[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1983 Considered and Passed Senate (CPS)]
110th CONGRESS
1st Session
S. 1983
To amend the Federal Insecticide, Fungicide, and Rodenticide Act to
renew and amend the provisions for the enhanced review of covered
pesticide products, to authorize fees for certain pesticide products,
to extend and improve the collection of maintenance fees, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
August 2, 2007
Mr. Harkin (for himself and Mr. Chambliss) introduced the following
bill; which was read twice, considered, read the third time, and passed
_______________________________________________________________________
A BILL
To amend the Federal Insecticide, Fungicide, and Rodenticide Act to
renew and amend the provisions for the enhanced review of covered
pesticide products, to authorize fees for certain pesticide products,
to extend and improve the collection of maintenance fees, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Pesticide Registration Improvement
Renewal Act''.
SEC. 2. REVIEW OF APPLICATIONS.
Section 3(c)(3)(B)(ii) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a(c)(3)(B)(ii)) is amended--
(1) in subparagraph (I), by striking ``within 45 days'' and
all that follows through ``and,'' and inserting ``review the
application in accordance with section 33(f)(4)(B) and,''; and
(2) in subparagraph (II), by striking ``within'' and
inserting ``not later than the applicable decision review time
established pursuant to section 33(f)(4)(B), or, if no review
time is established, not later than''.
SEC. 3. REGISTRATION REVIEW.
Section 3(g)(1) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a(g)(1)) is amended--
(1) in subparagraph (A)--
(A) in the first sentence, by striking ``The
registrations'' and inserting the following:
``(i) In general.--The registrations'';
(B) in the second sentence, by striking ``The
Administrator'' and inserting the following:
``(ii) Regulations.--In accordance with this
subparagraph, the Administrator''; and
(C) by striking ``The goal'' and all that follows
through ``No registration'' and inserting the
following:
``(iii) Initial registration review.--The
Administrator shall complete the registration review of
each pesticide or pesticide case, which may be composed
of 1 or more active ingredients and the products
associated with the active ingredients, not later than
the later of--
``(I) October 1, 2022; or
``(II) the date that is 15 years after the
date on which the first pesticide containing a
new active ingredient is registered.
``(iv) Subsequent registration review.--Not later
than 15 years after the date on which the initial
registration review is completed under clause (iii) and
each 15 years thereafter, the Administrator shall
complete a subsequent registration review for each
pesticide or pesticide case.
``(v) Cancellation.--No registration'';
(2) by redesignating subparagraph (B) as subparagraph (C);
and
(3) by inserting after subparagraph (A) the following:
``(B) Docketing.--
``(i) In general.--Subject to clause (ii), after
meeting with 1 or more individuals that are not
government employees to discuss matters relating to a
registration review, the Administrator shall place in
the docket minutes of the meeting, a list of attendees,
and any documents exchanged at the meeting, not later
than the earlier of--
``(I) the date that is 45 days after the
meeting; or
``(II) the date of issuance of the
registration review decision.
``(ii) Protected information.--The Administrator
shall identify, but not include in the docket, any
confidential business information the disclosure of
which is prohibited by section 10.''.
SEC. 4. MAINTENANCE FEES.
(a) Total Amount of Fees.--Section 4(i)(5)(C) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)(5)(C))
is amended by striking ``amount of'' and all that follows through the
end of clause (v) and inserting ``amount of $22,000,000 for each of
fiscal years 2008 through 2012''.
(b) Amounts for Registrants.--Section 4(i)(5) of the Federal
Insecticide Fungicide, and Rodenticide Act (7 U.S.C. 136a-1(i)(5)) is
amended--
(1) in subparagraph (D)--
(A) in clause (i), by striking by striking ``shall
be'' and all that follows through the end of subclause
(IV) and inserting ``shall be $71,000 for each of
fiscal years 2008 through 2012; and''; and
(B) in clause (ii), by striking ``shall be'' and
all that follows through the end of subclause (IV) and
inserting ``shall be $123,000 for each of fiscal years
2008 through 2012.''; and
(2) in subparagraph (E)(i)--
(A) in subclause (I), by striking ``shall be'' and
all that follows through the end of item (dd) and
inserting ``shall be $50,000 for each of fiscal years
2008 through 2012; and''; and
(B) in subclause (II), by striking ``shall be'' and
all that follows through the end of item (dd) and
inserting ``shall be $86,000 for each of fiscal years
2008 through 2012.''.
(c) Extension of Authority for Collecting Maintenance Fees.--
Section 4(i)(5)(H) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a-1(i)(5)(H)) is amended by striking
``2008'' and inserting ``2012.''
(d) Other Fees.--
(1) In general.--Section 4(i)(6) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-
1(i)(6)) is amended by striking ``2010'' and inserting
``2014''.
(2) Prohibition on tolerance fees.--Section 408(m) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)) is
amended by adding at the end the following:
``(3) Prohibition.--During the period beginning on the
effective date of the Pesticide Registration Improvement
Renewal Act and ending on September 30, 2012, the Administrator
shall not collect any tolerance fees under paragraph (1).''.
