SEC.
3. [136a] REGISTRATION OF PESTICIDES.
(a)
REQUIREMENT OF REGISTRATION.-Except
as provided by this Act, no person in any State may distribute
or sell to any person any pesticide that is not registered under
this Act. To the extent necessary to prevent unreasonable adverse
ettects 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 Act and that is not the subject
of an experimental use permit under section 5 or an emergency
exemption under section 18.
(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-
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(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) the 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) 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:
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(i) with respect to pesticides containing
active ingredients that are initially registered under this Act
after the date of enactment of the Federal Pesticide Act of 1978
[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) 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
Act, 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;
(iii) 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) and (ii), 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; |
(E) the complete formula
of the pesticide; and
(F) a request that the pesticide be classified for general use
for restricted use, or for both. |
(2)
DATA IN SUPPORT OF REGISTRATION.-
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(A) 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
he requires any additional kind of information under subparagraph
(B) of this paragraph, he 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, and the level
and degree of potential exposure of man and the environment to
the pesticide. 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 10, within 30 days after the Administrator
registers a pesticide under this Act he shall make available
to the public the data called for in the registration statement
together with such other scientific information as he deems relevant
to his decision.
(B)(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 Act, 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 6(d) of this Act.
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 Act. If a hearing
is held, a decision after completion of such hearing shall be
final. Notwithstanding any other provision of this Act, 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.
(C) Within nine months alter the date of enactment of this subparagraph
[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 (3-1) shall be required
to-
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(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. |
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(3)
TIME FOR ACTING WITH RESPECT TO APPLICATION.-
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(A) 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 his
determination that it does not comply with the provisions of
the Act in accordance with paragraph (6).
(B)(i) The Administrator shall, as expeditiously as possible,
review and act on any application received by the Administrator
that-
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(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. |
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(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 he determines that,
when considered with any restrictions imposed under subsection
(d)-
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(A) 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 his
determination that it does not comply with the provisions of
the Act in accordance with paragraph (6).
(B)(i) The Administrator shall, as expeditiously as possible,
review and act on any application received by the Administrator
that-
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(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 Act;
(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. |
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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 24(c) of this Act, 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, he shall notify the applicant
for registration of his determination and of his 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, he shall notify the applicant of his
decision and of his 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 6.
(7)
REGISTRATION UNDER SPECIAL CIRCUMSTANCES.-Notwithstanding the provisions of paragraph
(5)-
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(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 Act.
(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 Act, 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 Act.
(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 Act, 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 Act, 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 Act, 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. |
(d)
CLASSIFICATION OF PESTICIDES.-
(1)
CLASSIFICATION FOR GENERAL USE, RESTRICTED USE, OR BOTH.-
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(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, he 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, he 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, he shall
classify the pesticide, or the particular use or uses to which
the determination applies, for restricted use:
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(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. |
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(2)
CHANGE IN CLA5SIFICATION.-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,
he 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 6(b).
(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
16 of this Act. |
(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 Act.
(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 Act. 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
Act.
(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. |
(3-1) Section 102(b)(2)(A) of the Federal Insecticide,
Fungicide, and Rodenticide Act Amendments of 1988 (P.L. 100-532)
amended this subparagraph by striking out "an end use product"
and inserting in lieu thereof "the pesticide that is the
subject of the application". Before the amendment, the text
of this subparagraph contained the phrase "an end-use product",
with a hyphen. The amendment was executed to this subparagraph
to effectuate the probable intent of Congress. |
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