Document ID: EPA-HQ-OPP-2011-0886-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-12-14T05:00Z

Attachment A

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 

Section 4 - Reregistration of Registered Pesticides

SEC. 4. [7 U.S.C. 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 [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, 1988]) 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 ingredients for
which registration standards have been issued this section [December 24,
1988], list pesticide active 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
Administrator shall send by certified mail to the registrants of the
pesticide active ingredients under paragraph (2), 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. 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. 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 the date
of enactment of the Food Quality Protection Act of 1996 [Aug. 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.4–1  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.4–1 If Administrator
determines that the registrant is not meeting or the has not met the
schedule for the production of such data, the Administrator may proceed
in accordance with clause (iv) of section 3(c)(2)(B) 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) 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.

4–1 Indentation of the following sentences of this subparagraph is so
in original (as added by sec. 201(c)(2) of P.L. 104-170). Probably
should be indented the same as flush matter of this subparagraph. 

(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. 

(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.  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 the date of
enactment of the Food Quality Protection Act of 1996 [Aug. 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 the from the registrant, the Administrator
shall publish in 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 6(f)(1).
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 3(c)(2)(B)(iv) 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
6(f)(2). 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) 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. 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 the date
of enactment of the Food Quality Protection Act of 1996 [Aug. 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.4–2 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 3(c)(2)(B) 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. 

4–2 Indentation of the following sentences of this subparagraph is so
in original (as added by sec. 201(c)(2) of P.L. 104-170). Probably
should be indented the same as flush matter of this subparagraph.

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 specific minor use of the pesticide. If the
registrant does not commit to support a 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 the date of
enactment of the Food Quality Protection Act of 1996 [Aug. 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 6(f)(1). 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 3(c)(2)(B)(iv) 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 6(f)(2). 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 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 (e)(1) 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).

(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) 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 3(c)(2)(B) 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), 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. 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 the date of enactment of the Food Quality
Protection Act of 1996 [Aug. 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.4–3 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 

4–3 Indentation of the following sentences of this subparagraph is so
in original (as added by sec. 201(c)(2) of P.L. 104-170). Probably
should be indented the same as flush matter of this subparagraph.

schedule for the production of such data, the Administrator may proceed
in accordance with clause (iv) of section 3(c)(2)(B) 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 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. 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 the date of enactment of the Food Quality
Protection Act of 1996 [Aug. 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 6(f)(1). 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
3(c)(2)(B)(iv) 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 6(f)(2). 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) 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 3(c)(2)(B) 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 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) 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; 

(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 Act and section 408 of
the Federal Food, Drug, and Cosmetic Act 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) 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)(1) 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) 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 reregistration, had an average
annual gross revenue from to 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) 4–4 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) 4–5 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.

4–4 Subclause margins are so in original (as added by sec.
501(c)(1)(B)(ii) of P.L. 108-199). Probably should be further indented.

4–5 Subclause margins are so in original (as added by sec.
501(c)(1)(B)(ii) of P.L. 108-199). Probably should be further indented.

(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 Humans4–6 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.

4–6 So in original (as added by sec. 232(2) of P.L. 104-170). Probably
should be “Human”.

(H) The authority provided under this paragraph shall terminate on
September 30,

2008. 

(6) OTHER FEES.—Except as provided in section 33, during the period
beginning on the date of enactment of this section [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 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 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 reapportion the fee
among the remaining registrants and notify which the fee is imposed. The
Administrator shall 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) (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 which shall
be known as the Reregistration and Expedited Processing Fund.4–7

(2) 4–8 SOURCE AND USE.— 

(A) All moneys derived from fees collected by the Administrator under
subsection (i) 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 General Accounting 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 applications specified in
paragraph (3) in the same of the 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); 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.— 

4–7  ADVANCE \d1 Sec. 501(b) of P.L. 104-170 amended sec. 4(k)(1) (7
U.S.C. 136a–1(k)(1)) by inserting “which shall be known as the
Reregistration and Expedited Processing Fund”, without specifying the
Act that was being amended. The amendment was executed to this Act to
effectuate the probable intent of Congress. 

