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U.S. Code as of:
01/03/05
Section 136a-1. 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, that -
(1) there are no outstanding data requirements; and
(2) the requirements of section 136a(c)(5) of this title have
been satisfied.
(b) Reregistration phases
Reregistrations of pesticides under this section shall be carried
out in the following phases:
(1) The first phase shall include the listing under subsection
(c) of this section of the active ingredients of the pesticides
that will be reregistered.
(2) The second phase shall include the submission to the
Administrator under subsection (d) of this section of notices by
registrants respecting their intention to seek reregistration,
identification by registrants of missing and inadequate data for
such pesticides, and commitments by registrants to replace such
missing or inadequate data within the applicable time period.
(3) The third phase shall include submission to the
Administrator by registrants of the information required under
subsection (e) of this section.
(4) The fourth phase shall include an independent, initial
review by the Administrator under subsection (f) of this section
of submissions under phases two and three, identification of
outstanding data requirements, and the issuance, as necessary, of
requests for additional data.
(5) The fifth phase shall include the review by the
Administrator under subsection (g) of this section of data
submitted for reregistration and appropriate regulatory action by
the Administrator.
(c) Phase one
(1) Priority for reregistration
For purposes of the reregistration of the pesticides described
in subsection (a) of this section, 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) 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 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, 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) of this section
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) of this section 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) of this section 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) of this section 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 136a of this title, 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 136a(c)(2)(B) of this title with regard
to such cost sharing.
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) of this section
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) of this section,
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) of this section,
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) of this section,
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. Upon application
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 this section 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 this section; 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 subparagraph, 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) of section 136a(c)(2)(B) of this
title or other provisions of this section, as appropriate,
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 subparagraph, the
Administrator may take action to modify or revoke the extension
under this subparagraph 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 written notice to the registrant
revoking the extension of time for submission of data. Such
data shall instead be due in accordance with the date then
established by the Administrator for submission of the data.
(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) of this section
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) of this section 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) of
this section has been paid.
(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 136a(c)(2)(B)(iv) of this title 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. 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 paragraph
in regard to such unsupported minor use until the final deadline
established as of August 3, 1996, for the submission of data
under this section for the supported uses identified pursuant to
this paragraph unless the Administrator determines that the
absence of the data is significant enough to cause human health
or environmental concerns. On such a 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 paragraph, 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 section
136a(c)(2)(B)(iv) of this title 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 this
subparagraph, the Administrator may deny, modify, or revoke the
temporary extension under this paragraph 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.
(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) of this section who has submitted a notice
under subsection (d)(2) of this section 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 136a of this title 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 136a of
this title 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
136a of this title, 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 136a of this title and the
regulations issued under such section;
(E) an identification of data that are required to be
submitted to the Administrator under section 136d(a)(2) of this
title, 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 136a(c)(2)(B) of this
title with regard to such cost sharing; and
(I) evidence of compliance with section 136a(c)(1)(D)(ii)
(!1) of this title 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
subchapter and shall be subject to the penalties prescribed by
section 136l of this title.
(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) of this section,
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) of this section,
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) of this section,
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. Upon application 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 this
section 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 this section; 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 subparagraph, 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) of section 136a(c)(2)(B) of this
title or other provisions of this section, as appropriate,
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 subparagraph, the
Administrator may take action to modify or revoke the extension
under this subparagraph 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 written notice to the registrant
revoking the extension of time for submission of data. Such
data shall instead be due in accordance with the date then
established by the Administrator for submission of the data.
(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. 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 subparagraph in regard to
such unsupported minor use until the final deadline established
as of August 3, 1996, for the submission of data under this
section for the supported uses identified pursuant to this
subparagraph 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 subparagraph, 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 section
136a(c)(2)(B)(iv) of this title 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 this
subparagraph, 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.
(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 136d(d) of this title, 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, 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 136a of this
title 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 (e)(1) of this section 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 reregistration to
submit complete copies of studies summarized under subsection
(e)(1) of this section.
