SEC. 4. [136b]
REREGISTRATION OF REGISTERED PESTICIDES.
(a)
GENERAL RULE.-The Administrator
shall reregister, in accordance with this section, each registered
pesticide containing any active ingredient contained in any pesticide
first registered before November 1, 1984, except for any pesticide
as to which the Administrator has determined, after November
1, 1984, and before the effective date of this section [December
24, 1988], that-
(1) there are
no outstanding data requirements; and
(2) the requirements of section 3(c)(5) have been satisfied. |
(b)
REREGISTRATION PHASES.-Reregistrations
of pesticides under this section shall be carried out in the
following phases:
(1) The first
phase shall include the listing under subsection (c) of the active
ingredients of the pesticides that will be reregistered.
(2) The second phase shall include the submission to the Administrator
under subsection (d) of notices by registrants respecting their
intention to seek reregistration, identification by registrants
of missing and inadequate data for such pesticides, and commitments
by registrants to replace such missing or inadequate data within
the applicable time period.
(3) The third phase shall include submission to the Administrator
by registrants of the information required under subsection (e).
(4) The fourth phase shall include an independent, initial review
by the Administrator under subsection (f) of submissions under
phases two and three, identification of outstanding data requirements,
and the issuance, as necessary, of requests for additional data.
(5) The fifth phase shall include the review by the Administrator
under subsection (g) of data submitted for reregistration and
appropriate regulatory action by the Administrator. |
(c)
PHASE ONE.-
(1)
PRIORITY FOR REREGISTRATION.-For
purposes of the reregistration of the pesticides described in
subsection (a), the Administrator shall list the active ingredients
of pesticides and shall give priority to, among others, active
ingredients (other than active ingredients for which registration
standards have been issued before the effective date of this
section [December 24, 19881) that-
(A) are in use
on or in food or feed and may result in postharvest residues;
(B) may result in residues of potential toxicological concern
in potable ground water, edible fish, or shellfish;
(C) have been determined by the Administrator before the effective
date of this section [December 24, 1988] to have significant
outstanding data requirements; or
(D) are used on crops, including in greenhouses and nurseries,
where worker exposure is most likely to occur. |
(2)
REREGISTRATION LISTS.-For
purposes of reregistration under this section, the Administrator
shall by order-
(A) not later
than 70 days after the effective date of this section [December
24, 1988], list pesticide active ingredients for which registration
standards have been issued before such effective date;
(B) not later than 4 months after such effective date, list the
first 150 pesticide active ingredients, as determined under paragraph
(1);
(C) not later than 7 months after such effective date, list the
second 150 pesticide active ingredients, as determined under
paragraph (1); and
(D) not later than 10 months after such effective date, list
the remainder of the pesticide active ingredients, as determined
under paragraph (1). |
Each list shall be published
in the Federal Register.
(3)
JUDICIAL REVIEW.-The
content of a list issued by the Administrator under paragraph
(2) shall not be subject to judicial
review.
(4)
NOTICE TO REGISTRANTS.-On
the publication of a list of pesticide active ingredients under
paragraph (2), the Administrator shall send by certified mail
to the registrants of the pesticides containing such active ingredients
a notice of the time by which the registrants are to notify the
Administrator under subsection (d) whether the registrants intend
to seek or not to seek reregistration of such pesticides. |
(d)
PHASE TWO.-
(1)
IN GENERAL.-The registrant
of a pesticide that contains an active ingredient listed under
subparagraph (B), (C), or (D) of subsection (c)(2) shall submit
to the Administrator, within the time period prescribed by paragraph
(4), the notice described in paragraph (2) and any information,
commitment, or offer described in paragraph (3).
(2)
NOTICE OF INTENT TO SEEK OR NOT TO SEEK REREGISTRATION.-
(A) The registrant
of a pesticide containing an active ingredient listed under subparagraph
(B), (C), or (D) of subsection (c)(2) shall notify the Administrator
by certified mail whether the registrant intends to seek or does
not intend to seek reregistration of the pesticide.