 ADVANCE \d1 	4–8 Sec. 501(c) of P.L. 104-170 amended sec. 4(k)(2) (7
U.S.C. 136a–1(k)(2)) to read as provided above, without specifying the
Act that was being amended. The amendment was executed to this Act to
effectuate the probable intent of Congress.

(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 year4–9 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 

  4–10 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;

(III) proposes the initial or amended or 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 the date of
enactment of this section [October 25, 1988]. 

(C) 4–11 So long as the Administrator has not met the time frames
specified in clause (ii) of section 3(c)(3)(B) with respect to any
application subject to section 3(c)(3)(B) that was received prior to the
date of enactment of the Food Quality Protection Act of 1996 [Aug. 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 3(c)(3)(B) that were received prior to
such date of enactment 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

4–9 P.L. 107-73 (115 Stat. 686) amended sec. 4(k)(3)(A) by striking
“2001” and inserting “2002”; and by striking “1/7” and
inserting “1/10”. In an earlier enactment, sec. 501(d)(1) of P.L.
104-170 amended sec. 4(k)(3) (7 U.S.C. 136a–1(k)(3)) by striking
“for each of the fiscal years 1992, 1993, and 1994, 1/7th of the
maintenance fees collected, up to 2 million each year” and inserting
“for each of the fiscal years 1997 through 2001, not more than 1/7 of
the maintenance fees collected in such fiscal year”, without
specifying the Act that was being amended and without including a $
before “2 million”. The earlier amendment was executed to this Act,
and to strike “$2 million”, to effectuate the probable intent of
Congress. 

4–10 So in original (as added by sec. 501(e)(2)(C) of P.L. 108-199).
Probably should be no indent before “that”.

4–11 Sec. 501(d)(2) of P.L. 104-170 added subpara. (C) to sec. 4(k)(3)
(7 U.S.C. 136a–1(k)(3)), without specifying the Act that was being
amended. The amendment was executed to this Act to effectuate the
probable intent of Congress.

specified in clause (ii) of section 3(c)(3)(B) 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 3(c)(3)(B) 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) 4–12 ACCOUNTING AND PERFORMANCE.—The Administrator shall take
all steps necessary to ensure that expenditures from fees authorized by
subsection (i)(5)(C)(ii) are used only to carry out the goals
established under subsection (l). The Reregistration and Expedited
Processing Fund shall be designated as an Environmental Protection
Agency component for purposes of section 3515(c) of title 31, United
States Code. The annual audit required under section 3521 of such title
of the financial statements of activities under this Act under section
3515(b) of such title shall include an audit of the fees collected under
subsection (i)(5)(C) 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). 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). 	

(l) 4–13 PERFORMANCE MEASURES AND GOAL.—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 3(c)(2)(B) 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) that were approved or disapproved; 

4–12 Sec. 501(e) of P.L. 104-170 amended sec. 4(k)(5) (7 U.S.C.
136a–1(k)(5)) to read as provided above, without specifying the Act
that was being amended. The amendment was executed to this Act to
effectuate the probable intent of Congress.

4–13 Sec. 501(f) of P.L. 104-170 amended sec. 4 (7 U.S.C. 136a–1) by
redesignating subsecs. (l) and (m) as subsecs. (m) and (n),
respectively, and inserting a new subsec. (l), without specifying the
Act that was being amended. The amendments were executed to this Act to
effectuate the probable intent of Congress.

(2) the future schedule for reregistrations, including the projection
for such schedules that will be issued under subsection (g)(2)(A) and
(B) 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 16(b). 

(n) AUTHORIZATION OF FUNDS TO DEVELOP PUBLIC HEALTH DATA.— 

(1) DEFINITION.—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 3(c)(2)(B)(iv), or cancel a registration
under section 4, 6(e), or 6(f). 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 3 or reregistration under section 4. 

(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 3(c)(2)(B) 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, or other appropriate authorities. After a
determination is made under subsection (d), 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.