(B) The Administrator shall independently identify and publish
in the Federal Register the outstanding data requirements for
each active ingredient that is listed under subparagraph (B),
(C), or (D) of subsection (c)(2) of this section and that is
contained in a pesticide to be reregistered under this section.
The Administrator, at the same time, shall issue a notice under
section 136a(c)(2)(B) of this title for the submission of the
additional 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) of this section,
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) of this section,
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) of this section,
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.
Upon application 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 this section 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 this section; 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 subparagraph, 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) of section 136a(c)(2)(B) of this
title or other provisions of this section, as appropriate,
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 subparagraph, the
Administrator may take action to modify or revoke the extension
under this subparagraph 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 written notice to the registrant
revoking the extension of time for submission of data. Such
data shall instead be due in accordance with the date then
established by the Administrator for submission of the data.
(3) 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 136a(c)(2)(B)(iv) of this title 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.
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 paragraph in regard to
such unsupported minor use until the final deadline established
as of August 3, 1996, for the submission of data under this
section for the supported uses identified pursuant to this
paragraph unless the Administrator determines that the absence of
the data is significant enough to cause human health or
environmental concerns. On such a 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 paragraph, 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 section
136a(c)(2)(B)(iv) of this title 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 this
subparagraph, the Administrator may deny, modify, or revoke the
temporary extension under this paragraph 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.
(g) Phase five
(1) Data review
The Administrator shall conduct a thorough examination of all
data submitted under this section concerning an active ingredient
listed under subsection (c)(2) of this section and of all other
available data found by the Administrator to be relevant.
(2) Reregistration and other actions
(A) In general. - The Administrator shall make a determination
as to eligibility for reregistration -
(i) for all active ingredients subject to reregistration
under this section for which tolerances or exemptions from
tolerances are required under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.), not later than the last
date for tolerance reassessment established under section
408(q)(1)(C) of that Act (21 U.S.C. 346a(q)(1)(C)); and
(ii) for all other active ingredients subject to
reregistration under this section, not later than October 3,
2008.
(B) Product-specific data. -
(i) In general. - Before reregistering a pesticide, the
Administrator shall obtain any needed product-specific data
regarding the pesticide by use of section 136a(c)(2)(B) of this
title and shall review such data within 90 days after its
submission.
(ii) Timing. -
(I) In general. - Subject to subclause (II), 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.
(II) Extraordinary circumstances. - In the case of
extraordinary circumstances, the Administrator may provide
such a longer period, of not more than 2 additional years,
for submission of data to the Administrator under this
subparagraph.
(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
136a(c)(5) of this title. 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) Determination to not reregister. -
(i) In general. - 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.
(ii) Timing for regulatory action. - Regulatory action under
clause (i) shall be completed as expeditiously as possible.
(E) As soon as the Administrator has sufficient information
with respect to the dietary risk of a particular active
ingredient, but in any event no later than the time the
Administrator makes a determination under subparagraph (C) or (D)
with respect to pesticides containing a particular active
ingredient, the Administrator shall -
(i) reassess each associated tolerance and exemption from the
requirement for a tolerance issued under section 408 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a);
(ii) determine whether such tolerance or exemption meets the
requirements of that Act [21 U.S.C. 301 et seq.];
(iii) determine whether additional tolerances or exemptions
should be issued;
(iv) publish in the Federal Register a notice setting forth
the determinations made under this subparagraph; and
(v) commence promptly such proceedings under this subchapter
and section 408 of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 346a] as are warranted by such determinations.
(h) Compensation of data submitter
If data that are submitted by a registrant under subsection (d),
(e), (f), or (g) of this section are used to support the
application of another person under section 136a of this title, the
registrant who submitted such data shall be entitled to
compensation for the use of such data as prescribed by section
136a(c)(1)(D) (!2) of this title. 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) of this section 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) of this section
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) of this section 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)(1) of this section if data are reformatted under
subsection (e)(1)(C) of this section; or
(ii) on submission of data for such ingredient under
subsection (e)(2)(B) of this section if data are not
reformatted under subsection (e)(1)(C) of this section.