(B) If a registrant submits a notice under subparagraph (A) of
an intention not to seek reregistration of a pesticide, the Administrator
shall publish a notice in the Federal Register stating that such
a notice has been submitted. |
(3)
MISSING OR INADEQUATE DATA.-Each
registrant of a pesticide that contains an active ingredient
listed under subparagraph (B), (C), or (D) of subsection (c)(2)
and for which the registrant submitted a notice under paragraph
(2) of an intention to seek reregistration of such pesticide
shall submit to the Administrator-
(A) in accordance
with regulations issued by the Administrator under section 3,
an identification of-
(i) all data
that are required by regulation to support the registration of
the pesticide with respect to such active ingredient;
(ii) data that were submitted by the registrant previously in
support of the registration of the pesticide that are inadequate
to meet such regulations; and
(iii) data identified under clause (i) that have not been submitted
to the Administrator; and |
(B) either-
(i) a commitment
to replace the data identified under subparagraph (A)(ii) and
submit the data identified under subparagraph (A)(iii) within
the applicable time period prescribed by paragraph (4)(B); or
(ii) an offer to share in the cost to be incurred by a person
who has made a commitment under clause (i) to replace or submit
the data and an offer to submit to arbitration as described by
section 3(c)(2)(B) with regard to such cost sharing. |
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For purposes of a submission
by a registrant under subparagraph (A)(ii), data are inadequate
if the data are derived from a study with respect to which the
registrant is unable to make the certification prescribed by
subsection (e)(1)(G) that the registrant possesses or has access
to the raw data used in or generated by such study. For purposes
of a submission by a registrant under such subparagraph, data
shall be considered to be inadequate if the data are derived
from a study submitted before January 1, 1970, unless it is demonstrated
to the satisfaction of the Administrator that such data should
be considered to support the registration of the pesticide that
is to be reregistered.
(4)
TIME PERIODS.-
(A) A submission
under paragraph (2) or (3) shall be made-
(i) in the case
of a pesticide containing an active ingredient listed under subsection
(c)(2)(B), not later than 3 months after the date of publication
of the listing of such active ingredient;
(ii) in the case of a pesticide containing an active ingredient
listed under subsection (c)(2)(C), not later than 3 months after
the date of publication of the listing of such active ingredient;
and
(iii) in the case of a pesticide containing an active ingredient
listed under subsection (c)(2)(D), not later than 3 months after
the date of publication of the listing of such active ingredient. |
On application, the Administrator
may extend a time period prescribed by this subparagraph if the
Administrator determines that factors beyond the control of the
registrant prevent the registrant from complying with such period.
(B) A registrant shall submit data in accordance with a commitment
entered into under paragraph (3)(B) within a reasonable period
of time, as determined by the Administrator, but not more than
48 months after the date the registrant submitted the commitment.
The Administrator, on application of a registrant, may extend
the period prescribed by the preceding sentence by no more than
2 years if extraordinary circumstances beyond the control of
the registrant prevent the registrant from submitting data within
such prescribed period. |
(5)
CANCELLATION AND REMOVAL.-
(A) If the registrant
of a pesticide does not submit a notice under paragraph (2) or
(3) within the time prescribed by paragraph (4)(A), the Administrator
shall issue a notice of intent to cancel the registration of
such registrant for such pesticide and shall publish the notice
in the Federal Register and allow 60 days for the submission
of comments on the notice. On expiration of such 60 days, the
Administrator, by order and without a hearing, may cancel the
registration or take such other action, including extension of
applicable time periods, as may be necessary to enable reregistration
of such pesticide by another person.
(B)(i) If-
(I) no registrant
of a pesticide containing an active ingredient listed under subsection
(c)(2) notifies the Administrator under paragraph (2) that the
registrant intends to seek reregistration of any pesticide containing
that active ingredient;
(II) no such registrant complies with paragraph (3)(A); or
(III) no such registrant makes a commitment under paragraph (3)(B)
to replace or submit all data described in clauses (ii) and (iii)
of paragraph (3)(A); |
the Administrator shall
publish in the Federal Register a notice of intent to remove
the active ingredient from the list established under subsection
(c)(2) and a notice of intent to cancel the registrations of
all pesticides containing such active ingredient and shall provide
60 days for comment on such notice.
