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U.S. Code as of:
01/03/05
Section 136d. Administrative review; suspension
(a) Existing stocks and information
(1) Existing stocks
The Administrator may permit the continued sale and use of
existing stocks of a pesticide whose registration is suspended or
canceled under this section, or section 136a or 136a-1 of this
title, to such extent, under such conditions, and for such uses
as the Administrator determines that such sale or use is not
inconsistent with the purposes of this subchapter.
(2) Information
If at any time after the registration of a pesticide the
registrant has additional factual information regarding
unreasonable adverse effects on the environment of the pesticide,
the registrant shall submit such information to the
Administrator.
(b) Cancellation and change in classification
If it appears to the Administrator that a pesticide or its
labeling or other material required to be submitted does not comply
with the provisions of this subchapter or, when used in accordance
with widespread and commonly recognized practice, generally causes
unreasonable adverse effects on the environment, the Administrator
may issue a notice of the Administrator's intent either -
(1) to cancel its registration or to change its classification
together with the reasons (including the factual basis) for the
Administrator's action, or
(2) to hold a hearing to determine whether or not its
registration should be canceled or its classification changed.
Such notice shall be sent to the registrant and made public. In
determining whether to issue any such notice, the Administrator
shall include among those factors to be taken into account the
impact of the action proposed in such notice on production and
prices of agricultural commodities, retail food prices, and
otherwise on the agricultural economy. At least 60 days prior to
sending such notice to the registrant or making public such notice,
whichever occurs first, the Administrator shall provide the
Secretary of Agriculture with a copy of such notice and an analysis
of such impact on the agricultural economy. If the Secretary
comments in writing to the Administrator regarding the notice and
analysis within 30 days after receiving them, the Administrator
shall publish in the Federal Register (with the notice) the
comments of the Secretary and the response of the Administrator
with regard to the Secretary's comments. If the Secretary does not
comment in writing to the Administrator regarding the notice and
analysis within 30 days after receiving them, the Administrator may
notify the registrant and make public the notice at any time after
such 30-day period notwithstanding the foregoing 60-day time
requirement. The time requirements imposed by the preceding 3
sentences may be waived or modified to the extent agreed upon by
the Administrator and the Secretary. Notwithstanding any other
provision of this subsection and section 136w(d) of this title, in
the event that the Administrator determines that suspension of a
pesticide registration is necessary to prevent an imminent hazard
to human health, then upon such a finding the Administrator may
waive the requirement of notice to and consultation with the
Secretary of Agriculture pursuant to this subsection and of
submission to the Scientific Advisory Panel pursuant to section
136w(d) of this title and proceed in accordance with subsection (c)
of this section. When a public health use is affected, the
Secretary of Health and Human Services should provide available
benefits and use information, or an analysis thereof, in accordance
with the procedures followed and subject to the same conditions as
the Secretary of Agriculture in the case of agricultural
pesticides. The proposed action shall become final and effective at
the end of 30 days from receipt by the registrant, or publication,
of a notice issued under paragraph (1), whichever occurs later,
unless within that time either (i) the registrant makes the
necessary corrections, if possible, or (ii) a request for a hearing
is made by a person adversely affected by the notice. In the event
a hearing is held pursuant to such a request or to the
Administrator's determination under paragraph (2), a decision
pertaining to registration or classification issued after
completion of such hearing shall be final. In taking any final
action under this subsection, the Administrator shall consider
restricting a pesticide's use or uses as an alternative to
cancellation and shall fully explain the reasons for these
restrictions, and shall include among those factors to be taken
into account the impact of such final action on production and
prices of agricultural commodities, retail food prices, and
otherwise on the agricultural economy, and the Administrator shall
publish in the Federal Register an analysis of such impact.
(c) Suspension
(1) Order
If the Administrator determines that action is necessary to
prevent an imminent hazard during the time required for
cancellation or change in classification proceedings, the
Administrator may, by order, suspend the registration of the
pesticide immediately. Except as provided in paragraph (3), no
order of suspension may be issued under this subsection unless
the Administrator has issued, or at the same time issues, a
notice of intention to cancel the registration or change the
classification of the pesticide under subsection (b) of this
section. Except as provided in paragraph (3), the Administrator
shall notify the registrant prior to issuing any suspension
order. Such notice shall include findings pertaining to the
question of "imminent hazard". The registrant shall then have an
opportunity, in accordance with the provisions of paragraph (2),
for an expedited hearing before the Administrator on the question
of whether an imminent hazard exists.
(2) Expedite hearing
If no request for a hearing is submitted to the Administrator
within five days of the registrant's receipt of the notification
provided for by paragraph (1), the suspension order may be issued
and shall take effect and shall not be reviewable by a court. If
a hearing is requested, it shall commence within five days of the
receipt of the request for such hearing unless the registrant and
the Administrator agree that it shall commence at a later time.
The hearing shall be held in accordance with the provisions of
subchapter II of chapter 5 of title 5, except that the presiding
officer need not be a certified administrative law judge. The
presiding officer shall have ten days from the conclusion of the
presentation of evidence to submit recommended findings and
conclusions to the Administrator, who shall then have seven days
to render a final order on the issue of suspension.