(B) The registrants of pesticides that contain an active
ingredient that is listed under subsection (c)(2)(A) of this
section 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) of this section 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) of this
section 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) The Administrator shall exempt any public health pesticide
from the payment of the fee prescribed under paragraph (3) if, in
consultation with the Secretary of Health and Human Services, the
Administrator determines, based on information supplied by the
registrant, that the economic return to the registrant from sales
of the pesticide does not support the registration or
reregistration of the pesticide.
(C) 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.
(D)(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 employees; 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.
(5) Maintenance fee
(A) In general. - Subject to other provisions of this
paragraph, each registrant of a pesticide shall pay an annual fee
by January 15 of each year for each registration, except that no
fee shall be charged for more than 200 registrations held by any
registrant.
(B) In the case of a pesticide that is registered for a minor
agricultural use, the Administrator may reduce or waive the
payment of the fee imposed under this paragraph if the
Administrator determines that the fee would significantly reduce
the availability of the pesticide for the use.
(C) Total amount of fees. - 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 -
(i) for fiscal year 2004, $26,000,000;
(ii) for fiscal year 2005, $27,000,000;
(iii) for fiscal year 2006, $27,000,000;
(iv) for fiscal year 2007, $21,000,000; and
(v) for fiscal year 2008, $15,000,000.
(D) Maximum amount of fees for registrants. - The maximum
annual fee payable under this paragraph by -
(i) a registrant holding not more than 50 pesticide
registrations shall be -
(I) for fiscal year 2004, $84,000;
(II) for each of fiscal years 2005 and 2006, $87,000;
(III) for fiscal year 2007, $68,000; and
(IV) for fiscal year 2008, $55,000; and
(ii) a registrant holding over 50 registrations shall be -
(I) for fiscal year 2004, $145,000;
(II) for each of fiscal years 2005 and 2006, $151,000;
(III) for fiscal year 2007, $117,000; and
(IV) for fiscal year 2008, $95,000.
(E) Maximum amount of fees for small businesses. -
(i) In general. - For a small business, the maximum annual
fee payable under this paragraph by -
(I) a registrant holding not more than 50 pesticide
registrations shall be -
(aa) for fiscal year 2004, $59,000;
(bb) for each of fiscal years 2005 and 2006, $61,000;
(cc) for fiscal year 2007, $48,000; and
(dd) for fiscal year 2008, $38,500; and
(II) a registrant holding over 50 pesticide registrations
shall be -
(aa) for fiscal year 2004, $102,000;
(bb) for each of fiscal years 2005 and 2006, $106,000;
(cc) for fiscal year 2007, $82,000; and
(dd) for fiscal year 2008, $66,500.
(ii) Definition of small business. -
(I) In general. - In clause (i), the term "small business"
means a corporation, partnership, or unincorporated business
that -
(aa) has 500 or fewer employees; and
(bb) during the 3-year period prior to the most recent
maintenance fee billing cycle, had an average annual global
gross revenue from pesticides that did not exceed
$60,000,000.
(II) Affiliates. -
(aa) In general. - In the case of a business entity with
1 or more affiliates, the gross revenue limit under
subclause (I)(bb) shall apply to the gross revenue for the
entity and all of the affiliates of the entity, including
parents and subsidiaries, if applicable.
(bb) Affiliated persons. - For the purpose of item (aa),
persons are affiliates of each other if, directly or
indirectly, either person controls or has the power to
control the other person, or a third person controls or has
the power to control both persons.
(cc) Indicia of control. - For the purpose of item (aa),
indicia of control include interlocking management or
ownership, identity of interests among family members,
shared facilities and equipment, and common use of
employees.
(F) The Administrator shall exempt any public health pesticide
from the payment of the fee prescribed under paragraph (3) if, in
consultation with the Secretary of Health and Humans (!3)
Services, the Administrator determines, based on information
supplied by the registrant, that the economic return to the
registrant from sales of the pesticide does not support the
registration or reregistration of the pesticide.