(ii) After the 60-day period has expired, the Administrator,
by order, may cancel any such registration without hearing, except
that the Administrator shall not cancel a registration under
this subparagraph if-
(I) during the
comment period a person acquires the rights of the registrant
in that registration;
(II) during the comment period that person furnishes a notice
of intent to reregister the pesticide in accordance with paragraph
(2); and
(III) not later than 120 days after the publication of the notice
under this subparagraph, that person has complied with paragraph
(3) and the fee prescribed by subsection (i)(1) has been paid. |
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(6)
SUSPENSIONS AND PENALTIES.-The
Administrator shall issue a notice of intent to suspend the registration
of a pesticide in accordance with the procedures prescribed by
section 3(c)(2)(B)(iv) if the Administrator determines that (A)
progress is insufficient to ensure the submission of the data
required for such pesticide under a commitment made under paragraph
(3)(B) within the time period prescribed by paragraph (4)(B)
or (B) the registrant has not submitted such data to the Administrator
within such time period. |
(e)
PHASE THREE.-
(1)
INFORMATION ABOUT STUDIES.-Each
registrant of a pesticide that contains an active ingredient
listed under subparagraph (B), (C), or (D) of subsection (c)(2)
who has submitted a notice under subsection (d)(2) of an intent
to seek the reregistration of such pesticide shall submit, in
accordance with the guidelines issued under paragraph (4), to
the Administrator-
(A) a summary
of each study concerning the active ingredient previously submitted
by the registrant in support of the registration of a pesticide
containing such active ingredient and considered by the registrant
to be adequate to meet the requirements of section 3 and the
regulations issued under such section;
(B) a summary of each study concerning the active ingredient
previously submitted by the registrant in support of the registration
of a pesticide containing such active ingredient that may not
comply with the requirements of section 3 and the regulations
issued under such section but which the registrant asserts should
be deemed to comply with such requirements and regulations;
(C) a reformat of the data from each study summarized under subparagraph
(A) or (B) by the registrant concerning chronic dosing, oncogenicity,
reproductive effects, mutagenicity, neurotoxicity, teratogenicity,
or residue chemistry of the active ingredient that were submitted
to the Administrator before January 1, 1982;
(D) where data described in subparagraph (C) are not required
for the active ingredient by regulations issued under section
3, a reformat of acute and subchronic dosing data submitted by
the registrant to the Administrator before January 1, 1982, that
the registrant considers to be adequate to meet the requirements
of section 3 and the regulations issued under such section;
(E) an identification of data that are required to be submitted
to the Administrator under section 6(a)(2) indicating an adverse
effect of the pesticide;
(F) an identification of any other information available that
in the view of the registrant supports the registration;
(G) a certification that the registrant or the Administrator
possesses or has access to the raw data used in or generated
by the studies that the registrant summarized under subparagraph
(A) or (B);
(H) either-
(i) a commitment
to submit data to fill each outstanding data requirement identified
by the registrant; or
(ii) an offer to share in the cost of developing such data to
be incurred by a person who has made a commitment under clause
(i) to submit such data, and an offer to submit to arbitration
as described by section 3(c)(2)(B) with regard to such cost sharing;
and |
(I) evidence of compliance
with section 3(c)(1)(D)(ii) and regulations issued thereunder
with regard to previously submitted data as if the registrant
were now seeking the original registration of the pesticide. |
A registrant who submits
a certification under subparagraph (G) that is false shall be
considered to have violated this Act and shall be subject to
the penalties prescribed by section 14.
(2)
TIME PERIODS.-
(A) The information
required by paragraph (1) shall be submitted to the Administrator-
(i) in the case
of a pesticide containing an active ingredient listed under subsection
(c)(2)(B), not later than 12 months after the date of publication
of the listing of such active ingredient;
(ii) in the case of a pesticide containing an active ingredient
listed under subsection (c)(2)(C), not later than 12 months after
the date of publication of the listing of such active ingredient;
and
(iii) in the case of a pesticide containing an active ingredient
listed under subsection (c)(2)(D), not later than 12 months after
the date of publication of the listing of such active ingredient. |
(B) A registrant shall
submit data in accordance with a commitment entered into under
paragraph (1)(H) within a reasonable period of time, as determined
by the Administrator, but not more than 48 months after the date
the registrant submitted the commitment under such paragraph.