(3) Emergency order
Whenever the Administrator determines that an emergency exists
that does not permit the Administrator to hold a hearing before
suspending, the Administrator may issue a suspension order in
advance of notification to the registrant. The Administrator may
issue an emergency order under this paragraph before issuing a
notice of intention to cancel the registration or change the
classification of the pesticide under subsection (b) of this
section and the Administrator shall proceed to issue the notice
under subsection (b) of this section within 90 days of issuing an
emergency order. If the Administrator does not issue a notice
under subsection (b) of this section within 90 days of issuing an
emergency order, the emergency order shall expire. In the case of
an emergency order, paragraph (2) shall apply except that (A) the
order of suspension shall be in effect pending the expeditious
completion of the remedies provided by that paragraph and the
issuance of a final order on suspension, and (B) no party other
than the registrant and the Administrator shall participate
except that any person adversely affected may file briefs within
the time allotted by the Agency's rules. Any person so filing
briefs shall be considered a party to such proceeding for the
purposes of section 136n(b) of this title.
(4) Judicial review
A final order on the question of suspension following a hearing
shall be reviewable in accordance with section 136n of this
title, notwithstanding the fact that any related cancellation
proceedings have not been completed. Any order of suspension
entered prior to a hearing before the Administrator shall be
subject to immediate review in an action by the registrant or
other interested person with the concurrence of the registrant in
an appropriate district court, solely to determine whether the
order of suspension was arbitrary, capricious or an abuse of
discretion, or whether the order was issued in accordance with
the procedures established by law. The effect of any order of the
court will be only to stay the effectiveness of the suspension
order, pending the Administrator's final decision with respect to
cancellation or change in classification. This action may be
maintained simultaneously with any administrative review
proceedings under this section. The commencement of proceedings
under this paragraph shall not operate as a stay of order, unless
ordered by the court.
(d) Public hearings and scientific review
In the event a hearing is requested pursuant to subsection (b) of
this section or determined upon by the Administrator pursuant to
subsection (b) of this section, such hearing shall be held after
due notice for the purpose of receiving evidence relevant and
material to the issues raised by the objections filed by the
applicant or other interested parties, or to the issues stated by
the Administrator, if the hearing is called by the Administrator
rather than by the filing of objections. Upon a showing of
relevance and reasonable scope of evidence sought by any party to a
public hearing, the Hearing Examiner shall issue a subpena to
compel testimony or production of documents from any person. The
Hearing Examiner shall be guided by the principles of the Federal
Rules of Civil Procedure in making any order for the protection of
the witness or the content of documents produced and shall order
the payment of reasonable fees and expenses as a condition to
requiring testimony of the witness. On contest, the subpena may be
enforced by an appropriate United States district court in
accordance with the principles stated herein. Upon the request of
any party to a public hearing and when in the Hearing Examiner's
judgment it is necessary or desirable, the Hearing Examiner shall
at any time before the hearing record is closed refer to a
Committee of the National Academy of Sciences the relevant
questions of scientific fact involved in the public hearing. No
member of any committee of the National Academy of Sciences
established to carry out the functions of this section shall have a
financial or other conflict of interest with respect to any matter
considered by such committee. The Committee of the National Academy
of Sciences shall report in writing to the Hearing Examiner within
60 days after such referral on these questions of scientific fact.
The report shall be made public and shall be considered as part of
the hearing record. The Administrator shall enter into appropriate
arrangements with the National Academy of Sciences to assure an
objective and competent scientific review of the questions
presented to Committees of the Academy and to provide such other
scientific advisory services as may be required by the
Administrator for carrying out the purposes of this subchapter. As
soon as practicable after completion of the hearing (including the
report of the Academy) but not later than 90 days thereafter, the
Administrator shall evaluate the data and reports before the
Administrator and issue an order either revoking the
Administrator's notice of intention issued pursuant to this
section, or shall issue an order either canceling the registration,
changing the classification, denying the registration, or requiring
modification of the labeling or packaging of the article. Such
order shall be based only on substantial evidence of record of such
hearing and shall set forth detailed findings of fact upon which
the order is based.
(e) Conditional registration
(1) The Administrator shall issue a notice of intent to cancel a
registration issued under section 136a(c)(7) of this title if (A)
the Administrator, at any time during the period provided for
satisfaction of any condition imposed, determines that the
registrant has failed to initiate and pursue appropriate action
toward fulfilling any condition imposed, or (B) at the end of the
period provided for satisfaction of any condition imposed, that
condition has not been met. The Administrator may permit the
continued sale and use of existing stocks of a pesticide whose
conditional registration has been canceled under this subsection to
such extent, under such conditions, and for such uses as the
Administrator may specify if the Administrator determines that such
sale or use is not inconsistent with the purposes of this
subchapter and will not have unreasonable adverse effects on the
environment.