(G) 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.
(H) The authority provided under this paragraph shall terminate
on September 30, 2008.
(6) Other fees
Except as provided in section 136w-8 of this title, during the
period beginning on October 25, 1988, and ending on September 30,
2010, the Administrator may not levy any other fees for the
registration of a pesticide under this subchapter 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 than 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, to determine the registrant's
eligibility for a reduction or waiver of a fee, or to determine
the volume usage for public health pesticides.
(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.
(j) Exemption of certain registrants
The requirements of subsections (d), (e), (f), and (i) of this
section (other than subsection (i)(5) of this section) 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 136a(c)(2)(D) of this
title, 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 which shall be
known as the Reregistration and Expedited Processing Fund.
(2) Source and use
(A) All moneys derived from fees collected by the Administrator
under subsection (i) of this section shall be deposited in the
fund and shall be available to the Administrator, without fiscal
year limitation, specifically to offset the costs of
reregistration and expedited processing of the applications
specified in paragraph (3). Such moneys derived from fees may not
be expended in any fiscal year to the extent such moneys derived
from fees would exceed money appropriated for use by the
Administrator and expended in such year for such costs of
reregistration and expedited processing of such applications. The
Administrator shall, prior to expending any such moneys derived
from fees -
(i) effective October 1, 1997, adopt specific and cost
accounting rules and procedures as approved by the Government
Accountability Office and the Inspector General of the
Environmental Protection Agency to ensure that moneys derived
from fees are allocated solely to the costs of reregistration
and expedited processing of the applications specified in
paragraph (3) in the same portion as appropriated funds;
(ii) prohibit the use of such moneys derived from fees to pay
for any costs other than those necessary to achieve
reregistration and expedited processing of the applications
specified in paragraph (3); and
(iii) ensure that personnel and facility costs associated
with the functions to be carried out under this paragraph do
not exceed agency averages for comparable personnel and
facility costs.
(B) The Administrator shall also -
(i) complete the review of unreviewed reregistration studies
required to support the reregistration eligibility decisions
scheduled for completion in accordance with subsection (l)(2)
of this section; and
(ii) contract for such outside assistance as may be necessary
for review of required studies, using a generally accepted
competitive process for the selection of vendors of such
assistance.
(3) Review of inert ingredients; expedited processing of similar
applications
(A) The Administrator shall use for each of the fiscal years
2004 through 2006, approximately $3,300,000, and for each of
fiscal years 2007 and 2008, between 1/8 and 1/7 , of the
maintenance fees collected in such fiscal year to obtain
sufficient personnel and resources -
(i) to review and evaluate new inert ingredients; and
(ii) to ensure 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;
(II) proposes an amendment to the registration of a
registered pesticide that does not require scientific review
of data; or
(III) proposes the initial or amended registration of an
end use pesticide that, if registered as proposed, would be
used for a public health pesticide.
(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 October 25, 1988.
(C) So long as the Administrator has not met the time frames
specified in clause (ii) of section 136a(c)(3)(B) of this title
with respect to any application subject to section 136a(c)(3)(B)
of this title that was received prior to August 3, 1996, the
Administrator shall use the full amount of the fees specified in
subparagraph (A) for the purposes specified therein. Once all
applications subject to section 136a(c)(3)(B) of this title that
were received prior to August 3, 1996, have been acted upon, no
limitation shall be imposed by the preceding sentence of this
subparagraph so long as the Administrator meets the time frames
specified in clause (ii) of section 136a(c)(3)(B) of this title
on 90 percent of affected applications in a fiscal year. Should
the Administrator not meet such time frames in a fiscal year, the
limitations imposed by the first sentence of this subparagraph
shall apply until all overdue applications subject to section
136a(c)(3)(B) of this title have been acted upon.