The Administrator, on application of a registrant, may extend
the period prescribed by the preceding sentence by no more than
2 years if extraordinary circumstances beyond the control of
the registrant prevent the registrant from submitting data within
such prescribed period. |
(3)
CANCELLATION.-
(A) If the registrant
of a pesticide fails to submit the information required by paragraph
(1) within the time prescribed by paragraph (2), the Administrator,
by order and without hearing, shall cancel the registration of
such pesticide.
(B)(i) If the registrant of a pesticide submits the information
required by paragraph (1) within the time prescribed by paragraph
(2) and such information does not conform to the guidelines for
submissions established by the Administrator, the Administrator
shall determine whether the registrant made a good faith attempt
to conform its submission to such guidelines.
(ii) If the Administrator determines that the registrant made
a good faith attempt to conform its submission to such guidelines,
the Administrator shall provide the registrant a reasonable period
of time to make any necessary changes or corrections.
(iii)(I) If the Administrator determines that the registrant
did not make a good faith attempt to conform its submission to
such guidelines, the Administrator may issue a notice of intent
to cancel the registration. Such a notice shall be sent to the
registrant by certified mail.
(II) The registration shall be canceled without a hearing or
further notice at the end of 30 days after receipt by the registrant
of the notice unless during that time a request for a hearing
is made by the registrant.
(III) If a hearing is requested, a hearing shall be conducted
under section 6(d), except that the only matter for resolution
at the hearing shall be whether the registrant made a good faith
attempt to conform its submission to such guidelines. The hearing
shall be held and a determination made within 75 days after receipt
of a request for hearing. |
(4)
GUIDELINES.-
(A) Not later
than 1 year after the effective date of this section [December
24, 1988], the Administrator, by order, shall issue guidelines
to be followed by registrants in-
(i) summarizing
studies;
(ii) reformatting studies;
(iii) identifying adverse information; and
(iv) identifying studies that have been submitted previously
that may not meet the requirements of section 3 or regulations
issued under such section, |
under paragraph (1).
(B) Guidelines issued under subparagraph (A) shall not be subject
to judicial review. |
(5)
MONITORING.-The Administrator
shall monitor the progress of registrants in acquiring and submitting
the data required under paragraph (1). |
(f)
PHASE FOUR.-
(1)
INDEPENDENT REVIEW AND IDENTIFICATION OF OUTSTANDING DATA REQUIREMENTS.-
(A) The Administrator
shall review the submissions of all registrants of pesticides
containing a particular active ingredient under subsections (d)(3)
and (eXi) to determine if such submissions identified all the
data that are missing or inadequate for such active ingredient.
To assist the review of the Administrator under this subparagraph,
the Administrator may require a registrant seeking reregistra-tion
to submit complete copies of studies summarized under subsection
(e)(1).
(B) The Administrator shall independently identify and publish
in the Federal Register the outstanding data re-quirements for
each active ingredient that is listed under subparagraph (B),
(C), or (D) of subsection (cX2) and that is contained in a pesticide
to be reregistered under this sec-tion. The Administrator, at
the same time, shall issue a notice under section 3(cX2XB) for
the submission of the ad-ditional data that are required to meet
such requirements. |
(2)
TIME PERIODS.-
(A) The Administrator
shall take the action required by paragraph (1)-
(i) in the case
of a pesticide containing an active ingredient listed under subsection
(c)(2)(B), not later than 18 months after the date of the listing
of such active ingredient;
(ii) in the case of a pesticide containing an active ingredient
listed under subsection (c)(2)(C), not later than 24 months after
the date of the listing of such active ingredient; and
(iii) in the case of a pesticide containing an active ingredient
listed under subsection (c)(2)(D), not later than 33 months after
the date of the listing of such active ingredient. |
(B) If the Administrator
issues a notice to a registrant under paragraph (1)(B) for the
submission of additional data, the registrant shall submit such
data within a reasonable period of time, as determined by the
Administrator, but not to exceed 48 months after the issuance
of such notice. The Administrator, on application of a registrant,
may extend the period prescribed by the preceding sentence by
no more than 2 years if extraordinary circumstances beyond the
control of the registrant prevent the registrant from submitting
data within such prescribed period. |
(3)
(4-1) SUSPENSIONS
AND PENALTIES.-The Administrator shall issue a notice of
intent to suspend the registration of a pesticide in accordance
with the procedures prescribed by section 3(c)(2)(B)(iv) if the
Administrator determines that (A) tests necessary to fill an
outstanding data requirement for such pesticide have not been
initiated within 1 year after the issuance of a notice under
paragraph (1)(B), or (B) progress is insufficient to ensure submission
of the data referred to in clause (A) within the time period
prescribed by paragraph (2)(B) or the required data have not
been submitted to the Administrator within such time period. |
(g)
PHASE FIVE.-
(1)
DATA REVIEW.-The Administrator
shall conduct a thor-ough examination of all data submitted under
this section con-cerning an active ingredient listed under subsection
(c)(2) and of all other available data found by the Administrator
to be relevant.