(e) Reregistration and Expedited Processing Fund.--
(1) Source and use.--Section 4(k)(2)(A) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a-
1(k)(2)(A)) is amended--
(A) in the first sentence, by inserting ``and to
offset the costs of registration review under section
3(g)'' after ``paragraph (3)'';
(B) in clause (i), by inserting ``and to offset the
costs of registration review under section 3(g)'' after
``paragraph (3)''; and
(C) in clause (ii), by inserting ``and to offset
the costs of registration review under section 3(g)''
after ``paragraph (3)''.
(2) Expedited processing of similar applications.--Section
4(k)(3)(A) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a-1(k)(3)(A)) is amended by
striking ``2007 and 2008'' and inserting ``2008 through 2012''.
SEC. 5. PESTICIDE REGISTRATION SERVICE FEES.
(a) Documentation.--Section 33(b)(2) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)(2)) is amended--
(1) in subparagraph (C), by striking clause (ii) and
inserting the following:
``(ii) payment of at least 25 percent of
the registration service fee and a request for
a waiver from or reduction of the remaining
amount of the registration service fee.''; and
(2) by adding at the end the following:
``(D) Payment.--The registration service fee
required under this subsection shall be due upon
submission of the application.
``(E) Applications subject to additional fees.--An
application may be subject to additional fees if--
``(i) the applicant identified the
incorrect registration service fee and decision
review period;
``(ii) after review of a waiver request,
the Administrator denies the waiver request; or
``(iii) after review of the application,
the Administrator determines that a different
registration service fee and decision review
period apply to the application.
``(F) Effect of failure to pay fees.--The
Administrator shall reject any application submitted
without the required registration service fee.
``(G) Non-refundable portion of fees.--
``(i) In general.--The Administrator shall
retain 25 percent of the applicable
registration service fee.
``(ii) Limitation.--Any waiver, refund,
credit or other reduction in the registration
service fee shall not exceed 75 percent of the
registration service fee.
``(H) Collection of unpaid fees.--In any case in
which the Administrator does not receive payment of a
registration service fee (or applicable portion of the
registration service fee) by the date that is 30 days
after the fee is due, the fee shall be treated as a
claim of the United States Government subject to
subchapter II of chapter 37 of title 31, United States
Code.''.
(b) Amount of Fees.--Section 33(b) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)) is amended--
(1) in paragraph (3)--
(A) in subparagraph (A), by striking ``Pesticide
Registration Improvement Act of 2003'' and inserting
``Pesticide Registration Improvement Renewal Act''; and
(B) in subparagraph (B), by striking ``S11631'' and
all that follows through the end of the subparagraph
and inserting ``S10409 through S10411, dated July 31,
2007.''; and
(2) by striking paragraph (6) and inserting the following:
``(6) Fee adjustment.--
``(A) In general.--Effective for a covered
pesticide registration application received during the
period beginning on October 1, 2008, and ending on
September 30, 2010, the Administrator shall increase by
5 percent the registration service fee payable for the
application under paragraph (3).
``(B) Additional adjustment.--Effective for a
covered pesticide registration application received on
or after October 1, 2010, the Administrator shall
increase by an additional 5 percent the registration
service fee in effect as of September 30, 2010.
``(C) Publication.--The Administrator shall publish
in the Federal Register the revised registration
service fee schedules.''.
(c) Waivers and Reductions.--Section 33(b)(7)(F) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)(7)(F))
is amended--
(1) in clause (ii), by striking ``all'' and inserting ``75
percent''; and
(2) in clause (iv)(II), by striking ``all'' and inserting
``75 percent of the applicable.''.
(d) Refunds.--Section 33(b)(8)(A) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(b)(8)(A)) is amended by
striking ``10 percent'' and inserting ``25 percent.''.
(e) Pesticide Registration Fund.--Section 33(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(c)) is
amended--
(1) in paragraph (1)(B), by striking ``paragraph (4)'' and
inserting ``paragraph (5)'';
(2) in paragraph (3)--
(A) by striking subparagraph (B) and inserting the
following:
``(B) Worker protection.--
``(i) In general.--For each of fiscal years
2008 through 2012, the Administrator shall use
approximately \1/17\ of the amount in the Fund
(but not less than $1,000,000) to enhance
scientific and regulatory activities relating
to worker protection.
``(ii) Partnership grants.--Of the amounts
in the Fund, the Administrator shall use for
partnership grants--
``(I) for each of fiscal years 2008
and 2009, $750,000; and
``(II) for each of fiscal years
2010 through 2012, $500,000.
``(iii) Pesticide safety education
program.--Of the amounts in the Fund, the
Administrator shall use $500,000 for each of
fiscal years 2008 through 2012 to carry out the
pesticide safety education program.''; and
(B) by striking subparagraph (C); and
(3) in paragraph (5)--
(A) by redesignating subparagraphs (A) through (C)
as clauses (i) through (iii), respectively;
(B) by striking ``Amounts'' and inserting the
following:
``(A) In general.--Amounts''; and
(C) by adding at the end the following:
``(B) Use of investment income.--After consultation
with the Secretary of the Treasury, the Administrator
may use income from investments described in clauses
(ii) and (iii) of subparagraph (A) to carry out this
section.''.