(2) A cancellation proposed under this subsection shall become
final and effective at the end of thirty days from receipt by the
registrant of the notice of intent to cancel unless during that
time a request for hearing is made by a person adversely affected
by the notice. If a hearing is requested, a hearing shall be
conducted under subsection (d) of this section. The only matters
for resolution at that hearing shall be whether the registrant has
initiated and pursued appropriate action to comply with the
condition or conditions within the time provided or whether the
condition or conditions have been satisfied within the time
provided, and whether the Administrator's determination with
respect to the disposition of existing stocks is consistent with
this subchapter. A decision after completion of such hearing shall
be final. Notwithstanding any other provision of this section, a
hearing shall be held and a determination made within seventy-five
days after receipt of a request for such hearing.
(f) General provisions
(1) Voluntary cancellation
(A) A registrant may, at any time, request that a pesticide
registration of the registrant be canceled or amended to
terminate one or more pesticide uses.
(B) Before acting on a request under subparagraph (A), the
Administrator shall publish in the Federal Register a notice of
the receipt of the request and provide for a 30-day period in
which the public may comment.
(C) In the case of a pesticide that is registered for a minor
agricultural use, if the Administrator determines that the
cancellation or termination of uses would adversely affect the
availability of the pesticide for use, the Administrator -
(i) shall publish in the Federal Register a notice of the
receipt of the request and make reasonable efforts to inform
persons who so use the pesticide of the request; and
(ii) may not approve or reject the request until the
termination of the 180-day period beginning on the date of
publication of the notice in the Federal Register, except that
the Administrator may waive the 180-day period upon the request
of the registrant or if the Administrator determines that the
continued use of the pesticide would pose an unreasonable
adverse effect on the environment.
(D) Subject to paragraph (3)(B), after complying with this
paragraph, the Administrator may approve or deny the request.
(2) Publication of notice
A notice of denial of registration, intent to cancel,
suspension, or intent to suspend issued under this subchapter or
a notice issued under subsection (c)(4) or (d)(5)(A) of section
136a-1 of this title shall be published in the Federal Register
and shall be sent by certified mail, return receipt requested, to
the registrant's or applicant's address of record on file with
the Administrator. If the mailed notice is returned to the
Administrator as undeliverable at that address, if delivery is
refused, or if the Administrator otherwise is unable to
accomplish delivery of the notice to the registrant or applicant
after making reasonable efforts to do so, the notice shall be
deemed to have been received by the registrant or applicant on
the date the notice was published in the Federal Register.
(3) Transfer of registration of pesticides registered for minor
agricultural uses
In the case of a pesticide that is registered for a minor
agricultural use:
(A) During the 180-day period referred to in paragraph
(1)(C)(ii), the registrant of the pesticide may notify the
Administrator of an agreement between the registrant and a
person or persons (including persons who so use the pesticide)
to transfer the registration of the pesticide, in lieu of
canceling or amending the registration to terminate the use.
(B) An application for transfer of registration, in
conformance with any regulations the Administrator may adopt
with respect to the transfer of the pesticide registrations,
must be submitted to the Administrator within 30 days of the
date of notification provided pursuant to subparagraph (A). If
such an application is submitted, the Administrator shall
approve the transfer and shall not approve the request for
voluntary cancellation or amendment to terminate use unless the
Administrator determines that the continued use of the
pesticide would cause an unreasonable adverse effect on the
environment.
(C) If the Administrator approves the transfer and the
registrant transfers the registration of the pesticide, the
Administrator shall not cancel or amend the registration to
delete the use or rescind the transfer of the registration,
during the 180-day period beginning on the date of the approval
of the transfer unless the Administrator determines that the
continued use of the pesticide would cause an unreasonable
adverse effect on the environment.
(D) The new registrant of the pesticide shall assume the
outstanding data and other requirements for the pesticide that
are pending at the time of the transfer.
(4) Utilization of data for voluntarily canceled pesticide
When an application is filed with the Administrator for the
registration of a pesticide for a minor use and another
registrant subsequently voluntarily cancels its registration for
an identical or substantially similar pesticide for an identical
or substantially similar use, the Administrator shall process,
review, and evaluate the pending application as if the voluntary
cancellation had not yet taken place except that the
Administrator shall not take such action if the Administrator
determines that such minor use may cause an unreasonable adverse
effect on the environment. In order to rely on this subsection,
the applicant must certify that it agrees to satisfy any
outstanding data requirements necessary to support the
reregistration of the pesticide in accordance with the data
submission schedule established by the Administrator.
(g) Notice for stored pesticides with canceled or suspended
registrations
(1) In general
Any producer or exporter of pesticides, registrant of a
pesticide, applicant for registration of a pesticide, applicant
for or holder of an experimental use permit, commercial
applicator, or any person who distributes or sells any pesticide,
who possesses any pesticide which has had its registration
canceled or suspended under this section shall notify the
Administrator and appropriate State and local officials of -
(A) such possession,
(B) the quantity of such pesticide such person possesses, and
(C) the place at which such pesticide is stored.
(2) Copies
The Administrator shall transmit a copy of each notice
submitted under this subsection to the regional office of the
Environmental Protection Agency which has jurisdiction over the
place of pesticide storage identified in the notice.
(h) Judicial review
Final orders of the Administrator under this section shall be
subject to judicial review pursuant to section 136n of this title.
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