(2)
REREGISTRATION AND OTHER ACTIONS.-
(A) Within 1
year after the submission of all data concerning an active ingredient
of a pesticide under subsection (f), the Administrator shall
determine whether pesticides containing such active ingredient
are eligible for reregistration. For extraordinary circumstances,
the Administrator may extend such period for not more than 1
additional year.
(B) Before reregistering a pesticide, the Administrator shall
obtain any needed product-specific data regarding the pesticide
by use of section 3(c)(2)(B) and shall review such data within
90 days after its submission. The Administrator shall require
that data under this subparagraph be submitted to the Administrator
not later than 8 months after a determination of eligibility
under subparagraph (A) has been made for each active ingredient
of the pesticide, unless the Administrator determines that a
longer period is required for the generation of the data.
(C) After conducting the review required by paragraph (1) for
each active ingredient of a pesticide and the review required
by subparagraph (B) of this paragraph, the Administrator shall
determine whether to reregister a pesticide by determining whether
such pesticide meets the requirements of section 3(c)(5). If
the Administrator determines that a pesticide is eligible to
be reregistered, the Administrator shall reregister such pesticide
within 6 months after the submission of the data concerning such
pesticide under subparagraph (B).
(D) If after conducting a review under paragraph (1) or subparagraph
(B) of this paragraph the Administrator determines that a pesticide
should not be reregistered, the Administrator shall take appropriate
regulatory action. |
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(h)
COMPENSATION OF DATA SUBMITTER.-If
data that are submitted by a registrant under subsection (d),
(e), (f), or (g) are used to support the application of another
person under section 3, the registrant who submitted such data
shall be entitled to compensation for the use of such data as
prescribed by section 3(c)(1)(D). In determining the amount of
such compensation, the fees paid by the registrant under this
section shall be taken into account.
(i)
FEES.-
(1)
INITIAL FEE FOR FOOD OR FEED USE PESTICIDE ACTIVE INGREDIENTS.-The registrants of pesticides that
contain an active ingredient that is listed under subparagraph
(B), (C), or (D) of subsection (c)(2) and that is an active ingredient
of any pesticide registered for a major food or feed use shall
collectively pay a fee of $50,000 on submission of information
under paragraphs (2) and (3) of subsection (d) for such ingredient.
(2)
FINAL FEE FOR FOOD OR FEED USE PESTICIDE ACTIVE INGREDIENTS.-
(A) The registrants
of pesticides that contain an active ingredient that is listed
under subparagraph (B), (C), or (D) of subsection (c)(2) and
that is an active ingredient of any pesticide registered for
a major food or feed use shall collectively pay a fee of $100,000-
(i) on submission
of information for such ingredient under subsection (e)(i) if
data are reformatted under subsection (e)(1)(C); or
(ii) on submission of data for such ingredient under subsection
(e)(2)(B) if data are not reformatted under subsection (e)(1)(C). |
(B) The registrants of
pesticides that contain an active ingredient that is listed under
subsection (c)(2)(A) and that is an active ingredient of any
pesticide registered for a major food or feed use shall collectively
pay a fee of $150,000 at such time as the Administrator shall
prescribe. |
(3)
FEES FOR OTHER PESTICIDE ACTIVE INGREDIENTS.-
(A) The registrants
of pesticides that contain an active ingredient that is listed
under subparagraph (B), (C), or (D) of subsection (c)(2) and
that is not an active ingredient of any pesticide registered
for a major food or feed use shall collectively pay fees in amounts
determined by the Administrator. Such fees may not be less than
one-half of, nor greater than, the fees required by paragraphs
(1) and (2). A registrant shall pay such fees at the times corresponding
to the times fees prescribed by paragraphs (1) and (2) are to
be paid.