(f) Assessment of Fees.--Section 33(d)(2) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(d)(2)) is
amended by striking ``For fiscal years 2004, 2005 and 2006 only,
registration'' and inserting ``Registration''.
(g) Decision Review Times.--Section 33(f) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(f)) is
amended--
(1) in paragraph (1), by striking ``Pesticide Registration
Improvement Act of 2003'' and inserting ``Pesticide
Registration Improvement Renewal Act'';
(2) in paragraph (2), by striking ``S11631'' and all that
follows through the end of the paragraph and inserting ``S10409
through S10411, dated July 31, 2007.''; and
(3) in paragraph (4), by striking subparagraph (B) and
inserting the following:
``(B) Completeness of application.--
``(i) In general.--Not later than 21 days
after receiving an application and the required
registration service fee, the Administrator
shall conduct an initial screening of the
contents of the application in accordance with
clause (iii).
``(ii) Rejection.--If the Administrator
determines under clause (i) that the
application does not pass the initial screening
and cannot be corrected within the 21-day
period, the Administrator shall reject the
application not later than 10 days after making
the determination.
``(iii) Requirements of screening.--In
conducting an initial screening of an
application, the Administrator shall determine
whether--
``(I)(aa) the applicable
registration service fee has been paid;
or
``(bb) at least 25 percent of the
applicable registration service fee has
been paid and the application contains
a waiver or refund request for the
outstanding amount and documentation
establishing the basis for the waiver
request; and
``(II) the application contains all
the necessary forms, data, and draft
labeling, formatted in accordance with
guidance published by the
Administrator.''.
(h) Reports.--Section 33(k) of the Federal Insecticide, Fungicide,
and Rodenticide Act (7 U.S.C. 136w-8(k)) is amended--
(1) in paragraph (1), by striking ``March 1, 2009'' and
inserting ``March 1, 2014''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) by redesignating clauses (ii) through
and (iv) as clauses (v) through (vii),
respectively;
(ii) by inserting after clause (i) the
following
``(ii) the number of label amendments that
have been reviewed using electronic means;
``(iii) the amount of money from the
Reregistration and Expedited Processing Fund
used to carry out inert ingredient review and
review of similar applications under section
4(k)(3);
``(iv) the number of applications completed
for identical or substantially similar
applications under section 3(c)(3)(B),
including the number of such applications
completed within 90 days pursuant to that
section;''; and
(iii) in clause (vi) (as redesignated by
clause (i))--
(I) in subclause (II), by striking
``and'' at the end;
(II) in subclause (III), by
striking ``and'' at the end; and
(III) by adding at the end the
following:
``(IV) providing for electronic
submission and review of labels,
including process improvements to
further enhance the procedures used in
electronic label review; and
``(V) the allowance and use of
summaries of acute toxicity studies;
and'';
(B) in subparagraph (B), by striking ``and'' at the
end;
(C) in subparagraph (C), by striking the period at
the end and inserting a semicolon; and
(D) by adding at the end the following:
``(D) a review of the progress in carrying out
section 3(g), including--
``(i) the number of pesticides or pesticide
cases reviewed;
``(ii) a description of the staffing and
resources relating to the costs associated with
the review and decision making relating to
reregistration and registration review for
compliance with the deadlines specified in this
Act;
``(iii) to the extent determined
appropriate by the Administrator and consistent
with the authorities of the Administrator and
limitations on delegation of functions by the
Administrator, recommendations for--
``(I) process improvements in the
handling of registration review under
section 3(g);
``(II) providing for accreditation
of outside reviewers and the use of
outside reviewers in the registration
review process; and
``(III) streamlining the
registration review process, consistent
with section 3(g);
``(E) a review of the progress in meeting the
timeline requirements for the review of antimicrobial
pesticide products under section 3(h); and
``(F) a review of the progress in carrying out the
review of inert ingredients, including the number of
applications pending, the number of new applications,
the number of applications reviewed, staffing, and
resources devoted to the review of inert ingredients
and recommendations to improve the timeliness of review
of inert ingredients.''.
(i) Termination of Effectiveness.--Section 33(m) of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w-8(m)) is
amended--
(1) in paragraph (1), by striking ``2008'' and inserting
``2012''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in the subparagraph heading, by
striking ``2009'' and inserting ``2013''; and
(ii) by striking ``2009'' and inserting
``2013''; and
(B) in subparagraphs (B) and (C)--
(i) in the subparagraph headings, by
striking ``2010'' each place it appears and
inserting ``2014''; and
(ii) by striking ``2010'' each place it
appears and inserting ``2014''; and
(C) in subparagraph (D), by striking ``2008'' each
place it appears and inserting ``2012''.
SEC. 6. EFFECTIVE DATE.
This Act and the amendments made by this Act take effect on October
1, 2007.
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