(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 and performance
The Administrator shall take all steps necessary to ensure that
expenditures from fees authorized by subsection (i)(5)(C)(ii)
(!2) of this section are used only to carry out the goals
established under subsection (l) of this section. The
Reregistration and Expedited Processing Fund shall be designated
as an Environmental Protection Agency component for purposes of
section 3515(c) of title 31. The annual audit required under
section 3521 of such title of the financial statements of
activities under this subchapter under section 3515(b) of such
title shall include an audit of the fees collected under
subsection (i)(5)(C) of this section and disbursed, of the amount
appropriated to match such fees, and of the Administrator's
attainment of performance measures and goals established under
subsection (l) of this section. Such an audit shall also include
a review of the reasonableness of the overhead allocation and
adequacy of disclosures of direct and indirect costs associated
with carrying out the reregistration and expedited processing of
the applications specified in paragraph (3), and the basis for
and accuracy of all costs paid with moneys derived from such
fees. The Inspector General shall conduct the annual audit and
report the findings and recommendations of such audit to the
Administrator and to the Committees on Agriculture of the House
of Representatives and the Senate. The cost of such audit shall
be paid for out of the fees collected under subsection (i)(5)(C)
of this section.
(l) Performance measures and goals
The Administrator shall establish and publish annually in the
Federal Register performance measures and goals. Such measures and
goals shall include -
(1) the number of products reregistered, canceled, or amended,
the status of reregistration, the number and type of data
requests under section 136a(c)(2)(B) of this title issued to
support product reregistration by active ingredient, the progress
in reducing the number of unreviewed, required reregistration
studies, the aggregate status of tolerances reassessed, and the
number of applications for registration submitted under
subsection (k)(3) of this section that were approved or
disapproved;
(2) the future schedule for reregistrations, including the
projection for such schedules that will be issued under
subsection (g)(2)(A) and (B) of this section in the current
fiscal year and the succeeding fiscal year; and
(3) the projected year of completion of the reregistrations
under this section.
(m) 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 136n(b) of this title.
(n) Authorization of funds to develop public health data
(1) "Secretary" defined
For the purposes of this section, "Secretary" means the
Secretary of Health and Human Services, acting through the Public
Health Service.
(2) Consultation
In the case of a pesticide registered for use in public health
programs for vector control or for other uses the Administrator
determines to be human health protection uses, the Administrator
shall, upon timely request by the registrant or any other
interested person, or on the Administrator's own initiative may,
consult with the Secretary prior to taking final action to
suspend registration under section 136a(c)(2)(B)(iv) of this
title, or cancel a registration under section 136a-1, 136d(e), or
136d(f) of this title. In consultation with the Secretary, the
Administrator shall prescribe the form and content of requests
under this section.
(3) Benefits to support family
The Administrator, after consulting with the Secretary, shall
make a determination whether the potential benefits of continued
use of the pesticide for public health or health protection
purposes are of such significance as to warrant a commitment by
the Secretary to conduct or to arrange for the conduct of the
studies required by the Administrator to support continued
registration under section 136a of this title or reregistration
under this section.
(4) Additional time
If the Administrator determines that such a commitment is
warranted and in the public interest, the Administrator shall
notify the Secretary and shall, to the extent necessary, amend a
notice issued under section 136a(c)(2)(B) of this title to
specify additional reasonable time periods for submission of the
data.
(5) Arrangements
The Secretary shall make such arrangements for the conduct of
required studies as the Secretary finds necessary and appropriate
to permit submission of data in accordance with the time periods
prescribed by the Administrator. Such arrangements may include
Public Health Service intramural research activities, grants,
contracts, or cooperative agreements with academic, public
health, or other organizations qualified by experience and
training to conduct such studies.
(6) Support
The Secretary may provide for support of the required studies
using funds authorized to be appropriated under this section, the
Public Health Service Act [42 U.S.C. 201 et seq.], or other
appropriate authorities. After a determination is made under
subsection (d) of this section, the Secretary shall notify the
Committees on Appropriations of the House of Representatives and
the Senate of the sums required to conduct the necessary studies.
(7) Authorization of appropriations
There is authorized to be appropriated to carry out the
purposes of this section $12,000,000 for fiscal year 1997, and
such sums as may be necessary for succeeding fiscal years.
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