(B) The registrants of pesticides that contain an active ingredient
that is listed under subsection (c)(2)(A) and that is not an
active ingredient of any pesticide that is registered for a major
food or feed use shall collectively pay a fee of not more than
$100,000 and not less than $50,000 at such time as the Administrator
shall prescribe. |
(4)
REDUCTION OR WAIVER OF FEES FOR MINOR USE AND OTHER PESTICIDES.-
(A) An active
ingredient that is contained only in pesticides that are registered
solely for agricultural or nonagricultural minor uses, or a pesticide
the value or volume of use of which is small, shall be exempt
from the fees prescribed by paragraph (3).
(B) An antimicrobial active ingredient, the production level
of which does not exceed 1,000,000 pounds per year, shall be
exempt from the fees prescribed by paragraph (3). For purposes
of this subparagraph, the term "antimicrobial active ingredient"
means any active ingredient that is contained only in pesticides
that are not registered for any food or feed use and that are-
(i) sanitizers
intended to reduce the number of living bacteria or viable virus
particles on inanimate surface or in water or air
(ii) bacteriostats intended to inhibit the growth of bacteria
in the presence of moisture;
(iii) disinfectants intended to destroy or irreversibly inactivate
bacteria, fungi, or viruses on surfaces or inanimate objects;
(iv) sterilizers intended to destroy viruses and all living bacteria,
fungi, and their spores on inanimate surfaces; or
(v) fungicides or fungistats. |
(C)(i) Notwithstanding
any other provision of this subsection, in the case of a small
business registrant of a pesticide, the registrant shall pay
a fee for the reregistration of each active ingredient of the
pesticide that does not exceed an amount determined in accordance
with this subparagraph.
(ii) If during the 3-year period prior to reregistration the
average annual gross revenue of the registrant from pesticides
containing such active ingredient is-
(I) less than
$5,000,000, the registrant shall pay 0.5 percent of such revenue;
(II) $5,000,000 or more but less than $10,000,000, the registrant
shall pay 1 percent of such revenue; or
(III) $10,000,000 or more, the registrant shall pay 1.5 percent
of such revenue, but not more than $150,000. |
(iii) For the purpose
of this subparagraph, a small business registrant is a corporation,
partnership, or unincorporated business that-
(I) has 150 or
fewer emoloyees; and
(II) during the 3-year period prior to reregistration, had an
average annual gross revenue from chemicals that did not exceed
$40,000,000. |
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(5)
MAINTENANCE FEE.-
(A) Subject to
other provisions of this paragraph, each registrant of a pesticide
shall pay an annual fee by March 1 of each year of-
(i) in the case
of a registrant holding not more than 50 pesticide registrations,
$425 for each registration; and
(ii) in the case of a registrant holding more than 50 pesticide
registrations-
(i) in the case
of a registrant holding not more than 50 pesticide registrations,
$425 for each registration; and
(ii) in the case of a registrant holding more than 50 pesticide
registrations-
(I) $425 for
each registration up to 50 registrations; and
(II) $100 for each registration over 50 registrations, except
that no fee shall be charged for more than 200 registrations held
by any registrant. |
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(B) The amount of each
fee prescribed under subparagraph (A) shall be adjusted by the
Administrator to a level that will result in the collection under
this paragraph of, to the extent practicable, an aggregate amount
of $14,000,000 each fiscal year.
(C)(i) The maximum annual fee payable by a registrant under clause
(i) of subparagraph (A) (as adjusted under subparagraph (B))
shall be $20,000.
(ii) The maximum annual fee payable by a registrant under clause
(ii) of subparagraph (A) (as adjusted under subparagraph (B))
shall be $35,000.
(D) If any fee prescribed by this paragraph with respect to the
registration of a pesticide is not paid by a registrant by the
time prescribed, the Administrator, by order and without hearing,
may cancel the registration.
