III) Not later than 1 year after August 3, 1996, the
Administrator shall develop a process to identify and assist in
alleviating future disparities between Federal and State data
requirements.
(C) Simplified procedures
Within nine months after September 30, 1978, the
Administrator shall, by regulation, prescribe simplified
procedures for the registration of pesticides, which shall
include the provisions of subparagraph (D) of this paragraph.
(D) Exemption
No applicant for registration of a pesticide who proposes to
purchase a registered pesticide from another producer in order
to formulate such purchased pesticide into the pesticide that
is the subject of the application shall be required to -
(i) submit or cite data pertaining to such purchased
product; or
(ii) offer to pay reasonable compensation otherwise
required by paragraph (1)(D) of this subsection for the use
of any such data.
(E) Minor use waiver
In handling the registration of a pesticide for a minor use,
the Administrator may waive otherwise applicable data
requirements if the Administrator determines that the absence
of such data will not prevent the Administrator from
determining -
(i) the incremental risk presented by the minor use of the
pesticide; and
(ii) that such risk, if any, would not be an unreasonable
adverse effect on the environment.
(3) Application
(A) In general
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).
(B) Identical or substantially similar
(i) The Administrator shall, as expeditiously as possible,
review and act on any application received by the Administrator
that -
(I) proposes the initial or amended registration of an
end-use pesticide that, if registered as proposed, would be
identical or substantially similar in composition and
labeling to a currently-registered pesticide identified in
the application, or that would differ in composition and
labeling from such currently-registered pesticide only in
ways that would not significantly increase the risk of
unreasonable adverse effects on the environment; or
(II) proposes an amendment to the registration of a
registered pesticide that does not require scientific review
of data.

(ii) In expediting the review of an application for an action
described in clause (i), the Administrator shall -
(I) within 45 days after receiving the application, notify
the registrant whether or not the application is complete
and, if the application is found to be incomplete, reject the
application;
(II) within 90 days after receiving a complete application,
notify the registrant if the application has been granted or
denied; and
(III) if the application is denied, notify the registrant
in writing of the specific reasons for the denial of the
application.
(C) Minor use registration
(i) The Administrator shall, as expeditiously as possible,
review and act on any complete application -
(I) that proposes the initial registration of a new
pesticide active ingredient if the active ingredient is
proposed to be registered solely for minor uses, or proposes
a registration amendment solely for minor uses to an existing
registration; or
(II) for a registration or a registration amendment that
proposes significant minor uses.

(ii) For the purposes of clause (i) -
(I) the term "as expeditiously as possible" means that the
Administrator shall, to the greatest extent practicable,
complete a review and evaluation of all data, submitted with
a complete application, within 12 months after the submission
of the complete application, and the failure of the
Administrator to complete such a review and evaluation under
clause (i) shall not be subject to judicial review; and
(II) the term "significant minor uses" means 3 or more
minor uses proposed for every nonminor use, a minor use that
would, in the judgment of the Administrator, serve as a
replacement for any use which has been canceled in the 5
years preceding the receipt of the application, or a minor
use that in the opinion of the Administrator would avoid the
reissuance of an emergency exemption under section 136p of
this title for that minor use.
(D) Adequate time for submission of minor use data
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.
(4) Notice of application
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.
(5) Approval of registration
The Administrator shall register a pesticide if the
Administrator determines that, when considered with any
restrictions imposed under subsection (d) of this section -
(A) its composition is such as to warrant the proposed claims
for it;
(B) its labeling and other material required to be submitted
comply with the requirements of this subchapter;
(C) it will perform its intended function without
unreasonable adverse effects on the environment; and
(D) when used in accordance with widespread and commonly
recognized practice it will not generally cause unreasonable
adverse effects on the environment.

The Administrator shall not make any lack of essentiality a
criterion for denying registration of any pesticide. Where two
pesticides meet the requirements of this paragraph, one should
not be registered in preference to the other. In considering an
application for the registration of a pesticide, the
Administrator may waive data requirements pertaining to efficacy,
in which event the Administrator may register the pesticide
without determining that the pesticide's composition is such as
to warrant proposed claims of efficacy. If a pesticide is found
to be efficacious by any State under section 136v(c) of this
title, a presumption is established that the Administrator shall
waive data requirements pertaining to efficacy for use of the
pesticide in such State.
(6) Denial of registration
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 (continued)