(E) The authority provided under this paragraph shall terminate
on September 30, 1997. |
(6)
OTHER FEES.-During
the period beginning on the date of enactment of this section
[October 25, 1988] and ending on September 30, 1997, the Administrator
may not levy any other fees for the registration of a pesticide
under this Act except as provided in paragraphs (1) through (5).
(7)
APPORTIONMENT.-
(A) If two or
more registrants are required to pay any fee prescribed by paragraph
(1), (2), or (3) with respect to a particular active ingredient,
the fees for such active ingredient shall be apportioned among
such registrants on the basis of the market share in United States
sales of the active ingredient for the 3 calendar years preceding
the date of payment of such fee, except that-
(i) small business
registrants that produce the active ingredient shall pay fees
in accordance with paragraph (4)(C); and
(ii) registrants who have no market share but who choose to reregister
a pesticide containing such active ingredient shall pay the lesser
of-
(I) 15 percent
of the reregistration fee; or
(II) a proportionate amount of such fee based on the lowest percentage
market share held by any registrant active in the marketplace. |
In no event shall registrants
who have no market share but who choose to reregister a pesticide
containing such active ingredient collectively pay more man 25
percent of the total active ingredient reregistration fee. |
(B) The Administrator,
by order, may require any registrant to submit such reports as
the Administrator determines to be necessary to allow the Administrator
to determine and apportion fees under this subsection or to determine
the registrant's eligibility for a reduction or waiver of a fee.
(C) If any such report is not submitted by a registrant after
receiving notice of such report requirement, or if any fee prescribed
by this subsection (other than paragraph (5)) for an active ingredient
is not paid by a registrant to the Administrator by the time
prescribed under this subsection, the Administrator, by order
and without hearing, may cancel each registration held by such
registrant of a pesticide containing the active ingredient with
respect to which the fee is imposed. The Administrator shall
reapportion the fee among the remaining registrants and notify
the registrants that the registrants are required to pay to the
Administrator any unpaid balance of the fee within 30 days after
receipt of such notice. |
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(j)
EXEMPTION OF CERTAIN REGISTRANTS.-The
requirements of subsections (d), (e), (f), and (i) (other than
subsection (i)(5)) regarding data concerning an active
ingredient and fees for review of such data shall not apply to
any person who is the registrant of a pesticide to the extent
that, under section 3(c)(2)(D), the person would not be required
to submit or cite such data to obtain an initial registration
of such pesticide.
(k)
REREGISTRATION AND EXPEDITED PROCESSING FUND.-
(1)
ESTABLISHMENT.-There
shall be established in the Treasury of the United States a reregistration
and expedited processing fund.
(2)
SOURCE AND USE.-All
fees collected by the Administrator under subsection (i) shall
be deposited into the fund and shall be available to the Administrator,
without fiscal year limitation, to carry out reregistration and
expedited processing of similar applications.
(3)
EXPEDITED PROCESSING OF SIMILAR APPLICATIONS.-
(A) The Administrator
shall use each fiscal year not more than $2,000,000 of the amounts
in the fund to obtain sufficient personnel and resources to assure
the expedited processing and review of any application 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 any 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. |
(B) Any amounts made available
under subparagraph (A) shall be used to obtain sufficient personnel
and resources to carry out the activities described in such subparagraph
that are in addition to the personnel and resources available
to carry out such activities on the date of enactment of this
section [October 25, 1988]. |
(4)
UNUSED FUNDS.-Money
in the fund not currently needed to carry out this section shall
be-
(A) maintained
on hand or on deposit;
(B) invested in obligations of the United States or guaranteed
thereby; or
(C) invested in obligations, participations, or other instruments
that are lawful investments for fiduciary, trust, or public funds. |
(5)
ACCOUNTING.-The Administrator
shall-
(A) provide an
annual accounting of the fees collected and disbursed from the
fund; and
(B) take all steps necessary to ensure that expenditures from
such fund are used only to carry out this section. |
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(l)
JUDICIAL REVIEW.-Any
failure of the Administrator to take any action required by this
section shall be subject to judicial review under the procedures
prescribed by section 16(b).
(4-1) So in original. Margin of paragraph (3) should he aligned
with margin of preceding paragraph (2). |
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